USP 797 Compliance The Basics of Pharmaceutical Compounding Regulations

Richard Bays JD MBA RN CPHQ

copy R Bays 2013

USP 797 Compliance

What is the USP-NF

The United States Pharmacopeia and The National Formulary

(USP-NF) is a compilation of drug monographs biologics

medical devices dietary supplements reference tests and

standards and standards for compounding of sterile and non-

sterile drug preparations

USP 797 Compliance

Utilizing the USP

USPndashNF is recognized by law and custom in most countries

The United States the federal Food Drug and Cosmetic Act

(FDC Act) defines the term ldquoofficial compendiumrdquo as the

official USP the official NF or any supplement to them

The FDA may enforce compliance with official standards in

USPndashNF under the adulteration and misbranding provisions of

the FDampC Act

A State Board of Pharmacy may be charged with enforcement

of this law

USP 797 Compliance

Utilizing the USP

USP lt797gt HAS SPECIFIC GUIDELINES FOR

Design of the Facility

Environmental and Engineering Controls

Environmental Testing

Personnel Training and Competency Testing

Standard Operating Procedures and Documentation

Quality Assurance

Patient Monitoring and Adverse Events Reporting

Storage and Dating

USP 797 Compliance

lt797gt Purpose

ldquoTHE INTENT OF lt797gt IS TO PREVENT HARM AND

FATALITY TO PATIENTS THAT COULD RESULT FROM

MICROBIAL CONTAMINATION (NONSTERILITY)

EXCESSIVE BACTERIAL ENDOTOXINS LARGE CONTENT

ERRORS IN THE STRENGTH OF CORRECT

INGREDIENTS AND INCORRECT INGREDIENTS IN

COMPOUNDED STERILE PRODUCTS (CSPs)rdquo

The US Pharmacopeial Convention (USP)

wwwUSPOrg

USP 797 Compliance

What is the USP-NF

The United States Pharmacopeia and The National Formulary

(USP-NF) is a compilation of drug monographs biologics

medical devices dietary supplements reference tests and

standards and standards for compounding of sterile and non-

sterile drug preparations

USP 797 Compliance

Utilizing the USP

USPndashNF is recognized by law and custom in most countries

The United States the federal Food Drug and Cosmetic Act

(FDC Act) defines the term ldquoofficial compendiumrdquo as the

official USP the official NF or any supplement to them

The FDA may enforce compliance with official standards in

USPndashNF under the adulteration and misbranding provisions of

the FDampC Act

A State Board of Pharmacy may be charged with enforcement

of this law

USP 797 Compliance

Utilizing the USP

USP lt797gt HAS SPECIFIC GUIDELINES FOR

Design of the Facility

Environmental and Engineering Controls

Environmental Testing

Personnel Training and Competency Testing

Standard Operating Procedures and Documentation

Quality Assurance

Patient Monitoring and Adverse Events Reporting

Storage and Dating

USP 797 Compliance

lt797gt Purpose

ldquoTHE INTENT OF lt797gt IS TO PREVENT HARM AND

FATALITY TO PATIENTS THAT COULD RESULT FROM

MICROBIAL CONTAMINATION (NONSTERILITY)

EXCESSIVE BACTERIAL ENDOTOXINS LARGE CONTENT

ERRORS IN THE STRENGTH OF CORRECT

INGREDIENTS AND INCORRECT INGREDIENTS IN

COMPOUNDED STERILE PRODUCTS (CSPs)rdquo

The US Pharmacopeial Convention (USP)

wwwUSPOrg

USP 797 Compliance

Utilizing the USP

USPndashNF is recognized by law and custom in most countries

The United States the federal Food Drug and Cosmetic Act

(FDC Act) defines the term ldquoofficial compendiumrdquo as the

official USP the official NF or any supplement to them

The FDA may enforce compliance with official standards in

USPndashNF under the adulteration and misbranding provisions of

the FDampC Act

A State Board of Pharmacy may be charged with enforcement

of this law

USP 797 Compliance

Utilizing the USP

USP lt797gt HAS SPECIFIC GUIDELINES FOR

Design of the Facility

Environmental and Engineering Controls

Environmental Testing

Personnel Training and Competency Testing

Standard Operating Procedures and Documentation

Quality Assurance

Patient Monitoring and Adverse Events Reporting

Storage and Dating

USP 797 Compliance

lt797gt Purpose

ldquoTHE INTENT OF lt797gt IS TO PREVENT HARM AND

FATALITY TO PATIENTS THAT COULD RESULT FROM

MICROBIAL CONTAMINATION (NONSTERILITY)

EXCESSIVE BACTERIAL ENDOTOXINS LARGE CONTENT

ERRORS IN THE STRENGTH OF CORRECT

INGREDIENTS AND INCORRECT INGREDIENTS IN

COMPOUNDED STERILE PRODUCTS (CSPs)rdquo

The US Pharmacopeial Convention (USP)

wwwUSPOrg

USP 797 Compliance

Utilizing the USP

USP lt797gt HAS SPECIFIC GUIDELINES FOR

Design of the Facility

Environmental and Engineering Controls

Environmental Testing

Personnel Training and Competency Testing

Standard Operating Procedures and Documentation

Quality Assurance

Patient Monitoring and Adverse Events Reporting

Storage and Dating

USP 797 Compliance

lt797gt Purpose

ldquoTHE INTENT OF lt797gt IS TO PREVENT HARM AND

FATALITY TO PATIENTS THAT COULD RESULT FROM

MICROBIAL CONTAMINATION (NONSTERILITY)

EXCESSIVE BACTERIAL ENDOTOXINS LARGE CONTENT

ERRORS IN THE STRENGTH OF CORRECT

INGREDIENTS AND INCORRECT INGREDIENTS IN

COMPOUNDED STERILE PRODUCTS (CSPs)rdquo

The US Pharmacopeial Convention (USP)

wwwUSPOrg

USP 797 Compliance

lt797gt Purpose

ldquoTHE INTENT OF lt797gt IS TO PREVENT HARM AND

FATALITY TO PATIENTS THAT COULD RESULT FROM

MICROBIAL CONTAMINATION (NONSTERILITY)

EXCESSIVE BACTERIAL ENDOTOXINS LARGE CONTENT

ERRORS IN THE STRENGTH OF CORRECT

INGREDIENTS AND INCORRECT INGREDIENTS IN

COMPOUNDED STERILE PRODUCTS (CSPs)rdquo

The US Pharmacopeial Convention (USP)

wwwUSPOrg

USP 797 Compliance

lt797gt Purpose

The purpose of USP 797 is to protect the

health of patients by reducing the potential for

microbial contamination caused by an unclean

environment excessive bacterial endotoxins

large errors in the strength of ingredients and

the use of incorrect ingredients

USP 797 Compliance

lt797gt Purpose

The chapter was developed for use in healthcare

institutions pharmacies and physician practice

facilities It also applies to other facilities in which

compounded sterile preparations (CSPs) are

prepared stored and dispensed such as pharmacy

intravenous rooms chemotherapy clinics hospital

nursing stations and in operating rooms by

anesthesiologists

USP 797 Compliance

lt797gt Purpose

The US Pharmacopeia (USP) 797 provides the practice

standards to help ensure that compounded sterile

preparations are of high quality and is for the pre-

administration phase of sterile preparations It describes the

CSP requirements (guidelines USP 797 procedures and

compliance) for CSPs and sets the standards that apply to all

settings in which sterile preparations are compounded

Adherence to 797 will reduce the potential for contamination

caused by unclean environment pharmacist error lack of

quality control incorrect beyond-use dating and other factors

USP 797 Compliance

lt797gt Purpose

The standard applies to anyone who prepares CSPs and all places where

they are prepared CSPs include drugs nutrients biologics diagnostics

and radiopharmaceuticals

The guideline requires environmental controls to include a separate area

for compounding that meets a definite level of cleanliness and monitoring

to guarantee that control is maintained

For all preparers and places where CSPs are prepared the Joint

Commission requires a gap analysis and action plan for USP 797

compliance and is enforcing USP Chapter 797 within their standards The

Joint Commission may impose stricter compliance to 797 than the statesrsquo

Board of Pharmacy

USP 797 Compliance

lt797gt Impacts

Facility Operations

1048708 Hospital Pharmacy

1048708 Home Infusion

1048708 Retail Pharmacy

1048708 Clinic

1048708 Specialty

1048708 Nuclear pharmacy

1048708 Compounding

Health Practitioner Facilities

1048708 Ophthalmologist

1048708 Oncologist

1048708 Dermatologist

USP 797 Compliance

Complying with lt797gt

Complying with USP 797 requires the design and use of

cleanroom facilities as well as the development of policies

and procedures for cleaning sterility testing and personnel

and environmental monitoring

Aseptic manipulations using only sterile ingredients and

components entirely within ISO Class 5 or better conditions

are considered low risk

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

lt797gt Purpose

The chapter was developed for use in healthcare

institutions pharmacies and physician practice

facilities It also applies to other facilities in which

compounded sterile preparations (CSPs) are

prepared stored and dispensed such as pharmacy

intravenous rooms chemotherapy clinics hospital

nursing stations and in operating rooms by

anesthesiologists

USP 797 Compliance

lt797gt Purpose

The US Pharmacopeia (USP) 797 provides the practice

standards to help ensure that compounded sterile

preparations are of high quality and is for the pre-

administration phase of sterile preparations It describes the

CSP requirements (guidelines USP 797 procedures and

compliance) for CSPs and sets the standards that apply to all

settings in which sterile preparations are compounded

Adherence to 797 will reduce the potential for contamination

caused by unclean environment pharmacist error lack of

quality control incorrect beyond-use dating and other factors

USP 797 Compliance

lt797gt Purpose

The standard applies to anyone who prepares CSPs and all places where

they are prepared CSPs include drugs nutrients biologics diagnostics

and radiopharmaceuticals

The guideline requires environmental controls to include a separate area

for compounding that meets a definite level of cleanliness and monitoring

to guarantee that control is maintained

For all preparers and places where CSPs are prepared the Joint

Commission requires a gap analysis and action plan for USP 797

compliance and is enforcing USP Chapter 797 within their standards The

Joint Commission may impose stricter compliance to 797 than the statesrsquo

Board of Pharmacy

USP 797 Compliance

lt797gt Impacts

Facility Operations

1048708 Hospital Pharmacy

1048708 Home Infusion

1048708 Retail Pharmacy

1048708 Clinic

1048708 Specialty

1048708 Nuclear pharmacy

1048708 Compounding

Health Practitioner Facilities

1048708 Ophthalmologist

1048708 Oncologist

1048708 Dermatologist

USP 797 Compliance

Complying with lt797gt

Complying with USP 797 requires the design and use of

cleanroom facilities as well as the development of policies

and procedures for cleaning sterility testing and personnel

and environmental monitoring

Aseptic manipulations using only sterile ingredients and

components entirely within ISO Class 5 or better conditions

are considered low risk

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

lt797gt Purpose

The US Pharmacopeia (USP) 797 provides the practice

standards to help ensure that compounded sterile

preparations are of high quality and is for the pre-

administration phase of sterile preparations It describes the

CSP requirements (guidelines USP 797 procedures and

compliance) for CSPs and sets the standards that apply to all

settings in which sterile preparations are compounded

Adherence to 797 will reduce the potential for contamination

caused by unclean environment pharmacist error lack of

quality control incorrect beyond-use dating and other factors

USP 797 Compliance

lt797gt Purpose

The standard applies to anyone who prepares CSPs and all places where

they are prepared CSPs include drugs nutrients biologics diagnostics

and radiopharmaceuticals

The guideline requires environmental controls to include a separate area

for compounding that meets a definite level of cleanliness and monitoring

to guarantee that control is maintained

For all preparers and places where CSPs are prepared the Joint

Commission requires a gap analysis and action plan for USP 797

compliance and is enforcing USP Chapter 797 within their standards The

Joint Commission may impose stricter compliance to 797 than the statesrsquo

Board of Pharmacy

USP 797 Compliance

lt797gt Impacts

Facility Operations

1048708 Hospital Pharmacy

1048708 Home Infusion

1048708 Retail Pharmacy

1048708 Clinic

1048708 Specialty

1048708 Nuclear pharmacy

1048708 Compounding

Health Practitioner Facilities

1048708 Ophthalmologist

1048708 Oncologist

1048708 Dermatologist

USP 797 Compliance

Complying with lt797gt

Complying with USP 797 requires the design and use of

cleanroom facilities as well as the development of policies

and procedures for cleaning sterility testing and personnel

and environmental monitoring

Aseptic manipulations using only sterile ingredients and

components entirely within ISO Class 5 or better conditions

are considered low risk

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

lt797gt Purpose

The standard applies to anyone who prepares CSPs and all places where

they are prepared CSPs include drugs nutrients biologics diagnostics

and radiopharmaceuticals

The guideline requires environmental controls to include a separate area

for compounding that meets a definite level of cleanliness and monitoring

to guarantee that control is maintained

For all preparers and places where CSPs are prepared the Joint

Commission requires a gap analysis and action plan for USP 797

compliance and is enforcing USP Chapter 797 within their standards The

Joint Commission may impose stricter compliance to 797 than the statesrsquo

Board of Pharmacy

USP 797 Compliance

lt797gt Impacts

Facility Operations

1048708 Hospital Pharmacy

1048708 Home Infusion

1048708 Retail Pharmacy

1048708 Clinic

1048708 Specialty

1048708 Nuclear pharmacy

1048708 Compounding

Health Practitioner Facilities

1048708 Ophthalmologist

1048708 Oncologist

1048708 Dermatologist

USP 797 Compliance

Complying with lt797gt

Complying with USP 797 requires the design and use of

cleanroom facilities as well as the development of policies

and procedures for cleaning sterility testing and personnel

and environmental monitoring

Aseptic manipulations using only sterile ingredients and

components entirely within ISO Class 5 or better conditions

are considered low risk

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

lt797gt Impacts

Facility Operations

1048708 Hospital Pharmacy

1048708 Home Infusion

1048708 Retail Pharmacy

1048708 Clinic

1048708 Specialty

1048708 Nuclear pharmacy

1048708 Compounding

Health Practitioner Facilities

1048708 Ophthalmologist

1048708 Oncologist

1048708 Dermatologist

USP 797 Compliance

Complying with lt797gt

Complying with USP 797 requires the design and use of

cleanroom facilities as well as the development of policies

and procedures for cleaning sterility testing and personnel

and environmental monitoring

Aseptic manipulations using only sterile ingredients and

components entirely within ISO Class 5 or better conditions

are considered low risk

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Complying with lt797gt

Complying with USP 797 requires the design and use of

cleanroom facilities as well as the development of policies

and procedures for cleaning sterility testing and personnel

and environmental monitoring

Aseptic manipulations using only sterile ingredients and

components entirely within ISO Class 5 or better conditions

are considered low risk

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

lt797gt Applies to

The standards in this chapter are intended to apply to all

persons who prepare CSPs and all places where CSPs are

prepared (eg hospitals and other healthcare institutions

patient treatment clinics pharmacies

physicians practice facilities and other locations and facilities

in which CSPs are prepared stored and transported)

Persons who perform sterile compounding include

pharmacists nurses pharmacy technicians and physicians

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Risk Levels

An increase in complexity or duration of the compounding

process increases the risk level

Compounding or pooling multiple doses of sterile products

for administration to multiple patients or single patient on

multiple occasions is considered medium risk

For example - The transfer of multiple ampules or vials into a single

final sterile container or product If a sterility test is not performed

the usable shelf life is 3 days at room temperature 7 days at

refrigerated temperature and 45 days frozen at -20degC or colder

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Risk Levels

High-risk conditions include the use of non-sterile ingredients or

components or the exposure of sterile ingredients or components to

conditions less than ISO Class 5

For example - Measuring and mixing sterile ingredients in non-sterile devices before

terminal sterilization If a sterility test is not performed on high-risk preparations the

usable shelf life is 24 hours at controlled room temperature 3 days at refrigerated

temperature and 45 days frozen at -20degC or colder

Complying with USP 797 requires the design and use of cleanroom

facilities as well as the development of policies and procedures for

cleaning sterility testing and personnel and environmental monitoring

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Daily Compliance

Maintaining the work space

Are things organized and free of ldquoclutterrdquo

Does everything work

Is there enough work space

Are there hand washing supplies

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Daily Compliance

Refrigerators

Are there opened undated and non-initialed

Single Dose Vials (SDV) and Multiple Dose Vials

(MDV)

Is there food or other prohibited items

Check the Temperature log

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Daily Compliance

Check for Waste and Sharp disposal

Check Gauges

Check Temp recording ldquowheelsrdquo

Check Hood certification stickers

Are policies and procedures in place and guidelines

up to date and documented

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

CabinetsHoods - Working Aseptically

Unidirectional Airflow

First Air Zone

Nothing to be placed between the HEPA filter and the critical

compounding zone

Zone of Confusion

Turbulent area downstream of an obstruction possible source of

cross contamination

The advantages of unidirectional airflow should be exploited when

considering placement of materials within the DCCA

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

CabinetsHoods - Working Aseptically

Improper hand placement disrupts first air

Good aseptic technique in sterile compounding requires the

understanding and proper use of ldquoFirst-Airrdquo

ldquoFirst-Airrdquo is the air exiting the HEPA filter in a unidirectional airstream

and is virtually free of particulate contaminants

All critical manipulations must be carried out in the unobstructed

ldquofirst airrdquo zone in the direct path of the HEPA filter discharge

Proper product and process - placement with respect to the supply and

discharge will provide a contamination free compounding area

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Meeting Sterility Requirements

The ante-area or room is where personnel hand hygiene and

garbing procedures staging order entry CSP labeling and other high

particulate generating activities are preformed

This room leads into the sterile IV and compounding room This

transition room needs to be an ISO 8 or better approved room that is

pressurized to move particulate filled air through HEPA filters

The sterile IV products should be mixed in a positive pressure room

and in a ISO 5 or better approved hood

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Meeting Sterility Requirements

CHEMOTHERAPY

A negative pressure hood that is vented to the outside is

needed that is ISO 5 or better IN a negative pressure room

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

CSPrsquos stratification MICROBIAL CONTAMINATAION RISK LEVELS

LOW-RISK LEVEL

Compounded entirely under ISO Class 5 (Class 100) conditions

Compounding involves only transfer measuring and mixing manipulations with

closed or sealed packaging systems

Manipulations are limited to aseptically opening ampule penetrating sterile stoppers

on vials with sterile needles and syringes and transferring sterile liquids in sterile

syringes to sterile administration devices and packages of other sterile products

In the absence of passing a sterility test periods cannot exceed the following time

periods Before administration the CSPrsquos are properly stored and are exposed for

not more than 48 hours at a controlled room temperature for not more than 14 days

at a cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

CSPrsquos stratification MEDIUM-RISK LEVEL

All conditions apply as listed under low-risk level

Compounding involves only transfer measuring and mixing manipulations with closed or

sealed packaging systems that are performed promptly and attentively

Manipulations are limited to aseptically opening ampules penetrating sterile stoppers on vials

with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile

administration devices and packages of other sterile products

Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP

that will be administered either to multiple patients or to one patient on multiple conditions

Compounding process includes complex aseptic manipulations other than the single-volume

transfer

Compounding process requires unusually long duration

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are administered

over several days In the absence of passing a sterility test periods cannot exceed the

following time periods Before administration the CSPrsquos are properly stored and are exposed

for not more than 30 hours at a controlled room temperature for not more than 7 days at a

cold temperature and for 45 days in solid frozen state at ndash 20 degrees or colder

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

CSPrsquos stratification HIGH-RISK LEVEL

Non-sterile ingredients are incorporated or a non-sterile device is employed before

terminal sterilization

Sterile ingredients components devices and mixtures are exposed to air quality inferior

to ISO Class 5 (Class 100)

Non-sterile preparations are exposed for not more than 6 hours before being sterilized

Non-sterile preparations are terminally sterilized but are not tested for bacterial

endotoxins

It is assumed that the chemical purity and content strength of ingredients meet their

original or compendia specifications in unopened or in opened packages of bulk

ingredients

The sterile CSPs do not contain broad-spectrum bacteriostatic agents and are

administered over several days In the absence of passing a sterility test periods cannot

exceed the following time periods Before administration the CSPrsquos are properly stored

and are exposed for not more than 24 hours at a controlled room temperature for not

more than 3 days

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Ongoing Compliance

USP lt797gt requires policies and procedures for all aspects of

sterile compounding from personnel to product that

1048708 Communicates information

1048708 Perform audit and peer review activities

1048708 Follow Standard Operating procedures

1048708 Provide data for benchmarking

1048708 Documents regulatory compliance

1048708 Provides data valuable in cost evaluations

1048708 Applicable in a court of law

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Ongoing Compliance

Documents should be kept up-to-date

1 Correct form

2 Correct information on form

3 Form is complete

4 Information is legible and readily accessible

5 Demonstrates conformity No gap between actual performance

and established policy

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Ongoing Compliance

Personnel Training

Facility Staff

1 Daily calibration

2 Proper use of equipment

3 Documentation

1048708 Competency Evaluation of Garbing

1048708 Competency Evaluation of Cleaning amp Disinfecting Procedures

1048708 Competency Evaluation of Aseptic Work Practices

1048708 Environmental Monitoring

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

Ongoing Compliance

Personnel Training

Janitorial Staff

1 Proper cleaning procedures

2 Isolation of cleaning equipment

3 Documentation

USP 797 Compliance

QUESTIONS

USP 797 Compliance

QUESTIONS

Contact Information

Richard Bays JD MBA RN CPHQ RBaysConsultingGmailcom

+1 8323162701