IV ROOM PROJECTUSP <797>

By: Linh Huynh, MCPHS PharmD 2016 Candidate

PRIMARY ENGINEERING CONTROLS (PECS) PEC is a device or a room that provides an ISO class 5

environment for compounding CSPs (compounded sterile preparations).

PEC relies on high-efficiency particle air (HEPA) filter (which is ≥ 99.99% efficient in removing particles as small as 0.3 microns in size). Types NESH

1. Laminar Airflow Workbench

2. Biological Safety Cabinets3. Compounding Aseptic

Isolators4. Compounding Aseptic

Containment Isolators

1. Compounding Aseptic Isolators

- Microsphere IsoTech (vertical airflow)

THE ARCHITECTUREUSP <797> NESH

1. Buffer area (“cleanroom”) – area where a PEC is located and where activities such as preparation, compounding, and staging CSPs occur (must meet or exceed ISO 7).

2. Ante area – space for handwashing, garbing and product decontamination (must meet or exceed ISO 8).

The installation of Microsphere creates a special compounding environment.Our IV room is a combination of buffer area and ante area (not separation of 2 areas into 2 different rooms).It is not recommended but is acceptable in accordance with USP <797> , yet still might not be in compliance with the upcoming <800>.

IV ROOM DEVICESTypes NESH

1. Pharmacy Compounding Devices

2. Automated Compounding Devices

3. Repeater Pump4. Robotic Systems

Pharmacy Compounding Device – MicrosphereISO 5.

CLEANING AND DISINFECTING - FREQUENCY

USP <797> (minimum frequency)

NESH

1. ISO 5 PEC • beginning of each shift• before each batch• every 30 minutes when

compounding• after spills• when surface

contamination is known or suspended

2. Counters and easily cleanable work surface – DAILY

3. Floors – DAILY4. Walls – MONTHLY5. Ceilings – MONTHLY6. Storage shelving -

MONTHLY

1. ISO 5 PEC (Microsphere) – in compliance.

2. Counters and easily cleanable work surface – in compliance.

3. Floors – in compliance.4. Walls – N/A5. Ceilings – N/A6. Storage shelving - in

compliance.

CLEANING AND DISINFECTING - STEPSUSP <797> NESH

1. Cleaning with a germicidal detergent and water will remove visible solids or soiling before disinfecting.

2. Cleaning with a germicidal detergent will leave a residue that need to be removed from work surfaces by sterile 70% alcohol.

3. Disinfecting removes microbial contamination.

4. Cleaning should be done from the cleanest area to dirtiest area.

5. Great care must be exercised to avoid getting the HEPA filters wet during cleaning.

Follow the steps and compliance.1. Germicidal = CaviCide and

Sporicide (used alternatively weekly – by the end of the week)

2. 70% alcohol (spray and wipes) – use for daily cleaning.

3. Cleaning of Microsphere ISO 5 – follow manufacturer’s recommendation (left to right and top to bottom and use of wipers)

ENVIRONMENTAL MONITORING

USP <797> NESH1. Temperature2. Surface sampling3. Pressure and velocity 4. Particles5. Viable Monitoring

1. Temperature: Recorded daily – in compliance.

2. Others: N/A

EXPIRATION AND BUDS

NESH

AMPULS, SINGLE-DOSE AND MULTIPLE-DOSE CONTAINERS

USP <797> Classification NESH1. Single dose-containers –

intended for one use (include bags, bottles, syringes, ampules and vials) and may not be saved or used at anytime during the compounding process and 5microns filter straws or needles must be used when withdrawing contents from ampules.

2. Pharmacy bulk packages3. Multiple-dose vials – may be

reused or saved up to manufacturer’s recommend BUD or max of 28 days for reuse or saved and must be noted if intended to reuse.

1. Single dose-containers: In compliance.

2. Pharmacy bulk packages: N/A

3. Multiple-dose vials: Never reuse or save.

PERSONNEL RESPONSIBILITIESUSP <797> Requirements NESH

1. Hygiene and Garbing• Before entering compounding area, all personnel must

remove personal outer garments, all cosmetics and jewelry. No nail polish and natural nails should be kept trimmed and neat.

• Garbing procedures: o Shoe covers hair covers face mask.o Hand wash: remove debris from under fingernails

using running warm water and a nail cleaner wash hands then forearms to the elbows with soap and water for at least 30s dry hands and forearms using an electronic hand dryer or lint-free disposable towels.

o Non-shedding gowns waterless alcohol scrub powder-free gloves and disinfect the gloves with 70% alcohol.

2. Compounding Procedures• Periodically disinfecting gloves with 70% alcohol• The gowns can be reused during the workshift only and

must be hung inside-out. Shoes, hair cover and mask cannot be reused.

• All hand hygiene and garbing must be followed upon returning to compounding area.

3. Cytotoxic and other hazardous agents (OSHA requirements)

4. Specialty Preparations5. Compounding Competency• Low and medium risk operations: training and

competency assessments are required initially upon hiring or transferring to compounding responsibilities.

• And periodically every 12 months for all staffs involved.• Includes: Media-fill testing and glove fingertip testing.

1. Hygiene and Garbing – in compliance.

2. Compounding Procedures – in compliance.

3. Cytotoxic and other hazardous agents – N/A.

4. Specialty Preparations – N/A.5. Compounding competency – in

compliance .

PACKAGING AND LABELING

USP <797> Requirements NESHAll risk level CSP should contain at

least the following information:1. All solution, drug and ingredient

names, amounts, strengths and concentrations, and the total volume of CSP.

2. BUD and time.3. Appropriate auxiliary labeling.4. Any storage requirements, if CSP

will not be immediately administered.

5. Device-specific instruction (if applicable).

6. Identification of individual responsible for checking CSP (e.g. pharmacist initial).

In compliance. Note: BUD is only for 12 hours.

STANDARD OPERATIONAL PROCEDURES (SOPS)USP <797> NESH

• Lists and recommends SOPs and should be reviewed to guide the pharmacy department in developing, writing and implementing SOPs.

• SOPs are part of a good quality assurance program within the pharmacy.

• Cleaning and garbing procedures that are updated every year.

• Quality Assurance Program is online and all staffs involved are required to review every year.

PHARMACY PERSONNEL RESPONSIBILITIESPHARMACISTS PHARMACY TECHNICIANS

• Follow NESH’s SOPs:1. Inspection and Verification of

CSPs including checking correct ingredients, quantity and quality, labels, BUDs, calculations.

2. Preparation of immediate-use CSPs.

3. Competency: Media-fill Test & Gloved Fingertip Sampling (annually).

• Regularly update with current USP and IV compounding regulations/requirements.

• Oversee all the compounding activities.

• Assigned pharmacist(s) should also be responsible for IV training of new technicians.

• Follow NESH’s SOPs:1. Gowning and Garbing.2. Maintaining and Cleaning IV

room.3. Compounding techniques

(including review of calculations).

4. Temperature control.5. Competency: Media-fill Test &

Gloved Fingertip Sampling (annually).

THANK YOU!