Fbd Tray Dryer Validation Maliba

5/27/2018 Fbd Tray Dryer Validation Maliba

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VALIDATION

OF

FLUID BED AND

TRAY DRYER

A

Seminar

on

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CONTENT:

Why to validate?

Parts of Equipment Validation

Who should do Equipment Validation? Equipment qualification

Typical process flow of solid dosage form

Validation of fluid bed dryer Validation of Tray dryer

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WHY TO VALIDATE?

Equipment validation is Vital for

Safety

Fewer interruptions of work

Lower repair costs

Elimination of premature replacement

Less standby equipment

Identification of high maintenance cost

Reduction of variation in results

Greater confidence in the reliability of results3


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PARTS OF EQUIPMENT VALIDATION

Equipment

Validation

Installation

Qualification (IQ)

Operational

Qualification (OQ)

Performance

Qualification (PQ)

Design

Qualification (DQ)

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WHO SHOULD DO EQUIPMENT VALIDATION?

THE VENDOR OR THE USER? The user has the ultimate responsibility for

equipment qualification.

DQ should always be done by the user.

While IQ for a small and low cost instrument isusually done by the user, and

IQ for large, complex and high cost instruments

should be done by the vendor. OQ can be done by either the user or the vendor.

PQ should always be done by the user

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EQUIPMENT QUALIFICATION

Equipment qualification / validation includes

following things :

Design qualification (DQ)

Installation qualification (IQ)

Operational qualification (OQ)

Performance qualification (PQ)

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TYPICAL PROCESS FLOW OF

SOLID DOSAGE FORM

Addition of

raw material

-active

excipients

Preble

bending

-high speed

mixer

granulator

Granulating

- high speed

mixer

granulator

Drying

-fluid bed

dryer

-tray dryer

Tableting

-high speed

rotary

Blending

-v-blender

Addition ofraw material

-lubricant

-disintegrants

Sizing

-mill/sieve

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TYPICAL VARIABLE OF DRYING PROCESS

Control variable

Initial temperature

Load size

Drying temperature

program

Air flow programDrying time

Cooling time

Measured responses

Density

Yield

Moisture content

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VALIDATION

OFFLUID BED DRYER

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FLUID BED DRYER

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FBD CONTROL PARAMETERS

Fixed Variable

(monitor)

Response

(Test)

Bowl change

Porosity offilter bags

Bowl sieve

Inlet/exhaust air

temperatureProduct temperature

Drying time

Air volume

Humidity of incoming airHumidity of exhaust air

Particle size

distributionDensities

Loss on drying

Assay

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INSTALLATION QUALIFICATION(IQ) Installation Procedure: After checking all the specifications as mentioned

in the selection criteria, service engineer of the

manufacturer shall be called for commissioning, ifnecessary.

Authorized validation team shall carry out

installation. Department Head of production, QA &

engineering shall evaluate installation report

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Conti

Acceptance Criteria For Installation Qualification: The equipment shall fulfill the selection criteria & its

purpose of Application.

Name of the manufacturer & supplier shall be asmentioned in the Purchase order

The manufacturer/supplier shall provide complete

equipment manual along with the equipment

All recommended utilities of recommended

capacities are to be provided near the place of

installation13
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Conti Revalidation Criteria

The equipment shall be revalidated if;

Location of the equipment is changed. There is change of spare/parts,major maintenance

or breakdown that have a direct effect on the

performance of the equipment

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Conti

Conclusion:

The equipment shall be considered qualified for

installation provided it meets all the parameters

mentioned in the acceptance criteria.

After receiving installation report, it shall be

evaluated & released for operational

qualification, provided installation report is

evaluated & the equipment is found meeting all

parameters of acceptance criteria

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OPERATIONAL QUALIFICATION (OQ) Training record

Before initiating OQ ensure that SOPfor

Cleaning and operation of FBD is available.

Purpose:To train the qualification team forperforming OQ

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Conti Procedure Initiate the actual operation of the FBD to ensure

that machine is operating within specification.

Check the OQ parameters against theirspecifications.

Observe the functioning of all controls available

on control panel Record the observation

Perform and attach report of heat distribution

study as per ` Heat distribution study procedure 17
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Conti Acceptance criteria (Heat Distribution Study:)

Temperature difference between all thermocouples

and set temperature should not differ by more than

5 C.

All operating inputs provided on the equipment

when tested shall-successfully comply

-meet tolerance limit

The equipment should successfully perform when

operated as per SOP18


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Conti Critical gauges/indicators provided on the

equipment---calibrated

The equipment when operated shall not

- produce abnormal sound

-show any discrepancy in its smooth operation.

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Conti Revalidation Criteria:


Location of the equipment is changed. There is change of spare/ parts, major maintenance

or breakdown that have a direct effect on the

performance of the equipment

Critical gauges shall be replaced or corrected

At normal revalidation schedule.

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PERFORMANCE QUALIFICATION(PQ) To check Heat Distribution by placing 10

thermocouples in geometric pattern with the FBD

Shell and empty Product Container without any

load to ensure heat distribution in the dryingchamber

Heat distribution study will be performed at 65

5C for two hour after achieving the temperature

on the controlling sensors to ensure proper heat

distribution.

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Conti Procedure

After completion of OQ initiate the PQ of FBD.

The effectiveness of drying will be qualified by

determining reduction of % moisture content indrying process.

3 batches/ lots of any product will be taken for PQ

of FBD. At least 2.0 gm of sample is sampled for % MC

check from the top, middle and bottom trays andwill be reported

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Conti In case of any deviation inform to department

head for necessary action

Document the deviation details

Deviation is acceptable or not will be decided

-if yes

-if not

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Conti Acceptance criteria

The reduction in moisture content after drying

should be as per the specification in the BMR

% RSD of LOD should not be more than 6 %

The equipment should produce intended outputs

with respect to quality & quantity consistently

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Conti Revalidation Criteria:


Location of the equipment is changed.

There is change of spare/ parts, major

maintenance or breakdown that have a direct

effect on the performance of the equipment

At normal revalidation schedule.

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PROCEDURE FOR DRYING EFFICACY

STUDY IN FLUIDIZED BED DRYER:

Ensure the cleaning of machine Load the wet mass in the FBD product container

Set the process time & outlet temperature and run

the FBD. After completion of drying take out FBD bowl and

collect the sample

At least 2.0 gm of sample is sampled for % MCcheck from the top, middle and bottom trays and

will be reported

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Conti Sampling Procedure:

Ware nose mask, hand gloves before sampling.

Label the sample bag with details as Product

name, stage, date, time and sign

Collect app. 2.0 gms of dried material composite

sample in poly bag as per location shown

Record the details of analysis.

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Validation

of

Tray dryer

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TRAY DRYER

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TRAY DRYER CONTROL PARAMETERS

Fixed Variable

(monitor)

Response

(Test)

Trays Inlet/exhaust air

temperatureProduct temperature

Drying time

Air volume

Humidity of incoming airHumidity of exhaust air

Particle size

distributionDensities

Loss on drying

Assay

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INSTALLATION QUALIFICATION(IQ) Procedure:

Selection criteria shall be defined and based on

specific function to be carried out by the machine

& its efficiency.

Requirement of accessories shall be decided &

listed out.

Supplier or manufacturer selection

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Conti Purchase Details:

The purchase order no. & date shall be checked

The accessories & their spare parts if any shall be

checked as per purchase order

The delivery period shall be as per purchase order

Supplier or manufacturer name & address shall bechecked

Any deviation observed should be informed to the

supplier or manufacturer32


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Conti Details of the Equipment

Equipment name, make & model no. shall be

noted down

In-house identification no. shall be allocated

Location for installation shall be decided

Utilities required shall be listed down

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Conti Installation Procedure:

After checking all the specifications as mentioned

in the selection criteria, service engineer of the

manufacturer shall be called for commissioning, if

necessary.

Authorized validation team shall carry out

installation

Department Head of production, QA &

engineering shall evaluate installation report

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Conti Acceptance CriteriaFor IQ Fulfill the selection criteria & its purpose of

Application

The equipment shall be as per purchase order Accessories received shall be as per purchase order

Should meet pre-selected design parameters

Manufacturer/supplier shall provide completeequipment manual

Material of construction shall be as per purchaseorder

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OPERATIONAL QUALIFICATION (OQ) Training record

Before initiating OQ ensure that SOPfor

Cleaning and operation of Tray dryer is available.

Purpose:To train the qualification team forperforming OQ

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Conti Procedure

Initiate the actual operation of the TD to ensure

that machine is operating within specification.

Check the OQ parameters against their

specifications.

Observe the functioning of all controls available

on control panel

Record the observation

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Conti Acceptance criteria

All operating inputs provided on the equipment whentested shall-successfully comply

-meet tolerance limit

The equipment should successfully perform whenoperated as per SOP

Critical gauges/indicators provided on the equipment-

--calibrated The equipment when operated shall not

- produce abnormal sound

-show any discrepancy in its smooth operation.38


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PERFORMANCE QUALIFICATION(PQ) To check Heat Distribution by placing 10

thermocouples in geometric pattern with the TD

Shell and empty Product Container without any

load to ensure heat distribution in the dryingchamber

Heat distribution study will be performed at +45

C and +105C for one hour after achieving thetemperature on the controlling sensors to ensure

proper heat distribution.

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Conti Procedure

After completion of OQ initiate the PQ of TD

The effectiveness of drying will be qualified by

determining reduction of % moisture content indrying process.

3 batches/ lots of any product will be taken for

PQ of TD At least 2.0 gm of sample is sampled for % MC

check from the top, middle and bottom trays andwill be reported

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Conti In case of any deviation inform to department

head for necessary action

Document the deviation details

Deviation is acceptable or not will be decided

-if yes

-if not

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Conti Acceptance criteria Temperature difference between all thermocouples

and set temperature should not differ by more than

5 C. The reduction in moisture content after drying

should be as per the specification in the BMR

% RSD of LOD should not be more than 6 % The equipment should produce intended outputs

with respect to quality & quantity consistently

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REFERENCES

Berry I.R., and Nash R.A., Pharmaceutical

Process validation second edition, revised and

expanded; Marcel Dekker series; 83-110.

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SEMINAR OPEN FOR DISCUSSION

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Documents

Fbd Tray Dryer Validation Maliba