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PERFORMACE QUALIFICATION PROTOCOL OF DISPENSING BOOTH

TABLE OF CONTENT

Description Page No
Performance Qualification Protocol Approval
Objective
Scope
Responsibility
Pre requisite
Reference
 Testing Procedure  
·                     Airflow Laminarity by Smoke Test
·                     Non viable particle count
·                     Viable particle count
Performance qualification summary and conclusion
Abbreviation
Performance Qualification Approval
Particle count test report sheet  
 Viable particle count test report sheet  

 

Protocol Preparation and Approval

Preparation and Checking: 

  Validation Team
Prepared by Checked by
Dept QC QA Stores Stores QC QA
Name            
Signature            
Date            

 Approval: 

  Approved by
Plant Head Head- Quality Control Head- Quality Assurance
Name      
Signature      
Date    

 

 Objective: 

The objective of the protocol is to establish documentary evidence for  the Open Fronted Containment Facility to demonstrate that unit is qualified for correct operation as per guidelines outlined in this protocol.

Scope: 

This procedure applies to the performance qualification of Open Fronted Containment Facility comprising of the following tests

1.                  Air flow laminarity by smoke test

2.                  Non viable particulate count.

3.                  Viable particle count 

Responsibility:

Client:

1.                  Preparation, Review and approval of the protocol.

2.                  Providing required support during operation and preparation of PQ report.

3.                  Execution of Viable Particle count

Contractor(TEKNOPAK): 

1.                  Execution of protocol.

2.                  Collection of data and preparation of final PQ report. 

Pre Requisite:     

  1. Installation Qualification Documents
  2. Operation Qualification Documents

References:

United State Pharmacopoeia 39

ISO 14644 

TESTING PROCEDURE

AIR FLOW LAMINARITY TEST BY SMOKE TEST

Purpose: – 

The purpose of this test is to check the laminarity of Air flow  which is coming through HEPA filters of the unit. 

Apparatus Required: – 

Rod with cotton wrapped on one end.

Video camera for live demonstration of the activity.

Chemical required 

Titanium Tetra chloride :  B. N —————-

Acceptance Criteria:-

The smoke generated by the titanium tetrachloride should flow in a laminar way when the unit is in working condition. 

Operating Procedure:-

Switch on the unit, one hour before taking the measurement and allow the system to stabilize.

Assure that the magnehlic gauge reading is with in range (10 – 20 mm).

Wrap the rod one end with cotton and dip it in the Titanium tetra chloride solution.

Now move the rod inside the OFCF area from left to right selecting three locations (upper, middle and lower).

Cover the activity by video film.

Note: Follow safety precautions, avoiding the splashing of the reagent as it fumes densely.

Attachment: –

1.      Snaps of video film

2.      Video film disk

NON VIABLE PARTICULATE COUNT

Purpose: – 

The purpose of this test is to verify the cleanliness ISO Class-5 of the Installation in accordance with ISO 14644. 

Apparatus Required: – 

Discrete particulate counter. 

Acceptance Criteria:-

Particle Size Cumulative particle concentration per cubic meter
0.5m 1m 5m
ISO Class-5 3520 832 29

 Operating Procedure: 

Set up the particle counter in accordance with the manufacturer’s instructions.

Place the discrete particle counter in the sample locations.

Position of sample probe pointing in to the airflow.

Sample the volume of air.

Record the results in the test record sheet. 

Sampling points 

1                                                                                                         2

3

4                                                                                                          5

Attachment

Calibration certificate of Discrete particle counter.

Results Sheet

VIABLE PARTICLE COUNT

Purpose: – 

The purpose of this test is to demonstrate the capability of the installations air handling system to maintain the viable particle count as per USP-39 through settle plate technique and air sampler technique. 

Apparatus Required: –

Settling Plate. Air Sampler

Acceptance Criteria:-

Settling Plate:

Colony forming Unit = Less than 1cfu per 90 mm Petri plate.

Air Sampler:

Colony forming Unit = Less than 3cfu per cubic meter of air. 

Operating Procedure:- 

Settle Plate technique:

Switch on the unit, one hour before taking the measurement and allow the system to stabilize.

Assure that the magnehelic gauge reading is with in range (10 – 20 mm).

Keep the settling plate at the ‘3’ location as defined in the drawing.

Expose the plate for ‘1’ hour.

Analyze the plate for Microbiological analysis.

Air Sampler technique:

Switch on the unit, one hour before taking the measurement and allow the system to stabilize.

Assure that the magnehelic gauge reading is with in range (10 – 20 mm).

Start the Air sampler as per its operational manual

Sample the air at the center of the LAF safe zone by setting air sampling rate at 6m3/hr and sampling time =10 min.

Take the filter and  analyze the plate for Microbiological analysis

Note: Sampling shall be taken for ‘3’ consecutive days

Sample Location for Settle plate:

    1                                                2                                                      3

 Attachment:

Results Sheet.

Performance Qualification Summary and conclusion: 

_________________________________________________________________

Abbreviation 

Sl No. Common Term Abbreviation
1 HEPA High Efficiency Particulate Air
2 MG Magnehelic Gauge
3 NMT Not More Than
4 OQ Operation Qualification
5 PQ Performance Qualification
6 USP United States Pharmacoepia
7 ISO International Standard Organization
8 OFCF Open Fronted Containment Facility
9 QC Quality Control
10 QA Quality Assurance

Performance Qualification Approval 

The performance qualification documents is studied and approved by the Undersigned Authorized Personnel.

The approved Performance Qualification supersedes all the previous agreed specification.

Report Preparation and Review: 

  Validation Team
Prepared by Checked by
Dept QC QA Stores Stores QC QA
Name            
Signature            
Date            

 Report Approval: 

  Approved by
Plant Head Head- Quality Control Head- Quality Assurance
Name      
Signature      
Date      

 

 

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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