PHARMAGUIDEHUB

DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE

XXXXXX DISPENSING / SAMPLING BOOTH (RLAF)

PERFORMANCE
QUALIFICATION OF
DISPENSING/
SAMPLING BOOTH
(RLAF)

PHARMAGUIDEHUB
Location

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DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
XXXXXX DISPENSING / SAMPLING BOOTH (RLAF)

REPORT CONTENTS

S. No. SECTION TITLE Page No.

1.0 Protocol Approval...........................................................3

2.0 Overview..........................................................................4
2.1 Objective:............................................................................4
2.2 Purpose and Scope.............................................................4
2.3 Responsibility......................................................................4
2.4 Qualification Team.............................................................4
3.0 Training Record..............................................................5
4.0 Pre – Performance Qualification Requirements..........7
5.0 System / Equipment Description...................................8
5.1 System / Equipment details...............................................8
5.2 Generic Design....................................................................9
5.3 Safety Features Description.............................................10
5.4 Testing Procedures...........................................................10
6.0 Performance Qualification Procedure.........................11
7.0 Acceptance Criteria......................................................12
8.0 Qualification Report......Error! Bookmark not defined.
9.0 Approval of Qualification Report................................12
10.0 Observed Deviation........................................................1
11.0 List of Exhibits / Annexure............................................1
11.1 List of Exhibits....................................................................1
11.2 List of Annexure.................................................................1

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DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
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1.0 Protocol Approval

This is a specific Protocol for Performance Qualification of Dispensing/Sampling Booth which

is installed in the Warehouse.

This report has been approved by the following:

Name Department Signature Date

Prepared By

Checked By

Approved By

Final Approval

Final approval has been given by the following:

Name Signature Date

Approved By
(Plant Head)

Approved By
(Head – QA)

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2.0 Overview

2.1 Objective:

To establish the Methodology for the performance qualification of Dispensing/Sampling Booth

this is installed in the Warehouse.

2.2 Purpose and Scope

The purpose is to provide an outline for the performance qualification of equipment for its
intended use:

 Demonstrate that the RLAF of Dispensing/Sampling Booth shall perform reproducibly

and consistently within its full dynamic range of operation according to pre-laid
specifications.

 The RLAF unit of Dispensing/Sampling Booth shall be able to perform in worst cases.

 Assure that the RLAF unit performance of Dispensing/Sampling Booth shall be adequate
to support the process for which the system is intended.

 Ensure that the unit shall be included in preventive maintenance program.

The scope of this qualification exercise is limited to the performance qualification of RLAF
unit. The protocol is applicable to RLAF unit, Equipment Code no.XXXXXXXX.

2.3 Responsibility

 Protocol / Report Preparation: Production Executive / Manager, QA Executive /

Manager and Service Engineer.

 Approval of Protocol / Report: QA Manager

 Execution of Qualification Activity: Production Executive / Manager, Service Engineer

2.4 Qualification Team:

 User Department Executive / Manager

 Project Executive / Manager

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 Validation Manager

 Quality Assurance Manager

3.0 Training Record

3.1 Purpose

The purpose of the training was to familiarize the trainees with the Performance Qualification,
Performance Qualification procedure, Documentation Procedure and Overall Strategy of
Performance Qualification.

3.2 Scope

This Training is applicable to the RLAF unit of Dispensing/Sampling Booth installed in

Warehouse.

3.3 Topics

The following topics were covered during training:

 Performance Qualification Procedure.

 Documentation Practices for filling of report.

 Overall strategy of Qualification process.

 General precautions / guidelines to be followed during qualification.

 List of SOP’s used for training

S.No. SOP’s No. Title

01 XXXXXXX SOP on operating procedure for Dispensing/Sampling Booth

02 XXXXXXX SOP on cleaning procedure for Dispensing and Sampling Booth

03 XXXXXXX SOP for Preventive Maintenance of Dispensing/Sampling Booth

 Attach training record with the report as Annexure - 01

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DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
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DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
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4.0 Pre – Performance Qualification Requirements

Following instruments shall be required for the Performance Qualification of RLAF unit of
Dispensing/Sampling Booth installed in warehouse.

S. No. Equipment Name Equipment Calibration Calibration

Code / S. Certificate Due On
No. No.
1. Aerosol DOP
Generator
2. Aerosol DOP detector

3. Anemometer

4. Titanium
Tetrachloride (Smoke
Test)
5. Particle Counter

6. Camera

7. Stop Watch

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5.0 System / Equipment Description

5.1 System / Equipment details

The RLAF shall be used for the Dispensing/Sampling of raw material & excipients for attaining
a dust free & bacteria free workstation

Description

 Equipment Tag Number : XXXXXXXXXXXXXX

 Location : Warehouse

 Block : XXXXXXXXXXX

 Room No : XXXXXXXX

 Name of the system : RLAF

 Manufacturer’s Name / Address: XXXXXXXXXXXXX

 Model : XXXXXXXXXXXXXX

 Dimensions : Overall Diamentation

Height: XXXXX

Width: XXXXXXX

Length: XXXXXXXX

 Purchase Order Number : XXXXXXXXXXXX, Dated: XXXXXXXX

 Date of Installation : XXXXXXXXXX

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5.2 Generic Design

5.2.1 Working Principle

The sampling Booth is designed in accordance with cGMP principles. Sampling Booth shall be
used for Dispensing/sampling of raw materials. It shall be Reverse laminar airflow type.

Brief Machine Description

The RLAF comprises of following parts:

 Main body structure
 Supply Filters
a. Pre-filter (EU-5)
b. Intermediate filter (EU-7)
c. HEPA filter (EU-12)
 Motor blower
 Side panels
 Exhaust filter (EU-12)

Magnahelic gauges measures pressure differentials across all filters.

1. Main Body Structure:

Main body structure of RLAF of Dispensing/Sampling Booth provides a platform for fixing the
supply filters, motor blower, side panels, magnahelic gauges & exhaust filter. Main body structure
is fabricated using SS 304.

2. Supply Filters:

The function of supply filters is to supply dust free & bacteria free air. Supply filters consists, pre-
filter of 10 micron rating with efficiency of 90% down to 10 microns (EU5 grade); intermediate
filter of (3 micron rating) with efficiency 97% down to 3 microns (EU7 grade, microvee filter) and
final HEPA filter of 0.3 micron rating with efficiency of 99.997% down to 0.3 micron.

3. Motor Blower:

The motor blower is situated inside the main body structure. Motor blower is fabricated by using
MS powder coated.

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4. Side Panels

Side panels are provided to give the support to the main body structure. Side panels are fabricated
by using SS304.

5. Exhaust Filter

Exhaust filter consists of Minipleat HEPA filter of 0.3 micron rating with efficiency of 99.997%
down to 0.3 micron.

6. Finishing:

Outside surface of RLAF of Dispensing/Sampling Booth is matt finish.

5.3 Safety Features Description:

1. Noise Level:

The noise level should not more than 50db of blower motor.

2. Safety Guards:

The safety guards are provided for all moving parts.

3. Earthing Connections:

The Earthing connections are installed to reduce risk of any accident by overloading, voltage
variation or any other electrical fault. MCB should be provided.

4. Indicators Switches for Fluorescent lights

The Indicators should be provided for Fluorescent lights.

5.4 Testing Procedures

The following tests were done to evaluate the performance of RALF of Dispensing/Sampling
Booth:

Air velocity Test

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Measure the air velocity at five points (four at corners and one at the middle) 6 inches below
the surface of the filter / diffuser using calibrated anemometer. Calculate average of the five
reading of the filter.

1. CFM of the filter

Calculate air quantity of filter in CFM with the help following formula.

CFM = Average velocity of the air x Effective surface area of the filter

2. Air Laminarity Test

Smoke test was performed to check laminarity of air coming through HEPA Filter. Swab stick
shall be dipped in titanium tetrachloride and shall be placed 6.0” below the HEPA filter. The air
shall move in linear pattern. The path of air movement shall be monitored & safe zone shall be
marked on the basis of movement shown by smoke test study.

3. Differential Pressure between the filters

Differential Pressure between the filters was monitored every 10 minutes for half hour on
megnehelic gauges of all three filters.

4. Air Particle Count

The particle count of Sampling Booth was done through particle counter at 5 locations on working
height.

6.0 Performance Qualification Procedure:

The following procedure shall be used for the performance qualification of the RLAF unit of
Dispensing/Sampling Booth installed in Warehouse.

6.1 Ensure that OQ of system is completed and system is cleared for performance qualification.

6.2 The air velocity test and CFM calculation shall be done for each HEPA filter. The observations
were recorded as per Exhibit – E01.

6.3 The differential pressures between filters shall be checked. The observations shall be recorded as
per Exhibit – E02.

6.4 The smoke test shall be performed to check laminarity, air movement & safe zone determination.
The observations were recorded as per Exhibit – E03.

6.5 The particle count shall be done to ensure that booth complies ISO class 5 area specifications. The
observations were recorded as per Exhibit – E04.

The reports generated were attached in Annexure – 02.

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6.6 The preventive maintenance list of the maintenance department shall be updated. The observations
were recorded as per Exhibit – E05.

6.7 No Deviation was observed.

7.0 Acceptance Criteria

Performance qualification shall be considered acceptable when requirements listed in section 6.0 of
this protocol have been fulfilled and are as per the design specifications of the system.

8.0 Summary and Conclusion

The Dispensing/Sampling Booth bearing Tag No: XXXXXXXXXXXX have undergone the
following below mentioned testing parameter as per Protocol No: XXXXXXXXXX

Observations pertaining to the parameter were listed in Exhibit: 01 to Exhibit: 04

S.No. Testing Parameter Observation

01 Air Velocity & DOP Complies

02 Air Laminarity Complies

03 Differential Pressure between the filters Complies

04 Air particle count Complies

On the basis of above observation it is concluded that the Equipment is meeting the acceptable criteria.
Hence is qualified.

9.0 Approval of Qualification Report

The report shall be evaluated and proper references / conclusions / recommendations shall be
recorded by Quality Assurance.

The installation qualification report shall be evaluated and finally approved by quality assurance.

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10.0 Observed Deviation

Sr. Page Point Observed Deviation Deviation Deviation Corrective Action Taken Justification of Corrective action
No. No. No. Reported Approved By Corrective taken and
By Action justification
given by

Report Approved By

Department Head Quality Head

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11.0 List of Exhibits / Annexure

11.1 List of Exhibits

Exhibit No. Exhibit Title No. of

Pages
E01 Air Velocity Test, CFM Calculation and DOP 01
Testing Verification Checklist
E02 Differential Pressure Monitoring Data Sheet 01
E03 Smoke Test & Safe Zone Marking Verification 01
Checklist
E04 Particle Count Verification Checklist 01
E05 Preventive Maintenance List Up-dating Verification 01
Checklist
Total No. of Pages 05

11.2 List of Annexure

Annexure No. Annexure Title No. of

Pages
01 Training Record 01
02 Particle Counting Reports 01
Total No. of Pages 02

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Exhibit – E01

Air Velocity Test, CFM Calculation and DOP Testing Verification Checklist

Equipment Name / Description:

Tag no.: XXXXXXX

Location: Warehouse Date:

Avg. Air Velocity

S. No. Filter No. Filter Area Air Velocity Limit Actual Rated CFM Actual CFM DOP Testing

Remarks:

Checked By:
(Name) (Sign) (Date)

Verified By:

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(Name) (Sign) (Date)

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Title: Report for Performance Qualification of sampling Booth
Report No.: XXXXX Protocol No.: XXXXXXXX

Exhibit – E02

Differential Pressure Monitoring Data Sheet

Equipment Name / Description:

Tag no.: XXXXXXX

Location: Warehouse
S. Date:
No Start Time: End Time:
. Pre-filter Intermediate Filter HEPA Filter
Limit Actual Limit Actual Limit Actual
Magnehelic
Gauge No.
()
Time
(Mins.)
()
1. 0
2. 10
3. 20
4. 30
Remarks:

Checked By:
(Name) (Sign) (Date)

Verified By:
(Name) (Sign) (Date)

Exhibit E02: Page 1 of 1

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Exhibit – E03

Smoke Test & Safe Zone Marking Verification Checklist

Equipment Name /

Description: Tag no.:

XXXXXXX

Location: Warehouse
S. Movement of Safe Zone Marking
Filter Nature
No Smoke Marking Done Done By
No. of Flow
. From To
1.
2.
3.
4.
5.
Remarks:

Checked By:
(Name) (Sign) (Date)

Verified By:
(Name) (Sign) (Date)

Exhibit E02: Page 1 of 1

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Exhibit – E04

Particle Count Verification Checklist

Equipment Name / Description:

Tag no.: XXXXXXX

Location: Warehouse
S.
Specification Observations
No.
1. Ensure that particle count of area shall be
performed as per SOP Title: -
& equipment
shall complies to the ISO Class 5 grade

2. Reports shall be attached with the qualification

report
Remarks:

Checked By:
(Name) (Sign) (Date)

Verified By:
(Name) (Sign) (Date)

Exhibit E02: Page 2 of 1

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Exhibit – E 05

Preventive Maintenance List Up-dating Verification Checklist

Equipment Name /

Description: Tag no.:

XXXXXXX

Location: Warehouse
Preventive Maintenance Frequency of Due Date Entry
Program no. Preventive Done by
Maintenance

Remarks:

Checked By:
(Name) (Sign) (Date)

Verified By:
(Name) (Sign) (Date)

Exhibit E02: Page 3 of 1

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DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
XXXXXXXXXXXX DISPENSING / SAMPLING BOOTH (RLAF)

Annexure – 01

Training

Record

Equipment Name: Dispensing/Sampling Booth

Equipment Tag No.: XXXXX
Location: Warehouse
No. of Pages:

Exhibit E02: Page 4 of 1

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DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
XXXXXXXXXXXX DISPENSING / SAMPLING BOOTH (RLAF)

Annexure – 02

Particle Counting Reports

Equipment Name: Dispensing/Sampling Booth

Equipment Tag No.: XXXXXXX
Location: Warehouse
No. of Pages:

Exhibit E02: Page 5 of 1

 PHARMAGUIDEHUB
DOCUMENT No. PERFORMANCE QUALIFICATION OF EFFECTIVE DATE
XXXXXXXXXXXX DISPENSING / SAMPLING BOOTH (RLAF)

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