OQ COMPOUNDING 100 Ltrs ISOLATOR

OPERATION QUALIFICATION
Alpha-Pharma Healthcare
Customer :
#B205, Universal Business Park, Off Saki Vihar Road, Chandivali
Manufacturer : Klenzaids Contamination Controls (P) Limited
Equipment Name : Compounding Isolator for 100 Ltrs Vessel
Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 1 of 27
For
Compounding Isolator
For
100 Ltrs Compounding Vessel
Model No. :
IsoKlenzTM AP N HS 1.0 x 0.70 / 0.60 x 0.8 - 2
Prepared by : Maria Jeffries Checked by : Amit Panchal

Date : 22.06.2015 Date :
Revision control : 00 Revision No : 00
Description : OQ Protocol Approved by : Santosh Kelkar
Customer :
Table Of Contents Page No.
Pre Approvals 3
Introduction 4
Purpose 4
Responsibility 4
Brief Description of Modular Functions 5
Tests
1. Standard Operating Procedures 6
2. Chamber Pressure Tests 7
3. Power Continuity Verifications 10
4. Lighting Level Tests 11
5. Fan Control Checks 12
6. Modular Function Verifications 13
7. Air Change Rate Verification 15
8. Area Classification check 16
9. Gauntlet Breach Air Velocity Check 17
10. Noise Level Verification 18
11. HEPA Filter Integrity Verification 19
12. Recovery Time Determination Test 20
13. Procedures Verification 21

Date : 22.06.2015 Date :
Customer :
Post Approval 22
14. Appendix 23
A. Attachment 23
B. Re-qualification 25
C. Appexdix 26
PRE APPROVALS
Prepared By : ________________________ Date : _____________
(Klenzaids)
Approved By : ________________________ Date : _____________
(Klenzaids)
Reviewed By : ________________________ Date : _____________
Project Dept. (Client)
Checked By : ________________________ Date : _____________
Engineering (Client)
Approved By : ________________________ Date : _____________

Date : 22.06.2015 Date :
Customer :
Plant Operations (Client)
Approved By : ________________________ Date : _____________
QA (Client)
INTRODUCTION :
This is the Operational Qualification protocol for the Compounding Isolator of Alpha-
Pharma Healthcare at Mumbai. This document has been created to ensure that there is
sufficient information available to enable the equipment to be operated and maintained
safely, effectively and consistently.
PURPOSE :
The purpose of the Operational Qualification (OQ) is to verify that, the equipment or
systems perform and operate in accordance with the KLENZAIDS specifications and PT
Fonko International Pharmaceutical’s requirements. During operational qualification,
we establish the suitability of draft SOP prepared for the operation of the isolator and
document the observations for future reference.
RESPONSIBILITY :
A team shall first review and approve this protocol. The team comprising of a
representative from each of the following departments shall be responsible for over all
compliance of this protocol (Project Department, Engineering Department, Production
Department and Quality Assurance Personal, as a minimum).
Following approval of this protocol, the operation of the Compounding Isolator is

qualified by performing the prescribed tests and comparing the results against the given
Date : 22.06.2015 Date :
Customer :
acceptance criteria. As each test is completed, the individual performing the test initials
and dates each one. Exceptions are documented in the space provided and resolved prior
to closing the OQ.
Upon completion of the above test, the team reviews the test results and indicates their
acceptance by signing and dating the protocol completion page.
BRIEF DESCRIPTION OF MODULAR FUNCTIONS :
The Compounding Isolator is a fixed type single chamber unit integrated with Client’s
Compounding Vessel, RTP for product transfers. The unit will be used for compounding
of API. One exhaust blower is mounted within the service plenum powers the systems.
The system consists of SS 316 L canister type inlet and exhaust cartridge HEPA filters.
The isolator chambers are constructed from SS 316 L materials with sufficient coving
radius and TIG welded to ensure a crack and crevice free smooth inner surface.
The isolator is ergonomically designed for compounding of API with OELs of

1.0 µgm/m3 for 8 hrs TWA which lies within OEL level as per ISPE guidelines for
hazardous product handling.
The Isolator shall be operated under a negative pressure normally between - 80 Pa to

-120 Pa with respect to the surrounding environment. The isolator is designed with two
glove ports for providing operator access through the slanted view panel.
The Isolator has the functional units in main unit as follows :

Date : 22.06.2015 Date :
Customer :
Ventilation system
Differential pressure of the work area
Lighting system
Differential pressure of the filter systems
Control systems.
TESTS :
1. Standard Operating Procedures :
Purpose: To verify that SOP’s are complete enough to allow personnel to operate the
equipment and perform routine maintenance and monitoring.
Test Equipment: None
Procedure : Locate all documents listed below :

- Verify that the required SOP’s listed in the tables below are available.
- Review the SOP’s for completeness and exactness with the installed units.
- Note any deviations or discrepancies and recommend follow up actions required.
- Attach the copies of the standard operating procedures to this protocol.
SOP Type Available Acceptable Deviation Reviewed By

1. Operations
2. Decontamination
Procedures
3. Maintenance
Conclusions / Comments :

Date : 22.06.2015 Date :
Customer :
Pass () Fail ()
Initial / Date : Klenzaids Client : Alpha-Pharma Healthcare
2. Chamber Pressure Test :
Purpose : To verify that main chamber pressure are adequate to aid in providing
dispensing Isolator separation between the main chamber and ambient spaces.
Test Equipment : Calibrated Manometer / Magnehelic Gauge, Silicone tube for

connectivity, valve and Compressed air supply.
Procedure :
Connect the Manometer/Magnehelic Gauge and the Compressed air supply to the
Isolator as shown in the diagram below. Ensure that all the openings to the Isolator are
blocked off, Inlet filter and Exhaust filters blocked off, doors closed and all valves are
closed.
Open the air inlet valve on the compressed air line slightly until a pressure of +300 Pa is
recorded on the Manometer/Magnehelic Gage then close the valve on the compressed
air line. Wait until the pressure in the isolator has reduced to +250 Pa and note the time.
Formula :

Date : 22.06.2015 Date :
Customer :
Ratio of Leakage Rate/hr to Chamber Volume = Q/V

Q = Leakage Rate M3/hr
V = Volume of Enclosure M3
Q= 60 ((P2 V T1) -V)
t P1 T2
t = Duration of test Minutes
P1 = Start Test pressure Pa
P2 = End Test Pressure Pa
T1 = Start test Temperature ºC
T2 = End test Temperature ºC
The formula for calculating leakage rate is taken from ISO 10648-2.
Record the pressure within the Isolator every minute for a period of 5 minutes and record the
pressure in the table below.
Compressed Air
Test equipments connectivity :

Date : 22.06.2015 Date :
Customer :
CONTAINMENT ENCLOSURE UNDER TEST
Calibrated Manometer /Magnehelic Gauge
Results Table :
Time Starting Pressure Pa or Measured Pressure Pa Temp in deg cent.

mm WC mm WC
0 Mins
1 Mins
2 Mins
3 Mins
4 Mins
5 Mins
Acceptance Criteria : Not more than 42 Pa drop in 5 minutes.

Date : 22.06.2015 Date :
Customer :
3. Power Continuity Verifications :
Purpose : To verify the ratings and power continuity of MCB’s installed with in the
power panel.
Test Equipment : Calibrated Multimeter
Test Procedure :
i) Ensure that power is available to the Control Panel

ii) Check that all fuses are not defective using the Continuity tester, Record that all
fuses have been checked in the table below.
iii) Replace all MCB’s in the correct position, check circuit breakers are in the position.
iv) Ensure that power supply to the isolator is available
v) Check earth continuity.
Acceptance Criteria : MCB’s not damaged and rated as per electrical circuit diagrams :
MCB Tag No. Rating

Date : 22.06.2015 Date :
Customer :
4. Lighting Level Tests :
Test Equipment : A calibrated Lux meter.
Test Procedure :
i) Switch ON the power to the control panel.

ii) Light Switch shall be ON and confirm that all tubes are illuminated.
iii) Using lux meter, check the lighting intensity in the chamber at four corners and
one centre, total 5 points. Record the results in table below.
iv) Ensure that the locations are not shaded or obstructed from light source.
v) Calculate the average illumination level from the readings taken.
Procedure Expected results Meets test (Y/N)

Light switch ON Light illuminate
Light switch OFF Light extinguish
Acceptance Criteria : Minimum illumination level average 300 Lux.
Results Table :
Locations Recorded lux level

1 2 3 4 5 Average

Date : 22.06.2015 Date :
Customer :
Main Chamber
5. Fan Control Check
Purpose : To ensure that isolator Blower operates correctly.
Test Equipment : None.
Procedure :
i) Ensure power is available to the power control panel.
ii) Do the “Fan Start” operation through HMI
iii) Observe the fan for starting and rotation of impeller
iv) Do the “Fan Stop” operation through HMI and observe the fan
Results Table :
Test Actions Descriptions Acceptance Criteria

1 Pressing “Fan Start” Fan is initiated
2 Rotational Check on Fan Fan rotates in direction of Arrow on
impeller casing

Date : 22.06.2015 Date :
Customer :
3 Pressing “Fan Stop” Fan is stopped
6. Modular Functions Verifications :
Purpose : To ensure that the Modular function of the isolator match those specified in
the DQ.
Test Equipments : DQ
Procedure : Ensure power is available to the control panel. Perform each check as listed
and record the results in the table below
Results Table :
Status Action Equipment Status
Standby Switch on Lights Fan stopped, Isolator Pressure equal to room

Mode pressure, Isolator Lights ON.
Switch off Lights Isolator Lights OFF (Lights can be left on for rest of
test).

Date : 22.06.2015 Date :
Customer :
Status Action Equipment Status
Run Mode Press “Fan Start” Fan Starts, Fan Running Indication flashed On,
Negative (-ve) pressure developed in Isolator, Fan
speed slows Isolator pressure - 80 Pa to -120 Pa.
Breach Remove Glove Isolator Pressure equal to room pressure after 5 secs
fan speed increase, Containment Breach Indication
illuminated.
Replace Glove Isolator Pressure returns negative (-ve), Fan speed

reduces Isolator pressure returns to - 80 Pa to -120
Pa.
Filter Simulate Exhaust filter blocked indication illuminated when

Exhaust
Blocked Filter Differential pressure reaches to its blockage
set value.
Simulate Supply Supply filter blocked indication illuminated when

Filter Differential pressure reaches to its blockage
set value.
Run Mode Press “Fan Stop” Fan Stops.

Date : 22.06.2015 Date :
Customer :
7. Air Change Rate Verification :
Purpose : To ensure that the appropriate air change rates met those specify on the DQ
documents.
Test Equipments : Anemometer.
Procedure : With the Isolator running monitor the air entering or exhausting from the
Chamber using a vane anemometer. From this calculate the volume of air through the
chamber and then calculate the Air Change Rate. Record readings in table below
Acceptance Criteria : 20 Air Changes per hour (minimum)
Results Tables :
Chamber :
Chamber Filter area M2 Vol. into the Chamber Vol. No. of air changes
chamber M³/Hr M³ P / hr

Date : 22.06.2015 Date :
Customer :
8. Area Classification Check (Inside the Isolator Chamber) :
Purpose : To verify the particle level with in the isolator main chamber as specified in
the URS and / or mutually agreed.
Test Equipment : Portable Particle Counter.
Procedure :
i) Testing shall be conducted after 20 mins of Isolator runs in the healthy conditions.
ii) Select sampling location to collect samples.
iii) Tester shall be inserting the Isolator Chamber, through Canister
iv) Reading shall be taken on display.
v) Records the observations in result table.
vi) Attach the print out along with the document.
Results Table (Static Condition) :

Location Particle No. of Particles Time taken in mins
Chamber 0.5 micron
5 micron

Date : 22.06.2015 Date :
Customer :
Acceptance Criteria : Static condition 0.5 micron or larger particle shall not more than
3520000 in 1 cubic meter of air. 5 micron or larger particle shall not more than 29300 in 1
cubic meter of air.
9. Gauntlet Breach Air Velocity Check
Test Equipment : A calibrated thermal anemometer.
Procedure :
i) Determine that all other operating parameters have been met.
ii) Remove one gauntlet from chamber view panel
iii) Measure velocity at the geometric centre of the opening. A minimum of 3 samples
at a minimum of 1 location shall be taken
Record Results :
Glove port Size Recorded velocity Acceptance criteria

M/Sec M/Sec

Date : 22.06.2015 Date :
Customer :
> 1.0 M/Sec
10. Noise Level Verification :
Test Equipment : Calibrated sound meter.
Procedure :
i) With the Isolator switched off, record the background noise level in the room, this
need to be as low as possible
ii) Record the Background noise level in the results table
iii) Initiate the Isolator and record the sound level again standing 1 meter away from
the isolator.
Recorded back Recorded level isolator Acceptance criteria above

ground noise level running background noise.

Date : 22.06.2015 Date :
Customer :
< 70dbA
11. HEPA Filter Integrity Verification :
Purpose : To verify the integrity of all HEPA Filters housing and filter mounting frames.
The isolator chamber shall be operated at operational air flow for this test.
Test Equipment : Photometer, Oil Mist Generator.

Procedure :
- Start the isolator and ensure the blower running at normal conditions / flow rates.
- Apply Oil Mist to the upstream side of filters.
- Switch the Photometer to the upstream sample position and sample the DOP, adjust
the gain on the instrument to read 100%.
- Switch the Photometer to clear and select 0.01% with the selector switch on the
photometer, adjust the scale to read 0.000.
- Turn the sample switch on the Photometer to the downstream sample position.
- Scan around the outlet (downstream of the Filter)
- Record the readings in the Results table.
Acceptance Criteria :
Exhaust Filter penetration must not be greater than 0.01%.
Supply Filter penetration must not be greater than 0.01%.

Date : 22.06.2015 Date :
Customer :
Results Table : Compounding Chamber :

Filter Location Filter Penetration Test Result (Pass / Fail)
Identification No.
Inlet Filter
Exhaust Filter
16. RTP Operation Test :
Test Equipment : Beta port with canister for rotate RTP.
Procedure :
i) Ensure the faces of Alpha and Beta’s are cleaned.
ii) Dock the beta with canister to the Alpha port of rotate RTP several times.
iii) Confirm that the docking operations are possible.
Acceptance Criteria :
i) Beta elements docks to Alpha with out any excessive force.
ii) Beta is opened when Alpha is closed and vice versa.

Date : 22.06.2015 Date :
Customer :
12. Recovery Time Determination Test :
Purpose : To verify the amount of time required by the isolator main chamber to recover
to the previously validated particle levels after an event such as an open door or surge of
process generated contamination.
Test Equipment : Portable Particle Counter, Time keeping device capable of reading in
mins and seconds.
Procedure :
- Isolator shall be in running condition.
- Testing shall be conducted after 5 mins. of Isolator’s door in open conditions.
- Select sampling location to collect samples.
- Tester shall be inserting the Isolator Chamber.
- Reading shall be taken on display.
- Records the observations in result table.
- Attach the print out along with the document.

Date : 22.06.2015 Date :
Customer :
Results Table (Static Condition) : Compounding Isolator :

Location Particle No. of Particles Time taken in mins
Chamber 0.5 micron
5 micron
Acceptance Criteria : Recovery time shall be assessed mutually and to be logged in to
your SOP.
13. Procedures Verification :
Purpose : To verify the operation procedures formulated for the isolator.
Test Equipment : Internal tools and equipments etc.
Procedure :
i. Place the equipment and tools to be used in the process inside the isolator.
ii. Ensure that the gauntlets are fitted.
iii. Confirm that the operations are possible.
Equipment Descriptions
Alpha/Beta port Product and /or Samples can be removed to /from passive canister .
Inlet Filter The choked filter can be removed through the polythene bag.
Exhaust filter The choked filter can be removed through the polythene bag.

Date : 22.06.2015 Date :
Customer :
Cleaning - Sampling can be done through RTP canister.

- All areas can be reached directly or indirectly using a cleaning tool
and wash gun.
Acceptance Criteria : Operations can be carried out inside the isolator.
POST APPROVALS
Prepared By : ________________________ Date : _____________
(Klenzaids)
Approved By : ________________________ Date : _____________
(Klenzaids)
Reviewed By : ________________________ Date : _____________
Project Dept. (Client)

Date : 22.06.2015 Date :
Customer :
Checked By : ________________________ Date : _____________
Engineering (Client)
Approved By : ________________________ Date : _____________
Plant Operations (Client)
Approved By : ________________________ Date : _____________
QA (Client)
APPENDIX A - ATTACHMENT
DEVIATION LOG :
Deviation No. : Date :

Date : 22.06.2015 Date :
Customer :
To be completed before :
OQ (Y/N) :
PQ (Y/N) :
Operation (Y/N) :
To be completed by :
Approved by :

Date : 22.06.2015 Date :
Customer :
DEVIATION AND CORRECTION ACTION REPORT FORM :
Reference Test No. :
Nature of Deviation Major / Minor
Observation (Details of Deviation) :
Corrective Actions : Actions By :
Approved By :
Completion : Completed By : Date :
Disposition :
Acceptable : Y N
Conclusion :
Approved By :

Date : 22.06.2015 Date :
Customer :
APPENDIX B - REQUALIFICATION
Requalification :
Any change or modification to the equipment will be performed in accordance with the
appropriate change control procedure. A separate assessment will be made, if any changes or
modifications are requested and shall be checked for any further requalifications are required
and approved by KLENZAIDS CONTAMINATION CONTROLS (P) LTD.

Date : 22.06.2015 Date :
Customer :
APPENDIX C - LIST OF ATTACHMENTS
All documents attached to this report are listed below :
Attachment Number Document Reference Tests Confirm

Appended

Date : 22.06.2015 Date :

OQ COMPOUNDING 100 Ltrs ISOLATOR

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OPERATION QUALIFICATION

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 1 of 27

100 Ltrs Compounding Vessel

IsoKlenzTM AP N HS 1.0 x 0.70 / 0.60 x 0.8 - 2

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 2 of 27

Table Of Contents Page No.

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 3 of 27

Prepared By : ________________________ Date : _____________

Approved By : ________________________ Date : _____________

Reviewed By : ________________________ Date : _____________

Project Dept. (Client)

Checked By : ________________________ Date : _____________

Approved By : ________________________ Date : _____________

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 4 of 27

Plant Operations (Client)

Approved By : ________________________ Date : _____________

Following approval of this protocol, the operation of the Compounding Isolator is

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 5 of 27

BRIEF DESCRIPTION OF MODULAR FUNCTIONS :

The isolator is ergonomically designed for compounding of API with OELs of

The Isolator shall be operated under a negative pressure normally between - 80 Pa to

The Isolator has the functional units in main unit as follows :

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 6 of 27

1. Standard Operating Procedures :

Test Equipment: None

Procedure : Locate all documents listed below :

SOP Type Available Acceptable Deviation Reviewed By

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 7 of 27

Pass () Fail ()

Initial / Date : Klenzaids Client : Alpha-Pharma Healthcare

2. Chamber Pressure Test :

Test Equipment : Calibrated Manometer / Magnehelic Gauge, Silicone tube for

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 8 of 27

Ratio of Leakage Rate/hr to Chamber Volume = Q/V

Test equipments connectivity :

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 9 of 27

CONTAINMENT ENCLOSURE UNDER TEST

Calibrated Manometer /Magnehelic Gauge

Time Starting Pressure Pa or Measured Pressure Pa Temp in deg cent.

Acceptance Criteria : Not more than 42 Pa drop in 5 minutes.

Prepared by : Maria Jeffries Checked by : Amit Panchal

Equipment Name : Compounding Isolator for 100 Ltrs Vessel

Document No. : KCL-643-CI-OQ-04 Revision No. : R.0 Page No. 10 of 27

Initial / Date : Klenzaids Client : Alpha-Pharma Healthcare

3. Power Continuity Verifications :

Test Equipment : Calibrated Multimeter

Prepared By : ____________ Date : _

Approved By : ____________ Date : _

Reviewed By : ____________ Date : _

Checked By : ____________ Date : _

Approved By : ____________ Date : _

Approved By : ____________ Date : _