PINRACL { ichasra No, 1326-1380Village Manpu | pRoTocot no, | PLSTPRGICAS | EFFECTIVE DATE | {0S \¥ | ua PROTOCOL FOR PERFORMANCE RE. | 3 me QUALIFICATION OF COMPRESSED AIR SYSTEM | PAGE NO. | PROTOCOL FOR PERFORMANCE QUALIFICATION OF COMPRESSED AIR SYSTEMprorocot wo, | PLSTPROIGAS beParrienr OUALTY AssuRaNCe reef EFFECTIVE DATE | 0. 0S-\9 “| eunisiQFoeoL ron renronimwcene | pf Sine QUALIFICATION OF COMPRESSED AIR system | PAGE NO. 20F 11 | 1.0 TABLE OF CONTENTS [Sr No. Pepa ENTS _2____| PROTOCOL APPROVAL 3 INTRODUCTION 4 OBJECTIVE |___5 [scope neeeaaaae ue | —S___] RESPONSIBILITIES : a 05 | 7 REQUALIFICATION PROCEDURE AND ACCEPTANCE CRITERIA : 05-09 & | CHANGE CONTROL / QUALIFICATION CRITERIA 09 9 CONCLUSION AND SUMMARY + oo 10 | REFERENCE DOCUMENTS: __ 09 1 FINAL APPROVAL ot 42 DOCUMENTATION ae | 13 ABBREVIATION. I | ANNEXURES ATTACHED. SR. NO. ANNEX NO; TITLE 4 L REFERENCE DOCUMENTS i TEST PERFORMANCE FOR DEW POINT TEST 3 a TEST PERFORMANCE FOR OIL MIST TEST 4 Vv TEST PERFORMANCE FOR NONVIABLE COUNTS 5 v TEST PERFORMANCE FOR VIABLE COUNTS 6 vi SUMMARY AND CONCLUSION OF PERFORMANCE 7 MI FINAL APPROVAL,PINNACLE LIFESC ICE PVT j | Kasra No, 13284 220Vinage Manpura Feed iuseh Nea cian (HP) 174101 | PRoTocoL wo. | {,S/PRAICAS DEPARTMENT QUALITY ASSURANCE S200 ses eee Peer EFFECTIVE DATE | ¢j.0 SAR 7 "aun PROTOCOL FOR PERFORWANGE RE. : CHEE TLE | QUALIFICATION OF COMPRESSED AIR SYsTem | PAGE NO. eae | 2.0 PROTOCOL APPROVAL a oie Praaaae ES ae ree sicny | PARTICLURS: NAME DEPARTMENT DESIGNATION z PREPARED BY | Krishna Gopal Dixit _| Quality Assurance 7 EEE fo. Pawan Gupta Production Manager Wwe xl Aes Amit Kumar Maintenance Manager co" CHECKED BY —2 Manoj sharma Quality Control Manager i 0) s ity Control 9 A Deepak K Thakur —_| Quality Assurance Manager Whol eg ot APPROVED BY Ashwani Nautiyal Quality Assurance Head ZX orPINNACLE LIFESCIENCE PVT, LTD, Khasra No. 1528-1430Village Manpura, Tehsil Baddi, Distt. Solan (H.P) 174404 j Protocot no. | PLSIPRQICAS DEPARTMENT QUALITY ASSURANCE oo - EFFECTIVE DATE | g%j-0¢~1§ ae TROTOCRt FORPERFORMANICE RE. | pace No, Tae QUALIFICATION OF COMPRESSED AIR SYS 3.0 INTRODUCTION The Compressed air system consists of compressor dryer, storage tank end Cistrbution system equipped with oil & moisture trap system. Compressed air system in the facility to be validated as per this protocol. The qualification of compressed ait system shall be carried out once in a year or in case of any major change/Modification in the system. 4.0 OBJECTIVE ‘ . Jo provide @ documented evidence to demonstrate that Compressed Air System at shen operated as per established standard operating procedure shall perform effectively Ethe compressed air coming in direct contact with product during coating & packing shal be in compliance with the established standard, 5.0 SCOPE ‘This protocol is applicable for performance qualification of compressed air system installed at M/s Pinnacle Life Science Pvt. Ltd. 8.0 RESPONSIBILITIES (Preparation, Checking and Approval of Protocol) 8.1 Executive Quatity Assurance department shall be responsible for preperation and execution of protocol & compilation of results. 8.2 Officer or above of engineering, production & QC department is responsible for checking of protocol and complied report. 8.3 Head of Quality Assurance department is responsible for approval of protocol & complied report, 7.0 QUALIFICATION PROCEDURE AND ACCEPTANCE CRITERIA 7.1 Selection user points for qualification 7.1.1 Critical points-Those points where air comes in contact with the producti primary packing components, 7.1.2 Non critical points- Those points where air does not come in contact with the product/ primary packing components. 7.2 Only critical user points will be considered for quallfcetion.DEPARTMENT QUALITY ASSURANCE PINNACLE LIFESCIENCE PVT. LTD. Khasra No, 1326-4330Village Manpurs, Tehsil Baddi, Distt, Solan (H.P) 174401 PROTOCOL no, | PLSIPRGICAS EFFECTIVE DATE Jo 1-OS-\2 PAGE NO. SOF 11 PROTOCOL FOR PERFORMANCE RE- QUALIFICATION OF COMPRESSED AiR SYSTEM Uist of ‘equipment where compressed ir comes in dita Conladl primary packing components, ih the product 7 Table 4 Equipment Location Liquid Washing | First floor _| Liquid Manufacturing First floor Liquid Filling 7 First floor Ointment Filling First floor Tube Cleaning First floor Coating-01 First floor Coating - 02 First floor ” Granulation First floor Compression-01 First floor Compression-02 First floor ‘Compression-03 First floor Blister-01 First floor 13.__| Granulation ‘Second floor 14, | Blender ‘Second floor 18. _ | Compression-04 Second flaor 16. | Compression-05 ‘Second fioor [ 17. __| Compression-06 ‘Second floor | ___18, | Auto coater-o1 Second floor 19. | Auto coater-02 Second floor | 20. Coating solution preparation | Second floor 24 Biister-03 Second floor 22. Biister04 ‘Second floor 23 Biister-05 __| “Second fioor 24, | Alu- Alu packing-02 Second floor 25. Water System First floor 26. F&D Lab Second floor [27 Filter cleaning First floor 28. Service floor First floor 28, | Capsule Filling "Second floorDEPARTMENT | Khasra No. 1328-1830Village PROTOCOL FoR pERronMMNcE RE. | p,c> 5 QUALIFICATION OF COMPRESSED AIR SYSTEM i ACLE LIFESCIENCE PVT, Li lanpura, Tehsil Baddi, Distt. Solan (F PIN Pp) 174401 i eroroca. no, | PLSIRavGAs uur assurance 7.3. Sampler & sampling procedure:- 7.4 Testing procedures for Compressed Air. NOTE:- Samplin, ig and testing shall be performed in-house or out sourced approved agency, 7.4.1 Dew Point 7444 7442 744.3 7414 744.5 TANG 7.4.2 Oil Mist Test: 742.1 Cai Test: Set up the assembly for Dew Point Determination / Water / Vapor ‘or Dew point transmitter. Install a reducer pressure with gauge and flow meter to a point of monitoring and adjust the flow meter. Set the flow rate of compressed air to 100mi/minute for tube method _ and 100It/min for transmitter. Pass the compressed air through the Gastec Dew Point determination tube for 10 minutes. And in case of transmitter adjust the transmitter in front of flow. Observe the tube immediately for the color change from yellow to Purple Dragger tubes and in case of transmitter record the results. Perform the Dew Point determination test at identified locations as per Table-! and record in Annexure-I ify out the Oil Mist Test following either Method | or Method II 7.4.2.2 Method | (Gastec Tube Method) 742.24 74.2.2.2 Set up the assembly for oil mist determination (Make: Gastec Corporation, Japan, Principle: Dragger tubes). Set the flow rate of compressed air to 4 Liter/minuteDEPARTMENT Piwniac CENCE PUT. L7D, | Shasta No, 1328-41330Village Manpura, Tehsit Baddi, Distt. Solan (H.P} 174104 | protocot no. | PLSPRGICAS QUALITY ASSURANCE - as EFFECTIVE DATE |o1-CS- \% PROTOCOL FOR PeRroniMNCE RE. | 0 QUALIFICATION OF COMPRESSED AIR SYSTEM 7 "742.23 Pass the compressed air through the Gaslec oll mist determination tube for 20 minutes, 7.4.3 Observe the tube immediately for the color change from pink to blue for oil and pink to yellow for water if present. 7.43.11 Record the observation in the observation table 7.4.3.4.2 Carry the test for all the identified locations, 7.48.13 Perform the oll mist determination test at identified locations and recorg in Annexure-Iil” 7.4.3.2 Method Il (Filter Paper Method) to 1 Liter/minuto. 7.4.3.2.1 Set the flow rate of compressed 7.43.22 Purge the compressed air through the purified water container for § minutes, 7.4.3.2.3 Close the container and transfer to QC / Micro Lab, 74324 Filter the purged purified water through Cellulose Nitrate (0.45) Filter paper. 743.25 — Observe the Filter paper carefully under microscope. 7.43.26 — Record the observation in the observation table 7.43.27 — Carry the test for all the identified locations. 7.4.3.2.8 Perform the oll mist determination test at identified locations and record in Annexure -Ill, 7.44.1 Tests shall be performed in house or by an external agency competent to Carry out the testing and the reports in their formats shall be provided by the agency. Such reports shall be considered as raw data and compilation shall be carried out by engineering / validation department. j iDEPARTMENT | QUALITY ASSURANCE 7 i PINNACLE LIFESC NT. AT, | Shasra No, 1328-1330Village Manpura, Tehsil Baddi, Distt, Solan (HP) 174101 prorocot no, | PLSIPRGICAS | PROTOCOL FOR PERFORMANCE RE- 7 QUALIFICATION OF COMPRESSED AIR system | PAGE NO. Sort EFFECTIVE DATE [oJ ~ 0S “| ~ 7.44.2 “Setup the assembly for calibrated particle count Gnsiaumnt make: Mat ‘One or equivalent, Principle: Light scattering). 7.4.4.3 Connect the compressed air through PU tube {o the Clean SS Three way ‘Assembly and open the valve of compressed air 7.4.4.4 Allow the air to pass on for 1-2 minutes to flush the assembly. 7.4.4.5 Connect the particles counter to assembly from large opening side and start particle counter. * 7.4.4.6 Take the particle count for 1 minute for particle size of 0.51 and 5.0. (Sampling volume 1CFM ¢ 0.1). 7.4.4.7 Record the observation in the observation table. 7.4.4.8 Carry out test for all the identified locations and record in Annexure+lV. 7448 Perform the particle count test at identified locations. 7.4.5 Total Microbial Count Test: 7.4.5.4 Carry out the microbial following either Method | or Method Il or Method ill 7.45.2 Method I 7.4.5.2.1 Sterilize the SS assembly & sieve. 74.2.2 Connest the SS assembly's one side with compressed air point and connect the SS assembly another side with M air T sampler. 7.4.2.3 Operate the Milli pore Air sampler (Model: M air T) for operation and determination of microbial count. 74.5.2.4 Pass 1m? (1000 liter) compressed air over the Petri plates, using Soybean Casein Digest Agar (SCDA) plates. 7.4.5.2.5 Incubate the plates at 30-35°C for 72 hours for Bacterial count & the transfer the plates to 20-25°C for next 2 days for fungal / Yeast count. 7.4.5.2.6 Record the observation in the observation table. 7.4.8.2.7 Carty the test for all the identified locations and record,( PINNACLE LIFESCIENCE PVT. LTD, | Khasra No, 1328-4390Village Manpura, Tehsil Baddi, Distt. Solan (H.P) 4 on PROTOCOL NO, DEPARTMENT. QUALITY ASSURANCE See EFFECTIVE DATE PROTOCOL Fon mERFORMANGE RE. | QUALIFICATION OF COMPRESSED AIR SYSTEM 7 7.45.2.8 Perform the microbial count test at identified locations and record in Annexure-V, 7.4.5.3 Method It 7.4.5.3.1 Determine the viable volume of airflow discharge through, user point, by Passing the compressed air for 60 seconds, in a inverted measuring cylinder filled with water. Record the volume of water displaced (z mi]. Volume of air for § minutes is calculated as V in m? = (Z X 6) / 1000. 7483.2 Setup the air collection chamber and expose the sterlized Petri dish Inside chamber. 745.33 Bleed off the compressed air in to the chamber for 5 minutes so that compressed air passed over the media. 7.45.3.4 Incubates the plates at 30-35°C for 72 hours for Bacterial count & transfer the plates to 20-25°C for next 2 days for fungal / Yeast count, 7.45.35 Determine the TMC by counting number of colonies. 7-45.38 Record the observation (as TMC) in the observation table. TMC per m? is obtained the value by V. 7.4.5.3.7 Carry the test for all the identified locations and record. 7.4.8.3.8 Perform the microbial count test at identified locations and record in Annexure-V. 7.3.8.4 Method It! 7.8.5.4.1 Open the air valve to allow air to pass out about 2 minute to remove stagnant airin line, Attach the clean sterilized silicon tubing to the user point, 73.542 Open the air valve to bubble the air into 100 mi of sterilized Mili Q water by allowing air to pass to the tubing for about 2 minutes, 7.3.5.4.3 Visibly inspect the flask containing sterile water against white & black background by shaking the tube at frequent intervals to cheok the presence of suspended contaminants. Water should be free from suspended contaminants.DEPARTMENT QUALITY ASSURANCE 8.0 9.0 10.0 14.0 i PINNACLE LIFE CE PVT. LTD. | Khasra No. 1328-1390Village Manpura, Tensit Baddi, Distt, Solan (H.P) 174104 |enoroco. no, | PLSPROICRS EFFECTIVE DATE || 05-19 100F 11 PROTOCOL FoR peRronmwoeRe. [p70 QUALIFICATION OF COMPRESSED AIR SYSTEM. a 7.3.5.4.4 Immediately bring the flasks after bubbling the air in microbiology taboratory Perform the analysis by membrane filtration 7.3.5.4.5 No growth should be observed in the Medium after incubation for five days. CHANGE CONTROL / QUALIFICATION CRITERIA 8.1. If there is Updation / modification in Compressed Air System or if it is replaced by Rew one, then qualification shall be cartied out through change contro! system, CONCLUSION AND SUMMARY 9.1 Compressed Air System shall be considered to be qualified for the performance, Provided it shall meet the acceptance criteria for the same. 9.2 The results of the Performance qualification shall be summarized in summary report & the report shalll be prepared by Quality Control as per Annexure-VI. 93 After evaluation of details and summary reporis the Quality assurance and Production Head will be responsible for approval of the performance of the system, REFERENCE DOCUMENTS 10.1 Details of reference documents required for the Performance qualification of Compressed Air System shall be mentioned in Annexure-| FINAL APPROVAL 14.1 Final approval shall be prepared after completion of Performance qualification of ‘Compressed Air System as per Annexure-Vil 12.0 DOCUMENTATION 12.1 Separate report shail be prepared for each annex during Performance qualification of Compressed Air System,' QUALITY ASSURANCE PROTOCOL No. EFFECTIVE DATE QUALIFICATION OF COMPRESSEI PROTOCOL FOR PERFORMANCE RE- IR SYSTEM PAGE No. 11 OF 14 13.0 ABBREVIATIONS: Sr.No. | Abbreviations Description _ 1 CFM "| Cubic Feet Per Minute Z 2. cGMP Current good Manufacturing Practices i 3 PPM Part per millidn : |ear EC European Commission 5. PIC Pharmaceutical inspectorate 6. cru Colony Forming Unit : 7. NLT Not Less then [8 TMG Total Microbial Count *END OF PROTOCOL*Annexure - 1 Reference Protocol No. : (PLS/PROICAS-01 ‘TEST PERFORMANCE FOR DEW POINT TEST Date of Test Acceptance er rib eS Lei P & |4-oe Dew point shall be NMT ~ 40°C Sr. Sampling point Deser iption Test Results (°C) Pass / Fail Compiled by OM ot reataton Coat ~ure fess forad Cot) Ea Fi £2" | stip mathtn spam muse fess Loin (92) to 7 0 ~~ Remarks! Ail the results are complies/does not complies to the acceptance criteria, (Sign/Date Qy~ Format No. : QA/F-108-00Annexure -IL Reference Protocol No.: PLS/PRQICAS-01 PERFORMANCE, "OR OIL & MIST TE (8S Woe Date of Test Piles Acceptance eriteria-: Oil & Mist shall be NMT 0.1mg/m? Sr. | Sampling point Deserip Test Results Compited by oh ‘ ee “Bb Gentrayon fond | Not aboerverl! Pas &. Bs E teint (aL) ct : —_ 7 eS 2" [ehn'e macht wnem of gbs-ervee of Pass xcs =o | Remarks: All the results are coniplies/does not complies to the acceptance criteria, Syke Checked By: ae Verified aR ENG ae (Sign/Date) “Q\? (Sign/Date) Formal No, : QAE-105-09TEST PERFORMANCE Annexure -HE nce Protocol No. PLS/PRQ/CAS-01 Nooe- 1g SopV Acceptance criteria : NMT 67 ppm for WATER CONTENTS ee : a eee esse Sr. Sampling point Description Test Results Passes / Fail Compiled by . si Ad S| Cenacatton Point Nol ob gerve of fags Xe _| Col) . ZA\S o7" Ighniep mathia oan. Nof observe sl foss Xx Remarks; All the results are coniplies/does not complies to the acceptance criteria, Cheeked By: (Sign/Date) on Fonmat No, : QAVE-103-00 . AE Verified nO S- (Sign/Date) Page tof 4Annexure-LV Reference Protocol No.: PLS/PRO/CAS-01 v PERFORMANCE FOR NON VIABLE PARTICLE COUNT TEST Date of Test peo lD RI oe P Acceptance criteria : 5.0 um: s 100 1.0 ym : < 6000 0.5 um : = 400000 “TestRan | Sr. Sampling point Description “4 Passes / Fail | Compiled by A 05m | 5.0n| LOm : a . faces 6 N8 218 [Cemmnhin Point Cot) lguow | o trea SG « AB A | ohSo mackie wom | o jlo Pass os RY eA | Remarks: All the results are combffcdoes not complies to the acceptance criteria. Checked By: Verified By: cae a EMS 4 (Sign/Date) ~ Q\~" (Sign/Date) Format No, - @avE-103-00Annexure-V Reference Protocol No.: PLS/PRO/CAS-01 ‘TEST PERFORMANCE FOR VIABLE COUNT TEST Date of Test bieoe- 18 Ror a User point Deseri tion Test Results Passes / Rail Compiled by : AB Io enivarien Pornt tol) ieepu Ie Pes. aS : ; i 92") sho macliutyoom| irerulg? pass Pea | oS Remarks: All the results are ceulfiesidoes not complies to the acceptance criteria, Checked By: dees Verified ws CPx 3 (Sign/Datey “ON (Sizn/Date) Format No. : AF-103-09ANNEX - VI SUMMARY AND CONCLUSION Reference Protocol No. : .PLS/PRQ/CAS:04 enul pcactiaig et | £0. WEG. mi 29 \d' pnd Checked ide 9 Verified nC DEEER @ (Sign/Date) “OQ (Sign/Date) Foumat No. -GAIF-103-00 Page (ofReference Protocol No. ; PLS/PROICAS-01 ANNEX ~ VI FINAL APPROVAL, signs PARTICULARS DEPARTMENT NAME DESIGNATION sign ‘COMPILED BY QUALITY ASSURANCE [lhiwad Joued Soe Obfrcen. Ae 3 vost — RN PRODUCTON LO soon plo. Konegar As 7 0 gi 0S) AB REVIEWED BY ENGINEERING Dinih Hevea | Mt ona de re Sies a ee : su fare yt i aunuirvassurance — |Kaishn Gopchtet) Grew iive, i-us 3 APPROVED BY. | HEAD - QUALITY ASSURANCE Hiisho one Chat Hoad GA owe, a’ Formal No, : QMF-103-00