PFRFORMANCE QUALIFICATION Oe PROTOCOL p= nie Under Qa icaton Naw Protal Ne ‘Tunnel QCORP-154-07-2023 ‘Castomer Information Nan Saad Veterinary Pharmacy Produ Factory Ares. acaton: Ripadh -KSA ‘Visual Selition Tanel quipmene ID No: APD-O33 Manufacturer ROTA Verpackangsecinik Mode rssantsas Serial No La(Ae PERFORMANCE QUALIFICATION ene dl PROTOCOL aa_» Ta ke Onan Te Fate ‘nel OcoRr-0s4.07.2003 1 tne Qu! A co : 4. Stem Det pe tl cA, cueanCes tnd Ape rn a pet ulin a ed . eee . = _—1 pt Frm Nos QA00%6 Page ofWy PERFORMANCE QUALIFICATION, ‘iat PROTOCOL, 1 Pt Farm No: QA0076 Page af Wade Quinn Nae PraicolN ‘Tunnel OCORP-054-07-2023 Performance Qualification Protocol Approval ‘Quality Compliance sate indicts ta the documentation an information contin ein ‘complies wih the apple egltory, comport, ivisonaldepatmetalrequiements and ‘suet Good masuctring practices. ‘Customer site inate that his document seen prepared with our knowles, hat ‘you apee with the purpose ad scope ofthis document, ta the document hasbeen reviewed by ‘he appropiate ptsons and thal you urs the reso esponsibility for your departnent ering execution of thisaidaton pan ualey Compliance amie ‘Sigmalore Dai Prepare by: ‘Name Reena ‘Approved bye [Ramer T * Castor Name ‘Signatare Date Riiewed Name | Reviewer ise Name Apnea | Name Protocol Revision Ts Rivison No Dave Si Deerntonealy, eerronsaxcr. oui ieicxtion aes PROTOCOL ‘ite SPP int Cader Qualification Naw Protocol No: | ‘Tunnel QCORP-54-07-2023 2 Objective: ‘he objet fhe paomansgulfisin (PQ) tal 0 we hat alrite component of “Tame! as cnet ker in cise pre ctv and eprodly, aed on Sa Veterinary Parmaceacal Products aston oesent nl quiy nits. 3 Scope: ‘he scope of tis qulifeion prota isin on Tun os Vit Washing Teana Rom Su Veterinary Pharmacol Produces Factory 4. System Description 4A, Seructare Sesuporingconsincton in MS pnd. Tune hosing welded ties te wich ou walle inthe etng zone with ashests fe insulation, Vis an conveyed though the “Tunnel by an. . 30H ink conveyor. 42, Functional details of Dy $24, Drying ane In this zn, fieshairsscko in from thereon though e-file ands freed down onto the vs bythe lower zough a HEPA fer | mn, Sterilcing zone ad Cootng zoe: ‘Duc to poxtv differen the drying zone with efernee to washer, part of iris directed | fo the dying tamer to the washer, tobi slight drag of lean inde washer to rote the containers ding and afer the washag ele 442.2, Sterlaation Zone Inset onthe is ar ate to txparatrs between 300 -30°C and mana this temperature fara speed tne period, This wll ens seriization and depyroneation ofthe vis Cnt lower ipl encased within the mone sae om ow te convey ous let heats al shes the hot si nough High Temperature HEPA Fes. Temperature of sirin th zones cortnousl menitoed by RTD sens.uty PERFORMANCE QUALIFICATION es PROTOCOL splat SPP Ta de nN pea ‘Tunnel ‘OCONP-054-072023 “Gass are provid athe entry and eit of he seizing ze to avoid est loss during stat up nat thea ofthe cooing net avo aientering fom sterile ing are no the coting zoe of tune, Opening ad lasing ofthe gle achieved manual 423, Cooling Zone: tn the cootng zone, nt vil exing the erization ane are cooled dwn wom tener, Atte same time lent of he one designed in suc yay 0 5 oad ay ‘hema tess on te src ofthe vas 43. Drives 431, Drying and Caoingzone Deve system: ‘This ve system compos of Phase Blowes 4.32, Steritaing Zone Driv Sytem: “Tis rive system compromises of Phase motor coupled with lower throug et ive. The sped ofthe motor svi wing A.C. variable fequeney dive 433. Exhanst Blowers The vaporextacior ks othe vapor from the val generated du oprebeting ad isctarge imo the earmon exist dct comgnises of 3 Phase motor directly couple to | inpeer of blower. “Te cooling Zoe exlest blowers compromise a 3 Phase motes diedy couple simples of blowers 4 Transport Arrangemat ‘eco tes ah ofthe tunnel, The effetve with of te cenveyor A arte conveying ond den by an AC. Inivction Motor ay tin and socket rive The sped ofthe conveyor mors varied sing variable Frequency de 45, Control Iastrumenaton: Gener ‘ata reeodingon to printer to ep coninaous record of poses params at dese os + Plog tmpesues onto sup chur eon ‘A ls aspen lam isan print nt the printer. Fam No: Qnon7s Page SaPERFORMANCE. QUALIFICATION ars PROTOCOL, = SPP ‘nt Uder Qunien Nae Pract Ne ‘Tunnel OCORP=154-07-2023 Proximity sensor fo Adequate nnd and Mmm Accumulation wt Outed with slam Night mode opeation of uel Devine Zone: ‘Air temperatte monitoring ia the zone below the conveyor by RTD sensor with lem a igh cmperaue. ‘Pressure dere ndcation ky Magehalic gauge across HEPA ier, ‘String Zam: Press difreta ination by Magpcelic diffe gauge across HEPA Filer. Montaring th geste of Hot Air ew the HEPA fier by 2 RTD sens. “Themastat above the HEPA to ctf he ester power supply in case of PLC arto safeguard the HEPA filter, = Cooling Zone: ~ Presse dfere il ndcaton by Magncheti differential gauge across HEPA Ter | Artenperstre motoring inthe zone before te blower and below the eonveyor RTD sensor wth lar at ly Cempertue = Airvelosymostoing and controling wth ale tow iit. 446, PlectrelInstatlation ‘Separate salon SS304 Elia Panel (Cont cabinet) with devices mounted on MS ponder chasis. + PLC based con sytem Meters contd by fist siting vies 1+ Creat Drawn iy syste is isplaye onthe operator pane | + Operator inerfe with sren rovidag beter and easy manewering ‘riven by AC mtr atched with dives as equi 1 Sit cale foo onl cabinet o machin. “The elec sytem housed in pane ox nance o COMP standards. Panels freed ole hy fan aso, Foon es QAON76 geoeoly, vervonseaxcr aussaniestion ere oe PROTOCOL SsPPE [Ws Wade Qualitnion Na aol Ne ‘Tunnel QCORP-154.07-2023 4 Guards: ‘The tunel is covered with esl emovable guard of 8S. 304 dul bul 48 Lubrication ‘Greate equicementformectancal components wil be speifed inthe mntenane manta ‘5. Responsibilities: “The esponsibility of xh department involved inthis qualiation study ne sued below. 5.1 Mainenanee Deprtnont SAL Providing quai pron lp while evession ofthe prota 8 equred 5.2 Prodetion Departert 5.241 Providing ques person to hep wil execution of he preaea as equ 5.2. Providing accesibilty othe equipment 5.3 Valitaion Deparment 53.1 fing the PQ pote 532 Rls analysand determination of parameters to be hacked 533. Determinatonof esting prcedures and acepance eit 534 Exceton ofthe valdaton activi 5.35 Rept th nal sultan conclusions |) 6 Risk Analysis, Qualification Checks and Acceptance Cr | “The tii praneters ofthe psfrmaneeof Vil Stalin & Depyogenting Tunnel SDPTV- ‘650 Tunnel have Ben alate andthe following tess found necessary tobe pesfooed, G1 Adetlow Velocity: “This espera to dlemine the wrlow velocity dsuibton inside th ume 62 Fier System Leakage: ‘The purpose his test so contin thatthe HEPA fers installed on the tunnels prope insta ty verifying the sbsenee of bypass leakage in te installation, and tht i Fox Na: QAO Page of i(lly, reev0nxce: ov stintexti0n ers PROTOCOL oe SsPPE ni der Quien Nanos Protec No ‘Tunnel QCORP-54-07-2023 the fies ae fe of det (small oles ade damages io he er media ae Fame seal) an es (bypass leks the fie fame and ast sea, leaks inthe ier tank famewoa, All dose san readings shouldbe NOT 0.01% ofthe upstream hllengesrosl “oer eae ee (os tention es het 66 Meat Ditribaion Sey Keeling tore oral room ‘nite dann eet isd th age ul be ahi, oh, empire ‘als fo dificee location for dry heat lization a temperatures mre tan 310°C Lercegh Md lon Gabe. “The lactone col spo, wich represeats the lacaton of owes achieved empertre,soud be defined in is stage, 67 Heat Paetraion Study: For ach fond snfiguaia (vl si), the vale (iling tine) should provide testy ssuene oP Mor eter tobe produet under the mst alto trie Pont. The Fale should provide assurance at stilzton in ch enn as @ PrababliyofNon Stile Unit (PNSU) of Wo retin) witha Salty Fora No: AOS ages orttae sect, Wa cl, (Pees nll Men trem Vi (teiy| menronsance:cuasaricsti0n ans | PROTOCOL er SPPe {i Uader Quaiinon Nae reales “surance lve (SAL) of TH for bacterial endotosn with at ak BMS EU (endotoxin nits (HEA the rigjgggmowat is esctvated) F400") shad te NEP INUES., rare The Nad Meh is 1S vorn 68 Setiy Asmmmesiny, eh Aaa 954 Sige the major objective of th silising 200 in the tunnel estbish an assurance that no ties bacteria shoul be not ater depyrogenation, Pyrogen vil of cl spores wich onsiere ste most resistin he emperureshoudbe dsb ins the tun atthe ol pt lean “This sty shold give an indication dt dhe stration cycle wl killa ype of ness witht evi eof bacteris. Te pesnee of residual enftoxin canbe lected by the LAL tes Nevers a LAL. tet should be sehieved inal endotoxin via challenged inthe una 69 Output Vials Temperature: Sine the mje objective of he ong & tabilrng 70m athe tne iso establish ssiance hath tilized vil ht wl edie othe filing machine sould be co an stabil tmperatur als for ves ever oe ling machine shout be monitored "Temperature of vas owt of he cooing & tabling 20 shoul be NM 25°C 1. Performance Quulifieation Test Procedure “Tests wil be pesfrmod ty operiting the equipnt as pe ts operasing SOP to ensue dhe pesfomance ofthe tne and thatthe ry beat terization process fr vials canbe performed cffetvly and reproducibly as deseribed bow. TAL Aleta Velocig: 714 Strt ype tne! folowing the elated operational SOP. 111.2. Perormsbe ts tllowing Atow Veet Testing Proceaure SOP Nn VALS}, slag Alo Anerometer Frm No: Qn0076 aby,uuliy PERFORMANCE QUATIFICATION ier PROTOCOL, a | Pare Unie Under Qaritaton Naw Protect Wr ‘Tunnel 73 4 s QCORP-54-07-2023 iter Sysem Laahage: 71241 This text soul be conducted oly afer low velocity test tees ompetion faetch HEPA fer. 7122 This tet ill be applied in atest occupancy sae 11233 Perfo the tt flowing stalled Fier System Leakage Test SOP No.: VALODA, ng Acro! Generar and Phocometer Aire Pate Cou TAA ‘This test shold he conduct only afer fer stem leakage test sucess complain, 718.2 ‘Thi est il be api in aerestocapaney slat 712.3. Statup the tel olowing is operation SOP. 7134 esos the et flowing Alebome Panicle Count Test SOP Nos VALO29, wing Discrete article Counter. Diferenal Prasure across HEPA Pier 1. srt dierent ressire measremene meters calibrate ii. Switchontbe dere presiemeasuement meter andslet the siabepesune ii Win all NEPA fier ied the pressure erence an ari sal Be messed Iv. Place the one tbe (aeatveo pose) Before HEPA fier and one tbe (apstive or posi) aller HEPA fer depending on idirestion Record te test el vic Tf the ext ess re out of seseptane imi te fst must be sepeated ar taking neces acon Ale lo Direion Test 1. Alu drccton est shal be conte afer operational iow vest ichoked fi Notify te engincerng deputment to disable the Srefsmoke alam system C0 spaiabo, ii, Clean anttansferthe smoke est pprats(Smoke generate, 0 respective are Iv, Plug On snake generator, ad comeet a educer an hes pipe af deste size to gener to generat hin sta of smoke & setup he vdeo camer, oom he: QAD076 age t0 of(uly PERFORMANCE QUATIFICATION a ue PROTOCOL m SPre= Une der Quniton Nawee rsa Ne 16 W ‘Tunnel OCORP-054.07-2023 Form No: Qn0076 age Hof ‘Care sabe taken to ese tat the generator spoke does not obseure oF mask He sctviy bing performed vi. Observe wo stoke fam te generator oi lit reach he working evel sii tng Veo Recording, ake evidence fr eal dat of est vii atv te shal be video graphed (sing CEIDVD) such that it will provide video evidence rio ireton, eat Dstribation Study 26:1. efor tt this stay, the following ealibeation operations shuld be performed ‘+ Calitaton of tunel terpertre sensors 4+ Calitaton of the themocooples ving temperature calla, Discard any thermocouple that give unstable incor! eaings (80.4C ofthe st valu) 162 Ensure tt che tunel is empty before ring te guaiiestion wis 7163 Distribute FTGBHBEAE thermocouples inside the tunel in one row. The tips where the wis te soldered shold not make contac with he tunel ntrior wall or tunel conveyor. ‘264 Operate tunel by sting the tuonel per the set paramets. “165 esform >os un seniors calibration ater each heat dsbuton cycle using the ‘temperate albvatr and discard the filled seasos. 1166 After completion ofthe trilization cycles, caleulat th average ofall emperstte 1183 efine he oles point (old sp, “168 Auch We prinout ofthe da fogs. Heat Penetration Study Heat peairaton shouldbe done fr each lod coniguation (val ize) a the eld spat location define by he eat siblin sty 65.1 Inset the theratocoupls inside the ils hat located athe cod spot location eterscd inthe eat istbutin study 652 Pett lope iniestors containing NLT 210° EU athe cold spot defined by ‘he eat bution studyPERFORMANCE QUALIFICATION ers PROTOCOL, sia QCORP-054-07-2023 (653 CaeusteF|GOO"C) considering Z value as ea (It snot mentioned i the cesta ofthe bilo indeaton according tothe (lowing equation ry = Ysa Where > Fie he te Gn slau) to produce the equivalent stelizaton effet at the ference emperatue of 20°C, wich represents yee tally > Z value isthe temperature change (in nuts) required to cause a log secrete vale > Denies tewnee of h itv at enc fs omioa4 coment emp > tite sn inne > iste weg emperor (49 nr 5A Fm teapemure dam, ermine essing ine camayr spe) snd ener eet ache Fs QUO va 655. Rep he uence eine ig Bs cee he ded moccasins jes canbe err! he we ied sith be peas ec ofthe ee ation es, 656 Pat tan emo earn area het ptt cle an ded the ents fe ile ses 6:7 Atnh gp rt 18 SurityAsirmss Tet Ks G1 Sei nn with oplion of QU or gee ol ps peri 652 Dstt Wolpe nesta (ns ol pt oe me comer 663 Oper nl Yohigees torn tne ne cee atin tr 665 Recor tents 666 Atach heceriteatof he biologi indies. Form No: Qno07s age no 4a (yy PERFORMANCE QUALIFICATION Pry PROTOCOL, SsPPe Unie Under Quniteaton Name Procol Nae ‘Tunnel QCORP-054-07-2023 79 Output Vals Temperate: cy at TVS a tte ci gto stig Motorist oftva. SFemah ML Youd ef aad q— 3 BS Recoal hess. 5. Discrepancy, Justification and Corrective Acton: ‘A devo and dein sing hi quifcaon stu wl Be ted and ecumened os descibt ihe Veisor tmerrrarvmnpwasen, Sep. @per 6 = Discrepancies and onthe actions ep, fy, wl be ae th PO pat atachnens 9. Change Control “The changes ring this qulition sly wil be rated and documented as esr in the SarErToTerriarvHPmAtsE Sep. Ofoes + The change contol report ifany, wl beaded to the PO rept tachment 10, Requalification, Nextag gullChn Shends vc Revficrelh ara Re MethiGent wit be eoquatitid reering to an following the Validation Maser lan pees ‘chal sikh ford [SeRARRe hele cb tameadoeotem —— ee ee [our ure Goad Manicuring Pets | DN [:idewieon Number NA Not Aplicsle NPL ~ | National Company for Pharmaceutics | NT Not Les Than a Not More Than Farm Ne: QA0076PERFORMANCE. QUALIFICATION are PROTOCOL —_ vec cont tevoraus 7 Speen gaan Eco — Pharmaceutical I ion Co-operation Seheme mo eas ae eaaroaa aa ane a a Se ame TAS rama, [enters soe ae al poe ed Sone Dra Fea yfletocigcrmatia Pe the tests ant exciton procedures win the sepe ofthis qian potoco are consistent vith the ling efanes: 12.1 USP, eunercetiton 122 Validation f Pharmaccuea Processes ~ Sere Padus, Frederick Care an Janes P. Aatlloce, 2 Eon, 199. 123. PICIS Recotenaton ME GOS: Gude to Good Manufacring atc for Mediat Prods Sepmber 2008 12.4 WHO Quality Assunnoe of Pharmaceuticals, Compendium of Gideins and Related Matra, Vole 2, > jeden, 2007 12.5 NCP Validation Master Plan, VMPPV ALISO. Form No: QAI aoe Mor(1228.1) DRY HEAT DEPYROGENATION INTRODUCTION Caen ee ES ee ena tin ooraceaoon gaan ger rp ct prac agus ret arncigBate fcancr lo pant ey ae ach nds rin he cals fra negae cera, The seston of ox onthe epee) sis Si ec SS cee autre met eee mia shag lancaster anette Se saeco ep a argent ht ees en seen et el cee ae SRE Siesta nea inno es poarc apna ‘TECHNOLOGIES USED FOR DEPYROGENATION BY DRY HEAT saa sree pce ih lel ete ret, ne ee ee ea cee oven ce eee se va tbe nae ea hapa soap pe Batch Ovens ‘eyrserabn nd can tbe seed wn proce esate open prsearoagh ane Maa e ee ee ae tae inti ite senegal rari aths Sega ae at a ina eae eet inl ric etl rb ttl prt eer ‘nine be rcpt Pete ove atcha ave hulsbeenrcdn sens Inge el dor raion is "Inept oven rer ables ae se pointteperature, urseon of vel Continuous Tunnels a ee erga ns dee cing and cary Wega wx a ‘Miner Tues tal tse fonadhested Se stars or adn yes tat ciclo a heh oe ac alt rane tact greenies ppp or Sede papa, el rata onto lw ere cons ‘incite tin te hae ae essentiy santa arc coat, he tenpetire st te ls Sh pses ‘agit come wh nae wt reson, Ewe deere yssing te eae ed ‘wk ine as mes conmncy ated ug Usenet her et sorces, sch sear hh pesare ‘cay caetante, heeds deyogeraton unas senate, epson See Sora “ene ‘wor webotporma.crnDRY HEAT DEPYROGENATION FUNDAMENTALS eum astern Ree eae a a a ecmalatn eoce deserter. fang aed hr asl Feo tas conyers DEPYROGENATION PROCESS CONTROL accepted tsps eon pe ne ter epee ents ee ce ETERS fades ct nee ee So og Some em bare cone tet were See seg ‘tr a te tare Sagar etal igi amon ion pre men ecm Sater hed citar? Sales foment ete eng peor teteah ri to epi cont re s reenter ec Sargeras se ananes Diaspar ee ne lS {han 20" tsdetermine elaine tht provided 3250 yore “ riser SPN Se Son ean be ene 1-250. 50. F=f10° 3 a=¥ "10" at occ ve ne ea) at dobre overt couse ofthe proce Mary conver aa logge ae eauapped wih Se ee ogee neg eo coma ag «poe The reason cree saben alanon maser, anderen cana, The rather pple ey akston [Seton hee thse ozs lett wes nate stan. yes ee oa Facet tertne cvs tant seston ee pose VALIDATION “Times od sens aan Siang a can a ester selena ote) eae rea re ey a ttang ote ain eon ‘Stoica separ Soaps setae Equipment Qualification eget Cunitatn 2) pend pro toon he rocsing iment cde th en Fe Pate), earned age nde afartwandogcliasaon| “ee “ ‘Serrscbotphormacorspon uifiction OO) tpn uit poe al or pemntve mean and change cnt ‘SEGURA A iat ape on ores Empty Chamber Temperature Distribution for Ovens rca nen rr ene ecBicre ane era i a eee meee ‘pene te etpanre sion nwemantnay beat auc the waton ocnge thee Empty Temperature Distribution in Tunnels sexes unin yeaa ir age ee ee Sr eta genera ee See coaneed mse ar cas sateen Component Mapping a en on ereencsd es tas consent wit how they wale proceed, Cas aly Sion eareeiieis san eeareicemeah Geaveammcenavcega {traperaturen wil peerped wih prebosin canta wi the bottom ofthe centane, ‘toad Mapping in Ovens Fld ong ptr een tn Sopa bce fhe nt ht ay hee uy pc Sie ie tse the re tose toss woes oc sen ce ane dln depen cea emt ond apn ad ta, Eee stent terns ey bop dana nt ened ham ve pee das oak monte ctr within thea pt, Load Mapping in Tunnel eer at ante sen shea pace ro teeters the Ga tem at seeeina ier oe ei eee eigen ram oan SERGE AB. ie irpeneeateat teeeee renew serena cee ee cA erin oem ctr mera a aon ‘Stat ction ss ny oun Confirmation of Depyrogenation stg compres tbe epee si am rt gringo con fae oi erent eed mea wea, eed mars uit Bareiomamsa mann erences rere ae as peroneal eases temperate ocr ot ene wae reine proces ‘Seater els wists tae othe deeming ssa once was Een epee a Perey poms a tin = “ ‘weorebofphrma comSaige torecnon Sheaaytacme tm stmt st me ty te er! as oe Poi i efile tel tt ‘Tatprocas conde xcepble the smoun of estsn ese NM. 8 ROUTINE PROCESS CONTROL, niin aborts a re eu pe nk i era yea Srornfictcacrenca stat ates cman mo he Segre iP apace aorta mi Manet rae ra else ate SSR cae Se non lent meio APPENDIX ‘Additonal Sources of information = gia ht otc tp ty ants ine 78 + aT ati. Oy ean nn onthe of gis | Pome Sec 1990; (1412. 1 Reign 0, mop Stn ft rcs air enon REFERENCES. pean un erptnatpisenteeec cpenoe in 2 Aha erent Trp, 8 Fe teres fr te econ fenxsn in the vaiton doe ‘SRtMdenregnatot cs] rn fen! 12 (ah 2 sete etna eect