Innovative. Pharma-Tech Process Services is a high-energy, schedule-driven, technical service provider. Our innovative consulting services cover

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1 Iovative S o l u t i o s Pharma-Tech Process Services is a high-eergy, schedule-drive, techical service provider. Our iovative cosultig services cover Commissioig, Validatio ad Costructio Period Services to the pharmaceutical, biotechology, ad medical device idustries. We specialize i pharmaceutical ad biotechology reovatios, expasios ad greefield facilities. I short, we are the process doers that facilitate your process from desig to cgmp maufacturig. Our goal is to provide exceptioal service ad techical support to our cliets while maitaiig their project s critical schedule ad budget. We offer world class expertise i the followig areas: Pharmaceutical Costructio ad Project Maagemet Startup, Commissioig ad Validatio for the followig areas: Fermetatio & Cell Culture Purificatio & Harvest Formulatio & Fill Fiish Media/Buffer Prep & Storage Clea i Place (CIP) & Steam i Place (SIP) Direct & Idirect Impact Utilities

2 Costructio p e r i o d s e r v i c e s We provide world-class costructio period services to a broad rage of biopharmaceutical ad semicoductor cliets requirig clea costructio. We uderstad the costructio issues ad pressures that arise whe dealig with aggressive, fast paced, biopharma costructio projects with tight budgets ad tighter schedules. We facilitate commuicatio betwee the architect, costructio maager, subcotractors ad the ower to quickly resolve issues to ot oly maitai the costructio schedule but the desig itet. We protect our cliets from a subcotractor s or CM s poor iterpretatio of desig documets ad project specificatios that could result i costly rework ad schedule impacts. We are committed to cliet satisfactio ad we focus o buildig strategic parterships ad collaborative solutios that brig efficiecies to both your project s costructio schedule ad qualificatio life cycle. Our Costructio Period Services Iclude: Project ad Costructio Maagemet Strategic Plaig Costructio Supervisio ad Trade Coordiatio Modular Costructio Hygieic Pipig Detailed Desig Reviews Schedule ad Budget Developmet ad Trackig Project Scope ad Bid Package Developmet Vedor Audits Factory ad Site Acceptace Testig Puch Listig Agaist Desig Documets As-Builts (Record Drawigs) Turover Package Developmet Passivatio Coordiatio ad Plaig Procuremet ad Schedule Expeditig

3 Commissioig Pharma-Tech Process Services specializes i startup ad commissioig of biopharmaceutical maufacturig ad medical device productio facilities. Ulike most commissioig agets out there today, we actually commissio ad troubleshoot hardware ad software issues i the field. We work with the ower ad egieer to iitiate a corrective actio or chage cotrol immediately. Our past experiece i desig ad operatios of saitary process systems ad equipmet allows us to quickly resolve issues that will delay costructio, commissioig or qualificatio activities. Our goal is to start up your facility to operate as iteded by desig ad to meet the fial user s requiremets. We will work with you to develop a commissioig pla that outlies the resposibilities of the desig teams, costructio cotractors, commissioig agets ad owers durig the startup ad commissioig phase. We have a extesive library of startup ad commissioig templates ad checklists that allows us to quickly apply our procedures ad test plas to your specific project. We also idetify the required ispectios ad tests to be verified or leveraged ito validatio verificatio documets. This greatly miimizes documet developmet time ad allows for quicker documet review, approval ad executio. Poorly executed commissioig efforts will result i delayed ad costly validatio ad qualificatio activities. Our Startup & Commissioig Services Iclude: Protocol Geeratio ad Executio Istallatio ad Operatioal Commissioig Stadard Operatig Procedures Factory ad Site Acceptace Testig Maiteace Mauals Summary Reports Pla, Coordiate ad Direct All Startup ad Commissioig Activities with Required Vedors, Cotractors, Owers ad Costructio Maagers to Best Meet the Project Schedule System Walk Dow ad Puch Listig Agaist Desig Documets Drawig ad Utility Verificatio Cotrol System Testig & Troubleshootig Fuctioal Specificatio Review cgmp Documetatio Turover Package Review ad Developmet Riboflavi Coverage Testig Chage Cotrol Maagemet Equipmet Operatio Traiig ASTM E2500 Cleaig ad Sterilizatio Developmet

4 Validatio x Pharma-Tech s validatio team provides a broad rage of services from system ad compoet level impact assessmets to validatio master plaig ad staff augmetatio. We ca work with you to develop validatio master plas to best utilize ad leverage successful commissioig activities ito your validatio strategy. We work closely with each cliet to provide the desired level of detail ad cotet to be writte withi their validatio documets. We have a extesive library of Validatio ad Qualificatio templates ad procedures that allows us to quickly apply our test procedures to your project. This greatly miimizes documet developmet time ad allows for quicker documet review ad approval. Our success stems from our ability to help our cliets defie appropriate fuctioal ad performace specificatios for which the equipmet is tested. Errors durig the fuctioal specificatio review phase will have a tremedous impact o the cost ad delivery of your validatio project. It is imperative to catch errors o paper early i the desig phase rather tha durig the costructio or qualificatio phases. Our Validatio & Qualificatio Services Iclude: Validatio Project ad Master Plaig Criticality & Impact Assessmets Protocol Geeratio ad Executio Istallatio Qualificatio Operatioal Qualificatio Performace Qualificatio Factory ad Site Acceptace Testig Summary Reports GMP Documetatio Quality Assurace Plaig Chage Cotrol FAT & SAT Testig Process Validatio Cleaig ad Sterilizatio Validatio Temperature Mappig Kaye Validator 2000/Biological Idicators DeltaV Computer Software Validatio Material Verificatio I/O Testig Alarms ad Security Testig Cotrol Loop Testig Riboflavi Coverage Testig Validatio Procedures Traiig 21 CFR Part 11 Compliace GAMP Compliace Detailed Desig Specificatios Fuctioal Specificatios User Requiremets Specificatios C&Q Leverage Strategies Process Developmet Process Aalytical Techology ASTM E2500 Compliace

5 Clea i Place ad cycle developmet Pharma-Tech Services is a idustry leader i Clea i Place systems, cycle developmet ad cleaig validatio. We offer a wide array of services ad expertise required to validate your maufacturig cleaig procedures for both maual ad automated cleaig processes. Our CIP cycle developmet ad cleaig validatio programs provide documeted evidece that esure your cleaig ad equipmet procedures are capable of removig residual process soils, effectively, repeatedly ad efficietly. We summarize all relevat cleaig qualificatio data, parameters ad test summaries i our exclusive CIPTOPs. Let us compile yours today! Clea i Place Services: CIP Troubleshootig ad Cosultatio Surveys ad Assessmets Cotrol Loop Tuig Spray Device Modificatio ad Specificatio FAT, SAT, RV, IV, PV, IQ, OQ, PQ Cleaig Impact/Risk Assessmet CIP Cycle Developmet ad Optimizatio Protocol Developmet ad Executio Parameter Developmet ad Justificatio Maual ad Automated Operatios DeltaV, Rockwell, Parts Washers Parts Washer Load Cofiguratio Rise Out Curves Riboflavi Coverage Testig Visual Ispectio Desig of Experimets Cofied Space Etry Cycle Optimizatio Reduce time, water ad deterget usage Custom Passivatio ad De-rougig Procedures Stadard Operatig Procedure Developmet Portable TOC Aalysis CIP Cleaig Validatio Master Plaig Protocol Developmet ad Executio Acceptace Criteria Developmet Test Method Developmet Swab ad Rise Recovery Studies CIP Sample ad Data Maagemet Cotiuous Moitorig Strategies Exclusive Pharma-Tech CIPTOP Turover Packages

6 Steam i Place ad Thermal Validatio Pharma-Tech Services is a idustry leader i Steam i Place systems, cycle developmet ad sterilizatio validatio. We offer a wide array of services ad expertise required to validate your sterilizatio ad aseptic processig procedures. Our SIP cycle developmet ad sterilizatio validatio programs provide documeted evidece that esure your sterilizatio procedures are capable of providig adequate kill, lethality ad sterilizatio, effectively, repeatedly ad efficietly. We summarize all relevat SIP ad sterilizatio qualificatio data, parameters ad test summaries i our exclusive SIPTOPs. Let us compile yours today! Steam i Place Services: Steam i Place Troubleshootig ad Cosultatio Clea Steam ad Sterility Surveys ad Assessmets Cotrol Loop Tuig FAT, SAT, RV, IV, PV, IQ, OQ, PQ Sterilizatio Impact/Risk Assessmet SIP Cycle Developmet ad Optimizatio Protocol Developmet ad Executio Parameter Developmet ad Justificatio DeltaV, Rockwell, Autoclaves Autoclave Load Cofiguratio Thermal Mappig Biological Idicator Lethality Verificatio Desig of Experimets Cofied Space Etry Kaye Validator 2000 Operatio ad Traiig Cycle Optimizatio Sterilizatio Empty ad Full Vessel Decotamiatio Empty ad Full Vessel Autoclaves Dry ad Liquid Loads Stadard Operatig Procedure Developmet SIP Sterilizatio Validatio Acceptace Criteria Defiitio Media Simulatio ad Challege Cotamiatio Ivestigatio Thermal Validatio Temperature ad Humidity Room ad Equipmet Qualificatio Shippig Validatio Cold Rooms ad Refrigerators Oves ad Icubators Clea Steam Cosultatio Clea Steam Geerator Start-Up ad FAT Clea Steam System Desig ad Operatio Clea Steam Quality Testig Clea Steam System Start-Up ad Tuig Exclusive Pharma-Tech SIPTOP Turover Packages