2 Background and History Oakwood Laboratories, L.L.C. (“Oakwood”) is a pharmaceutical company specializing in the development of sustained-release injectable products, located in the Cleveland, Ohio area.Oakwood began as the research division of Ben Venue Laboratories which, prior to its acquisition by Boehringer-Ingelheim, was the largest independent parenteral contract manufacturer in the U.S.In 1997 Oakwood was spun off as a separate entity when Ben Venue was acquired by Boehringer-Ingelheim.Oakwood developed its own sterile injectable facility to enhance its partnering and development activities. Its manufacturing services are aimed at:Contract development partnersContract manufacturing customers of standard injectable productsStrategic partners for Oakwood’s proprietary products
3 Manufacturing Capabilities Main featuresMicrobiology and analytical laboratoriesRaw material weighing areaNon-aseptic compounding roomAseptic equipment preparation and staging areasAseptic formulation roomAseptic filling roomAseptic lyophilization areaVial capping roomShipping, receiving and warehouse spaceSpecifications and CapacitiesTotal area: 16,000 s.f.Batch size: 19,000 5mL vials (limiting factor is lyophilizer volume, after planned water system upgrade)Batches per year: 75 – 100Number of vials per year: 1,425,000 – 1,900,000Oakwood’s aseptic facility was inspected by the FDA in February 2007, July 2009, April 2011 and April Oakwood also had PAI audits in January 2010 & July 2011, and was recommended for commercial manufacture.
4 Production Capabilities and Constraints CapabilitiesConstraintsRoute of AdministrationInjectablesOrals, Transdermals etc.SizeSmall volume parenterals (SVP)Large volume parenterals (LVP), BagsFormulationsLiquids, Oils, Lyophilized Products, Suspensions, MicrospheresPowders, ImplantsClass of DrugLiquid & Freeze Dried SVPClass III Controlled SubstancesHigh Potency ProductsGenotoxics, Cytotoxics, Penicillins, CephalasporinsContainer Closure SystemVials with plug or lyophilized stopper, Capped aluminum sealsSyringes, Ampoules, Cartridges, Screw top bottlesSterilization Method0.22µ Sterile filtration, Aseptic filling processTerminal sterilization
5 Packaging Capacity and Constraints Fill VolumeVial TypeVials Per MinuteMaximum Batch Size(1 Shift)Lyo Chamber Capacity1mL2cc/13mm5030,0002mL5cc/20mm19,0005mL5cc/20 or 10cc/20mm3521,00010mL10cc/20mm or 30cc/20mm30 mL30cc/20mm2012,000*50mL is also possible with some equipment modification.
6 Water for Injection (WFI) Generation2 gallons per minute4000 liter tankDistributionContinuous hot loop83°C +/- 3°CAmbient WFIIn-line heat exchanger
7 Formulation Non-Aseptic Aseptic Total area: 215 s.f. Class 8 (100,000) Water or oil-based liquid handling tanks:Maximum: 250LJacketed: heating/coolingAsepticTotal area: 123 s.f.Class 5 (100), 7 (10,000)
8 Component Preparation Cozzolli Vial Washer Model: GW24-164Cycle time: 5-7 minutes5mL-10mL (20mm) vials: 144 vials per cycle2mL (13mm) vials: approximately 256 vials per cycle
9 Dry Heat Depyrogenation Gruenberg Dry Heat OvenModel: T55HB6, 83PTSSInternal dimensions:44” (w) x 55” (d) x 62” (h)One loading rack22 Shelves3 Trays per shelfDepyrogenation CycleValidated250°C for 180 minutes
10 Steam Sterilization Steris Autoclave Model: 1221-D-B Sterlizer Chamber dimensions:45” (w) X 120” (d) X 78” (h)Steam Sterilization CycleValidated121°C for 35 minutes
11 Filling/Stoppering Chase Logeman Filler with Peristaltic Pump Single nozzleMaximum fill volume variability (3δ): ± 6%Stopper bowl and track assemblyAuto trayer
12 Lyophilization Hull Lyophilizer Model: 132FXS200S Chamber Capacity Manual cleaning (no CIP capacity)SIP validated for sterilization of chamberChamber Capacity132 s.f.5mL-10mL vials19,000 units2mL vials30,000 units
13 Capping West Capper Total Area: 173 s.f. Class 7 (10,000)/ Class 8 (100,000)13mm & 20mm flip off capsVials per minute: 28-30
14 Manufacturing Quality Quality UnitValidationIQs / OQs / PQs of facility, utility and equipmentProcess validation: Sanitization, cleaning, manufacturingQuality ControlChemistryDevelopment and validation of test methodsRoutine monitoring of utilitiesIn-process, finished product and stability testsMicrobiologyQuality AssuranceDocumentation: Review, approval and retention of all controlled documentsProtocols, SOPs, batch records, logbooks, change controlsInspection and release: Raw material, work in-process, finished productChange control systemInvestigations, deviations, OOS and CAPA
15 Oakwood AdvantagesAvailable: Oakwood currently has the capacity to move quickly on customers’ projects, with no lengthy waiting periods.Flexible: Oakwood is willing to work on standard, as well as difficult, complex or smaller products.User Friendly: At Oakwood, you will work directly with the functional experts in all areas, not customer service representatives, hence reducing delays and miscommunications
16 Contact InformationIf you would like to learn more about Oakwood’s sterile manufacturing capabilities, please contact either of the following Oakwood representatives.Dave Henderson, Vice President of Manufacturing OperationsOakwood Laboratories, L.L.C.7670 First PlaceOakwood Village, Ohio 44146(440) x232OrRyan Skubic, Business Development and Client Project Coordinator(440) x231
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