Transcript www.oakwoodlabs.com
ASEPTIC MANUFACTURING CAPABILITIES
Agenda
Oakwood Overview Manufacturing Capabilities Quality Systems
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OVERVIEW OF OAKWOOD
Background and history
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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 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 partners Contract manufacturing customers of standard injectable products Strategic partners for Oakwood’s proprietary products
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MANUFACTURING CAPABILITIES
Oakwood’s aseptic manufacturing capabilities Production capabilities and constraints Filling capacity Manufacturing equipment
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Manufacturing Capabilities
• • • • • • • • • Main features Microbiology and analytical laboratories Raw material weighing area Non-aseptic compounding room Equipment preparation and staging areas Aseptic formulation room Aseptic filling room Aseptic lyophilization area Vial capping room Shipping, receiving and warehouse space • • • • Specifications and Capacities Total area: 24,000 s.f.
Batch size: 19,000 5 ml vials (limiting factor is lyophilizer volume) Batch per year: 50 - 75 Vial per year: 950,000 – 1,425,000 • • • Oakwood plans to increase its manufacturing capacity Adding additional personnel to maximize current facility output Update equipment to increase capacity Acquisition or construction of an additional facility
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Production Capabilities and Constraints
Parameters Route of Administration Size Formulations Class of Drug Container Closure System Sterilization Method Capabilities
Injectables Small volume parenterals (SVP) Liquids, Lyophilized Products, Suspensions, Microspheres Liquid & Freeze Dried SVP • Class III and Class IV Controlled Substances Vials with plug or lyophilized stopper, Capped aluminum seals 0.22µ Sterile filtration, Aseptic filling process
Constraints
Orals, Transdermals etc.
Large volume parenterals (LVP), Bags Powders, Implants Genotoxics, Cytotoxics, Penicillins, Cephalasporins Syringes, Ampoules, Cartridges, Screw top bottles No Terminal Sterilization
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Filling Capacity
Fill Volume
1mL 2mL 2mL 5mL 10mL 30mL
Vial Type
2cc/13mm 2cc/13mm 5cc/20mm 5cc/20mm 10cc/20mm 30cc/20mm
Vials Per Minute Maximum Batch Size (1 Shift)
50 30,000 50 30,000 50 30,000 35 35 20 21,000 21,000 10,500
Lyo Chamber Capacity
30,000 30,000 19,000 19,000 19,000 10,500
Water for Injection (WFI)
Capacity • 4000 liter tank Distribution • • Continuous hot loop 83 °C +/- 3°C Ambient WFI • In-line heat exchanger
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Formulation
Non-Aseptic • Total area: 215 s.f.
• Class 8 (100,000) • ‒ ‒ Water or oil-based liquid handling tanks: Maximum: 250L Jacketed: heating/cooling Aseptic • Total area: 123 s.f.
• Class 5 (100), 7 (10,000 )
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Component Preparation
• • Cozzolli Vial Washer Model: GW24-164 2mL (13mm) vials 5mL-30mL (20mm) vials
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Dry Heat Depyrogenation
Gruenberg Dry Heat Oven • Model: T55HB6, 83PTSS • ‒ Internal dimensions: 44” (w) x 55” (d) x 62” (h) • • ‒ ‒ One loading rack 22 Shelves 3 Trays per shelf ‒ Depyrogenation Cycle 250 °C for 180 minutes
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Steam Sterilization
Steris Autoclave • Model: 1221-D-B Sterlizer • ‒ Chamber dimensions: 45” (w) X 120” (d) X 78” (h) • ‒ ‒ Steam Sterilization Cycle 123 °C for 30 minutes equipment 123 °C for 70 minutes stoppers
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Filling/Stoppering
Chase Logeman Filler with Peristaltic Pump • Single or double nozzle • Maximum fill volume variability: ± 4% • Stopper bowl and track assembly • Auto trayer
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Lyophilization
• • Hull Lyophilizer Model: 132FXS200S Manual cleaning (no CIP capacity) SIP validated for sterilization of chamber • • • • Chamber Capacity 132 s.f.
– 66 trays 2mL vials ‒ 30,000 units ‒ 5mL-10mL vials 19,000 units ‒ 30mL vials 10,500 units
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Capping
• • • • • West Capper Total Area: 173 s.f.
Class 8 (100,000) 13mm & 20mm flip off caps Vials per minute: 100 Video-jet printer
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QUALITY SYSTEMS
Quality Unit and Responsibilities Quality Systems
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Quality Unit and Responsibilities
• Quality Unit Validation IQs / OQs / PQs of facility, utility and equipment Process validation: Sanitization, cleaning, manufacturing • • Quality Control Chemistry Development and validation of test methods Routine monitoring of utilities In-process, finished product and stability tests Microbiology Development and validation of test methods Routine monitoring of utilities In-process, finished product and stability tests • • • • • Quality Assurance Documentation: Review, approval and retention of all controlled documents Protocols, SOPs, batch records, logbooks, change controls Inspection and release: Raw material, work in-process, finished product Change control system Investigations, deviations, OOS and CAPA
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Quality Systems
• • • • • Management Review Quality Policy and Quality Manual Resource Management Trending Training Annual Product Review • • • • Internal Audits • Batch Release Documentation Documentation Control Maintenance and Use Logbooks Change Control and Engineering Change Control Systems • • • • • • Facility and Equipment Controls Validation Master Plan Facility, Equipment, and Utility Qualification Re-evaluation through requalification Environmental Monitoring and Building Automation System Preventative Maintenance, Maintenance Work Orders and Calibration Recertification
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Quality Systems —continued
• • • Material Controls Incoming Release Testing Vendor Audits Quarantine, Approved, and Non-Conforming Storage • • • • • • Production and Process Controls In-process Process Checks Fill weights, Crimp Inspection, In-process Analytical Testing, Finished Product Inspection Final Product and Stability Testing Batch Record Review Quality Assurance Auditing Environmental and Personnel Monitoring Deviations and Investigations Corrective and Preventative Actions
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