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Presentation of Manufacturing Capabilities

Presentation of Manufacturing Capabilities. 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.

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Presentation of Manufacturing Capabilities

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  1. Presentation of Manufacturing Capabilities

  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 partners • Contract manufacturing customers of standard injectable products • Strategic partners for Oakwood’s proprietary products

  3. Manufacturing Capabilities • Main features • Microbiology and analytical laboratories • Raw material weighing area • Non-aseptic compounding room • Aseptic 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: 16,000 s.f. • Batch size: 19,000 5mL vials (limiting factor is lyophilizer volume, after planned water system upgrade) • Batches per year: 75 – 100 • Number of vials per year: 1,425,000 – 1,900,000 • Oakwood’s aseptic facility was inspected by the FDA in February 2007, July 2009, April 2011 and April 2012. Oakwood also had PAI audits in January 2010 & July 2011, and was recommended for commercial manufacture.

  4. Production Capabilities and Constraints

  5. Packaging Capacity and Constraints *50mL is also possible with some equipment modification.

  6. Water for Injection (WFI) • Generation • 2 gallons per minute • 4000 liter tank • Distribution • Continuous hot loop • 83°C +/- 3°C • Ambient WFI • In-line heat exchanger

  7. 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)

  8. Component Preparation • Cozzolli Vial Washer Model: GW24-164 • Cycle time: 5-7 minutes • 5mL-10mL (20mm) vials: 144 vials per cycle • 2mL (13mm) vials: approximately 256 vials per cycle

  9. 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 • Validated • 250°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 Cycle • Validated • 121°C for 35 minutes

  11. Filling/Stoppering • Chase Logeman Filler with Peristaltic Pump • Single nozzle • Maximum fill volume variability (3δ):± 6% • Stopper bowl and track assembly • Auto trayer

  12. Lyophilization • Hull Lyophilizer Model: 132FXS200S • Manual cleaning (no CIP capacity) • SIP validated for sterilization of chamber • Chamber Capacity • 132 s.f. • 5mL-10mL vials • 19,000 units • 2mL vials • 30,000 units

  13. Capping • West Capper • Total Area: 173 s.f. • Class 7 (10,000)/ Class 8 (100,000) • 13mm & 20mm flip off caps • Vials per minute: 28-30

  14. Manufacturing Quality • 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

  15. Oakwood Advantages • Available: 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 Information • If 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 Operations Oakwood Laboratories, L.L.C. 7670 First Place Oakwood Village, Ohio 44146 (440) 505-2011 x232 dhenderson@oakwoodlabs.com Or Ryan Skubic, Business Development and Client Project Coordinator Oakwood Laboratories, L.L.C. 7670 First Place Oakwood Village, Ohio 44146 (440) 359-0000 x231 rskubic@oakwoodlabs.com

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