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Presentation of Manufacturing Capabilities
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Presentation of Manufacturing
Capabilities
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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 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
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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.
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Production Capabilities and Constraints
Capabilities Constraints
Route of Administration
Injectables Orals, Transdermals etc.
Size Small volume parenterals (SVP)
Large volume parenterals (LVP), Bags
FormulationsLiquids, Oils, Lyophilized Products, Suspensions, Microspheres
Powders, Implants
Class of Drug
Liquid & Freeze Dried SVP• Class III Controlled
Substances• High Potency Products
Genotoxics, Cytotoxics, Penicillins, Cephalasporins
Container Closure System
Vials with plug or lyophilized stopper, Capped aluminum seals
Syringes, Ampoules, Cartridges, Screw top bottles
Sterilization Method
0.22µ Sterile filtration, Aseptic filling process
Terminal sterilization
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Packaging Capacity and Constraints
Fill Volume Vial TypeVials Per Minute
Maximum Batch Size
(1 Shift)Lyo Chamber
Capacity
1mL 2cc/13mm 50 30,000 30,000
2mL 2cc/13mm 50 30,000 30,000
2mL 5cc/20mm 50 30,000 19,000
5mL5cc/20 or
10cc/20mm35 21,000 19,000
10mL10cc/20mm
or 30cc/20mm
35 21,000 19,000
30 mL 30cc/20mm 20 12,000 19,000
*50mL is also possible with some equipment modification.
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Generation 2 gallons per minute 4000 liter tank
Distribution Continuous hot loop 83°C +/- 3°C
Ambient WFI In-line heat
exchanger
Water for Injection (WFI)
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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)
Formulation
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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
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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
Dry Heat Depyrogenation
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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 Validated 121°C for 35 minutes
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Filling/Stoppering
Chase Logeman Filler with Peristaltic Pump Single nozzle Maximum fill volume
variability (3δ): ± 6% 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. 5mL-10mL vials
19,000 units
2mL vials 30,000 units
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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
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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
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
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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
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
