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Clinical Manufacturing

The SRI Pharmaceutical Formulation Development Facility, which includes a new Class 100 clean room maintained under the International Congress of Harmonization guidelines, is designed to provide pharmaceutical and biopharmaceutical companies with a single, quality resource for the manufacture of oral, topical, parenteral, and other Clinical Trial Materials (CTM) for Phase I / II studies.

These drug product manufacturing activities are supported by our Quality Control & Quality Assurance unit, which tests, inspects, and releases the products in full compliance with regulations of the FDA and international regulatory agencies.

The SRI facility also offers primary and secondary packaging services for solid, semi-solid, and liquid dosage forms, including overencapsulation. SRI also can design the labels and kits for secondary packaging.

Our extensive collection of manual and semi-manual manufacturing equipment includes:

Mixing and Blending

• Hobart Mixer M-802, 80 quart capacity
• Planetary Mixers with interchangeable mixing bowls, 3 units
• V-Blender, Patterson-Kelley Blend Master V-Blender and Twin Shell Blenders with multiple capacity V shells, 0.5 to 8 quart capacity
• V-Blender, O-Hara Technologies VB-1.5, 48 quart / 1.5 ft3  capacity

Capsule Filling

• Mini-Cap 50, manual capsule filler, Size 00 to 4, 50 caps/plate
• Manual capsule filler, 3 units, Sizes 0, 2, 4, 300 caps/plate
• DB capsule filler, 100 caps/plate
• Semiautomatic capsule filler, VanGuard VSF-II, up to 25,000 capsules/hr
• Automatic capsule inserter/loader, ChemiPharm PCL V-28
• Capsule bander, Shinogi Qualicaps
• Capsule polisher and sorting machine, Vanguard PCX-IV, 300,000 capsules/hr

Milling

• High speed mills, two units, Retsch MS100 and ZM100
• Low speed mills, multiple units

Granulation

• Roller compactor, Vector-Freund TF-Mini, 4 kg/hr
• Granulator/oscillator, Vector

Tabletting

• B2 Stokes 16 Station tablet press, 650 tablets/min
• Pan coater, Vector Corporation LDCS-3 Hi-Coater, 3.5-4 kg
• Pan coater, Erweka AR400, 1-2 kg
• Unit Filling
• Liquid filler, Fillmaster 5000, 4 oz. to 1 gal, liquids and semisolid
• Peristaltic pump, Eclipse Modular King, 34-2500 ml/min
• Powder dispenser, M&O Perry Industries, LM-14, 2 mg-10 g
• Eclipse electronic filling system

Packaging

• Blister pack fill and seal, MTS Packaging MTS-300
• Heat sealer, American International Electric AIE 305AI
• Laminated tube sealer, SITCO STS-7, seals polyethylene laminated materials
• Capping machine, WestCapper FW-4 serum vial sealer

Autoclave (two units)

Lyophilizer (two units)

Depyrogenating oven (two units)

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     Last Updated Jan 25, 2010