Facility Specifics
FDA Registered
- Specializing in active pharmaceutical ingredients (APIs)
- Site registration number 1416120
Building
- Brick and concrete construction
- Aggregate floor space of approximately 36,000 square feet Situated on 65,000 square feet of land
- Houses offices, a technical library, an analytical laboratory, packaging and shipping departments, laboratories for bench scale chemistry, a large glassware laboratory, and a production area
- Designed for the performance of all types of chemical syntheses, from bench scale through production
Safety & Pollution Controls
Laboratory safety and air pollution control equipment are incorporated throughout the building for maximum efficiency as well as personnel comfort and protection, and includes:
- Efficient fume hood and production exhaust trunks
- An exhaust scrubbing system where all exhausts flow through a packed column to remove contaminants prior to release into the atmosphere
- An air make-up system where HEPA filtered air is fed into the production suites, minimizing the potential for contamination between laboratories
- Safety showers and eyewashes
- Sprinkler equipped production, process laboratory, finishing, and solvent storage areas
- A waste solvent storage area separate from the rest of the facility
Production Area
- Consists of seven suites containing pairs of reactors, a preparative separations laboratory, and isolated finishing areas
Individual Reactor Suites
- Two 500 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 48 x 20 centrifuge.
- Two 300 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 40 x 20 centrifuge
- Two 200 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 40 x 20 centrifuge
- Two 100 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 40 x 20 centrifuge
- Two 200 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux o & Tolhurst 40 x 20 centrifuge
- One 150 gallon Hastelloy reactor for running cryogenic reactions down to minus 85°C
- Two 25 gallon glass lined DeDietrich jacketed reactors, equipped with agitator and glass condenser for distillation or reflux
- One 50 gallon glass lined Pfaudler jacketed reactor, equipped with agitator and glass condenser for distillation or reflux & one 50 gallon DeDietrich jacketed reactor
- Two 50 gallon glass lined Pfaudler jacketed reactor, equipped with agitator and glass condenser for distillation or reflux
- Small and large scale glassware laboratories for development, scale-up, and small scale production.
Ancillary Production Equipment
- Parr rocker type, high pressure hydrogenation apparatus (Model 4000); capacity: 500 mL; up to 400 atm. and 350°C
- Aminco rocker type, high pressure hydrogenation apparatus; capacity: 1 gallon; up to 400 atm. and 350°C
- Thin film distillation unit
- Sparkler filter press; horizontal stainless steel plates
- T. Shriver 18" polypropylene filter press
- Ceramic filter funnels, 18 in. and 24 in. diameters
- High capacity and high vacuum pumps
- Oldershaw distillation units (4)
- Buchi R152 20 L rotary evaporator (3)
- Two Buchi RE111 5 L rotary evaporators
- Mettler PR8001 and PM4800 balances
- Ohaus I-10 balance
- Tanks, various: 100-, 65-, and 40-gallon stainless steel and polypropylene, equipped with Lightnin stirrers
- Millipore Ultra Filtration - 2 units that are Pellicon Mini Cassette Units and a Pellicon CUF-1 LV
Finishing Area
The finishing area is 1500 square feet and comprised of five isolated drying/packaging rooms. Each room is supplied with class 100,000 single pass air, equipped with 99.97 HEPA filters. This area includes:
- Two United McGill and one Scherrer vacuum shelf dryers
- Two Fitzmill grinder-blenders
- Small Benchtop Fitzmill grinder-blender
- Virtis laboratory scale freeze drier with seven square foot capacity and (2) with 22 square foot Capacity
- Small Benchtop Fitzmill Grinder