Manufacturing Facility Details
Building
Morton Grove Facility
- Brick and concrete construction
- Aggregate floor space of approximately 88,000 square feet
- Houses offices, analytical laboratory, synthetic laboratories, kilo labs, GMP production suites, warehousing, and packaging and shipping
- Designed for the performance of most chemical syntheses, from bench scale through production
- FDA registered facility specializing in active pharmaceutical ingredients (APIs). Our site registration number is 1416120
Production Area
Individual Reactor Suites
Our production area consists of ten suites containing pairs of reactors:
- Two 500 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux & Tolhurst 48 x 20 centrifuge
- Two 300 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux & Tolhurst 40 x 20 centrifuge
- Two 200 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux & Tolhurst 40 x 20 centrifuge
- Two 100 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux & Tolhurst 40 x 20 centrifuge
- Two 200 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux & Tolhurst 40 x 20 centrifuge
- One 150 gallon Hastelloy reactor for running cryogenic reactions down to minus 85°C
- 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
- Two 25 gallon glass lined DeDietrich jacketed reactors, equipped with agitator and glass condenser for distillation or reflux
- Two 63 liter glass reactor systems with insulated, glass lined steel jacketed bodies and all glass domes with attached reflux and stripping condensers utilizing single fluid heating/cooling with a temperature range of -20°C to 120°C
- 50L Jacketed Glass reactor systems with single fluid heating/cooling with a temperature range of -40°C to 180°C
- 20L Jacketed Glass reactor systems with single fluid heating/cooling with a temperature range of -40°C to 180°C
- 1 and 5L Jacketed Glass reactor systems with single fluid heating/cooling with a temperature range of -40°C to 180°C
- Small and large scale glassware laboratories for development, scale-up, and small scale production
- Mettler-Toledo EasyMax systems used during process development, which allow for precise experimental control
- Scale chromatography offerings include 4" - 12" diameter glass gravity columns (2-50kg silica) and a Biotage Flash 400 system
- Small and large scale glassware laboratories for development, scale-up, and small scale production
Production Area
Ancillary Production Equipment
Our production area houses a preparative separations laboratory containing:
- Parr high pressure hydrogenation apparatus (Model 4000); capacity: 500 mL; up to 400 atm. and 350°C
- Bench-top stirred 600 mL Parr reactor, rating: 3000 PSI at up to 350°C, wetted parts constructed of C276, safety rapture disc rated to 1000 PSI, pressure gauge, 0-600PSI
- Stirred, 2 gallon Parr reactor, rating: 2000 PSI at up to 350°C, wetted parts constructed of C276, safety rapture disc rated to 1000 PSI, pressure gauge, 0-600PSI
- Multiple stainless steel Star filter presses
- High capacity and high vacuum pumps
- Buchi R111 5 L rotary evaporators
- Buchi R152 20 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 stirrers
- Millipore Ultra Filtration - 2 units that are Pellicon Mini Cassette Units and a Pellicon CUF-1 LV
- Quadro Ytron HV0 Wet Mill & Emulsifier (Hastelloy C)
Production Area
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:
- Maxi Lab glass filter dryer (1), .05 square meter filter area, 5 liter cake capacity
- GL Filtration contained hastalloy filter dryer (2), .05 square meter filter area, 7 liter cake capacity
- GL Filtration contained hastalloy filter dryer (2), .16 square meter filter area, 32 liter cake capacity
- GL Filtration contained hastalloy filter dryer (1), .4 square meter filter area, 80 liter cake capacity
- Two United McGill and one Scherrer vacuum shelf dryers
- Virtis laboratory scale freeze drier with seven square foot capacity and (2) with 22 square foot capacity
- Large Fitzmill grinder-blenders (2)
- Small Benchtop Fitzmill grinder (2)
A Controlled Environment
Safety & Pollution Controls
Regis incorporates laboratory safety and air pollution control equipment throughout the building for maximum efficiency as well as personnel comfort and protection. This 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 eyewash stations
- Sprinkler equipped production, process laboratory, finishing, and solvent storage areas
- A segregated waste solvent storage area separate from the rest of the facility