Manufacturing Facility Details

The Regis Technologies Facility

Regis management continuously reinvests in the company. Between 1995 and 2001, Regis expanded and improved every lab and manufacturing area. This included a new production facility with six dedicated reactor suites, individual kilo lab suites, an expanded quality control department and the installation of a cryogenic reactor. Plans are underway for increasing capacity with additional production labs, individual kilo lab suites and reactor suites. The net result is loyal and satisfied customers and employees.

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

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