Isolated production suites with walk in hoods are available as well as analytical suites. All production areas have chemical resistant ﬂooring, non-porous walls and are serviced with low particulate air. UV ﬁltered lights and windows accommodate UV sensitive chemistries. The plant is engineered to be in compliance with NFPA regulations for handling of hazardous and ﬂammable materials. We generate DI water, create our steam and cooling water while capturing all waste water on site. The site has a bulk loading and unloading system.
Many cGMP processes require dedicated equipment and have a high degree of complexity. At Ortec, we have a lot of experience designing and implementing custom systems to support our customers’ needs. Here are some of the dedicated systems that we have implemented at Ortec:
- 50 gallon, Incoloy 25-6 Mo reactor with variable agitation and temperatures to 250° C. Vacuum to less than 1 TORR and pressure up to 110 psig.
- Manufacturing suite with multiple, 500 gallon glass lined reactors, capable of low temperature (-30°C) and low pressure (10 torr) operation. Equipped with a large scale wiped film molecular still and evaporator, and multiple 500 gallon glass lined blending vessels.
- Bulk scale 316 SS reactor train with feed tanks and bulk storage for acrylic solution polymerization. Variable agitation with temperatures to 155°C and vacuum to 28 inches Hg.
We also have the following equipment that is available and ready to help with your project needs:
1, 3, 5, 10 and 100 liter glass reactors in lab suites with variable agitation and temperature range of -20°C to 220°C. Vacuum to less than 1 torr
100 liter Glass Lined reactor with variable agitation and temperature range of -25° C to 170° C. Vacuum to less than 1 torr
50 gallon Glass Lined reactor with variable agitation and temperature range to 170° C
2,500 gallon, 316 stainless steel reactor with variable agitation and temperature to 170° C. Vacuum to 28 torr
2,500 square foot validated Class 100,000 clean room with a USP/EP validated water system
2 and 4 inch Wiped Film Molecular Stills and Evaporators
In-situ, Real-Time reaction monitoring
4CV High Temperature, High Viscosity Polymer Reactor
HOW CAN ORTEC HELP YOU?
Are you considering outsourcing your chemical manufacturing? Want to free up your assets to focus on other projects? Need a partner who has the quality systems and regulatory knowledge to meet your demands? Someone who can hit specs, improve efficiencies, and get you quickly to market without going over budget?