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 NFDA 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: