Cytotoxic and highly potent APIs (HPAPIs)
Handling of cytotoxic and other highly active substances requires adequate facilities and enclosures as well as a lot of experience.
ChemCon offers high-containment operations for the manufacturing of cytotoxic substances and highly potent active pharmaceutical ingredients (HPAPIs). Our services include HPAPI manufacturing under GMP conditions, utilizing cutting-edge technology, comprehensive product experience, and rigid training procedures.
ChemCon manufactures HPAPIs in gram to kilogram quantities.
cGMP manufacturing (OEL > 1 µg/cbm):
(comparable to SafeBridge class III)
- Cleanroom: class 100,000 (can also be operated as class 10,000)
- Cross-contamination prevention by use of dedicated equipment
- Cedicated SHE experts to assess compound potency and evaluate and monitor processes
- Quality control laboratories equipped with laminar flow safety benches for HPAPI testing
- Validated cleaning procedures
- Certified hazardous waste disposal
Isolator train class 10,000:
- Reactor capacities in isolator train: two 100 L reactors or one 200 L reactor
- –60 °C to + 200 °C
- Clean in place (CIP) for isolator train
- Decontamination unit
- Vacuum drying oven in isolator train
- Tray lyophilization option in isolator train
- The incoming air for cleanrooms is filtered by a pre-filter, a main-filter, and a HEPA filter
- The incoming air for the isolator train is filtered by a second HEPA filter stage
- The exhaust air of the isolator is filtered by push-push HEPA filters that can be exchanged and disposed while the isolator is completely sealed