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In safe hands!

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

Feasibility Review

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