Services

You are here:Services » API Services cGMP » HPAPIs and Cytotoxic Substances

Highly Potent APIs and Cytotoxic Substances

To top

In Safe Hands!

ChemCon offers high-containment operations for the manufacturing of cytotoxic substances and highly potent active pharmaceutical ingredients (HPAPIs). Our services include HPAPI manufacturing under cGMP conditions, utilizing cutting-edge technology, comprehensive product experience, and rigid training procedures.

ChemCon is able to manufacture HPAPIs from gram to kilogram quantities. With a multi-product track record of two decades, ChemCon is experienced in the process development and manufacturing of numerous cytotoxic substances and HPAPIs. In November 2016, ChemCon’s handling of cytotoxic substances has been reviewed and certified as flawless by the regional German health authorities (Reg.Präs. Tübigen).

To top

cGMP manufacturing (OEL down to 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
  • dedicated 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
To top

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

Download as pdf

To top