High Potency Apis (HPAPI)

Industries

The manufacture of High Potency Active Pharmaceutical Ingredients (HPAPIs) is a great manufacturing challenge, being one of the sectors with more manufacturing complexity because the operator must be protected from the very high toxicity product that is being manufactured. The number of injectable oncology products is increasing, in which bidirectional containment is necessary to protect both the product and the operator.

At tri-consulting we can help you simplify and improve your production processes and your Quality system to minimize the high risks involved in working with HPAPI products.

  • Advice on the design of clean rooms and the design and drafting of SOPs:
    • Personnel flow.
    • Materials flow.
    • Garments.
    • Cleaning and disinfection.
  • Validations:
    • Thermal.
    • SIPs.
    • Aseptic process.
    • Cleaning and disinfection.
    • Equipment cleaning.
      • Garments life cycle.

industries

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