CLEANING REGIMEN

As a contract service provider, clean-ability between contracts is of primary emphasis. Powdersize institutes a three cycle cleaning regimen to ensure the cleanliness of equipment surfaces meet the demands of pharmaceutical processing. Between runs of active pharmaceutical ingredients (API’s), 100% cleaning verification is performed via equipment swabs and quantifiable analytical testing to ensure the levels of residual prior products meet the acceptance criteria of :

Cleaning Acceptance Criteria:
  • Visually Clean (~ 4ug/in2)
  • Less than 10 ppm crossover between products
  • Less than 1/1000th of the therapeutic dose of product A into the minimum dose of product B

 

Post cleaning, equipment is stored in HEPA filtered positive pressure equipment storage bays. After final assembly, a sterilization wipe/rinse is completed prior to charging product to the process.