Control of Aseptic Processes

These procedures are primarily required in cleanrooms, where production takes place and potential contamination is controlled. There are many guidelines from how the air flows and is filtered to how possible contamination and room conditions are monitored, and then how data is stored and reported. The air must be filtered by HEPA filters to retain particles and microorganisms.

People enter controlled areas wearing sterile cleanroom garments, and the controlled areas are monitored in terms of temperature, humidity and total particles. There are also microbiological controls to avoid introducing microbiological contamination.

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Topics discussed:

  • Regulation requirements for the pharmaceutical industry
  • Validation of active air sampling
  • Settle plate and real time technique history and cost
  • Classification and monitoring comparison
  • Cleanroom classes (ISO 4.8, 5, 7, 8)