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WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(2006; 62 pages)
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Sterile Production

Aseptic processing and sterilization by filtration

Aseptic processing

  • Objective is to maintain the sterility of a product, assembled from sterile components

  • Operating conditions so as to prevent microbial contamination

  • What do you think are the aspects that require careful attention?

Aseptic processing and sterilization by filtration

Aseptic processing

We have already discussed the fact that terminal sterilization of a product is preferable as it reduces the risk of and provides more assurance of sterility. However, for some types of products, this is not possible.

Another method to prepare a sterile products then is to maintain the sterility of a product, assembled from sterile components. All operating conditions should be such to prevent microbial contamination.

What do you think are the aspects that require careful attention?

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Last updated: May 3, 2013