Which sterilisation methods are used in the manufacture of sterile products?

The following processes can be used in the manufacture of sterile products in order to achieve the required reduction of bioburden:

• Steam sterilisation (moist heat)
• Dry heat sterilisation
• Sterilisation by radiation
• Gas sterilisation (microbicidal gases)
• Sterile filtration

These methods are described in the following Chapters.

[GMP Compliance Adviser, Chapter 12.D]

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