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Updated Annex 1 2022 – Sterile Product Manufacturing

The latest draft of the Annex 1, governing the production, control and distribution of sterile pharmaceutical products has been released. The purpose of this document is to detail the controls required around the manufacture of sterile products. Special requirements are needed in order to minimise risks of microbiological, particulate and pyrogen contamination of sterile products; it also provides guidance as to how sterile products are best protected. There have been a few details changed and added in order to remain in line with regulations and providing the highest standard. 

Changes you may need to be aware of

How CES Ltd can help

  • The need to rotate between two different disinfectants remains, although the fact that one of these should be a sporicidal agent is a new one.
  •  There is now a requirement for a contamination control strategy – this is intended to shift the risk review process to one that assesses the impact of a contamination event in a wider context. 
  • Quality Risk Management and regularly reviewing risk assessments – it was noted that this needs to be extended to both control and distribution of pharmaceutical products as well as manufacturing. 
  • Design of cleanrooms – Annex 1 stresses the importance of ‘quality-by-design’, with emphasis on design being reflective of an intent to maintain contamination control.  

At Critical Environment Solutions Ltd, we can provide you with a full range of cleanroom products that can support your transition into ensuring your cleanroom or controlled environment complies with current regulations such as: 

  • Disinfectant
  • Cleanroom cleaning equipment
  • Cleanroom gloves
  • Cleanroom wipes 
  • Cleanroom garments
Email us at or call us on 01793512505 if you would like advice on which products are best tailored to your cleanroom or controlled environment. 
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