Ecolab offers insights into the latest Annex 1 updates

14 May 2020

The latest draft of EudraLex Vol. 4, Annex 1 (v.12), features updates to the guidelines following the public consultation feedback on the 2017 draft. Ecolab have carried out a thorough review to assess the changes relating to cleaning and disinfection and the implications for end users.

Specifically, there is still a focus on the clear distinction between cleaning and disinfection and the importance of disinfectant residue removal. Effective product rotation remains important, and the use of sterile disinfectants in Grade C and D areas is now being highlighted as a consideration where Quality Risk Management (QRM) demands.

Validation should demonstrate the effectiveness of disinfectants in the specific manner in which they are used and should support the in-use expiry periods of prepared solutions.

Ecolab are able to support with guidance on:

  • Appropriate use of a range of product formats which are sterile and ready-to-use
  • Validation expertise Including the ValidexTM programme
  • Interpretation and implementation of the regulations, providing service excellence from their Technical Consultants

More information about Ecolab’s products and services in relation to Annex 1 can be found at ecolablifesciences.com/annex1



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