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