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