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Ecolab offers insights into the latest Annex 1 updates

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  program 
  • 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 

Ecolab Life Sciences, 11 Winnington Avenue, Northwich, Cheshire. CW8 4DX 

www.ecolablifesciences.com 

For more information about this release, please contact Emily Buck on 

emily.buck@ecolab.com 

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