ANNEX 1 – WHAT IMPACT WILL IT HAVE ON YOUR CLEANING AND DISINFECTION?
The revised Annex 1 of the GMP guidelines is close to publication. CRG recently invited global industry experts from Ecolab Life Sciences division to discuss the pending impact of Annex 1 on Cleaning and Disinfection.
From the seminars, we learnt that key areas which may be affected by the new Annex 1 requirements are:
Cleaning and Disinfection – a clear distinction is being made between cleaning and disinfection. Greater clarity and requirements are now placed on validation and the burden of proof for disinfection processes.
Ready to Use – with increasing stringency over filter usage, water usage and general requirements for proof of sterility and performance in use, the burden of producing disinfectants from concentrates increases significantly. This makes ready to use products a far more attractive option, when total cost of ownership is considered.
Residues – with specific requirements now on the removal of residues and potential risks to product and processes being attributed to residues, there is a strong need for a risk based approach for the management of disinfectant residues.
Transfer Disinfection – the new Annex 1 introduces the need to have a validated list of items transferred in with the process and chemistry used to disinfect these items. Anything not on the list requires monitoring and a risk based approach to be taken in line with the bioburden risk.
Training & Validation – there is an increased requirement for training of operators including specifically, cleaning and disinfection.
Cleaning in Place (CIP) – The new Annex 1 lists a full set of requirements which should be considered as part of any assessment when moving to single use technology.
In all of these areas, Clean Room Garments and Ecolab are uniquely placed to help, providing solutions for each as well as high quality, personalised training and validation delivered by our experienced team of Global Technical Consultants (GTCs).
For more information or for copies of the presentations, please speak to your CRG account manager or email service@cleanroom.com.au.
