To support compliance to the EU GMP Annex 1 draft guidelines, Ecolab has developed new products to add to its range of market leading cleaning and disinfectant solution. Here we explain how they can complement your cleaning procedures.
Key areas which may be affected by the draft 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.
- The use of low residue products with controlled application will minimise residues throughout the process. See the Klercide Low Residue Quat Metered Dose Concentrate.
- A wide range of products which can be used effectively in rotation, including sporicidal action. See Klercide Sporicidal Enhanced Peroxide 1L Spray, Klercide Sporicidal Enhanced Peroxide Pouch Wipes and Klercide Sporicidal Enhanced Peroxide 5L.
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.
- The SteriShield Delivery System (SDS) – the closed system which makes every use like the first, by ensuring the integrity of the contents in-use. See the Klercide Sporicidal Enhanced Peroxide 1L Spray
- The burden is increasing on the preparation of products made from concentrates - Ecolab has a full range of solutions to offer, including a concentrate with metred dose. See the Klercide Low Residue Quat Metered Dose Concentrate.
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.
- Klercide Low Residue range of products, see the Klercide Low Residue Quat Metered Dose Concentrate.
- Ensuring controlled application of the quantities applied will help to reduce the residues
- A range of products for residue removal is available
The draft 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.
- Sporicidal product recommendations for high bioburden risk. Klercide Sporicidal Enhanced Peroxide 1L Spray
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