Annex 1, Cleaning and Disinfectants
GMP Annex 1 aims to prevent contamination in the final product. The updated guidelines include further clarification and additional instructions for sterile manufacturers to consider. Under the new guidelines, manufacturers must review their processes and take all steps necessary to assure the sterility of the products manufactured within its facilities.
One key change to be aware of is regarding cleaning and disinfection. Cleaning first to physically remove dirt particles and chemical contamination from surfaces with a neutral detergent has been expanded to include a second stage – the use of a disinfectant to kill any microbiological contamination. Additionally, Annex 1 now requires you to introduce a sporicidal disinfectant so that you rotate a broad spectrum and a sporicidal agent.
Principles Behind Rotational Cleaning
Different chemicals work in different ways. Rotating between two different types of disinfectant prevents resistance which can occur when the same disinfectant is used continuously therefore rotating the chemicals ensures that the most effective chemical is used for different types of bacteria. For example, a disinfectant will kill microorganisms on inanimate objects and surface but will not always be effective on bacterial spores.
The disinfection process must be validated to demonstrate the effectiveness of the chemicals used. This process should include:
- Training all staff members on the importance of rotational cleaning
- Train staff on how to properly use each disinfectant and when
- Maintain records of your disinfectant schedule to track the efficacy of the rotation
- Make changes to the rotation if resistance does develop
Our range of cleaning and disinfectants offers effective control in minimising contamination. With our industry expertise and knowledge we have developed an extensive range of products to meet the requirements of Annex 1 and assist you with the challenges this new revision brings.