Annex 1 - Detergent and Disinfectants

What is EU GMP Annex 1?

Annex 1 of EU GMP provides specific guidance on the manufacture of sterile medicinal products. The latest version of the guidance has recently been published and will come into force on August 25th, 2023.

This new version is substantially different to the previous version and includes additional guidance on Cleaning and Disinfection processes. The purpose of this article is to explain the key changes with respect to cleaning and disinfection.

This blog forms part of a series of posts from Micronclean that will look at the key parts of EU GMP Annex 1, explain the key requirements to remain compliant with Annex 1 and then suggest how Micronclean's products and services could help you remain compliant.

So, what does Annex 1 say about effective Cleaning and Disinfection in a Cleanroom Environment?

Annex 1 states that for disinfection to be effective it must be a two-stage process. The first stage should be a process to remove surface contamination and the second stage should be disinfection using a rotational system based on two types of disinfectants which have different modes of action.

Stage 1 of the process is very important as any surface contamination could affect the effectiveness of the disinfectants that are in use.  In addition, any cleaning programme should effectively remove disinfectant residues

So, what does Annex 1 recommend for removing surface contamination in a Cleanroom Environment?

Annex 1 does not stipulate what should be used to remove surface contamination, however, Micronclean would recommend that you use a Neutral Detergent which is formulated to work alongside your chosen disinfection regime. In practice, most people will use a sterile version of this Neutral Detergent and the accompanying disinfectants, as this is recommended for Grade A and B Cleanrooms, and could also be specified as part of the contamination control regime for lower grade rooms.

To be effective at removing surface contamination any Sterile Neutral Detergent should be low foaming (which can help to prevent staining), have a neutral pH so that it does not affect the surface it is cleaning and be formulated to be compatible with the disinfectants that are used subsequently (i.e., does not negatively affect the efficacy of the disinfectant performance).

Micronclean's Sterile Neutral Detergent Delta is specially formulated to be compatible with our Alpha and Beta disinfectants and is available in a variety of pre-mixed formats including Trigger Sprays, Pre-Saturated Wipes, Disposable and Laundered Mops and 5L RFU containers.

Pre-mixed, or ‘ready-made' chemicals are best practice as suggested in Annex 1, which reduces the risk for errors and waste chemicals.

So, what does Annex 1 recommend for disinfection of surface in a Cleanroom Environment?

Annex 1 recommends using more than one type of disinfecting agent, which have different modes of action, so that their combined usage is effective against bacteria and fungi, and prevents the build-up of resistance.

Micronclean have two rotational disinfectants that have been proven in large scale field trials, these are Alpha and Beta. Alpha is a synergistic blend of quaternary ammonium compounds (these have a positive charge which attracts the bacteria and long alkyl chains which pierce the cell wall). Quaternary ammonium compounds also initiate autolysis, where a cell is destroyed through the action of its own enzymes. Beta contains a triamine as its main active, which penetrates the cell wall and attacks the RNA affecting its ability to replicate. In this way Alpha and Beta have different modes of action and prevent the long-term build-up of resistance.

In normal use Micronclean would recommend a disinfection regime that follows the pattern shown below:

Micronclean's pre-mixed Sterile Alpha and Beta products are available in a variety of formats including Trigger Sprays, Pre-Saturated Wipes, Disposable and Laundered Mops and 5L RFU containers.

How Micronclean can help you with your compliance to Annex 1?

For more information about how we can help you please contact us.

Author
Michelle Simpson
Product Director