New Annex I regulations for sterile drug manufacturing processes, monitoring, quality control, and more were published on 25 August this year. The new guidelines, the result of 14 years of work, are a significant departure from the original 2008 good manufacturing practices and are meant to reflect the realities of modern sterile manufacturing. The clock is ticking when it comes to updating your cleanroom protocols to become Annex I compliant, as the new regulations go into effect on 25 August next year.

1.     Institute New Protocols for Cleaning

Beginning with your cleaning practices is one of the simplest places to start. Annex I provides clear definitions of ‘cleaning’ and ‘disinfecting’. Regulations state that a production area must be cleaned and disinfected in order to be considered aseptic. Cleaning refers to the removal of non-viable contamination, while disinfection refers to the elimination of microbes. Annex I confers that ‘cleaning’ and ‘disinfecting’ are two separate tasks that together maintain patient safety by removing contaminants from drug manufacturing zones.

Current Annex I states:

4.24    The Cleaning process, prior to the Disinfection process, is Essential.

Any residues that remain may inhibit the effectiveness of the Decontamination process

4.36    For Disinfection to be effective, prior cleaning to remove surface contamination should be performed

5.4       The Cleaning process should be Validated to:

Remove any residue or debris that would detrimentally impact the effectiveness of the disinfecting agent used.

Minimise chemical, microbial, and particulate contamination of the product during the process and prior to disinfection.

This mandate is intended to eliminate residues left behind by many disinfectants. These residues may reduce the subsequent disinfectant’s efficiency and should be removed completely. You can start implementing this procedure right away to be ready for the new requirements when they go into effect.

2.     Use Products to Ensure Elimination of Residues and Efficient Application of Disinfectant

Suite® products by Benchmark have been developed and tested thoroughly to facilitate the removal of residues, bioburden, endotoxins, and other contaminants. Because of the impending implementation of Annex I regulations, now is an excellent time to assess the efficiency and reliability of your current cleanroom standard operating procedures and products.

Among Suite’s cleaning products are mops, sponges, wipers, and reaching tools that use proprietary Ultra-Fiber technology. The highest concentration of microscopic fibres possible is packed densely into Ultra-Fiber material. When wiped with Suite Ultra-Fiber, submicron crevices of cleanroom surfaces (e.g. epoxy or steel) are penetrated down to an endotoxin level, eliminating cross-contamination through carryover.

3.     Validate Disinfecting Procedures and Products

Disinfectant qualification standards are outlined in Annex I. Whether they are pre-saturated wipes, sprays, or solutions diluted from concentrate, all disinfectants need to be put through efficacy testing to ensure they work properly for their full duration of use. To ensure the application process is effective on the surfaces of the equipment for which it is designed, tests must be conducted at each individual facility.

Rotational updates to the disinfectant regulations are continued in Annex I. It is recommended to use a combination of disinfectants, including a sporicide, on a regular basis. There are no hard and fast rules in Annex I about which compounds must be used and when; rather, it is up to risk management teams to make those calls based on their own assessments and regular audits of the products on hand. Suite® also provides product transfer tools and PPE such as gloves, masks, hoods, and goggles to shield workers from harsh biocides like broad-spectrum disinfectants and sporicidal cleaners.

The purpose of Annex I is to acknowledge the development of cutting-edge methods and standards in life science production. You should start assessing your existing tools, processes, and equipment now in order to make sure your production is compliant with good manufacturing practices by August 2023.

You can learn more about our Suite product range here, and ask your Benchmark Regional Manager for assistance preparing your facility and processes for Annex I regulations.