Tessa Rossi, GMP Microbiologist at Bidvest Noonan, discusses the new Annex 1 revision, the EU guidance document for the manufacture of sterile medicinal products, and what this means for sanitisation in the pharmaceutical sector.
Cleaning and disinfection achieve two distinctly different objectives. Each plays a crucial role in ensuring that a facility and its equipment are ready to be used for pharmaceutical manufacturing.
In light of the new Annex 1 revision, it has become apparent that there is a paradigm shift forcing cleaning and disinfection to be considered as two clearly separate, distinct tasks and that both these aspects have to be incorporated into the contamination control strategy.
Cleaning refers to the removal of all dirt, soil, and residues (non-viable particulates) from a surface. Detergents are used to clean surfaces. Disinfection specifically refers to killing any microorganisms (viable particulates) that are present on the surface. Disinfectants are used to accomplish this but do not necessarily employ cleaning as part of its mode of action.
Aside from the regulatory requirement to separate these two tasks and to include both as part of an effective sanitisation regime, it is also imperative to ensure effective contamination control. Non-viable particulates, such as soil, can often harbor microorganism within it. In addition to this risk, any dirt, debris, dust, and other non-viable particulates all pose a risk to the product itself, with both viable and non-viable contaminants required to be kept within defined cleanroom parameters.
Effective cleaning also primes surfaces and equipment for disinfection, as disinfectants become less effective if surface contaminants are present. Disinfection, in turn, if effective, eliminates viable (microbial) contaminants that could pose a risk to product safety.
An effective sanitation procedure in pharmaceutical facilities should include the following steps, combining both cleaning and disinfection as part of the process:
- Removal of larger debris and particulates
- Surface rinse
- Cleaning with detergent
- Post cleaning rinse
- Disinfection
- Post disinfection rinse (if applicable)
- Validation