AGMA is a trusted, global supplier of chemicals, specialising in the formulation of cleaning and biocidal solutions, of which AGMA’s healthcare range is manufactured specifically for use in GMP cleanrooms. These bespoke chemical products are developed, formulated, and manufactured in the UK at their Northumberland facilities.
As a British, family-run SME, AGMA has the ability to communicate and react swiftly to meet the requirements of customers worldwide, through successful collaboration with those designing, building and working within cleanroom environments, delivering quality products with reliability and flexibility in supply, for over 55 years.
What is a neutral detergent?
A neutral detergent is a cleaning solvent which has a mid-range pH, is non-corrosive and is surface-friendly. A recent shift in focus following Annex 1 has seen AGMA proactively addressing potential queries surrounding chemical products for cleanrooms. Established best practice is to separate cleaning from disinfection, this practice is now formally recognised within the updated GMP guidance.
Why use neutral detergents in cleanrooms?
Annex 1 of EU Good Manufacturing Practice (GMP) provides specific guidance on the manufacture of sterile, medicinal products. These requirements must also be considered by manufacturers of non-sterile products where necessary. Cleaning and disinfection are among the key areas where guidance has been extended.
The guidelines (clause 4.33) state that ‘for disinfection to be effective, prior cleaning to remove surface contamination should be performed.’ With this clear definition of the requirement to clean and disinfect as two separate stages, the requirement for a product such as a neutral detergent must be considered.
Clause 4.33 also states that ‘cleaning programmes should effectively remove disinfectant residue’ therefore emphasising the need for a product such as a neutral detergent to remove any residues generated during the disinfection stage. The need to clean before and after disinfection comes from the risk that surface contamination can affect the efficacy of a disinfection agent, where surface contamination prevents the effective disinfection mode of action (anti-bacterial, anti-fungicidal, etc.).
Annex 1 also states the requirement for sterile disinfectants and detergents used in grade A and B areas. Sterile products may also be required for grade C and D areas according to the Contamination Control Strategy (CCS).
AGMA products are designed to allow users to meet the revised standards introduced by Annex 1, and various formats of Neutral Detergent are available.
Shop AGMA Neutral Detergents at Cleanroomshop
AGMA Sterile Neutral Detergent 5L
Designed and processed for use in all grades of cleanrooms, each 5-litre bottle is filled and individually double-wrapped in cleanrooms, then sterilised by irradiation. Great paired with a mop system!
AGMA Sterile Neutral Detergent Spray
Designed and processed for use in all grades of cleanrooms, each 900ml spray bottle is filled and individually double-wrapped in cleanrooms and then sterilised by irradiation. This spray has excellent in-use shelf-life and the bottle is designed not to contract during use.
AGMA Sterile Neutral Detergent Wipes
White resealable pouches containing 10 high quality, low linting, polycellouse cleaning wipes, impregnated with Neutral Detergent. This product is also terminally sterilised by irradiation.