What are the benefits of Aqueous Critical Cleaning in Pharmaceutical Manufacturing?
The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. Virtually any pharmaceutical manufacturing equipment from tablet press to a stainless steel mixing tank can achieve their defined critically clean criteria using aqueous cleaning. Typically aqueous cleaners are formulated to ensure maximal cleaning performance by using key ingredients such as surface active agents (surfactants) that are excellent wetting agents that allow the cleaning solution to penetrate into crevices while getting under soils to allow for removal. Often very dilute solutions of aqueous cleaner effectively removes even worst case substances off a variety of hard surfaces including stainless steel, glass, plastic, or porcelain.
The proper use of aqueous cleaning helps manufacturers minimize surface residue and makes cleaning validation easier. Aqueous cleaners are available in low toxicity formulations that make achieving acceptable residue levels easy during cleaning validations. Often even multi-product facilities can find a single aqueous cleaner that cleans all residues on all surfaces. This means less cost for the manufacturer because only one cleaner has to be validated.
Aqueous cleaners are suitable for a variety of cleaning methods such as manual, soak, machine, and automated clean-in-place (CIP). The range in formulation from acidic to basic, high emulsifying to low foaming, and availability of liquid concentrates to powder blends ensures that a cleaner can be found to clean whatever residues are encountered using whatever the cleaning method is being used. Most pharmaceutical companies use liquids because they tend to be easier to handle when dispensing doses, though powders are more economical, especially for manual cleaning.
Aqueous cleaners are usually biodegradable, causing them to have low environmental impact, and are also readily disposable after use requiring no further treatment. Moreover, aqueous cleaners have excellent worker safety characteristics and replace semi aqueous or solvent-containing cleaners that tend to have more worker safety concerns and are harsher to the environment.
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