How does aqueous critical cleaning differ from basic cleaning for appearance? How does this apply to the pharmaceutical industry?
The aqueous critical cleaning process involves using aqueous cleaners to remove residues from surfaces where the surface cannot function properly without successful cleaning. This is distinguished from simple cleaning for appearance. Aqueous critical cleaning is often used on high value surfaces or surfaces that are used to manufacture high value products. In the case of pharmaceutical manufacturing, the glass, ceramic, plastic, and metal surfaces that make up the tools and equipment used to manufacture pharmaceuticals must be free of any interfering cross contamination. If there is any interfering cross contamination, then the resulting high value pharmaceutical being made can be rendered unusable. There is also the risk that the cross contamination is not detected and contaminated pharmaceuticals can be released for use by humans or animals, thereby putting their health at risk, while exposing the manufacturer to liability. Surely, the aqueous cleaning processes in pharmaceutical manufacturing are some of the most critical of all aqueous critical cleaning processes.
Pharmaceutical process equipment, tools and R&D implements are typically made from fairly robust and cleanable materials such as stainless steel, Teflon, polypropylene, synthetic elastomers, glass and ceramic. Although the materials are relatively easy to clean, the tools and equipment often have difficult-to-clean structures. The kinds of residues found in pharmaceutical manufacturing can include many water-insoluble and otherwise very difficult-to-clean residues. Because of the broad range of formulations available with aqueous cleaners, it is possible to find a cleaner that will work even on the most difficult structures and residues by whatever cleaning method is desired. Not only can you find an effective cleaner, but aqueous cleaners are economical and are relatively safe for the environment and workers.
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