Excerpt: The Aqueous Cleaning Handbook

Source: Alconox, Inc.
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Excerpt: The Aqueous Cleaning Handbook

Malcolm C. McLaughlin, M.A.
Alan S. Zisman, M.D.
and the
Technical Services Staff of Alconox, Inc.

Pharmaceutical equipment includes everything from bench scale lab apparatus used for trials to full scale bulk manufacturing equipment. Regardless of scale, all pharmaceutical equipment must meet government standards for cleanliness. These standards are commonly referred to as Good Manufacturing Practice (GMP) and more recently, current Good Manufacturing Practice (cGMP), or more recently still as conforming to Quality Systems (QS). There are additional regulations, established by agencies including the US FDA, the EU (European Union), and the Interna-tional Conference on Harmonization (ICH), that must be followed. For a discussion of cleaning validation requirements, see chapter 8 on cleaning validation and for examples of standard operating procedures (SOPs) used in pharmaceutical process equipment cleaning, see Chapter 7 on cleaning procedures.

Residues, found in pharmaceutical cleaning, range from easy to clean water-soluble excipients to difficult to clean petrolatum/metal oxide mixtures. To simplify regulatory compliance, it is desirable to use as few cleaners as possible to remove the entire range of residues encountered. It is also desirable for these cleaners to work in a wide range of cleaning procedures including manual, soak and ultrasonic cleaning, as well as clean-in-place spray systems.

Typically, surfaces to be cleaned are constructed of glass, 316L stainless steel, Teflon, polypropylene, and silicon elastomers used in seals. In some cases, pharmaceutical manufacturers will use disposable seals, pipes and filters to avoid having to validate their cleaning. In some cases, it is safer and more cost effective to use equipment once rather than clean it.

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Excerpt: The Aqueous Cleaning Handbook