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Pharmaceutical Manufacturing and Packing Sourcer
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The effective cleaning of equipment used in pharmaceutical production processes has been well-documented in previous years and is reflected in the attention paid by the regulatory authorities (originally the FDA and more recently the EU authorities). This is detailed in actual or proposed modifications to the regulations and guidelines, that is, the EU guide to good manufacturing practice Annex 15, Federal register part 211 subpart L.
This article does not intend to discuss cleaning validation regulations, measuring levels of cleanliness or the setting of limits. Instead, the focus will be placed on the choice of method used in cleaning equipment. This will be highlighted in a case study which will demonstrate changes that are required when a clean-in-place system replaces a manual cleaning method on two similar types of equipment used to process the same product.
Method of Cleaning
Minimising cross-contamination can be achieved by dedicating a facility and its equipment to the manufacture of one product. This does not mean procedures do not have to be developed and validated, although it is easier to validate and becomes a more general cleanliness activity, as defined in current good manufacturing practice (cGMP). This however is an expensive option, although for some products such as penicillin, this is required due to the very low levels of contamination required to cause an allergic reaction. More commonly, equipment will be used for multiproduct manufacturing and, therefore, effective cleaning methods are essential to prevent the contamination of one product by another.
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By George W Smith, Head of Process Technology & Validation and Lance Pryce, Senior Scientist at Manesty
George Smith is a Chemist with experience gained at RP Scherer and GSK in solid dosage manufacture and development, and at Colorcon in the design of film coating materials and equipment. He is currently Head of Process Technology Research and Validation at Manesty, UK, where he is responsible for running customer trials, solving process related problems, customer training and liaising with academia to develop further understanding of tabletting and coating processes. He has recently completed an MPhil at Manchester University, investigating the factors involved in tablet film coating.
Lance Pryce is a Chemist with previous experience working at Sensient Technologies in the development of functional film coating materials, and on worldwide legislation of natural and synthetic colours. Lance is currently a Senior Scientist at Manesty, UK, where he is involved in running customer trials, customer training and optimising customers' film-coating processes.
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