CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRIES
نویسندگان
چکیده
منابع مشابه
Determination of Residual Ceftazidime in Pharmaceutical Product line: A Cleaning Validation Study by HPLC
The manufacturing equipment in pharmaceutical industry, could be used in multiple and sharedproduction lines, therefore there is the possibility for the products components and active ingredients tointermix and pollute one another. In this purpose the cleaning methods are used, to reduce the residueslevels from the machinery surfaces and decrease the residues to acceptable level but these metho...
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Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particle, dust, lubricants, raw materials, intermediates. Mainly cleaning is performed to remove product and non-product contaminating material. Ineffective cleaning can lead to adulterated pr...
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A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision. ross contamination with active ingredients is a real concern. The...
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Introduction Total organic carbon (TOC) analysis provides a quick and efficient analytical process for cleaning validation in the pharmaceutical industry. When a single piece of equipment in a pharmaceutical manufacturing facility processes different active pharmaceutical ingredients (APIs), cross-contamination between products must be kept to an absolute minimum. Cleaning validation is the ove...
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The application and efficacy of cleaning and disinfection methods are reviewed, together with the relevant European and French legislation. European Commission Hygiene Directive 93/43/EEC of 14 June 1993 proposes the adoption of hazard analysis and critical control points (HACCP) for the meat industry, and this includes cleaning and disinfection. It is necessary to organise a team for washing, ...
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ژورنال
عنوان ژورنال: International Journal of Research in Pharmacy and Chemistry
سال: 2020
ISSN: 2231-2781
DOI: 10.33289/ijrpc.10.2.2020.10(39)