Company insight
Cleaning validation helps avoid contamination
In pharmaceutical businesses, validating the effectiveness of cleaning processes is vital. All major regulators and international organisations operating in the health and pharmaceutical fi elds have expressed their directives in regard to cleaning validation. In its range of disinfecting and decontaminating equipment, LAST Technology ensure that this is carried out.
occur. This kind of procedure must be documented to demonstrate that good manufacturing practices have been followed. There are three types of contamination. One is physical (such as external foreign elements), chemical (like residues from previous processing) and biological (such as fungi, bacteria and endotoxins). There are three stages to cleaning validation. First is protocol, which defines the cleaning procedures, the sampling points and techniques, the products to be used and
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leaning validation is enacted on a facility and its equipment so that product contamination does not
allows for collecting of equipment. Next is detection and analysis, where the results are checked through microbiological analysis. Lastly is report, where all the compliance based on the results is collected. For FDA, validation of cleaning procedures plays a decisive role in preventing cross-contamination. Its regulations strongly recommend the use of technological equipment that is designed to the highest standards and follows guidelines. They organise and standardise procedures in order to prevent residues or bacterias within ready-to-market pharmaceuticals. EMA has made it mandatory to establish health-based
exposure limits (HBELs) for all medicines. Toxicological and pharmacological data, on which the calculation of HBELs is based, are updated throughout a product’s life cycle. LAST Technology invests in research and develops new technologies to enhance its machinery for the pharmaceutical industry. This allows it to better manage the processes and cleaning validation phases required by the most important health and pharmaceutical safety bodies. Thus to ensure that each production batch complies with international legislative requirements. ●
www.lasttechnology.it
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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