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Pharmaceutical Manufacturing and Packing Sourcer
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The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create and maintain the correct level of microbial contamination in the aseptic suite. This article focuses on two important issues - creating and maintaining a spore-free environment and preventing spore contamination that may result from the use of disinfectants.
Control of Bacterial Spores
One of the most difficult requirements in a life science cleanroom is the control of bacterial spores. They can enter the cleanroom on people and on components at a surprisingly high rate. Research has shown that 40 per cent of consumables as they are taken from stores are contaminated with bacterial spores (1). The rest of the study showed that if the transfer disinfection procedure employed comprised of spraying solely with alcohol, only 27.6 per cent of the spores would be removed. The results of the different methods tested are shown in Table 1. Annexe 1 of GMP states that 'transfer of materials into and out of the unit is one of the greatest potential sources of contamination' (2).
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
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Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
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PDA Europe Annual Meeting 2019
24 June 2019, Hilton Amsterdam
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