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1st October 2018 Content supplied by: Cherwell Laboratories Ltd
SAS Microbial Air Samplers and the Revised EU GMP Annex 1
The draft revision to EU GMP Annex 1 places greater emphasis on the idea of continuous environmental monitoring (EM) within pharmaceutical facilities. EM is already a critical component within a licensed manufacturing facility and selection of the right sampler is key in delivering reliable data for compliance. A well-defined EM program will ensure that safety standards are met and meet the risk management criteria now focused on in the draft Annex 1. In the draft viable EM is covered in a lot more detail. Microbiological methods of monitoring are not only mentioned but there are recommendations for how to apply them. Advice is offered about best practices for viable EM and this includes continuous monitoring during filling operations. Furthermore, it advises on how to approach data and the expectation to speciate isolates from grade A and B areas.
To ensure compliance it is recommended that existing EM programs are scrutinised and audited to ensure best practice. An audit of the current arrangements would consider what current methods are being used, what data is being collected and challenge why are these fit for purpose. Then consider what EM is actually being performed as it covers many elements, including viable particles, non-viables, pressure, temperature, humidity etc.
The selection of the appropriate sampler for viable particle monitoring is of course one vital component in delivering an effective EM program. The SAS samplers are appropriate for clean room use; they are easy to clean and disinfect, made from materials compatible with clean rooms, but are convenient, light weight and easy to use. The sampling technique is effective and well accepted for collecting viable particles. The SAS range also offers alternative solutions for not only general EM sampling, but also specialist sampling in Isolators and for compressed air. The benefit is that all systems deploy the same sampling technique - multi point impaction sampling. Cherwell also offer regular calibration of the SAS samplers which is vital in maintaining the known effectiveness of the samplers.
Date Published: 1st October 2018
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