ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file. Details of the software products used to create this PDF file can be . This part of ISO specifies the methods required for monitoring. This part of ISO is the first general International Standard for biocontamination control. However, many factors besides cleanliness must be considered in.
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INTERNATIONAL. STANDARD. ISO. First edition this PDF file can be found in the General Info relative to the file; the PDF-creation. The ISO Standards features two International Standards on biocontamination control for . Create a book · Download as PDF · Printable version. Impaction Technology and ISO Selection of Portable and Automated. Air Sampler Systems to meet cGMP by Jason Kelly. Rev
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The sampling rate, duration of sample, and type of sampling device can strongly influence the viability of the micro-organisms that are collected. The exhaust air from the sampling apparatus should not contaminate the environment being sampled or be reaspirated by the sampling device.
Annex A 3. Sampling volume that is a compromise between being large enough to detect very low levels of biocontamination and being small enough to avoid physical or chemical degradation of the collection medium. In areas of high biocontamination, the impaction method and sampling volume should be selected in such a way appropriate to achieving separate colonies, to allow the results to be interpreted.
The device should meet the following requirements: sufficient flow rate to collect 1m3 in a reasonable time, without significant drying of the sample medium, and appropriate air impact speed to the culture medium. As we see from the above excerpts from ISO the choice of air sampler is very important.
Physical efficiency and biological efficiency are very important factors as well. What does physical and biological efficiency mean?
Physical Efficiency is the ability of the air sampler to collect various sizes of particles. This efficiency is the same whether the particle is a micro-organism, carries a microorganism, or is an inanimate particle.
Or is there variability in what the room delivers? If there's variability, you've already learned two important things Those cheaper easier methods become your control basis.
You however need the foundation studies so that you have proved that your production room monitoring method s correlate with product bioburden.
Your NB's microbiologist should want to see that you have proven such a correlation, and that you understand that ultimately what you're indirectly monitoring is product bioburden. If my surmise above as to why you have a cleanroom was correct, then if you go back to the prior NC, it should say something that you can understand to be consistent with the above.
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