There are many reasons for using less than one (<1) cfu instead zero: Detection Limits Sampling Limitations False Sense of Security Risk Management Example: In a cleanroom where air samples are taken, if an active air sampler processes 1 cubic meter of air and no colonies are detected after incubation, the result is reported as…
A settle plate is an agar plate, placed in a defined location. For consistency of sampling, for cleanroom it used in the pharmaceutical industry for semi-quantitative determination of microbial contaminations in the air. After four hours, they have undergone their maximum weight loss and should not be used for further examinations. Experiments showed that the…
Samples are retained to fulfil two purposes; Reference sample A sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages or intermediates,…
Microbiological water analysis estimates the number of bacteria present and identifies microorganisms. The microbial population in a water sample can change over time, which can lead to inaccurate assessments of water quality. Therefore, it is recommended that water samples be transported and analyzed within six hours. It is dependent on your validation research of…
1. Random Sampling This method involves selecting samples randomly from a batch or lot. It is widely used for various pharmaceutical products. – Guidelines: ISO 2859-1:1999 (Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection). 2. Stratified Sampling In this method, the batch…
