Microbiological contamination models for use in risk assessment during pharmaceutical production

This paper describes the fundamental mechanisms of microbial contamination during manufacture of pharmaceutical products. Models are derived that describe air and surface contact contamination. These models can be used to develop and improve methods of microbial risk assessment. The use of the FMEA (FMECA) method of risk assessment is discussed and, when used with the correct risk factors, its use endorsed

Cleanroom software development

The 'cleanroom' software development process is a technical and organizational approach to developing software with certifiable reliability. Key ideas behind the process are well structured software specifications, randomized testing methods and the introduction of statistical controls; but the main point is to deny entry for defects during the development of software. This latter point suggests the use of the term 'cleanroom' in analogy to the defect prevention controls used in the manufacturing of high technology hardware. In the 'cleanroom', the entire software development process is embedded within a formal statistical design, in contrast to executing selected tests and appealing to the randomness of operational settings for drawing statistical inferences. Instead, random testing is introduced as a part of the statistical design itself so that when development and testing are completed, statistical inferences are made about the operation of the system

Calculation of air supply rates and concentrations of airborne contamination in non-UDAF cleanrooms

This article reviews a series of scientific articles written by the authors, where the following topics were investigated in relation to non-unidirectional airflow cleanrooms. (1) The air supply rate required to obtain a specified concentration of airborne contamination. (2) The calculation of concentrations of airborne contaminants in different ventilation and dispersion of contamination situations. (3) The decay of airborne contamination (a) during the ‘clean up’ test described in Annex 1 of the EU Guidelines to Good Manufacturing Practice (2008); (b) during the recovery rate test described in Annex B12 of ISO 14644-3 (2005); (c) associated with clean areas, such as airlocks, to reduce airborne contamination before a door into a cleanroom is opened. Worked examples are provided to demonstrate the calculation methods to provide solutions to the above topics