Monday, 13 August 2018

Selection of microbial monitoring locations on personnel

Having a documented rationale for the assessment and review of the personnel monitoring locations is important for the microbiologist should understand why certain locations are monitored and what the data relating to each individual site means, especially when action level excursions occur and investigations need to be executed. Such a document also serves as a justification to present to auditors or inspectors.

In relation to this, a new paper has been published. Here is the abstract:

The assessment of personnel working in aseptic processing areas, whether this is for supporting Grade B (ISO class 7 in operation) or more critical Grade A (ISO class 5) activities is an important part of the environmental monitoring programme. Guidance from regulators is limited as to how and when personnel monitoring is performed, especially in relation to the locations to be selected on the cleanroom gown. In this paper we examine the potential sites for monitoring and provide a risk-based rationale for the most appropriate sites. The intention is not to provide a defined approach that every aseptic processing facility should adopt; instead we offer a schematic that other organisations can consider, to either base their own operator sampling regime upon or to benchmark their own monitoring regime against. This is on the expectation that regulators expect personnel monitoring locations to be defined and justified.

The reference is:

Satyada, R. and Sandle, T. (2018) Rationale for the selection of microbial monitoring locations on personnel working in aseptic processing areas, European Journal of Pharmaceutical Science and Technology, 23 91): 17-23

For details, contact Tim Sandle

Posted by Dr. Tim Sandle

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