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
Posted by Dr. Tim Sandle