The Pharmaceutical Manufacturing Unit (PMU) of the UK’s Portsmouth Hospital Trust specialises in the aseptic preparation of pharmaceuticals and parenteral nutrition, cytotoxics and patient-controlled analgesia in a variety of administration devices. With two aseptic rooms, eight isolators, two preparation rooms and a checking and labelling area, an extensive environmental monitoring (EM) programme is in place that incorporates both active and passive air sampling to ensure the environment is free from microbial contamination.
The EM programme involves active and passive air monitoring as well as contact plates and is performed weekly (at a minimum) in all areas. Routine monitoring is performed with Tryptone Soy Agar (TSA) and also monthly with Sabouraud Dextrose Agar (SDA).
Monitoring can involve in excess of 50 active air samples, and the need to sample 1,000 litres of air at each location means high speed air samplers are essential to ensure monitoring is performed in a timely fashion and events can be reacted to if the need arises.
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