EC Microbiology

How to get started with an in-house microbial air sampling plan.

The microbial air monitoring in aseptic activities is an important process to guarantee the quality of medicine for the patients’ health. The protocol to apply these tests should be a fundamental part of the education of the involved personnel.

The steps for the implementation of an active microbial air sampling plan are: A. Proper training on aseptic practices. Competencies for hand hygiene, garbing and aseptic techniques should be a minimal requirement for the involved staff. B. Risk assessment. Identification of the potential sources of contamination. C. Standard Operating Procedure. A SOP document should be prepared to cover all the steps of the air sampling plan. D. Sampling plan. The sampling should be performed when staff and material are in the area while activities are ongoing. E. Sampling location. Caution must be taken to ensure the sampling process doesn’t contaminate the operation. F. Material. Adopt the model of air sampler suitable for the correct operation. G. Growth media. Adopt the agar media as indicated by the regulatory authorities. H. volume of air. It is suggested a volume of 1000 litres of air. I. Protocol and result interpretation must be part of the sampling plan.

 Keywords: Safe Sterile Preparations; USP Chapter <797>; In-House Microbial Air Sampling Plan

1. USP General Chapter <797>. "Pharmaceutical Compounding—Sterile Preparations". USP–NF 2023, in USP Compounding Compendium, USP, Frederick, MD, USA.