Monday, 30 November 2015

Risk assessment for aseptic transfer

Aseptic transfer is a wide ranging term, covering the inoculation of agar tubes and plates in a microbiology laboratory to the transfer of items into a cleanroom within a sterile products manufacturing facility or a compounding pharmacy. Across the range of applications the overriding requirement is aseptic technique, to either render the material free of contamination (through bioburden reduction) or to prevent adventitious contamination from operators or the environment.

In a new article for Clean Air and Containment Review, Tim Sandle focuses on the best practices for aseptic transfer within a pharmaceutical facility or pharmacy.

Here contamination can result in product adulteration and lead to a potential risk infection for the patient. In order to minimise the possibility of contamination, a risk-centric approach is required. Given several high profile product contamination events worldwide (some with serious consequences for patients), microbial contamination risks remain ever present and, in some cases, ill-controlled. The article considers the key risks and risk mitigations.

The reference is:

Sandle, T. (2015) Importance of Risk Assessment for a Aseptic Transfer in Pharmaceutical Compounding, Clean Air and Containment Review, Issue 24, pp18-23

For details, please contact Tim Sandle

Posted by Tim Sandle