Ensuring the safe transfer of active pharmaceutical ingre- dients (APIs) and formulation ingredients during high potency and aseptic processing is vital to both the quality of final products and the sterility of manufacturing processes.
The most challenging aspect of handling these components lies
in the transfer of materials from process to process, with operator error and human contaminants posing the greatest risks to
product contamination. This has fuelled the need for new transfer
methods that are both enclosed and minimize the requirement
for operator intervention. This article explores the advantages associated with sterile transfer valve technology, and more specifically, looks at the emerging benefits being achieved through the
adoption of split butterfly valve (SBV) technology.
The transfer of materials into and out of the aseptic core is one
of the greatest potential sources of contamination. If managed
incorrectly, a potential bridge can be created with the external
environment. To manage the risks, there needs to be an understanding about where potential hazards occur. As previously
mentioned, the most common source of contamination is from
people; a fully gowned operator may release as many as 10,000
colony-forming units per hour. As human intervention is present
at almost every stage of pharmaceutical manufacturing processes,
solutions to counter these potential risks are vital.
Regulations and standards for cleanroom environments have
gone some way to alleviating and managing the risks. Ranging
Exploring the benefits of sterile transfer valve technology
Global Product Manager, ChargePoint Technology