Disinfection is an essential aspect of the contamination control process but should not be considered as a stand-alone activity. Historically, disinfectants were often chosen solely based on their bactericidal effect tested on compendial organisms that were exposed to the biocide in a test tube. i.e., a laboratory suspension test.
Over the course of time, it is has developed to be more elaborate in the industry. It is now clear, throughout the revised Annex 1, that Risk Assessment is at the forefront of the decision-making process. It is cited repeatedly throughout the document and is of the utmost importance when developing a strategy for a holistic approach to disinfection control.
A well-thought-out contamination control strategy
The emphasis is shifting towards a greater need for risk assessment in the proposed revision to Annex 1. Manufacturers will have to have
a well-thought- out contamination control strategy in place which includes consideration for disinfection steps in the process.
In current facilities and processes, the use of disinfectants and the effectiveness may need to be reassessed to ensure that the appropriate laboratory testing is performed, that the original disinfection testing includes in house environmental flora and that a system is in place to allow the ongoing assessment of new local isolates into the disinfection regime.
At Sure Laboratories, we help customers to assess their current disinfection protocols and set up a well-thought-out contamination control strategy. We focus on reducing risks and a holistic approach to disinfection control.
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