Norms evolution impacts microbiology lab needs and practices. To be conform, new impactors appear on the market. Conformity, cost and availability are key factors to make a choice. Once the right model found, one last headache remains : how can you ensure the transition from one bio-collector to another ?
Objective : Minimal disturbance of the routine air sampling plan.
Why : In food, pharmaceutical and medical industries, priority is given to batch release, in compliance with norms and internal policy. Microbiological air analysis (bacteria, yeasts and molds) must be sufficient to secure the production during installation and first air impactions with the new device.
Solution : Build up a transition sampling plan, using at the same time the old and the new model on a defined period of time. This protocol is the key to handle the process and maintain the production. It has to include :
1 – IQOQ of new device, to ensure their proper functionning and train yourself to use it !
2 – Define the acceptance values of the new bio-impactor, thinking about a potential change in sampling speed (100L/min or 200L/min) or numbers of sampling heads (1 to 3).
3 – Definition of the common sampling plan : Preserve the cartography of critical points and duplicate the samplings. Be sure to determine the period of time, intervals and how many samples per device.
The Performances Qualification is available with some suppliers, and provides a documented check to certify that microbiological impactors are in the best position to perform efficiently and in a reproductible way, based on the approved method.
Be careful : each user must adapt it to his own specifications !
Once the transition plan approved and experienced, thanks to acceptance values, final sampling plan can be launched. The old air sampler retires, after many years of loyal service ! What about recycling it ? Check if your supplier offers the equipment removal, to do one last action for the environment !
Our team will support you during the transition towards Airwel microbiological air samplers, discover them here !
