The evolution of standards impacts microbiology lab needs and practices. To ensure compliance, new impactors appear on the market. Conformity, cost and availability are key factors to make a choice. Once the right model is 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.
In the food, pharmaceutical, and medical industries, priority is given to batch release, in compliance with standards and internal policies. Microbiological air analysis (bacteria, yeasts, and molds) must be sufficient to secure production during installation and the first air impactions with the new device.
Solution : Build up a transition sampling plan, simultaneously using the old and the new model over a defined period of time. This protocol is the key to managing the process and maintaining production. It must include:
1 – IQOQ of the new device: To ensure its proper functioning and ensure proper user training!
2 – Define the acceptance criteria of the new bio-impactor: Taking into account a potential change in sampling speed (100L/min or 200L/min) or the number of sampling heads (1 to 3).
3 – Definition of the joint sampling plan: Preserve the mapping of critical points and duplicate the samples. Be sure to determine the timeframe, intervals, and the number of samples per device.
What about PQ?
Performance Qualification is available from some suppliers and provides a documented check to certify that microbiological impactors are optimally positioned to perform efficiently and in a reproducible way, based on the approved method.
Please note: Each user must adapt it to their own specifications!
What about the old equipment?
Once the transition plan is approved and validated thanks to acceptance criteria, the 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 equipment removal to make one last gesture for the environment!
Our team will support you during the transition towards Airwel microbiological air samplers, discover them here :
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