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Continuous Microbiological Environmental Monitoring in Grade A Isolators and Fill-finish spaces
How can you be sure that you are in control of your aseptic manufacturing process?
Isolators are designed to keep operators out and sterile products safe. Monitoring grade A isolators and fill-finish spaces is essential to ensure product quality and patient safety, raise cost savings and increase process efficiencies. Nevertheless, traditional microbial monitoring often involves process interruptions.
A biofluorescent particle counter (BFPC) like the BioTrak® Real-Time Viable Particle Counter replaces traditional techniques to provide continuous and real-time airborne microbial monitoring without process interruptions or microbiology overhead. Increase your profitability by significantly reducing costs while improving the quality of drug products undergoing aseptic fill-finish!
Three instruments in one, the TSI BioTrak Particle Counter offers continuous ISO-compliant optical particle counting, real-time viable particle counting, and microbial sample collection for speciation.
Real-time viable particle counting – how does it work?
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Eliminate aseptic interventions and costs
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How the BioTrak helps you to be in control of your aseptic manufacturing process
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>> Monitor continously grade A areas for the full duration of your critical process with BioTrak and Benefits:
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>> Capture all interventions, transient events and any system deterioration with BioTrak and TSI´s Facility Monitoring Software FMS with OPC UA functionality. Benefits:
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>> Replace the traditional methods such as settle plates, active air samplers and particle counters with rapid microbial monitoring methods - the proven alternative. Benefits:
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Business Benefits:- Ensure microbial corrective and preventative actions (CAPA) |