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Truly isolate your aseptic process

Understand Rapid Microbial Methods to Increase Profitability

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?

Eliminate aseptic interventions and costs
for microbial monitoring and: 

  • Reduce line-stoppages
  • Increase efficiency and capacity
  • Enhance process understanding
  • Improve profitability

 

How the BioTrak helps you to be in control of your aseptic manufacturing process 

>>  Monitor continously grade A areas for the full duration of your critical process with BioTrak and
TSI´s Facility Monitoring Software FMS with OPC UA functionality.

Benefits:

  • Partial batch segregation
  • Better understanding of intervention impact
  • Data integrity and reduction of human error

>> Capture all interventions, transient events and any system deterioration with BioTrak and TSI´s Facility Monitoring Software FMS  with OPC UA functionality.

Benefits:

  • High time-stamped resolution data
  • Fast reaction to contamination excursions
  • Seamless integration of addtional parameters via FMS

>> Replace the traditional methods such as settle plates, active air samplers and particle counters with rapid microbial monitoring methods - the proven alternative.

Benefits:

  • Enhance process unerstanding and operator training
  • Eliminate interventions
  • High data resolution to identify potential source of contamination
  • Reduce personnel in critical areas

            

 

           

Business Benefits: 

-       Ensure microbial corrective and preventative actions (CAPA)
-       Accelerate closure of Root Cause Investigations
-       Faster release of manufacturing areas after excursion
-       Reduce product waste and microbiology costs
-       Reduce line-stoppages
-       Increase efficiency and capacity
-       Improve profitability
-       Continuous manufacturing​