Sensitivity range: 1 cfu

Most recent EU GMP Annex 1 regulations encourage the use of continuous viable air monitoring in critical areas. The BioCapt® Single-Use (BCSU) cleanroom microbial monitor from Particle Measuring Systems is an active sampling method that is superior to the use of settle plates and creates validated and actionable data. It fully meets ISO 14698-1 and anticipated EU GMP Annex 1 single-use regulatory requirements.

The BCSU helps minimize microbial false positives in monitored clean areas by reducing contamination from the handling of settle plates. This results in a decrease in investigations and an increase in productivity. The specialized packaging and single-use features additionally eliminate


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many costly and time-consuming sterilization steps such as autoclaving, disinfecting, and handling.

The BCSU comes in multiple choices of agar and 3 flow rates to suit both routine monitoring and fast sampling needs. The 25 L/min device continues to recover microorganisms under stressed conditions after two hours of continuous air sampling, thereby reducing the number of plate changes required for continuous air sampling.

Most recently released to fulfill requests from the market for troubleshooting and analytical applications, the 100 LPM BCSU uses the same innovative radial slit design as the 25 & 50 LPM models, and shares the advantages of the known and trusted single-use technology. Validated at the Centre for Applied Microbiology & Research (CAMR), it achieves isokinetic sampling for minimal air turbulence in compliance with ISO 14698-1 and can be used for sampling and troubleshooting at 100 LPM.

Use the BCSU in conjunction with the MiniCapt® Mobile and MiniCapt Remote instruments for a fully validated microbial monitoring solution. Learn more about this innovative continuous air sampling solution below.

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BioCapt® Single-Use
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BioCapt® Single-Use
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Features

  • Complies with ISO 14698-1
  • Meets anticipated EU GMP Annex 1, rev 12 single use requirements
  • Store culture media at 2-25°C, with a shelf life of 12 months
  • Offered in standard culture media of trypticase soy agar (TSA) and sabouraud dextrose agar (SDA), as well as client-specific, pre-validated microbiological culture media
  • Compatible with leading active air monitoring systems
  • Replaces settle plates in cleanrooms
  • Reduces the risk of spills that cause contamination
  • Use as part of a Data Integrity program
  • 100 LPM plates compatible with MiniCapt® Mobile the MiniCapt Pro and other active air samplers available on the market

Benefits

  • Helps eliminate false positives by reducing the risk of contamination by improper handling of media plates
  • Eliminates time-consuming cleaning and process steps associated with traditional stainless steel microbiological samplers
  • Simplified standard operating procedures eliminate possible injuries and handling concerns with stainless-steel impactors
  • Reduces risk of contamination during the introduction and withdrawal of microbiological sampling plates in sterile production areas

Applications

  • Continuous viable air monitoring
  • Viable microbial air sampling in cleanrooms and associated controlled environments
  • USP 797 environmental viable airborne particle testing
  • Bioburden monitoring of medical device manufacturing environments
  • Microbial monitoring of aseptic manufacturing areas
  • Microbial monitoring of surgical facilities
  • Use with MiniCapt® Pro for a completely validated solution
  • A family of BioCapt and MiniCapt products that provide flexible monitoring options for isolators and other  applications including troubleshooting
 

Supporting Materials

Specification Sheets

BioCapt® Single-Use Microbial Impactor >

BioCapt® Single-Use 100 LPM Microbial Monitor >

BioCapt® Stainless Steel Microbial Impactor >

MiniCapt® Pro: Remote Microbial Air Sampler >

Pharmabilites Brochure >

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