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Quality by Design and Single-Use Air Sampling Approaches

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Minimizes False Positives

BioCapt® Single-Use Viable Microbial Impactor

The BioCapt® Single-Use Microbial Impactor helps minimize false positives for microbial activity in pharmaceutical cleanrooms by reducing contamination from handling of agar plates. This results in a decrease in investigations while increasing production. Additionally, many costly and time consuming sterilization steps, such as autoclaving, disinfecting, handling and logistics are eliminated. This innovative approach to viable microbial air sampling and monitoring builds on the collection efficiencies of the BioCapt stainless steel viable impactor, while also virtually eliminating false positives through specialized packaging and single-use application.

The BioCapt Microbial Impactor (Single-Use) achieves sampling with minimal air disruption and can be used to sample efficiently at 25 or 50 L/min to suit both routine monitoring and fast sampling needs. This new device has a proven recovery of microorganisms under stressed conditions after two hours of continuous air sampling (25 L/min flow rate) reducing the number of plate changes required for continuous air sampling.

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BioCapt® Single-Use Microbial Impactor

Features

  • Complies with ISO 14698-1
  • Culture media validated to be stored either at room temperature or under refrigeration, with a shelf life of up to nine months for viable monitoring
  • Offered in standard culture media of trypticase soy agar (TSA) and sabouraud dextros agar (SDA), as well as client-specific, pre-validated microbiological culture media
  • Compatible with leading active air monitoring systems

Benefits

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

Applications

  • 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
  • Microbiological monitoring of surgical suites or operating rooms

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