BioLaz

BioLaz™ Real-Time Microbial Monitor

The BioLaz Real-Time Microbial Monitor provides real-time detection of biological organisms in controlled environments used for the manufacture of sterile products. The sensor can be connected directly to Pharmaceutical Net, FacilitySight®, or your own software, and is designed to operate unattended for continuous operation. The BioLaz has been independently tested to meet the rigorous requirements of USP <1223> Validation of Alternative Microbiological Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality, for the Pharmaceutical market. BioLaz samples air into the sensor via a stainless steel sample probe. As the air passes through the system it is illuminated by a laser and the biological particles fluoresce. Those fluorescing biological particles are then counted in one of two size channels, depending on their size. The BioLaz has been designed with a small footprint in a 316L stainless steel enclosure to fit in constrained space. The unit provides its own air flow using an internal pump, eliminating the cost of and need for external vacuum lines.

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Product Description

BENEFITS

  • Immediate notification when biological particles are present
  • Verify biological levels are acceptable prior to filling
  • Separation of finished product (based on timing of alarms)
  • Immediate notification for alarm response
  • Faster batch release
  • Reduced operator error
  • Paperless data management

FEATURES

  • Capable of single Bio-Count detection. One Bio-Count is representative of one CFU.
  • Validated to USP <1223> and EP 5.1.6 requirements.
  • Not constrained by physical and biological efficiencies associated with impact air samplers.
  • Not constrained by the type and quality of the growth media.
  • Real-time, continuous counting free from error sources including contamination, mishandling, and inaccurate counting.
  • Easy to operate and does not require any special handling, training, or logistics.

APPLICATIONS

  • Sterility test isolators
  • Filling lines
  • Aseptic transfers
  • Biotech applications – product to patient
  • Troubleshooting contamination events
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