Microbial Impactor: BioCapt® Single-Use
Single-use, microbial impactor for Annex 1 monitoring, virtually eliminates false positives.
Continuous Viable Air Monitoring: The Superior Solution
Recent regulations strongly advocate for continuous viable air monitoring in critical areas. The BioCapt® Single-Use Microbial Impactor from Particle Measuring Systems (PMS) sets a new standard, surpassing the traditional use of settle plates by generating validated and actionable data compliant with Annex 1 and all modern global regulations.
Key Benefits
Minimized Microbial False Positives:
- Unique slit design significantly reduces false positives in monitored clean areas.
- Decreases contamination from operator handling, reducing investigations and boosting productivity.
Elimination of Sterilization Steps:
- Test ready: fully prepared, gamma irradiated, and double bagged.
- No need for autoclaving, disinfecting, handling, or logistics.
- Saves time and reduces costs, enhancing operational efficiency.
Innovative Sampling and Monitoring:
- Higher quality assurance through continuous monitoring
- Air sampling solution superior to the use of settle plates that creates validated and actionable data.
- Virtually eliminates false positives from handling through specialized packaging and single-use application.
Efficient and Flexible Sampling
The BioCapt Single-Use Microbial Impactor ensures minimal air disruption while offering efficient sampling at various flow rates (25-50, and 100 L/min). This versatility meets routine monitoring, fast sampling, troubleshooting, and analytical needs. The 25 L/min device continues to recover microorganisms at four hours of continuous air sampling, reducing the frequency of plate changes required.
Automation-Ready
Most recently released is the BioCapt Single-Use AutoM microbial impactor. The latest advancement in microbial air sampling is designed to enhance the reliability and consistency of readings in constrained and robotic pharmaceutical manufacturing environments. Its unique design minimizes human interference in the monitoring process and can eliminate it entirely when robotics are used. The magnetic lid ensures secure sealing from vapor and gasses (e.g. VHP) and safe handling, facilitating easy integration into existing filling lines, whether manual or robotic.
The BioCapt Single-Use microbial impactor is a one-time-use product. With the increased focus on sustainability and Particle Measuring Systems’ commitment to reaching the goal of Net Zero, we have summarized this product’s environmental impact. Click here to learn more.
Product Details
Resources
- Environmental Monitoring in the Pharmaceutical Industry: Handbook
- Quality by Design and Single-Use Air Sampling Approaches
- Microbial Control and Monitoring in Aseptic Processing Cleanrooms
- A Review of EN ISO 17141, ISO 14698 andInstrumentation Conformance
- Single Use Device Media Dehydration and Biological Recovery Efficiency
- 4 Hour BioCapt Single Use Impactor Case Study
- BioCapt® Single-Use 100 LPM Frequently Asked Questions
- Feller Table of Statistical Corrections for BioCapt® Instruments
- Active Air Sampler Comparison in Remote Settings
- Microbial Data Collection: Managing the Expectations of Auditors
- Quality Risk Management: Does QRM + RMM = Better EM?
- Microbial Monitoring of Compressed Gas
- Particle Data Collection and Interpretation for ISO Cleanrooms
- Case Study: Isolator Contamination Control at AST
- Annex 1 2022 Frequently Asked Questions
- Annex 1 2022 v. Annex 1 2008: A side-by-side comparison (effective date August 25, 2023)
- Airflow Visualization Studies: The Impact of Annex 1 (2022) on Sterility Assurance
Accessories
Part of a Facility Monitoring System (FMS)
The BioCapt Single Use is ideal for continuous viable monitoring as part of a complete cleanroom monitoring system. It can be used with an external pump or with the MiniCapt Pro viable monitoring with pump from Particle Measuring Systems. Our FMS are definitive, modular, and turn-key solutions for Cleanroom Environmental Contamination Monitoring.
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