Viable Cleanroom Monitor: BioCapt® Impactor
Sensitivity: 1 cfu
The BioCapt® Microbial Impactor by Particle Measuring Systems (PMS) enables the capture of microbiologically viable particulates on a suitable media surface for later incubation and enumeration. With precision-cut slits to ensure laminar flow, the BioCapt Viable Cleanroom Monitor maximizes collection efficiencies for viable particles in accordance with ISO 14698-1. The 25 L/min flow rate ensures sample volume is collected slowly enough to enable sampling during the maximum amount of process time while avoiding desiccation of the collection medium. Flow visualization studies prove that the BioCapt viable cleanroom monitor does not interfere with the laminar flow in the manufacturing environment ensuring the safety of the drug. Biological efficiency is guaranteed by ensuring optimal impaction velocity and giving statistical control over false-positive results.
Product Details
- Stainless steel
- Protects petri dish from unintentional contamination
- Vacuum draws air down over media for viable particle sample collection
- Meets ISO 14698-1/Annex B for physical and biological collection efficiencies
- 316L stainless steel atrium is autoclavable
- Optimal slit design ensures microorganisms are undamaged during sampling
- Immediate and easy detection of false-positives
- 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
Resources
- Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1
- Data Quality – The Journey of Cleanroom Data Management Life Cycle
- Cleanroom Microbial Monitoring Data for Actionable Insights to Meet and Exceed the Auditor’s Expectations
- Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements
Part of a Facility Monitoring System
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