DualCapt System - DualCapt

The DualCapt Particle and Microbiological Instrument is a single solution, combining non-viable airborne particle counting with simultaneous microbial air sampling in a single unit using the BioCapt® Impactor  head. The airflow through the instrument is provided by an external (house) vacuum source monitored by an internal pressure sensor to assure the flow rate stays within calibration limits. Control of the instrument is achieved through FacilitySight® software or by any configured SCADA system. The internal non-viable  particle sensor collects data at 0.5 and 5.0 μm at a 1 CFM (28.3 LPM) flow rate.


The slits in the BioCapt® Impactor Head are precision cut to ensure laminar flow, thus maximizing collection efficiencies for viable particles of interest in accordance with ISO 14698-1. Biological efficiency is guaranteed by ensuring optimal impaction velocity also giving statistical control over false positive results. The BioCapt Impactor is fully autoclavable and all sample air is exhausted outside of the cleanroom to prevent contamination of the cleanroom environment.

 

  • Simultaneous sampling of both microbial and non-viable particulate contamination in the same instrument package
  • 0.5 and 5.0 µm non-viable particle counting at 1.0 CFM (28.3 LPM)
  • The BioCapt Impactor is validated to ISO 14698-1:Biocontamination Control of Cleanrooms and Associated Controlled Environments
  • High physical and biological collection eficiency calculated per ISO 14698-1/Annex B
  • Compliant with cGMP, GAMP®, and pharmacopeial regulatory requirements
  • 25 L/min low rate for the BioCapt Impactor ensures sample volume is collected quickly enough to avoid physical or chemical degradation of the collection medium
  • Optimal slot design in BioCapt Impactor ensures laminar low and that microorganisms are undamaged during sampling
  • Autoclavable BioCapt Impactor
  • Immediate detection of false positives
  • All sample air lines are vented outside to prevent contamination of the cleanroom or clean zone

Features & Benefits

  • Simultaneous sampling of both viable and non-viable particulate contamination in the same instrument package
  • 0.5 and 5.0 µm non-viable particle counting at 1.0 CFM (28.3 LPM)
  • The BioCapt Impactor is validated to ISO 14698-1
  • Biocontamination Control of Cleanrooms and Associated Controlled Environments
  • High physical and biological collection eficiency calculated per ISO 14698-1/Annex B
  • Compliant with and pharmacopeial regulatory requirements
  • 25 L/min low rate for the BioCapt Impactor ensures sample volume is collected quickly enough to avoid physical or chemical degradation of the collection medium
  • Optimal slot design in BioCapt Impactor ensures laminar low and that microorganisms are undamaged during sampling
  • Autoclavable BioCapt Impactor
  • Immediate detection of false positives
  • All sample air lines are vented outside to prevent contamination of the cleanroom or clean zone

Applications

  • Cleanroom and clean room device non-viable particulate and biocontamination monitoring
  • Bi-annual certiications for both particulate and microbiological environmental monitoring, as required by USP Chapter 797
  • Simultaneous non-viable particle and viable microbial monitoring of aseptic filling areas.

Literature

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      • Kenelec Scientific Headquarters
        23 Redland Drive, Mitcham, VIC, Australia 3132
        Ph: +61 3 9873 1022
        Fax: +61 3 9873 0200
      • National Freecall No.
        1300 73 2233
      • Kenelec Scientific NSW
        Building 5, 49 Frenchs Forest Road, Frenchs Forest NSW, Australia 2086
        Ph: +61 2 8977 4017
        Fax: +61 2 8977 4000