DualCapt Non-Viable Particle Counter AND Microbial Air Sampler0 pages

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Particle and Microbiological Instrument

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Simultaneous sampling of both viable and non-viable particulate contamination in the same instrument package >

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0.5 and 5.0 m non-viable particle counting at 1.0 CFM (28.3 LPM) >

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The BioCapt Impactor is validated to ISO 14698-1: Biocontamination Control of Cleanrooms and Associated Controlled Environments High physical and biological collection efficiency calculated per ISO 14698-1/Annex B >

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Compliant with cGMP, GAMP >
, and pharmacopeial regulatory requirements >

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25 L/min flow rate for the BioCapt Impactor ensures sample volume is collected quickly enough to avoid physical or chemical degradation of the collection medium 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 >

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Optimal slit design in BioCapt Impactor ensures laminar flow and that microorganisms are undamaged during sampling >
Ѯ 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 >

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Autoclavable BioCapt Impactor >

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Immediate detection of false positives All sample air lines are vented outside to prevent contamination of the cleanroom or clean zone >

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software or by any configured SCADA system. The internal non-viable particle sensor collects data at 0.5 and 5.0 >
m at a 1 CFM (28.3 LPM) flow rate.The slits in the BioCapt >

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ծ 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. >

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Cleanroom and clean air device non-viable particulate and biocontamination monitoring >

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Bi-annual certifications for both particulate and microbiological environmental monitoring, as required by USP Chapter 797 >

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Simultaneous non-viable particle and viable microbial monitoring of aseptic filling areas >

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Without measurement, there is no control.

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