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Model: AirCapt™ MP8 Multipoint Microbial Monitoring System

Hãng sản xuất: Particle Measuring Systems (PMS) - USA

The AirCapt™ MP8 Multipoint Biological Monitoring System enables remote-controlled simultaneous microbial air sampling of up to eight independent locations. Control of the system is achieved through BioManager or by any configured SCADA system. The slits in the BioCapt™ Impactor Head are precision cut to ensure laminar flow, thus maximizing collection efficiencies for microbial 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. Each BioCapt Impactor Head is fully autoclavable and all sample air is exhausted outside of the cleanroom to prevent contamination of the cleanroom environment. The system can also be expanded from eight to sixteen sample locations by adding the optional MP8 to MP16 module.

BENEFITS

• 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 GMP, GAMP , and 21 CFR Part 11 regulatory requirements

• 25 L/min flow rate ensures sample volume is collected quickly enough to avoid physical or chemical degradation of the collection media

• Optimal slot design in BioCapt Impactor Head ensures laminar low and that microorganisms are undamaged during sampling

• Autoclavable BioCapt Impactor Head

• Immediate detection of false positives

• No operator intervention required during the sampling process

• All sample air lines are vented outside to prevent contamination of the cleanroom or clean zone

• All sampling recipes, warnings, alarms, data trends and reports, and audit trails managed by BioManager software or in-house SCADA platform.

APPLICATIONS

• Automated Cleanroom and clean air device biocontamination monitoring

• Generate baseline biocontamination data for newly constructed and commissioned installations

• Microbial monitoring of aseptic filling areas

FREQUENTLY ASKED QUESTIONS:

• Can I use a hand-held device or portable sampler, or do you recommend fixed locations?

• In Grade A areas, do I have to monitor continuously for microbiological particles like I have to for non-viable particulates?

• To use your equipment, do I have to validate a new media supplier, or can I utilize my existing media?

• What is the difference between physical and biological collection efficiency?

• What sample air flow rate is best for my microbial sampler?

• Where should I locate my microbial monitoring sample points?

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