Device built-in

Merck MAS-100 NT Microbial Air Sampler (with IQ/OQ Validation Package) Product Introduction

The Merck MAS-100 NT is a GMP-compliant professional microbial air monitoring system widely used in pharmaceutical, medical device, and hospital cleanroom environments. This complete system includes Installation/Operational Qualification (IQ/OQ) documentation, meeting the latest FDA 21 CFR Part 11 and EU GMP Annex 1 requirements.

Core Features

1. Regulatory Compliance Design

• Certified to ISO 14698-1/GB/T 16293 standards
• Pre-installed audit trail software compliant with 21 CFR Part 11
• Each unit includes uniquely numbered IQ/OQ documents (with 3-level calibration certificates)

2. Precision Sampling Technology

• Andersen Impaction Principle: 400-hole precision sieve achieves ≥99.9% capture rate for 0.5μm particles
• Smart Flow Control: Adjustable 50-100L/min (default 100L/min) with automatic altitude compensation
• Multi-level Alarm System: Real-time monitoring of critical parameters (±5% flow deviation, battery status, etc.)

3. User-Friendly Operation

• 4.3" color touchscreen: Supports Chinese/English language switching
• 28 preset programs: Including dynamic/static monitoring and settle plate synchronization modes
• Data storage: 1000 time-stamped records with USB PDF report export

Technical Specifications

Typical Applications

• Grade A Cleanrooms: Online monitoring of sterile filling lines
• Vaccine Production: Biosafety cabinet validation
• Hospital ICUs: Regular microbial air screening
• Food Packaging: Cleanroom compliance testing

Service Support

• IQ/OQ Services: On-site validation (including third-party notarization)
• Annual Calibration: Recommended flowmeter traceability calibration every 12 months
• Consumables Kit: Original culture dishes + glycerol membrane adapters

System Components

1. Main unit (with sampling head)
2. Adjustable stand (1-1.5m height)
3. IQ/OQ documentation (Chinese/English versions)
4. NIST-traceable calibration flowmeter

This system has been successfully implemented in 3,000+ global pharmaceutical facilities. Its modular design allows future upgrades to MAS-100 EX (remote monitoring capable). Merck provides 24-month extended warranty with 48-hour emergency response (major Chinese cities).

Note: The 2023 version features improved anti-static sampling head design, reducing false positives by 40%. Contact local Merck distributors for technical details.