Sensitivity range: 1 cfu
The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS). This new all-in-one remote monitoring product fully meets EU GMP Annex 1 regulatory requirements and the operational needs of the pharmaceutical manufacturing industry where flexible connectivity and compliance are of value.
Designed for mounting in tight spaces and loaded with features, the MiniCapt Pro has a small footprint and gives the user flexible installation options with an internal pump, Power over Ethernet (PoE), WiFi, and analog and digital I/O capabilities. The external 316L stainless steel enclosure protects the unit during cleaning activities and from harsh environments. The MiniCapt Pro accommodates various settle plate options and was designed for seamless use with the BioCapt stainless steel impactor and the BioCapt Single-Use. The MiniCapt Pro is offered in two models and flowrates for added customization.
The MiniCapt Pro can be fully integrated into Particle Measuring Systems’ FacilityPro® system or other FMS via MODBUS communications.
Features
- EU GMP Annex 1 and ISO 14698-1 compliant
- PoE option for simple installation and communications
- Quick disconnect mounting bracket with optional NFC configuration for simplified installation
- Adjustable height and diameter mechanism for versatile agar dish use with BioCapt®, additional compatibility with BioCapt® Single-Use
- Modern and easy-to-use data and sample configuration management by integration with the FacilityPro® system or other existing monitoring systems
- HEPA-filtered blower options eliminates environmental contamination from instrument operation
- User-defined power options: PoE, DC, or AC power
- Digital I/O
- WiFi capability
Benefits
Fully Compliant
- EU GMP, ISO, USP, EP, and JP compliant
- Data Integrity in accordance with 21 CFR 11 and other most recent data management requirements
- Use with BioCapt Single-Use for a validated solution
Precision (BioCapt® and BioCapt® Single-Use)
- Sensitivity: 1 CFU
- Meets ISO 14698-1
- Radial slit design ensures optimal recovery for microorganisms during sampling
- Immediate and easy detection of false-positive results
- Feller correction only above 57 CFU needed, max 3% overlap deviations at 200 CFU
Security
- Remote Sampling ensures low user intervention and minimized false contamination
- No environmental contamination of critical control points with optional HEPA-filtered inlet and exhaust air
- Single-Use Sampling method with BioCapt® Single-Use
Applications
- EU GMP Annex 1 environmental monitoring compliance
- Microbial air sampling of critical control points in cleanrooms and associated controlled environments
- Microbial air sampling in aseptic manufacturing areas (e.g., cleanrooms, isolators, RABS) according to regulations
Additional information
| Product Type | Fixed Location, Remote Sampling |
|---|---|
| Sampling Environment | Air |
| Application | Production Monitoring |
| Method | Continuous Monitoring by Impaction |
Supporting Materials
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