Remote Microbial Air Sampling Using the MiniCapt Pro

Particle Measuring Systems' (PMS) MiniCapt^®Pro Remote Microbial Air Sampler utilizes the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring in accordance with ISO Class 5/7, GMP Grade A/B, and for use in background areas that are monitored by a Facility Monitoring System (FMS).

This all-in-one remote monitoring system completely adheres to the EU GMP Annex 1 regulatory stipulations and the operational requirements of the pharmaceutical manufacturing sector, where versatile connectivity and adherence are of value.

The MiniCapt Pro is intentionally designed to be mountedin tight spaces and has a varietyof features. It has a small footprint and offers users versatile installation options with an internal pump, analogand digital I/O, WiFi, and Power over Ethernet (PoE) capabilities. The external 316 L stainless steel enclosure safeguards the unit during cleaning tasks and from harsh surroundings.

The MiniCapt Pro comprises a number of settle plate options and was engineered for seamless use with the BioCapt Single-Use and the BioCapt stainless steel impactor. The MiniCapt Pro comes in two models and flowrates for increased customization.

The MiniCapt Pro can be completely incorporated with Particle Measuring Systems’ FacilityPro^® system or other FMS via MODBUS communications.

Features

User-fixed power options: PoE, DC, or AC power

Fast disconnect mounting bracket with optional NFC configuration for easy installation

EU GMP Annex 1 and ISO 14698-1 compliant

Adjustable height and diameter mechanism for versatile agar dish use withBioCapt^®, it is also compatible withBioCapt^®Single-Use

PoE option for uncomplicated installation and communications

HEPA-filtered blower options remove environmental contamination from instrument operation

Advanced and user-friendly data and sample configuration management by combining with the FacilityPro^® system or other prevalent monitoring devices

WiFi capability

Digital I/O

Benefits

Fully Compliant

ISO, EU GMP, EP, USP, and JP compliant

Can be used with BioCapt Single-Use for a validated solution

Data integrity following 21 CFR 11 and other latest data management necessities

Precision (BioCapt^® and BioCapt^® Single-Use)

Adheres to ISO 14698-1

Sensitivity: 1 CFU

Instant and easy identification of false-positive outcomes

Feller correction of only above 57 CFU is required, and a maximum of 3% overlap deviations at 200 CFU

Radial slit design guarantees ideal recovery for microorganisms during sampling

Security

No environmental contamination of critical control points with optional HEPA-filtered inlet and exhaust air

Remote Sampling to ensure low user intervention and minimized false contamination

Single-Use Sampling method withBioCapt^®Single-Use

Applications

Compliance with EU GMP Annex 1 environmental monitoring regulations

Microbial air sampling in aseptic manufacturing areas (e.g., cleanrooms, isolators, RABS) according to regulations

Microbial air sampling of crucial control points in cleanrooms and associated controlled environments

Available Accessories

Isolator Kit

Image Credit: Particle Measuring Systems

The Isolator Kit is an add-on adapter kit that allows the MiniCapt Remote Microbial Sampler to remotely sample inside aseptic locations where the placement of the MiniCapt sampler is unfeasible because of space limitations or other restrictions.

Remote Sampling Top (MCR)

Image Credit: Particle Measuring Systems

A remote sampling top is available for the MiniCapt Remote Microbial Sampler.

Remote Microbial Air Sampling Using the MiniCapt Pro

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