Máy lấy mẫu vi sinh không khí MiniCapt® Pro dành cho ngành dược, tuân thủ Annex 1

Hiệu chuẩn, bảo trì, bảo hành tại công ty SAO NAM – Đại lý và trung tâm dịch vụ chính Hãng PMS với kỹ sư được đào tạo .

• Liên hệ Ngay để được tư vấn chi tiết: 028 6260 2704
• Website:    https://saonamchem.com/        https://saonam.vn/                                  https://pmsvietnam.vn/
• Email: info@saonamchem.com
• Địa chỉ: 92 Đường số 13, Phường Bình Trị Đông B, Quận Bình Tân, TP.HCM

---

offers fully compliant remote microbial monitoring with built-in pump and advanced communication options for remote viable monitoring.

November 28, 2022, Boulder, CO – 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 isolator microbial monitoring. This new product meets EU GMP Annex 1 regulatory requirements and the operational needs of the pharmaceutical manufacturing industry where flexible connectivity and compliance are of value. Loaded with features, the MiniCapt Pro’s small footprint is designed for mounting in tight spaces and gives the user all-in-one flexible installation options with a  HEPA-filter compatible internal pump, various power options including Power over Ethernet (PoE), WiFi, and digital I/O capabilities. The external 316L stainless steel enclosure is liquid resistant and has an IP65 rating that protects the unit during cleaning activities and from harsh environments. The mounting bracket with optional NFC allows for simple installation, removal, and reprogramming after service. The MiniCapt Pro collects viable particulate contamination using the BioCapt® and BioCapt Single-Use microbial impactors, and accommodates various settle plate options. “The MiniCapt Pro remote viable air sampler is an example of how Particle Measuring Systems Engineers build flexibility into their products to meet the evolving and specific needs of their customers.” said Paul Hartigan, Global Aerosol Product Line Manager at Particle Measuring Systems. He continued, “We are excited about the addition of the Power over Ethernet (PoE) capability and the optional Smart Bracket mounting system that incorporates NFC capabilities to simplify service and installation.  This remote microbial sampler adds to our world-class line of viable monitoring and contamination control products. Our customers especially benefit from the small footprint and all-in-one nature of this instrument, giving them the ability to monitor aseptic processes close to critical control points.” After initial installation, the MiniCapt Pro’s plug-and-play connectivity allows it to easily integrate into PMS or third-party facility monitoring and compliant data management software systems. Additionally, the quick-release mounting bracket stores essential sensor data such as the IP address at the point of measurement, reducing installation time and errors after calibration or servicing. The MiniCapt Pro is part of Particle Measuring Systems’ Pro Series of advanced contamination control solutions. Use the MiniCapt Pro alone, or together with other viable and nonviable, remote and portable, instruments in the Pro Series line of instruments to monitor clean and aseptic manufacturing areas with the full confidence of meeting global regulatory requirements.

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