FacilityPro® Cleanroom Software for Pharmaceuticals

*(We don’t sell this item in Vietnam)

FacilityPro® Cleanroom Software by Particle Measuring Systems provides the interface, data management, and reporting for an environmental monitoring system. FacilityPro’s ability to manage viable, nonviable, and environmental data through a common system improves the efficiency of production operations and quality investigations.

With the FacilityPro industrial automation architecture, the data processing is performed by the Processor while the data management, display, and storage are performed by the software. This design approach increases system reliability and data integrity.

Features

Map for visual indication of viable, nonviable, and cleanroom environmental status
Configurable display
Alarm notification and e-signature acknowledgement
Configurable reports including audit, statistics, and trend reports
Batch identifiers and data filters
Automation of sample collection, driven by recipes
Cubic-meter algorithms for nonviable particle counting data
Volume-based or time-based viable sampling
Remote data viewing and reporting

Benefits

Designed specifically for pharmaceutical cleanroom monitoring
Integration and control of viable and non-viable sampling
High data integrity
Ultimate efficiency and reduced error
Simple installation and validation
Flexible integration

Applications

Monitoring of critical pharmaceutical environments including:

Filling lines
Isolators and RABS
Blow-Fill-Seal
Lyophilizer processes and transfer carts
Biosafety cabinets and flow hoods
General cleanroom and facility monitoring

Supporting Materials

Specification Sheets

FacilityPro® SMART NG / Pharmaceutical Net Pro Software >

FacilityPro® SCADA NG >

Pharmabilites Brochure >

Application Notes & Brochures

Paper Series: Guides to Particle Technology >

Planning and Installing a Facility Monitoring System >

21 CFR Part 11 and Data Integrity FAQ >

Data Integrity: Understand and Comply with GMP and FDA Requirements for 21 CFR Part 11 >

Assuring Data Integrity in an Environmental Monitoring System [Frequently Asked Questions] >

Particle Counter Data Collection and Interpretation for Pharmaceutical Manufacturing >

Webinars

Pharmaceutical Data Management for Root Cause Identification in Critical Environments (Case Study) >

Tackling the 21CFR11 Challenge: From Paper to Paperless >

Steps to Ensuring a Successful Audit – Effective Risk Assessment Design Webinar >

Private: EU GMP Annex 1 Review, Insights, and Feedback >

Understanding ISO Standards: 14644-2:2015 Cleanroom Monitoring (English) >

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