Pharmagraph
Pharmagraph specializes in GMP/GAMP-compliant monitoring solutions tailored for both small hospital pharmacies and large pharmaceutical production facilities. Their systems accurately track non-viable and viable particle counts, differential pressure, temperature, relative humidity, and air flow, ensuring precise, reliable, and secure results. Pharmagraph offers comprehensive support, from sensor supply to installation, qualification, training, and calibration, ensuring systems are delivered on time and meet all specifications.
With 30 years of expertise in design, production, installation, and ongoing support of high-quality monitoring systems, Pharmagraph assists clients throughout every stage of the system lifecycle.
iVAS Roam air sampler
The iVAS Roam air sampler expands on existing viable air sampling technology, providing assured sampling performance compliant with EN 17141:2020. This portable air sampler features an innovative design and user-friendly graphical interface. With over 20 years of experience in cleanroom technology, Pharmagraph has designed the iVAS Roam to integrate with enVigil FMS software or operate as a standalone unit, allowing setup and sampling records management through the iVAS Roam Manager software.
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The iVAS Roam is designed for cleanroom environments of all grades, supporting a compliant environmental monitoring strategy. Key features include:
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- Integral barcode reader for plate details and sample record information capture.
- Two RFID readers for operator ID and unit location tracking.
- Retaining mechanism for easy movement between sampling locations.
- Adjustable plate height and size.
- Ability to deploy a single site configuration to multiple units.
- Comprehensive audit trail with a detailed record of all changes for regulatory compliance.
- Real-time data synchronization for up-to-date compliance monitoring.
- Advanced reporting and visualization for easy interpretation and analysis in multiple formats.
The enVigil V FMS (Environmental Monitoring System)
The enVigil V FMS (Environmental Monitoring System) is a fully configurable software system designed specifically for GMP manufacturing environments. Tailored to each client’s unique requirements, enVigil V supports a range of settings from high-throughput biopharmaceutical production to patient-specific ATMP facilities, aiding in regulatory compliance across diverse applications.
enVigil V can operate on a single Windows-based PC or scale to a full Windows Server application on virtual machines, with an optional Hot Standby feature to ensure data continuity. Equipped with advanced reporting tools and electronic signature capabilities, it ensures full GMP compliance.
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The enVigil software suite, developed by Pharmagraph over 30 years, offers a robust EU-GMP/GLP-compliant monitoring system for industries such as pharmaceuticals and satellite manufacturing, where environmental monitoring is essential. The suite also enables expansion to include equipment monitoring (e.g., fridges, freezers, and incubators). Key features supporting regulatory requirements, including EU-GMP Annex 1, cGMP, GAMP, and 21 CFR Part 11, include:
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- User-friendly graphical interface
- Facility mimic displays with real-time alarm visualization
- Trending for both real-time and historical data
- Batch reporting with electronic signatures
- Compliance prediction tools
- Detailed reconciled alarm reports with trend analysis
- Advanced reporting and data analytics
- Integration with other data systems (OPC, Modbus, and more)
- Support for various particle counters, air samplers, and environmental sensors
enVigil–PnP monitoring system
The enVigil–PnP monitoring system offers a straightforward, cost-effective solution tailored for GMP/GLP compliance, making it ideal for hospital pharmacies and IVF clinics. This system supports a range of package sizes, optimized to handle up to 20 particle counters, 20 active air samplers, and 60 environmental inputs. Its design allows for easy deployment, verification, and validation, ensuring that facilities can implement effective monitoring with minimal setup complexity.
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The enVigil software suite, developed by Pharmagraph over 30 years, offers a robust EU-GMP/GLP-compliant monitoring system for industries such as pharmaceuticals and satellite manufacturing, where environmental monitoring is essential. The suite also enables expansion to include equipment monitoring (e.g., fridges, freezers, and incubators). Key features supporting regulatory requirements, including EU-GMP Annex 1, cGMP, GAMP, and 21 CFR Part 11, include:
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- User-friendly graphical interface
- Facility mimic displays with real-time alarm visualization
- Trending for both real-time and historical data
- Batch reporting with electronic signatures
- Compliance prediction tools
- Detailed reconciled alarm reports with trend analysis
- Advanced reporting and data analytics
- Integration with other data systems (OPC, Modbus, and more)
- Support for various particle counters, air samplers, and environmental sensors
Viable Air Samplers – iVAS
Pharmagraph’s range of intelligent iVAS air samplers offers exceptional efficiency and consistency in microbiological monitoring. Designed to support 90mm Petri dish media, the iVAS series incorporates an HPV-tolerant controller, which measures actual flow and sample volume within the sample head. The iVAS units integrate seamlessly into existing environmental monitoring (EM) programs, ensuring compliance with EU-GMP Annex 1 and USP 797 standards.
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Available in both pedestal and tri-clamp mounting options, iVAS samplers function as standalone units or integrate within isolators and filling machines. Each iVAS unit features a perforated sieve head, dual impellers, flow/volume control, and communication systems in a comprehensive, highly integrated sampling solution. The iVAS sampler controls airflow and measures sample volume, maximizing regulatory compliance and supporting both continuous and intermittent sampling modes.
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Key Features:
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Self-contained design, eliminating the need for external vacuum systems
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Suitable for Grade A zones, with single-cable connection
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Dual flow rates: 100 L/min or 50 L/min, with continuous or intermittent sampling options
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Integrated HPV-tolerant control module for precise flow and volume measurement
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D50 particle capture efficiency: 1.1 µm at 100 L/min, 1.4 µm at 50 L/min
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Adjustable 90mm Petri dish holder
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Available data for physical and biological collection efficiency
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Host controller with Modbus interface supports up to six iVAS units
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Engineered for use in isolators or RABS lines requiring Hâ‚‚Oâ‚‚ decontamination, the iVAS sampler demonstrates verified physical and biological efficiency. Independent testing, conducted by Public Health England’s Biosafety Investigation Unit, validates high collection accuracy at both 100 L/min and 50 L/min flow rates.
Environmental Sensors
The Pharmagraph Series 2000 and MX5000 I/O systems connect to sensors to provide accurate measurements of differential pressure, temperature, humidity, and airflow through industry-standard 4-20 mA current inputs. These systems accommodate equipment storage facilities, achieving temperature accuracies of ±0.1°C for monitoring fridges, freezers, and incubators.
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Temperature measurement utilizes highly stable and accurate Platinum Resistance Thermometers (RTDs). Relative humidity is gauged using industry-standard Vaisala sensors, which also measure temperature within the same unit. Differential pressure is assessed using CMR and Setra sensors, which can be positioned close to the measurement point or connected via pneumatic tubing to the instrumentation panel. Additionally, CO2 levels in incubators are monitored with industry-standard Vaisala sensors.