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 Portable Air Sampler - VS8600 Series
The iVAS Roam is a portable viable air sampler developed by Pharmagraph to support compliant environmental monitoring in cleanroom environments of all grades. Designed for EN 17141:2020 compliance, it combines over 20 years of cleanroom monitoring expertise with a user-friendly interface and practical features. The unit can function as a standalone device—managing setup and sample records via the companion iVAS Roam Manager software—or be fully integrated into Pharmagraph’s enVigil FMS system.
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Its design includes an integral barcode reader to capture plate details directly into the sample record, as well as two built-in RFID readers for recording operator ID and sampling location. A secure retaining mechanism allows the sieve head to be moved easily between sample points, and the adjustable plate height accommodates different plate sizes. These features make the iVAS Roam a flexible and intuitive solution for portable viable air sampling in regulated environments.
enVigil–V FMS: Environmental Monitoring System
enVigil V is a configurable environmental monitoring software system designed for pharmaceutical, healthcare, electronics, and satellite production facilities. Developed to meet regulatory requirements such as EU-GMP, cGMP, and GAMP, it supports multiple particle counters, active air samplers, and environmental sensors. The system features a modern dashboard for high-level statistics and system parameters, server clusters for multiple network clients, and cloud connectivity for integration with third-party applications. It enables SQL data transfer, multi-level mimic diagrams, trend displays with multiple cursors, and reconciled alarm reports with trend metrics.
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Additional functionalities include touch screen interfaces, tablet compatibility, alarm message displays, SMS/email alerts, and interfaces with external systems via OPC, ModBus, and ODBC/SQL databases. The system operates on a server/client architecture with optional hot standby functionality. Batch reporting with electronic signatures is supported, and it is compatible with Windows 10, Windows Server, and virtual machine environments. enVigil V is available in development and runtime licenses with database sizes ranging from 25 to 10,000 I/O points. It can run up to 128 concurrent tasks, including I/O drivers, SMS/email communications, auto-archiving, real-time calculations, scheduling, batch reporting, and ModBus/OPC interfaces.
enVigil–IMS: Isolator Monitoring System
enVigil–IMS is a robust and scalable particle monitoring solution designed specifically for isolators and RABS filling machines in pharmaceutical environments. It offers continuous monitoring of airborne particles with hydrogen peroxide protection, real-time alarm notifications, data logging, and full instrument tracking. The system supports up to eight particle counters and eight active air samplers, managed via a central vacuum pump and intelligent pump controller with digital interface to the isolator’s PLC.
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Key features include customizable alarm and warning thresholds, support for both counts/ft³ and counts/m³ at >0.5μm and >5.0μm channels, and integration with third-party SCADA systems via OPC and SQL/ODBC. enVigil–IMS ensures compliance with 21 CFR Part 11 and GAMP standards and is delivered with a full validation package including Functional Design Specifications and IQ/OQ protocols. Its modular design and optional electronic signatures, batch reporting, and network view nodes make it ideal for complex aseptic production setups.
enVigil–PnP: Cleanroom & Lab Monitoring System
enVigil–PnP is a user-friendly, cost-effective monitoring solution designed to ensure GMP/GLP compliance in cleanrooms, hospital pharmacies, and IVF clinics. It supports up to 20 particle counters, 100 active air samplers, and 160 environmental inputs, making it ideal for facilities of varying sizes.
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The system includes an intuitive dashboard with real-time status indicators, trend analysis, alarm notifications, data logging, and export to MS Excel. Optional features include instrument tracking, batch reporting, SMS/email alerts, OPC server integration, and network view nodes. It also supports isolator gassing and particle counter swap-out to reduce downtime.
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Available in configurations with or without particle counting, enVigil–PnP is easy to deploy and validate, supplied with a Verification Protocol, FDS, and IQ/OQ documentation. Its modular design allows it to scale from a single sensor to full-facility monitoring as your needs grow.
VE8206 6 Channel iVAS Controller
The Pharmagraph VE8206 iVAS Controller provides a reliable and efficient interface for iVAS intelligent Viable Air Samplers, enabling consistent microbiological monitoring. It features a pre-configured MX6001 controller that supports up to six iVAS units via Ethernet connection to a host PC. Each iVAS unit connects through a single RS485/power cable using screw terminals, simplifying installation in plant rooms or under filling machines while allowing flexible placement of samplers within isolators or cleanrooms. The VE8206 also includes opto-isolated inputs and outputs for direct hardware integration, such as with isolator PLCs, supporting hardware control of up to four iVAS units. When using Modbus software control, it can support all six.
VE8212 Viable Sampling Stations
The VE8212 Series provides plug-and-play connectivity for Air Samplers and seamless integration with enVigil PnP monitoring systems. Each VE8212 unit connects up to five Air Samplers and includes local RS485 digital I/O for alarm beacons. Powered by a standard 24VDC supply, the VE8212 enables fast deployment and qualification. With a single Ethernet IP address and a few clicks in the enVigil PnP configurator, connected Air Samplers are automatically recognized, with sample progress clearly displayed. The system supports both 100 LPM and 180 LPM Air Sampler models, with flow rate specified at ordering. VE8212 also supports pre-configured RS485 interfaces for environmental sensors, alarm modules, and watchdogs, allowing simple configuration and scalable expansion via standard Ethernet switches.
VF8924 Air Sampler Controller
The VE8212 Series provides plug-and-play connectivity for Air Samplers and seamless integration with enVigil PnP monitoring systems. Each VE8212 unit connects up to five Air Samplers and includes local RS485 digital I/O for alarm beacons. Powered by a standard 24VDC supply, the VE8212 enables fast deployment and qualification. With a single Ethernet IP address and a few clicks in the enVigil PnP configurator, connected Air Samplers are automatically recognized, with sample progress clearly displayed. The system supports both 100 LPM and 180 LPM Air Sampler models, with flow rate specified at ordering. VE8212 also supports pre-configured RS485 interfaces for environmental sensors, alarm modules, and watchdogs, allowing simple configuration and scalable expansion via standard Ethernet switches.
VS8500 Series iVAS (Intelligent Viable Air Sampler)
The VS8500 Series iVAS (Intelligent Viable Air Sampler) is a compact, high-performance solution for microbiological monitoring in critical environments. Designed for flexibility, it supports multiple flow rates and sampling modes to meet varied viable sampling needs. All essential components are integrated into a single unit, eliminating the need for an external vacuum and simplifying installation in both new and existing facilities. The iVAS connects seamlessly with Pharmagraph’s enVigil V EMS software, offering real-time and historical data logging within a 21 CFR Part 11 compliant system. Built-in instrument tracking ensures easy calibration and location management. While optimized for enVigil, the iVAS also operates using standard Modbus protocol and runs on 24Vdc, making it compatible with a wide range of monitoring and application platforms.