enVigil Software

Particle Monitoring for Isolators and RABS Filling Machines

Isolator and filling machine manufacturers provide both bespoke isolator filling machines for specific products and the new multi format isolator for multiple products. Pharmagraph have developed the enVigil-IMS Isolator Monitoring System to address this emerging technology. enVigil-IMS is provided with an overview menu with status indicators, trends, alarms, data logging, instrument tracking, batch reports and OPC data to third party SCADA applications. Optional modules are also available to support network view nodes, electronic signatures and an ODBC/SQL Database exchange utility to collect logged data from the enVigil-IMS application. enVigil- IMS offers support for isolator gassing operations and particle counter “swap-ability” in order to minimise system downtime due to contamination failures. The intelligent pump controller (P5050) supports up to eight particle counters with a central vacuum pump and up to eight active air samplers and includes a digital control interface to the Isolator controller PLC. enVigil-IMS is complete with an application specific GAMP compliant documentation suite that includes a Functional Design Specification and Installation and Operational Acceptance Test Protocols allowing the enVigil-IMS system to be easily designed, configured, installed, commissioned and verified.

Scalable, modular solution

The enVigil-IMS application allows configuration of the system to include sampling point descriptors, alert (warning) and action (alarm) levels, counts per cubic feet and counts per cubic metre for >0.5μm and >5.0μm size channels, hydrogen peroxide protection valves and instrument tracking facilities. The enVigil-IMS application provides a data historian function maintaining historic information for alarms, periodic data and audit logs, all of which are maintained in a 21 CFR Part 11 compliant environment.

Particle Counting

enVigil-IMS offers particle counting with Hydrogen Peroxide protection for Isolator applications:

Pharmagraph S1816VS

For applications with a remote vacuum source and offering “Swap-ability” in the clean room without the need for re-programming and thereby reducing system down time.

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Stainless Steel Diverter Ball Valve

To protect the particle counter from the ingress of Hydrogen Peroxide Vapour and condensing deposits. These occur during decontamination and which over time will render the particle counter useless.

Integral Viable Monitoring

The Pharmagraph air sampler provides an integral fan impeller which is monitored and controlled to maintain the correct sample volume and D50 value. The active air sampler is provided in 316 grade stainless steel and can be provided with a conventional screw head or a 1/16 turn bayonet fitted head with either a pedestal base or tri-clamp mount.

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Download the full enVigil-IMS Brochure here to find out more.

enVigil-IMS Brochure download

Demonstrates GMP/GLP compliance for cleanrooms and laboratories.

enVigil-PnP provides a simple to use, cost effective solution which ensures a GMP/GLP compliant system and is ideally suited to modern day hospital pharmacy and IVF clinic operations. With a range of package sizes supporting up to 20 particle counters, 100 active air samplers and up to 160 environmental inputs enVigil-PnP is easy to deploy, verify and validate.

enVigil-PnP is provided with an overview menu with status indicators, trends, alarms, data logging, reports and data to MS Excel. Optional modules are also available to support instrument tracking, batch reporting, network view nodes, OPC server and GSM modem support for data on alarm to email and SMS text.

enVigil-PnP offers support for isolator gassing operations and particle counter “swap-ability” in order to minimise system downtime due to contamination failures. If you do not require particle counting, then enVigil-PnP offers a low-cost version for environmental or viable (active air sampling) monitoring only.

enVigil-PnP is complete with a simple Verification Protocol that includes a Functional Design Specification and Installation and Operational Acceptance Test Protocols allowing the enVigil-PnP system to be easily designed, configured, installed, commissioned and verified.

Scalable, modular solution

Pharmagraph’s monitoring systems can start small, saving initial investment, then scale up as the facility grows, building on existing hardware and monitoring sensors and providing additional monitoring stations as the system grows. Initial systems can start as small as a single environmental parameter and scale up to an entire facility of parameters because of its modular nature

Particle Counting

enVigil-PnP supports two particle counters detailed as follows:

Pharmagraph S1816 Series Particle Counter

The Pharmagraph S1816 series particle counter contains a Met One 6015 sensor and is housed in a stainless-steel enclosure suitable for pharmaceutical applications. The S1816 particle counter offers either Ethernet or RS485 Serial communication protocols. The Met One 6015 sensor is compliant with the ISO 21501-4 calibration standard for particle counters. The Met One 6015 sensor provides >0.5μm and >5.0μm size channels at a 1.0 cfm (28.3 L/min) flow rate. The S1816VS serial version offers “swap-ability” when deployed with Pharmagraph vacuum pump controllers (P4150-4G/CC9058). This aids quick replacement if the sensor requires a calibration service or becomes contaminated, as the particle counter network address is determined by the sampling position and not the individual sensor. This in turn reduces system downtime.

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Met-One 6015P Particle Counter

The Met-One 6015P particle counter offers a particle counter with an integrated vacuum pump and is compliant with the ISO 21501- 4 calibration standard for particle counters. The 6015P provides >0.5μm and >5.0μm size channels at a 1.0 cfm (28.3 L/min) flow rate and offers Ethernet connectivity. The Met-One 6015P provides an integrated pump particle counter solution which reduces installation costs and can easily be fitted to Isolators, Micro Biological Safety Cabinets and LAF workstations.

Building Blocks for Compliance

Pharmagraph’s unique approach enables you to deploy a compliant monitoring system with minimal configuration and documentation by using standard building blocks. With the introduction of the highly capable enVigil PnP offering, you can now put together a system more rapidly than ever.

How it works

enVigil PnP software uses a click-to-configure software system and a template approach to qualification documentation. Highly functional hardware building blocks map directly onto equivalent software configuration screens and document templates.

The building blocks cover three categories to suit the scope of your application:

• Airborne particle monitoring
• Environmental monitoring
• Microbiological monitoring

Download the full enVigil-PnP Brochure here to find out more.

enVigil-PnP Brochure download