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enVigil–IMS
Monitoring for Isolator and Filling Machines
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.
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.
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.
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.