Envigil-FMS Pharmaceutical Monitoring System

enVigil-FMS Pharmaceutical Monitoring

Cleanroom Management International is the official partner of Pharmagraph Ltd Pharmagraph was founded in 1992 and focussed on the manufacturing of data acquisition modules. Later a separate division was founded that developed software solutions for Pharmaceutical Monitoring applications only.
The focus on this specific market segment enables Pharmagraph to improve the software on a continuous basis and to build new features into the Envigil-FMS monitoring system that are required to follow the GMP guidelines throughout the complete software lifecycle.
21 CFR Part 11 Compliance
Pharmagraph software has been written from the ground up to comply with the tough demands of 21 CFR part 11 through the use of tight security, proprietary binary logging and provision of an audit trail. The software system is secured via unique usernames and passwords, with automatic log out when the system is left idle. A secure binary format is used for data log files making it virtually impossible to alter records. An audit trail logger automatically tracks changes to the system configuration, recording what has been changed, by whom, when and for what reason. The audit trail logger also records operator log in and log out activity, including failed log in attempts.
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enVigil-V suite of software
The enVigil suite of software is provided in three variants:
  1. enVigil V-FMS (Cleanroom and Filling Line Monitoring)
  2. enVigil-IMS (Isolator Monitoring)
  3. enVigil-PNP (Plug and Play)
The enVigil software suite which is deployed specifically for facility and environmental monitoring applications. With a pedigree that has been derived from thirty years’ experience in providing EU-GMP compliant monitoring solutions, the enVigil software range offers an EU-GMP/GLP compliant monitoring system for a range of applications. From pharmaceutical cleanrooms to satellite manufacturing facilities, Pharmagraph’s enVigil systems are deployed worldwide to measure environmental parameters such as airborne particulates, differential pressure, temperature, humidity and air flow.
These systems may also be expanded to include equipment monitoring of fridges, freezers and incubators. The monitored facilities range from pharmaceutical aseptic filling sites, stem cell/ATMP facilities, IVF clinics, hospital pharmacies, blood banks, cold chain storage suites and satellite manufacturing facilities.
Monitoring
Applications enVigil-FMS:
  • pharmaceutical aseptic filling suites
  • stem cell/ATMP facilities
  • IVF clinics
  • hospital pharmacies
  • blood banks
  • cold chain storage suites and
  • satellite manufacturing facilities
enVigil-V Facility Monitoring System (FMS)
The enVigil software suite which is deployed specifically for facility and environmental monitoring applications. With a pedigree that has been derived from thirty years’ experience in providing EU-GMP compliant monitoring solutions, the enVigil software range offers an EU-GMP/GLP compliant monitoring system for a range of applications. From pharmaceutical cleanrooms to satellite manufacturing facilities, Pharmagraph’s enVigil systems are deployed worldwide to measure environmental parameters such as airborne particulates, differential pressure, temperature, humidity and air flow. These systems may also be expanded to include equipment monitoring of fridges, freezers and incubators. The monitored facilities range from pharmaceutical aseptic filling suites, stem cell/ATMP facilities, IVF clinics, hospital pharmacies, blood banks, cold chain storage suites and satellite manufacturing facilities.
At the heart of the enVigil suite of software is the adherence to the requirements of the EU-GMP Annex 1, cGMP, GAMP and 21 CFR Part 11 thereby ensuring the installed system can meet current regulatory requirements.
Envigil V
Monitoring
Envigil-FMS Key Features:
  • support for viable monitoring
  • support for non-vaible monit
  • support for environmental sensors
  • modern dashboard interface
  • ability to show high level stats and system parameters
  • server clusters support multiple network clients sharing information
  • cloud connectivity enables data to be sent to third party applications
  • SQL Data to third party databases
  • multi-level mimic diagrams
  • trend displays with multiple cursors
  • touch screen clients, Tablets, Alarm message displays and beacons
  • reconciled alarm reports with Quality Trend Metrics
GAMP 5 Category 4 Software
enVigil V offers a configurable environmental monitoring software system (GAMP Category 4 software) aimed at Pharmaceutical, Healthcare, Electronic and Satellite production facilities. enVigil V has evolved from many years of applications with a need to address the regulatory requirements of EU-GMP, cGMP, GAMP and associated standards. Envigil V can be installed on Windows 10, Windows Server and virtual machine Windows OS platforms, the system offers high flexibility and a robust platform.
Sample locations
enVigil Licenses
enVigil V is available as both development and runtime licenses with license sizes of 25, 50, 100, 200, 500 and 10,000 Input/ Output (I/O) point database. Up to 128 individual tasks can run concurrently within the enVigil V application and these can range from individual I/O drivers, SMS text /e-mail communications, auto-archiving, real time calculations, scheduling, batch reporting and interfaces to external systems via OPC, ModBus and ODBC/SQL database applications.
Batch Reporting
Vacuum System
When viable and non-viable particle monitoring is required another important aspect is the vacuum system needed to provide the necessary vacuum for the particle counters and possibly the microbial air samplers. The selection of a vacuum system is an important part of the monitoring system because the selected vacuum source will have impact on the initial investment, the annual maintenance costs, noise and vibration levels and the energy consumption. In general the selection consists of an external central vacuum or a vacuum pump per monitoring position. An alternative can also be provided with the MET ONE 6015P particle counter or the iVas Air Sampler both with an internal vacuum source.
Vacuum pump controller
Isolator Monitoring System (enVigil-IMS)
Isolator Monitoring System; Isolator and filling machine manufacturers provide both bespoke isolator filling machines for specific products and the new multi format isolator for multiple products.
Pharmagraph has 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.
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Equipment Validation
Envigil-IMS Isolator Monitoring
Pump Controller
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.
System Diagram Isolator Monitoring
Grade-A environment
System Configuration and functionalities
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 with VHP decontamination
enVigil-IMS offers particle counting with Hydrogen Peroxide protection for Isolator applications. The S1816 protective enclosure for applications with a remote vacuum source offers “Swap-ability” in the clean room without the need for re-programming and thereby reducing system down time.
Protective Enclosure
Ideally suited for VHP Decontamination Cycles
6015P with internal vacuum
Easy integration in monitoring applications
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 samplers suited for filling line and isolator applications provides an integral fan impeller which is monitored and controlled to maintain the correct sample volume and D50 value. The active air sampler made of 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 read more
enVigil–PnP Monitoring System
enVigil-PnP demonstrates GMP/GLP compliance for cleanrooms and laboratories. It 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.
Monitoring
Optional Modules Envigil-PNP:
  • instrument tracking
  • batch reporting
  • network view nodes
  • OPC server
  • 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.
enVigil-PNP operator interface
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.
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.
enVigil software can integrate following parameters
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:
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