enVigil-PnP System

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.
  
  
• 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:

• Airborneparticlemonitoring
• Environmentalmonitoring
• Microbiologicalmonitoring

21 CFR Part 11

Compliance Assured

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.