Pharmagraph has launched its latest FMS software offering; enVigil V. enVigil V systems are deployed specifically for facility and environmental monitoring applications. Evolved from a need to address the requirements of EU-GMP, cGMP, GAMP and associated regulatory standards. enVigil V offers a configurable facility monitoring software system aimed at pharmaceutical and healthcare production including Isolator and RABS Filling Lines.
Enhancements to the previous enVigil-FMS software version focus on providing additional features to address virtual machine deployment and filling line applications. enVigil V offers capability for multiple servers to connect to distributed network view nodes in a network cluster. Aimed at the increased deployment of enVigil systems running on a server and virtual machine platforms, the network cluster offers unrivalled oversight of the monitoring system installations.
Multiple filling suites can be managed through individual enVigil V server applications running a self- contained monitoring system for each line. This enables system deployment to be easily achieved in terms of commissioning, verification and validation without interruption to existing filling suites.
The network cluster topology enables personnel from production, engineering and quality control to have easy oversight of each filling suite. Coupled with the enVigil V dashboard mimic it provides meaningful information about production performance, alarm management, batch reporting/ sign off and any failure investigations that may be required.
enVigil V offers advanced cubic metre particle monitoring to reduce system downtimes by offering an “Out of Compliance Predictor” and “Cubic Metre Event Monitoring” for the non-viable particle counting element of the filling line application.
The Out of Compliance Predictor enables filling line systems to predict out of compliance operation and offers corrective action to be taken before alarm conditions occur, thereby avoiding investigations, write ups and prolonged system downtimes.
The Cubic Metre Event Monitoring application allows out of compliance events to be corrected, acknowledged and cleared as soon as the system is back in a compliant state. It allows cubic metre alarm status to be cleared once satisfactory operating conditions are re-established, typically within a few minutes. The clearance of the cubic metre alarm status is enabled once the system returns to a compliant state with the clearance being executed by a suitably privileged user (Supervisor or Manager), which is audit logged accordingly.
The enVigil V software also includes an instrument tracking facility. This enables both production and QC personnel to know which instruments (non-viable and viable particle counters) were used in which sampling positions. If there are any production related issues involving the particle monitoring system, then the instrument tracking facility can assist in the identification and root-cause investigation of any instrument failings.
John Wallingford – Pharmagraph Operations Director commented - “Isolator and RABS filling line applications are the way that the industry sector is moving, and particle monitoring systems need to be integrated to offer better functionality and oversight.”
Pharmagraph was formed specifically to meet the needs of clients seeking GMP/GAMP compliant solutions for their facility and environmental monitoring requirements, whether in small hospital pharmacies or pharmaceutical production facilities. Supplying systems that measure non-viable particle counts, active air viable sampling, temperature, relative humidity, pressure, air velocity, which deliver accurate, clear and secure results.