The product has been designed to be used in a cleanroom environment with validation in accordance with current GAMP® technological control and quality risk management features, including data integrity controls and the use of electronic records and signatures, mean that it operates in full compliance with the FDA’s 21 CFR Part 11.

The Volume Dosing measurement principle means that actual flow rates are recorded, negating the need to rely upon internal parameters or algorithms to convert pressure measurements into flow rates.

All surfaces that come into contact with test gases are manufactured from FDA-listed materials.

The human-machine interface is large, intuitive and easy to adjust, improving user experience. LED strips along the side of the machine indicate test status, providing feedback to operators at a distance.

Security

The Palltronic Flowstar V uses access management features to prevent unwanted access to critical functions. Through the use of usernames and passwords, four access levels (Super Administrator, Administrator, Supervisor and Operator) can be set up for various functional access. The access to functions can be configured by the Super Administrator.

Auditing

All data captured for audit purposes by the Palltronic Flowstar V fulfils ALCOA+ principles; the framework for good documentation practice in regulated industries. It complies with requirements set out by all global authorities including the FDA, MHRA and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and thus supports all companies inspected by such bodies that are expected to regularly review data having a direct impact on batch release and patient safety.

The event audit trail feature logs instrument activity, whilst the record audit trail feature logs test program, access management, user, date/time change and configuration records. These primary records, including test results, cannot be altered after generation and storage and any added comments must be electronically signed. A back-up of these records can be performed manually or automatically using the instrument’s expanded storage capacity.

Automation

The Palltronic Flowstar V can be automated through various automation protocols including ethernet (for data download, backup or archiving) and OPC UA, Profibus or DeviceNet (for interfacing with control levels on other systems).

The supplementary PAS-X software allows the instrument to be connected to a manufacturing execution system (MES) allowing filter integrity testing to be performed remotely. This allows increased control over filter integrity test performance, as well as reducing the need for operator interaction.

Synchronization

The Data Management System (DMS) Pro software is designed to automatically manage data across multiple Palltronic Flowstar V instruments simultaneously. It allows your instruments to synchronize their date / time, test programs and access management, whilst providing an automated and continuous back up of test results, users, settings and audit trails to assigned locations on your network.

Analysis

The mPath™ Operation Insights Software (OIS) allows the user to monitor and analyse performance across multiple Palltronic Flowstar V instruments whilst receiving troubleshooting guidance on filter integrity test failures. Results can be analysed in numerous ways including by instrument, operator or filter part to help identify areas for improvement and reduce non-value added events.

MUX

The Palltronic Flowstar V MUX instrument allows the user to perform up to 16 filter integrity tests sequentially without operator intervention. This reduces the need for separate Palltronic Flowstar V instruments as well as the time required for an operator to set up each filter integrity test, monitoring test execution and subsequent disassembly.

Printing

The Palltronic Flowstar V integrity test instrument allows the use of either an external printer connected directly to the instrument via the USB port, or a network printer to which the data can be sent. The instrument is also capable of generating the printout as a file, using common data formats, such as PDF and/or XML.