The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

Designed to be used in any cleanroom environment, the Palltronic Flowstar V integrity test instrument has been developed and validated in accordance to the current GAMP guidelines. It has complete technological controls and features required for operating in a 21 CFR Part 11-compliant environment and includes quality risk management features such as data integrity controls and electronic records/signatures.

The instrument has been designed to ensure that the measuring block and the internal components, where the gas flows, are manufactured from FDA-listed material.

The human-machine interface is a large, intuitive, easily adjustable screen designed to aid user experience and operation. The instrument also includes status indicating LED strips, providing feedback to operators during use.

Features

Technology

• Direct flow measurement

Ease of Use

• Automatic control of the test system
• Storage of test parameters and recipes
• Light instrument with a small footprint
  Intuitive user interface with 12 in. (1280 x 800) color touch screen and adjustable screen angle
• LED alarm strip

Quality and Regulatory

• Developed in accordance with GAMP 5
• IP54 rated design
• Compliance to 21 CFR Part 11
• Electronic records and electronic signatures
• Automated data entry through barcode reader
• Test repeat control feature
• Data security and audit trail
• Test parameters and records can be stored electronically
• Fade-resistant printouts

Network Integration and Automation

• Possibility to connect to OPC-UA, Profibus, DeviceNet, ProfiNET
• Lightweight Directory Access Protocol (LDAP)
• USB and LAN networking connectivity

Data Management

• Configurable instrument grouping and time/parameter synchronization

Electronic Records and Electronic Signature (ERES) Features

The instrument has all features and requirements required to be operated in accordance with 21 CFR Part 11 and other guidelines like the Medicines and Healthcare Products Regulatory Agency (MHRA) related to data integrity and electronic signature safety. Access management prevents uncontrolled access to critical functions on the Palltronic Flowstar V integrity test instrument.

Access management and password management allows the electronic signing of test records. The Palltronic Flowstar V integrity test instrument allows:
- Configurable access control management (four access levels – Super Administrator, Administrator, Supervisor and Operator)
- Configurable password management

Audit Trail Features

The instrument captures all data needed for audit purposes, facilitating the review process regardless of frequency, while complying with all data integrity requirements issued by the FDA, MHRA, and Pharmaceutical Inspection Cooperation Scheme (PIC/S). This ease of review plays a major role for regulated companies that are expected to regularly review data with a direct impact on batch release and patient safety. The Palltronic Flowstar V integrity test instrument fulfils ALCOA PLUS principles which require that data be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available. ALCOA has served as a framework for guaranteeing data integrity and good documentation practice (GDP) by regulated industries. In addition, the Palltronic Flowstar V integrity test instrument has an event audit trail which logs activities on the instrument and a record audit trail which includes test program records, access management records, user records, date/time change records and configuration records.

The primary records of the Palltronic Flowstar V integrity test instrument, including the test results, cannot be altered after generation and storage. Only signatures and any comments with the signature can be added. With this approach the test result is a static record. Finally, with the different data backup possibilities, including manual and automatic backup options, and the expanded data storage capacity on the instrument, the Palltronic Flowstar V integrity test instrument ensures compliance with all data backup, retention and retrieval requirements.

State-of-the-Art Automation Protocols and Remote Control

The Palltronic Flowstar V test instrument guarantees industry communication standards along the path to digitalization. It can be automated through several optional interfaces, optimizing ease of use and reducing time and costs. It provides:
- An interface to a network (ethernet) to download results for backup or archiving
- Interfaces to SCADA/MES for remote control, transmission of results and data collection (OPC UA)
- Interfaces for control levels for other systems (Profibus, DeviceNet, OPC UA)

Remote Printing

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.

 

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