Datasheets

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

• Direct flow measurement

• 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

• 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

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

• 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.

Remote Data Management

The data management system (DMS) Pro software can be used as a utility and is designed to automatically manage the data of one or multiple Palltronic Flowstar V instruments simultaneously. This includes the following features:

• Synchronization of date and time
• Synchronization of test programs
• Usage of active directory
• Automated and continuous backup of test results, test programs, users, settings and audit trail to assigned locations on the network

mPath™ Operational Insights Software

mPath™ Operational Insights Software is a centralized data analytics solution, facilitating root cause identification of filter integrity false fails, errors and aborts, and reducing test related wasted time by up to 30%. It aids in monitoring compliance to 21 CFR Part 11 and data integrity requirements, and it offers instant troubleshooting guidance to bring false fails to pass, improving process efficiency in individual cases.

Designed to facilitate process visualization and asset management, mPath operational insights software interfaces with the Palltronic® Flowstar IV and V filter integrity test instruments, centralizing audit trails, test records and test results analytics. It helps better visualize all integrity test instruments on site, detailing their calibration and maintenance status, and the number of tests performed per device.

Thanks to real time data transfer and acquisition, mPath operational insights software sends alerts to enable immediate action to improve process efficiency and reduce downtime.

The mPath operational insights software:

• Improves process efficiency
• Facilitates quality risk management
• Facilitates monitoring regulatory compliance
• Improves readability, comfort, safe operation
• Meets regulatory requirements
• Prevents uncontrolled access
• Secures highest quality levels for batch release
• Facilitates the detection of unauthorized record editing
• Enables controlled easy access with lower risks to forget user ID and password
• Reduces operator interaction, setup times, manual input errors

The mPath operational insights software must be installed on the same network that contains the Palltronic Flowstar instruments to be connected to. The application supports up to 40 instruments connections at one time. In order to connect to an instrument, a license must be obtained for that specific serial number of the Palltronic Flowstar instrument.

Once the license is obtained and imported into the application, the administrator will enter the IP address of the Palltronic Flowstar instrument into mPath operational insights software and the application will automatically start importing historical records from the machine.

Palltronic Flowstar IV and V filter integrity test instruments need to be connected to an edge PC, local server to web server where the mPath OIS is installed, for data acquisition. Any PC in the same network can then access mPath OIS through a web browser.

The mPath operational insights software is compatible with the relevant sections of the Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 11 and is developed according to good automatic manufacturing practices (GAMP) 5 guidelines. It exhibits a system audit trail and electronic records. Access is controlled via role-based access permissions, and individual users are password-protected.

For full details, specifications and ordering information, see the datasheet for this mPath operational insights software.