Filter Integrity Testing Documentation

The Palltronic Flowstar instruments have been developed in accordance with Good Automated Manufacturing Practice (GAMP) guidelines. Detailed validation guides are available that have been structured to these guidelines. In addition, detailed validation guides are available along with protocols for creating Installation Qualification (IQ) and Operational Qualification (OQ) documents. Further validation support is available on request - calibration and test certificates are supplied with each instrument.  

GAMP guidelines recommend the inclusion of suppliers' testing and documentation in the validation of an instrument to avoid duplication of testing. For Palltronic Flowstar instruments, completed Operational Qualifications (OQ1) containing extensive qualification studies performed on  reference instruments are available. Following this, a shorter OQ2 protocol on your specific instrument is then performed, saving you both time and cost.

  Filter Integrity Testing
A Guide to Pall's Range of Integrity Test Instruments
Filter Integrity Testing Services
Filter Integrity Testing Accessories
Filter Integrity Testing Documentation
Filter Integrity Testing Automation
Filter Integrity Testing Callibration and Servicing
Filter Integrity Testing

All of this is backed up by installation, commissioning and validation services, operator training and worldwide technical support to ensure trouble-free operation. Pall can provide onsite or offsite IQ/OQ testing, and assist you with PQ protocols. Full training on all aspects of operation is available from our training specialists. Customized programs can be provided, ranging from basic seminars on the principles of the integrity test to advanced operator training. Certificates can be provided to all attendees for inclusion into personal training records.

Ordering Information

 

Product

Item Part Number
Palltronic Flowstar IV instruments - All

Qualification Documents

GGFD0410