IQ/OQ/PQ Certification Kit is offered for powder flow tester.
December 12, 2013 -
Customized IQ/OQ/PQ (Installation/Operation/Performance Qualification) document comes with instructions on steps to accomplish installation, operation, and performance protocol for instrument, allowing users to self-certify PFT via Certification Kit. Calibrated reference powder, BCR-116 Limestone, is certified by the European Commission in Belgium and comes with Certificate of Calibration as well as step-by-step testing methodology and expected range of values for unconfined failure strength.
|Original Press Release |
Brookfield Engineering Laboratories, Inc.
11 Commerce Blvd.
Middleboro, MA, 02346
Powder Flow Tester IQ/OQ/PQ Certification for Pharmaceutical Industry
The Brookfield PFT Powder Flow Tester can now be certified for IQ/OQ/PQ (Installation Qualification/Operation Qualification/Performance Qualification) through a choice of programs offered by Brookfield Engineering.
Customers can choose to self-certify their PFT with a Certification Kit available from Brookfield. The kit includes a customized IQ/OQ/PQ document and a calibrated reference powder called BCR-116 Limestone. The IQ/OQ/PQ document comes with clear instructions on each step required to accomplish the installation, operation and performance protocol for the instrument. BCR-116 Limestone is certified by the European Commission in Belgium and comes with a Certificate of Calibration. Brookfield provides additional documentation with the BCR-116 Limestone which explains the step-by-step methodology for testing the instrument with the powder and the expected range of values for “unconfined failure strength” at each “consolidating stress”.
The customers second option is to arrange for a Brookfield representative or authorized dealer come to the their facility with the PFT calibration kit to verify the performance of their Powder Flow Tester. Both methods confirm the performance of the PFT and enable the customer to complete the IQ/OQ/ PQ. Calibration testing measures the output of the position, load force and torque sensors in the instrument. These three measurements verify that the instrument is working properly. The values are recorded in the PQ section of the document. Once the calibration check procedures are completed, the instrument is ready for service. Several pharmaceutical industry customers around the world are currently using the Brookfield Powder Flow Tester and have utilized these services for IQ/OQ/PQ.
For more information about the new IQ/OQ/PQ for the PFT, visit www.brookfieldengineering.com or call 800.628.8139 (USA and Canada) or 508.946.6200.