Test Equipment Validation

Filter integrity testing can be one of the most critical procedures in a filtration process and may be an essential requirement for batch release of a product. The increasing requirement for accuracy and documentation has resulted in a wider use of automated integrity test equipment. Use of such equipment must be validated to ensure that it satisfies both process and regulatory requirements. Features and Benefits of Test Equipment Validation Pall's expertise ensures instrument validation of your integrity test instruments will meet the latest industry and regulatory requirements All materials, measuring equipment and labor supplied by Pall for trouble-free testing Completed GAMP OQ1 document on reference instruments saves time and costs Tests can be performed on-site or off-site for maximum flexibility The ultimate benefit to you is a faster and more secure validation process to meet regulatory requirements Top Test Equipment Validation Tests Installation Qualification (IQ) We check all the equipment components and documentation. The suitability of the testing environment and services are also checked if the instrument is qualified on your site.

Operational Qualification (OQ)

We offer two options.

• GAMP* guidelines state that the OQ of standard instruments such as integrity test units can be divided into two parts. A completed OQ1 containing extensive qualification studies on a reference instrument. A shorter OQ2 protocol on your specific instrument is then performed, saving both time and cost.
• Alternatively, all OQ tests in the form of a standard system acceptance test (SAT) can be performed on your specific instrument. A customized SAT protocol can also be prepared for you if required.

*Good Automated Manufacturing Practice guidelines issued by the GAMP Forum and ISPE.

Performance Qualification (PQ)

We can also assist in generating customized PQ protocols and, if required, perform the tests.

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Test Equipment Validation Service Specifications

Where are Tests Performed?

• In our purpose-designed laboratories. If required, you can view the testing.
• Or we set up and perform the tests at your location.

Equipment and Materials

We have all the necessary equipment to ensure that qualification tests are performed accurately and reliably. We also supply materials such as filters. This capability means that we can offer a fast, professional and cost-effective service.

Range of Qualification Service

The service covers the Palltronic Flowstar and Palltronic Aquawit instruments. Specialized versions of these instruments can also be qualified as appropriate.

Documentation

• Standard Qualification and Validation Documents - standard protocols for IQ/OQ2 or SAT can be purchased from Pall. Completed OQ1 documents are also available together with validation support documentation based on GAMP guidelines.
• Customized Protocols - we work closely with your personnel to ensure that the format and content of customized protocols meet your requirements.
• Reports - on completion of the tests, the final reports are reviewed, approved and signed by a competent Pall specialist. The full documentation is then submitted to you for approval.

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Ordering Information and Charges

Charges

Each project is assessed individually. Wherever possible, we provide a fixed price in advance. Where this is not possible, we will offer an estimate to assist you in budgeting and cost control. The final invoice gives details on items such as labor, and materials.

What’s the Next Step?

Contact your local Pall representative, or contact Pall at 800-717-7255 or biotech@pall.com. We will contact you to discuss your specific requirements and forward your enquiry to Pall technical specialists.

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