Leak Testing Equipment Validation Support Package FAQ’s

It’s easy! Contact your local Uson Representative or call Uson directly at 1-855-GETUSON | 1-855-438-8766 to order your package or email us at service@uson.com.

Packages are available for the Sprint mD, Sprint iQ and Optima vT leak testers

Since 1963 Uson has been manufacturing leak testing equipment and providing leak testing expertise to the medical device, transportation, industrial and packaging industries. We have assisted thousands of customers to successfully develop their own IQ, OQ documentation maintain quality standards and compliance with Unites States Code of Federal Regulations, Title 21, parts 820,210 and 211, and the European Union – Good Manufacturing Practice Directive 91/356/ EEC (Eu-GMP). We guarantee the quality and accuracy of our packages and provide you with the ability to modify the documents if needed to meet your company-specific requirements.

Examples of IQ Validation Data include:

• Is the leak tester situated in close proximity to the electrical and air supplies required?
• Is it located at an ergonomic height that is comfortable and safe for the operator?
• Is there enough information available to ensure that the equipment can be operated in a safe and effective manner? (e.g manuals available, SOP)
• Is there a record of key components and features installed?
• Is there a calibration record?
• Is there a maintenance record?

Examples of OQ Validation Data includes:

• Is the equipment functionality in accordance with the requirements of the functional specification? (this may be defined in the user requirements specification, URS)
• Is the operation of the equipment safe for operators?
• Does the equipment operate in such a way that it s safe for the product?
• Are the documented procedures in place for all aspects of the equipment operation?

The package documents can be modified to meet specific requirements.

Uson can help! Onsite expert support completing and customizing the documentation is available at an hourly rate [check this]. Contact your local Uson representative or Uson directly at 1-855-GETUSON | 1-855-438-8766 or email service@uson.com for a quote.

Package prices are dependent on tester build and options. Our Service team members can provide pricing information based on your tester(s) upon request.  They will also go over the package documents with you and answer any questions you may have.