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Leak Tester IQ and OQ

The medical device and pharmaceutical industries are full of acronyms for various documents and procedures: FDA, SOP, CFR, NIST, IQ,OQ etc.

In this post I would like to talk about IQ and OQ documents, full names Installation Qualification and Operational Qualification. These two qualification activities, along with process qualification, form the basis of a sound quality assurance program.

Let’s dive in deeper….

Installation Qualification

The IQ process is designed to ensure that equipment is installed correctly so that it functions as designed and will do so in a safe manner. For something like an automatic leak tester such as Sprint mD, it can be a simple enough process and may 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?

Once installation qualification has been completed, we can address:

Operational Qualification.

The OQ process challenges parameters that are documented by the SOP ( standard operating procedure) that will have been determined to be those that will ensure that a process delivers consistent quality and that everything about a piece of equipment functions correctly, as designed and is capable of producing the desired outcome.

In the OQ we will look at:

  • 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?

Of course, like most aspects of medical device and pharmaceutical manufacturing, there are regulations which must satisfied. In this case we look to 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).

For complicated pieces of equipment, you are probably beginning to realize that the creation of the documents required to record all this information is a considerable task. In fact, many companies have an official validation engineer responsible for the performance of these qualifications plus the creation and maintenance of the documentation.

To make matters a little easier for some, Uson has produced a Validation Support package.

SprintMD small.jpgThis Validation Support Package includes protocols, worksheets and other information to allow users to easily validate Uson testers for use in their processes. The packages assist customers in developing the documents and testing to provide assurance that their tester operates to specification and meets regulatory requirements of their applications. The documents have been designed to minimize the resources and the time needed for the customer to perform Installation Qualification (IQ), Operational Qualification (OQ), and meet the requirements of their Performance Qualifications. These packages are currently available for Sprint mD, Sprint iQ and Optima, and customers may modify these protocols to comply with company-specific requirements in accordance with the license agreements. Uson can also offer additional pricing for our Field Service personnel onsite assistance in filling this documentation with the tester should it be required.

For more details please contact me at

Joe Pustka

Director Applications Engineering

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