Kojair – preferred partner to execute IQ/OQ validation

Kojair offers IQ/OQ validation for all its devices. We have noticed that the demand for quality tests has increased during the last years. Therefore, Kojair has put a lot of effort into IQ/OQ tests and documentations. This results in a high-level IQ/OQ validation for the benefit of the end-user.
In most cases the IQ/OQ validation is based on the client’s specifications also called URS, User Requirements Specifications. However, Kojair can also provide a URS for you based on our technical specifications.

What is IQ OQ ?

Installation Qualification (IQ)

Installation Qualification (IQ) verifies that the instrument or equipment being qualified, as well as its sub-systems and any ancillary systems, have been delivered, installed and configured in accordance with the user requirements specifications (URS).

Operational Qualification (OQ)

Once each protocol of the IQ phase has been met, Operational qualification (OQ) is performed to check that the equipment’s performance is consistent with the user requirements specification, within the manufacturer-specified operating ranges. During the OQ phase, all the items in the test plan are tested individually and their performance documented. This is a prerequisite for technical acceptance of the equipment and the facility, so it can be performed once the IQ has been successful.

Performance Qualification (PQ)

PQ is the final step in qualification processes for equipment, and this step involves verifying and documenting that the equipment is working reproducibly within a specified working range. Rather than testing each instrument individually, they are all tested together as part of a partial or overall process. Before the qualification begins, a detailed test plan is created, based on the process description. This validation stage is performed by the customer.

Kojair can arrange IQ/OQ validation on your location. Please contact your area sales manager for more information and possibilities, click here

The KI Discus test has been designed to enable operator and environment protection factors and, where appropriate, product protection and cross contamination factors to be measured for:

–        Class I and Class II Kojair microbiological safety cabinets.
–        Special hybrid facilities such as carcinogen and radio-pharmaceutical cabinets.
–        General purpose laboratory fume cupboards.

The results of the KI Discus test are available within a few minutes.

What is a KI discus test:

A fine mist of potassium iodide droplets, produced by a spinning disk, is used as a challenge aerosol to measure the containment of a Kojair safety cabinet. Centripetal collectors sample the air outside or inside the cabinet – depending on the nature of the test. The collectors deposit any potassium iodide particles that are in the sampled air on the filter membranes. At the end of the sampling period the filter membranes are placed into a solution of palladium chloride whereupon the potassium iodide “develops” to form clearly visible and easily identified grey/brown dots.

A knowledge of the number of droplets in the challenge produced by the mist generator and the number collected in the air samplers enables the protection factor for the cabinet to be calculated. All open-fronted microbiological safety cabinets are assessed on this protection factor

The KI-Discus test is defined in the European Standard for microbiological safety cabinets, EN-12469:2000.

According to EN 12469:2000 Apf (cabinet protection factor) has to be less than 100,000 for each collector or there should not be more than 62 brown dots on the KI discus filter membrane after development in palladium chloride.

Kojair can arrange KI discuss test on (your) location. Please contact your area sales manager for more information and possibilities, click here