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OEL TEST – Operators exposure at work

The main purpose of the OEL test is to demonstrate that installed equipment (protective chambers, isolators, weighing, …) reduce the presence of potentially dangerous particles in the air during the working process with the substances in form of powder, which are carried out primarily in the pharmaceutical industry.

 Air sample pump

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KI DISCUS TEST – test of the operator and environment protection according to EN 12469:2000

KI DISCUS test was developed in order to enable checking of protection or protection factor (as specified in the standard) for operators, products and the environment, where there is a potential risk of contamination from protective microbiological and cytostatic chambers Class I and II. The test is performed in accordance with EN 12469:2000 standard.

 KI DISCUS test

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Measuring the speed of air flow

We perform measurements of speed of the air flow in the work area of chamber and the inlet air flow speed. The test is performed in accordance with the recommendations of standard EN 12469:2000 and cGMP Annex 1.

 Measuring the speed of air flow

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Testing the casing seal - Isolators, Protective chambers with glows

The purpose of the test is to verify sealing the casing seal of protective chambers and isolators. The test is carried out on the systems where there is no direct contact with the product of work (a raw material, products).

 Testing the casing seal of isolator

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Counting quantity of particles and classification of working area

Counting of particles in working area is performed by isokinetic probe. Clean room meets the criteria, in so far as the number of particles corresponds to the requirements of ISO 1466-1 or cGMP Annex 1.

 Counting particles in the chamber

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Test of integrity of filters and sealing locations

The test is carried out by two methods - the method using the particle counter and the cold aerosol generator and a method of using a photometer.

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Visual smoke test

Using the smoke cartridge or a marker of the air flow we check whether the air flow is laminar, with no reverse currents and turbulences.

Visual

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