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Measuring the number of particles in the room and room classification

The purpose of the test is to measure the number of particles present in the area of measuring, and according to known concentration of particles place the clean area in one of the known cleanliness grade. Standards that are most frequently used in EU are: ISO 14644-1 and cGMP Annex1.

 Measuring number of particles

Read more: Quantity of particles

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Testing the integrity of filters and sealing joints sealing

The purpose of the test is to determine whether the HEPA filters are intact and properly installed and to test the sealing joints sealing (appropriateness of housing and contact surface). The test is performed in accordance to ISO14644-3 guidelines, which demand testing on two different methods, that previous standard treats as equal.

 Measuring integrity of filters

Read more: Integrity of filters

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Visual smoke test

The purpose of the test is to prove with help of visualisation of air flow movement, that for example ventilation-filtration systems are capable of protecting critical area from contamination with particles from environment and determine, whether vertical (direct/laminar) air flow movement direction is homogenous below entire filtration/distribution surface.

 Visual smoke test

Read more: Smoke test

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Measuring air quantities and the number of air exchanges

The purpose of the test is to measure intake air quantities in the room, on the basis of which, considering the known space volume, it is possible to calculate number of air exchanges. Test is performed in accordance with ISO 14644-3 standard.

  Air quantity meter

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Decontamination time - time to establish the initial state

The purpose of the test is to determine the required time for the room to return to prescribed cleanliness grade after it has been contaminated (loaded) with particles. Logical is to perform test in clean environments with uneven (turbulent) flow regimes and rooms to cleanliness grade ISO 8.

 Counting particles in clean room

Read more: Decontamination time

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Measuring relative moisture and temperature

The purpose of the test is to prove with measurements, whether air ventilation system is capable of providing temperature and air moisture values within the projected values. Test is performed in accordance with ISO 14644-3 standard recommendations.

 Measuring relative moisture and temperature

Read more: Moisture and temperature

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Light measurement

The purpose of the test is to determine or to test through measurement whether the illumination in the working area of tested device or clean production facilities correspond to final user project demands.

 Measuring light 

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Measuring pressure differences among various rooms

The purpose of the test is to measure pressure differences between various rooms, and establish correct air flow direction. Measurement is performed in accordance with ISO 14644-3 standards recommendations.

 Measuring pressure differences

Read more: Pressure differences

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Noise measurement

The purpose of the test is to determine or to test whether the noise in the working area of tested device or clean production facilities is lower from maximum allowed, prescribed in project users demands.

  Noise

Read more: Noise

About Validation

In addition to manufacturing equipment for clean technology, Iskra Pio performs the validation of devices.

We validate
- clean rooms
- weighing booths
- sampling booths
- LAF rooms
- all kinds of safety
cabins (Class I, II,
III)

Validations are performed by a team of trained experts who use annually calibrated measuring devices.
After completing the validation, they also prepare a report (also in English), which is variable for inspection services.