Body-Box Test is a method for assessing the cleanliness and suitability of cleanroom clothing for sterile production environments.
It measures the number and size of particles emitted by a person wearing a cleanroom clothing system inside a small cleanroom cell, while performing a series of predefined movements.

The lower the particle emission, the better the performance of the clothing system.
Body box test is part of the quality management strategy of risk and contamination control for cleanroom clothing, as required by Annex 1 of the European GMP, and according to the requirements of the Israeli Ministry of Health.

The guiding standard on the subject is: IEST-RP-CC003.4
Which defines that Body-Box Test is a small cleanroom cell with controlled air flow and particle counter, used to measure the particle emission rate of a person wearing a cleanroom clothing system.

The following standards also mention and provide instructions on the test method of the body box:

– ISO 14644-14:2016 Cleanrooms and associated controlled environments – Part 14: Assessment of suitability for use of equipment and materials by airborne chemical concentration
– ISO 14644-16:2019 Cleanrooms and associated controlled environments – Part 16: Energy efficiency in cleanrooms and separative devices
– EN 14605:2005+A1:2009 Protective clothing against liquid chemicals – Performance requirements

Exdron manufacture Compliant Body-Box test kit, and can deliver Instal, train you and validate the unit for you in as quickly as 2-3 weeks.