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testing and validation solutions
Our garments are systematically tested and validated to demonstrate controlled particle, microbial and ESD performance under real cleanroom conditions. Certification is supported by repeatable data and compliance with ISO, GMP and IEST requirements.
Contamination control
our in-house laboratory
Our dedicated in-house cleanroom laboratory supports the validation and qualification of cleanroom garments in line with the lifecycle approach defined in GMP Annex 1. Through structured testing and decades of experience, we define and verify the maximum number of reuse, washing, and sterilization cycles, demonstrating consistent garment performance throughout the validated lifecycle.
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In-house body box
Evaluating cleanroom garment effectiveness
using body box testing
The most effective method to study cleanroom garment performance is testing in a body box. This test provides a comprehensive assessment of the type and quantity of particles dispersed from operators through the garment, including dispersal rates under varying movement conditions.
Our expert technician enters the body box wearing the required clothing and performs a series of movements at a defined rhythm, standardized according to IEST-RP-CC003.5, which are identical for all garments tested.
why garment qualification matters
In contamination-controlled environments, garments form a critical barrier between the operator and the cleanroom process. Since people remain the primary source of contamination, garments must be managed as an essential component of the overall contamination control strategy.
A structured garment qualification program, based on a lifecycle approach, ensures that garments are not only initially fit for use but continue to perform as intended throughout defined reuse, washing, and sterilization cycles. This approach supports consistent contamination control performance in line with ISO 14644-1 principles, GMP Annex 1 lifecycle expectations, and recognized IEST guidance.
frequently asked questions
All alsico cleanroom fabrics are tested and validated to ensure consistent performance throughout their lifespan. Cleanroom garment validation includes washing, sterilization, and wear simulations to confirm that filtration efficiency, particle control, and fabric strength remain stable after repeated use.
The number of validated cycles depends on the fabric type, cleanroom application, and washing method.
Cleanroom garment tests typically focus on particles ≥0.5 µm and ≥5 µm, as these sizes are critical for ISO classification and GMP compliance. Measuring both provides insight into fine particle release as well as larger fiber or skin flake emissions.
Fabric tests provide valuable baseline information on filtration efficiency, air permeability, and particle release, but they cannot fully predict garment performance on their own. Garment design, seams, closures, fit, and operator behavior all influence final contamination control, which is why fabric and garment testing must be combined.
Common laboratory tests include particle emission testing, filtration efficiency, air permeability, surface resistivity for ESD control, tensile and tear strength, abrasion resistance, and comfort-related measurements such as moisture vapor transmission and air permeability.
Yes. Body box test results provide objective, documented evidence of garment performance and are commonly used to support GMP audits, garment qualification files, and contamination control strategies.
Body box testing is most commonly applied to garments used in ISO 5–7 cleanrooms and GMP Grade A and B environments, where operator-related contamination poses the highest risk.
Body box testing measures particle emission from a complete garment worn by a person in motion, while Helmke Drum testing evaluates particle release from fabric samples or garments under mechanical agitation. Body box tests are more representative of in-use conditions, whereas Helmke Drum tests are useful for material benchmarking and assessing potential damage.
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