Through-Life Performance of Reusable Cleanroom Garments: Evidence-Based Replacement Intervals for Annex 1 Compliance

A new study from Micronclean on title (https://www.ejpps.online/post/performance-of-cleanroom-garment-fabrics-when-processed-in-an-industrial-laundry-cleanroom-undergar) joins an existing Micronclean study “Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry, Comparing Irradiation and Autoclave Sterilisation” (https://www.ejpps.online/post/vol24-6-performance-of-cleanroom-garment-fabrics-when-processed-in-an-industrial-laundry) to provide the strongest peer reviewed evidence to date on how cleanroom garment fabrics truly behave through life.

The results from these studies are directly relevant to EU GMP Annex 1 Clause 7.11, which states “Reusable garments should be replaced if damage is identified, or at a set frequency that is determined during qualification studies. The qualification of garments should consider any necessary garment testing requirements, including damage to garments that may not be identified by visual inspection alone”.

Study 1: Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry, Comparing Irradiation and Autoclave Sterilisation

A large-scale comparative study tested market-leading fabrics up to 100 processes, comparing gamma irradiation vs autoclaving.

Key findings:

• Fabrics degrade at different rates.
• Autoclaving performs as well as, and sometimes better than, irradiation.
• The true performance and commercial lifespan of a fabric can only be assessed by evaluating multiple factors, most of which cannot be identified through visual inspection alone.

As a result, the normal commercial life of an irradiated Micronclean cleanroom garment has been set at 50 process cycles.

Study 2: Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry: Cleanroom Undergarments and Non-Sterile Outer Garments

A large-scale study was conducted across our standard non-sterile outer garment fabric and our three undergarment fabrics (Buxton, Carsington, Sandwash).

Key Findings

• A fabric’s performance and usable life depend on several factors that visual inspection alone cannot accurately determine.
• The three undergarment fabrics degrade at different rates which leads to different commercial lives for each of them:
  • Buxton: 60 processes.
  • Carsington: 100 processes.
  • Sandwash: 100 processes.
• The non-sterile outer garment fabric has a commercial life of 100 process cycles.

Notes on Commercial Life

A cleanroom garment’s commercial life may be shorter than that suggested by the technical data alone, as the overall quality of the garment might be unacceptable even when the individual measured fabric parameters remain within specification.

Why This Matters

These studies provide peer reviewed Annex 1 aligned, process and fabric data that cleanroom operators can embed into their quality systems. This evidence can then be used to establish qualification based garment replacement intervals that minimise contamination risk while remaining both sustainable and cost-efficient.

The Takeaway

Reusable garments don’t all perform the same. Lifespan must be defined by data, not appearance. These new studies provide the industry with the evidence it needs to make informed, compliant and sustainable choices.

Author
Marta Underwood
Cleanroom Textile Group Product Manager