Qualification of the reusable cleanroom garment’s life cycle in a laundry, according to EU Annex 1  

Reusable cleanroom garments are rightfully the most widely used solutions of protecting the final product and production from contamination originating from the operator in a controlled environment.

There are several reasons for this:

  • Cleanliness of reusable cleanroom garments is guaranteed as they are washed and/or sterilized using a special qualified cleaning and sterilization process.
  • Flow of the garments through a cleanroom laundry is segregated so cross-contamination cannot occur.
  • Water and detergents chosen are yearly validated by a reputable external expert.
  • Folding techniques executed by the operators contribute to the quality at the end-user and make aseptic gowning possible.
  • Qualification of the product end-of-life cycle once the defined final cycle is reached, the garments are collected and continue their life: they are either used for other purposes, recycled into another product, or even transformed into another garment.
  • Reusable garments are durable, as they circulate again and again until they reach their pre-qualified and defined lifespan cycle.

The new publication of Annex 1 of the GMPs published on 22/08/2022 now clearly references reusable garments in paragraph 7.17: “The garment management processes should be evaluated and determined as part of the garment qualification program and should include a maximum number of laundry and sterilization cycles.”

One question you may naturally ask, and rightly so, is how to know when the reusable item has reached its end of use? Thanks to Elis Cleanroom‘s decades of experience, extensive internal and external test executions  and intensive collaboration with their customers and suppliers, they could map the complete behavior of the cleanroom garment, starting from the first washing and sterilization, taking into account the garment’s wearing and transportation, and qualifying all cycles up to the last one. Even this last cycle still needs to be of superior quality and performs as well as a new garment. Therefore, it is essential to work with reliable partners and opt for excellent garment and textile quality.

All garments should furthermore have impeccable traceability by having a unique chip/identification per article. In this way you know perfectly how many garments are in circulation; per product category and per size; latest outscan at the laundry, are the articles circulating according to FIFO, how many washes per article, visibility on department level. It is even possible to monitor operators behaviour by data driven insights on taken and returned garments. This is how you can prove you are SOP compliant.

So as a first conclusion: To ensure the maintenance of cleanroom garments on rent, traceability is the main management tool. But in the section 7.17, Annex 1 highlights a crucial parameter, which is the qualification of the lifespan of reusable garments. As Elis Cleanroom positions itself as a contamination control partner and technical expert, they anticipated and met the requirements of section 7.17, by conducting several studies to determine the lifespan cycle of their sterile reusable garments. Proactively, they started in 2020 collecting sterile garments with a predefined number of washing/sterilization cycles at several of their cleanroom laundries across Europe and coming from various pharmaceutical clients with sterile production(s).

With their wide range of garments, not only at different stages of wear but also with different types of sterilization, such as autoclaving or gamma irradiation, the quality assurance specialists have established a test protocol. By defining the necessary tests to demonstrate the integrity of the quality of reusable technical garments, three key elements are important:

  • Do sterile garments still protect against particles from operators throughout their lifespan? Chapter 7.11: Garments and their quality must be suitable for the process and quality of the working area.
  • Are the raw materials and seams of cleanroom garments still of excellent quality (Chapter 7.17: After washing, check for damage and visual cleanliness)? Are they still low-linting after X maintenance cycles? (Chapter 7.11: Garments and their quality must be suitable for the process and quality of the working area)
  • When do the garments reach the end of their lifespan? Chapter 7.17: Garments must be eligible for the maximum number of laundry and sterilization cycles.

Considering the above necessary elements, Elis Cleanroom have implemented the following test protocol:

  • Helmke Drum Particle Count (according to IEST-RP-CC 003.5)
  • Body Box Particle Count (particle retention) (according to IEST-RP-CC 003.5)
  • Visual inspection (fabric surface microscopy and accessory examination

Once the protocol  was established and all the garments were gathered, the end-of-life qualification tests were started up, evaluations were performed and lifespan cycle report was created.

Elis Cleanroom has a dedicated innovation center at the Bolsward factory in the Netherlands. Here, various new tests, daily batch controls and product qualifications are undertaken to ensure compliance with cleanroom regulations and recommendations, such as the recent published EU Annex 1 recommendations.

All the tests and evaluations are performed by the  QA Manager Johannes Kuyvenhoven and kept under supervision of the  GMP & Operations Director Kim Thorsøe.

The same end-of-life qualification is conducted with our reusable cleaning mops and cleanroom goggles and is also finished now and ready to be spread.

The life cycle qualification reports can be requested through your local Elis Cleanroom contact or via cleanroom@elis.com

About Elis Cleanroom

Elis Cleanroom is your partner in contamination control for all cleanroom laundry requirements in Europe and Latin America. Their sustainable solutions include garment rental, cleaning systems, mats, sterile goggles, footwear, autoclave bags and covers. All these items are chipped and can be tracked by Elis Connect™ data system accessible to clients. Internal autoclaving provides an efficient contamination control solution. With currently 30 cleanrooms in 17 countries, Elis Cleanroom are the experts in reusable cleanroom laundry handling such as washing, sterilization, packing and delivery /pick up service on customers’ site, with a back-up laundry for every laundry (contingency planning), providing local customers the opportunity to reduce the carbon footprint of deliveries/collections.

In 2023, Elis Cleanroom will open a new factory in Knutsford, UK and one in Granollers, ES. Moreover, Elis Cleanroom celebrates an extension of their Italian factory. This expands their reach and opportunities in these countries. This follows the successful opening in 2022 of the extension of the Beelitz factory in Germany and the new Nyköping factory in Sweden.