Service Swiss Medtech Expo 2023

GMP-Annex 1 in focus: How to fulfil the highest standards with the right cleanroom textiles

In a world where the requirements for the production of sterile pharmaceuticals are constantly increasing, choosing the right cleanroom textiles is crucial. bardusch AG, with a tradition of 150 years, is at the heart of this development and offers customised solutions.

The GMP Annex 1 requirements of the European Union set minimum standards for the manufacture of sterile medicinal products and sensitive products. A central element of these requirements is the validation of cleanroom garments to ensure sterility and particle-free operation. This is a key worry for quality managers, as the choice of the right textiles directly influences the quality and safety of the final product.
bardusch AG actively supports its clientele in the validation of their individual cleanroom garments. With a team of experts able to validate cleanroom textiles according to the specific requirements of each client, bardusch offers tailor-made solutions that meet the strict GMP Annex 1 criteria.
"At bardusch, we have prepared intensively for the new GMP Annex 1 requirements. We meet all the specifications, especially with regard to the validation of cleanroom garments. Our new cleanroom laundry in Selzach is equipped with state-of-the-art infrastructure according to ISO 14644, and our quality and environmental management system is certified according to ISO 9001:2015 and ISO 14001:2015. The RABC system (Risk Analysis and Biocontamination Control System) meets the requirements of EN 14065:2016," confirms Patrick Wenger, Head of bardusch AG in Selzach.
A special added value of the company lies in its comprehensive service cycle. This includes the collection, decontamination, sterilisation and on-time delivery of reprocessed textiles. State-of-the-art cleanroom infrastructures, regular quality controls and 100% batch traceability ensure that cleanroom garments always meet the highest standards.
Patrick Wenger knows what is important to customers: "For anyone looking for a reliable partner in the field of cleanroom textiles, bardusch AG is the first choice. With a nationwide presence in Switzerland, a fail-safe IT system and an international network, bardusch is always ready to respond to its customers' needs - even in exceptional situations."
bardusch not only offers first-class cleanroom textiles and services, but also customer-friendly leasing price models that enable predictable monthly costs without tying up capital. With the "Swiss washed" label, the company guarantees 100% Swiss production.

Your next step?
Put your trust in the expertise of bardusch AG. Visit the branch in Selzach or contact bardusch directly to learn more about their tailor-made solutions and benefit from their decades of experience.