06.06.23

Bardusch AG supports customers in validating their cleanroom garments according to GMP Annex 1 requirements

Mastering GMP Annex 1 requirements: bardusch AG's expertise in cleanroom textiles and reliable services.

Bardusch Annex 1 Artikel Beitragsbild
In our interview with Patrick Wenger, branch manager of the cleanroom laundry in Selzach, you will learn how bardusch meets the new requirements of GMP Annex 1 while offering customized solutions for your cleanroom processes. In doing so, bardusch relies on individual consulting, comprehensive cleanroom services and the highest quality standards, offering customers real added value for their demanding cleanroom processes.

Cristina Aniceto: Patrick, GMP Annex 1 comes into force on August 25, 2023, and brings new requirements for the manufacture of sterile drugs and other sensitive products. These new requirements also relate to cleanroom garments to ensure sterility and particle-free production. How do we at bardusch AG ensure that we meet these requirements?

Patrick Wenger: At bardusch, we have prepared intensively for the new requirements of GMP Annex 1. 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.

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