EU regulatory compliance Articles
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Rust-Oleum Europe Addresses Compliance - Case Study
Overview Rust-Oleum is part of RPM International Inc, one of the world’s largest paint manufacturers with a presence in 150 companies worldwide. Ensuring compliance with regional regulations and maintaining the right to sell in markets is paramount for the business. “The greatest challenge for our department, is meeting the requirements of new and increasingly complex environmental, ...
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Certification - Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
Cleanroom certification is based on ISO 14644-1, “Classification of air cleanliness by particle concentration” standards. The specifics of the assessment may vary slightly for FDA or EU GMP regulations, but the underlying methodology is standard. Certification demonstrates that the entire area meets a specific ISO classification by particle concentration. That is, irrespective of the ...
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Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom (LS)
As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.). The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the ...
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Ask Enhesa Vol. 5
Featuring contributions from Paula Diaz, Kengo Okuda, Sansanee Dhanasarnsombat, Wassila Nabourema, Elizabeth Tomassetti and Tjeerd Hendel-Blackford You asked and we answered! Enhesa’s team of multilingual regulatory analysts are committed to providing quality insight and analysis around the latest EHS news and developments via our Enhesa Flash, webinar series, and blog posts. In ...
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Get the Lead Out - Standards Aid in RoHS Compliance
RoHS, the seminal European sustainability directive, and others like it challenge manufacturers to eliminate hazardous substances in their products. With RoHS compliance deadlines ongoing through at least the next five years, and more to come from other regions and nations, ASTM Committee F40 is helping companies with testing standards and other resources. The recent introduction of the new ...
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European Union Biocidal Products Regulation and Its Impact on Industry: A Practical Briefing
The European Union (EU) Biocidal Products Regulation (BPR) has entered into EU law. This legislation changes the way in which biocidal active substances and biocidal products are regulated in the EU. The new EU regulatory system differs from other global regulatory systems for biocidal substances and redefines what are considered biocidal products and treated articles. Companies competing in this ...
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