R&D Cleanroom Industry Articles

Ensuring Cleanroom Compliance: The Pillar of Safe and High-Performing Manufacturing

In the world of pharmaceutical manufacturing, biotechnology, and advanced material production, cleanrooms serve as the backbone of contamination control. However, designing and maintaining a compliant cleanroom is not just about meeting regulatory expectations—it is about ensuring safe, consistent, and high-quality manufacturing processes.

Nelson Labs Launches Innovative Rapid Sterility Testing in Laboratories in the U.S.A and Europe

Nelson Labs, a global leader in microbiological and analytical chemistry testing, has unveiled its cutting-edge Rapid Sterility Testing service, an innovation poised to significantly expedite product release timelines for pharmaceutical and medical device manufacturers.

Eli Lilly U.S. Manufacturing Investment to Exceed $50 Billion

Eli Lilly and Company announced plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical manufacturing sites in the United States.

Kenox Pharmaceuticals Expands Capabilities to Strengthen Drug Development Offerings

Kenox Pharmaceuticals Inc. (Kenox), a leading innovator in Orally Inhaled and Nasal Drug Products (OINDPs), has expanded its capabilities to support GLP pre-clinical studies with small-scale non-sterile GMP manufacturing. This strategic growth strengthens Kenox’s drug...
Annex 1 and First Air: Critical Considerations for Cleanroom Design and Compliance

Annex 1 and First Air: Critical Considerations for Cleanroom Design and Compliance

The implementation of EU GMP Annex 1 marks a transformative shift for the sterile filling industry. With new requirements emphasizing barrier technology and “first air” contamination control, pharmaceutical manufacturers face critical decisions in adapting their processes. Johannes Rauschnabel of Syntegon explores how equipment suppliers can play a pivotal role in facilitating compliance and seamless integration of these advanced standards.

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Biomerics Announces Merger with Precision Concepts Medical

Biomerics Announces Merger with Precision Concepts Medical

Biomerics, the leading vertically integrated contract manufacturer for the interventional medical device market, announced today that it has entered into definitive agreements to merge with Precision Concepts’ medical business (“Precision Concepts Medical”).

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