Cleanroom Standards
Get the latest cleanroom standards news and tips below. Cleanroom Connect brings you the latest cleanroom standards news from around the world, featuring current topics and news from cleanroom standards organizations and governing bodies.
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.
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.
ISPE Provides New Guidance on Membrane-Based Water for Injection Systems
ISPE announced the release of the ISPE Good Practice Guide: Membrane-Based Water for Injection Systems. This Guide provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based water for injection (WFI) systems, including generation, storage, and distribution.
New ISPE Guide Includes Updated Guidance for Controlled Temperature Chambers
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).
New ISPE Guide for Controlled Temperature Chambers
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).
CWS acquires Specialised Sterile Environments Limited
CWS Cleanrooms, the German based services group has acquired Specialised Sterile Environments Ltd. (SSE), an Irish company specialised in Cleanroom cleaning, decontamination and hygiene services to the Irish Pharma and Medtech industry.
RESET® Spearheads New Airborne Particulate Monitoring Standard
Working with an international team of experts from universities on the forefront of air quality monitoring research, RESET® will be releasing a new air quality standard aimed at providing a framework for qualifying airborne particulate sensors – specifically optical particle counters – used for indoor and outdoor air quality monitoring.
Clean Room Design: Pharmacy Flow with USP 797 and USP 800 Standards
It’s the cleanest room in a hospital, but most of us will never step foot in it. Pharmacies and compounding laboratories are a hot topic in the health care world as the US Pharmacopeial Convention’s (USP) revised guidelines necessitate new pharmacy design to meet USP 797 and USP 800 compliance.
TSI Introduces New AeroTrak+ Remote Airborne Particle Counters
TSI introduces a new range of AeroTrak®+ Remote Airborne Particle Counters (APCs) for monitoring manufacturing cleanrooms. TSI is so confident about the performance of the new laser technology inside, that all models are covered by an industry-exclusive standard 5 year laser warranty.
ANSI/ANAB Accredits Quality Certification Services
The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, has accredited Florida Certified Organic Growers, Inc. DBA Quality Certification Services in accordance with the international standard ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services; and pertinent certification scheme requirements and regulations under the U.S. Food & Drug Administration (FDA)’s Food Safety Modernization Act, or FSMA. ANSI’s conformity assessment accreditation programs were reorganized in December 2018 under the ANSI National Accreditation Board (ANAB) brand, a wholly owned subsidiary of ANSI.
Rubber Glove Market Research Predicts Steady Growth
The global Rubber glove market is set to grow at an exponential CAGR during the forecast period attributed to its increasing demand across several industrial applications. Rubber gloves are being used for several industrial and household purposes.
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