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.
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.
India Disposable Gloves Market
The growth of disposable gloves market in India is driven by growing awareness about hygiene, disease prevention, and safety among the Indian populace coupled with surge in the number of end users. Moreover, technological advancements in manufacturing gloves and unprecedented growth of the healthcare sector are expected to provide lucrative opportunities to market players in the near future.
EU MDR: The European Union Medical Device Regulation of 2017
If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply.
EP & Clean Tech China 2019
Regulation and standards for “clean plants” have been increasing in recent years as China’s pharmaceutical R&D and production industry develops rapidly. EP & Clean Tech China 2019, hosted by CCCMHPI, UBM EMEA and UBM Sinoexpo, is an annual event of the pharma clean industry, that will blow a strong, new pharma clean wind in Hall N4 of Shanghai New International Expo Centre (SNIEC). Over 100 Chinese and overseas quality clean enterprises will gather on-site, to showcase the latest pharma cleanroom equipment and products, engineering technologies, and solutions, etc.
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