Cleanroom Standards Articles

Thomas Scientific Accelerates Investment in Its Controlled Environments Team

Thomas Scientific’s team of controlled environments & cleanroom experts is committed to providing high-quality products and service solutions that meet the proper requirements for clean manufacturing.

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.

RESET® Spearheads New Airborne Particulate Monitoring Standard

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.

TSI Introduces New AeroTrak+ Remote Airborne Particle Counters

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.

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ANSI/ANAB Accredits Quality Certification Services

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.

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India Disposable Gloves Market

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.

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EU MDR: The European Union Medical Device Regulation of 2017

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.

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EP & Clean Tech China 2019

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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AGT Unveils Cleanroom Technology, Energy Efficiency and Fast Build Times to Empower Growers

AGT Unveils Cleanroom Technology, Energy Efficiency and Fast Build Times to Empower Growers

The Next Generation Greenhouse: AGT Unveils Cleanroom Technology, Energy Efficiency and Fast Build Times to Empower Growers
Sleek, modern structures full of patent-pending technologies such as Natural Earth Air System, oil bath fans and variable daylight control ushers in a new era for greenhouses

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QuantumClean® & ChemTrace® Show How to Reduce Wafer Fab CoO at SEMICON Europa 2018

QuantumClean® & ChemTrace® Show How to Reduce Wafer Fab CoO at SEMICON Europa 2018

QuantumClean & ChemTrace will demonstrate how its ultra-high purity chamber tool part cleaning, proprietary coatings and microcontamination analytical testing can help reduce wafer fabrication Cost-of-Ownership (CoO). Solutions’ information is available during show hours at SEMICON Europa at the Messe München Exhibition Center in Munich, Germany from November 13 — 16, 2018 (booth A4510).

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Medical Device Single Audit Program – How Should You Prepare?

Medical Device Single Audit Program – How Should You Prepare?

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP) whereby recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of various regulatory agencies.

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