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.
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 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.
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).
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.
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.
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 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.
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.
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.
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.