Cleanroom Standards Articles

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.

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.

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.

USP 797 Cleanroom Performance

USP 797 Cleanroom Performance

USP General Chapter <797> provides standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency.

read more
ASHRAE – American Society of Heating, Refrigerating and Air-Conditioning Engineers

ASHRAE – American Society of Heating, Refrigerating and Air-Conditioning Engineers

ASHRAE, founded in 1894, is a global society advancing human well-being through sustainable technology for the built environment. The Society and its members focus on building systems, energy efficiency, indoor air quality, refrigeration and sustainability within the industry. Through research, standards writing, publishing and continuing education, ASHRAE shapes tomorrow’s built environment today. ASHRAE was formed as the American Society of

read more
Clean Room Windows Selection

Clean Room Windows Selection

What factors should you consider when evaluating clean room windows? When does provide visibility into a clean room operation without allowing people into the clean room operation. This promotes a cleanly environment and decreases the possibility of contamination.

The most important part of maintaining a clean environment as it corresponds to clean room windows, you want to ensure that there are minimal window ledges in the clean room environment. Ledges are a great place to collect contaminants that could set back your queen room operation.

read more