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.

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.

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.

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

Cleanroom Wall Panel Substrates, which is best for my application?

Cleanroom Wall Panel Substrates, which is best for my application?

From Pharmaceutical Cleanrooms to Aerospace Cleanrooms, modular wall systems provide a durable surface that is easy to clean and can be quickly adapted to resize or shape the cleanroom. Due to the wide range of cleanroom applications, you have several factors to consider when choosing your cleanroom’s modular wall systems and your Wall Panel Substrates. When scoping a cleanroom for your business, you have to take into account the following:

read more
Clean Room Classification & Cost Implications

Clean Room Classification & Cost Implications

Clean room Classification and clean room size greatly affects the cost of a clean room, both from a planning and implementation cost perspective, as well as an operational cost perspective. Many customers will come forth with the idea that they will build a larger clean room than necessary – just in case they need the extra space. This often times results in increased operational costs and unforeseen expenses.

read more