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.

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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).

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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).

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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.

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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

Nov 1, 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).

Medical Device Single Audit Program – How Should You Prepare?

Medical Device Single Audit Program – How Should You Prepare?

Jul 30, 2018 | , , , , , , ,

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.

New Modbus Flow Totalizer for Hazardous Applications

New Modbus Flow Totalizer for Hazardous Applications

Jul 24, 2018 | , , , , , ,

SignalFire Wireless Telemetry introduces the ModQ Sentry, a Modbus Flow Totalizer that interfaces with pulse-type inductive turbine (and other) flow meters to provide instantaneous flow rates, accumulated totals and status information. Units are configurable for volume and time settings and offer options to configure the K factor to match the turbine.

Cleanroom Gowning Best Practices

Cleanroom Gowning Best Practices

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Proper cleanroom garments for cleanroom gowning are designed to trap and prevent human contaminants, such as those generated by the skin and body, or carried in on their own cleanroom garments, from entering the clean environment. The procedures for cleanroom gowning vary somewhat by industry, but in general, they follow a procedure of “donning” (putting on sterile cleanroom garments) prior to entering, and “doffing” or “de-gowning” (removing special cleanroom garments after exiting), similar to the following:

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