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.

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.

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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New Modbus Flow Totalizer for Hazardous Applications

New Modbus Flow Totalizer for Hazardous Applications

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.

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ISO Class 4 Microelectronics Cleanroom Completed for NexLogic Technologies, Inc.

ISO Class 4 Microelectronics Cleanroom Completed for NexLogic Technologies, Inc.

NexLogic Technologies, Inc. has announced the completion of its International Standards Organization (ISO) 14644-1 Class 4/10,000 and the equivalent Federal Standard 209E (FS209E) Class 10 clean room as an integral part of its new microelectronics services and manufacturing capability.

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Compounding Pharmacy Safety violations

Compounding Pharmacy Safety violations

In December, the Food and Drug Administration issued a thorough inspection report on PharMEDium’s Tennessee plant that resulted in a pause in pharmaceutical production, until otherwise permitted. PharMEDium, one of the nation’s largest compounding pharmacy companies, is owned by AmerisourceBergen. It supplies medications to about 77% of hospitals nationwide.

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Single Pass Versus Recirculating Clean Rooms

Single Pass Versus Recirculating Clean Rooms

The decision that will influence the design of a cleanroom air handling system determining the method to use should be made depending of the desired preciseness of your control. If you are controlling temperature and humidity very tightly, you want to use a recirculating system so that once you’ve conditioned that air, you are not letting the conditioned air escape.

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