Cleanroom Standards Articles

Ensuring Cleanroom Compliance: The Pillar of Safe and High-Performing Manufacturing

In the world of pharmaceutical manufacturing, biotechnology, and advanced material production, cleanrooms serve as the backbone of contamination control. However, designing and maintaining a compliant cleanroom is not just about meeting regulatory expectations—it is about ensuring safe, consistent, and high-quality manufacturing processes.

Nelson Labs Launches Innovative Rapid Sterility Testing in Laboratories in the U.S.A and Europe

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.

Annex 1 and First Air: Critical Considerations for Cleanroom Design and Compliance

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 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.

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.

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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

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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Aseptic Gowning for the Cleanroom

Aseptic Gowning for the Cleanroom

Correct aseptic gowning procedures are of utmost importance to ensure a safe and compliant operation in the cleanroom environment. Particulate is difficult to detect because it is invisible to the naked eye. Contamination is commonly introduced to the cleanroom environment through the people who enter the cleanroom.

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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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