Journal contents list

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Issue 38: Spring/summer 2019

Main feature

A global study of the performance of cleanroom garments over their life cycle

Matheus Barbosa, Jean-François Teneul

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Abstract

Sterile garments for cleanroom use often present a variable performance over their entire life cycle as they are vulnerable to damage from laundering and sterilization methods. A study was conducted to understand how reusable garments perform when subjected to multiple laundering and irradiation cycles - tear strength, particle shedding, permeability, etc.. The study enables a cost comparison with single use garments.

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Standards

Monitoring of nanoscale particles in cleanrooms: ISO 14644-12, outreach article

Anne Marie Dixon-Heathman, Dr David Ensor

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Abstract

Within the International Organization for Standardization (ISO), Technical Committee (TC) 209 is chartered with standardization of cleanrooms and associated controlled environments. A series of 15 international standards (thirteen parts under ISO 14644 and ISO 14698 Parts 1–2) has been established for controlling contamination by means of cleanroom technology. The standards address design, classification, and monitoring, and support operation of cleanrooms.

One of the committee's most recently published standard, ISO 14644-12, Cleanrooms and associated controlled environments-Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration, provides specifications for the cleanroom monitoring of nanoscale particles (nanoparticles) smaller than 100 nm with a condensation particle counter or equivalent. The standard provides guidance for air monitoring for the purpose of identifying the contributions of sources to the cleanroom burden of particles.

Sources of nanoscale particles are primarily from the processes in the cleanroom. The standard includes example specifications for instrumentation performance and information on how to apply the data. Intended users include process engineers and cleanroom specialists. It is anticipated that as the nanotechnology field advances, this standard may find extensive use.

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EN ISO 374, Protective gloves against dangerous chemicals and micro-organisms, summary of changes and FAQs

Peter Clarke

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Abstract

Purchasers of disposable gloves for protection against dangerous chemical and micro-organisms should ensure that they comply with the most recent EN ISO 374 standard. This article highlights changes made to the EN 374 standard at the last update. The latest EN ISO 374 standard defines the required capabilities for gloves that protect workers whose hands are subject to chemical and/or micro-organism exposure. The article includes a number of FAQs to help readers understand the changes, new performance ratings, test methods and rating symbols.

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New energy standard: ISO 14644-16:2019 – Part 16: Energy efficiency in cleanrooms and separative devices

Regulatory reflections

Cleanroom regulatory trends: A review of FDA warning letters

Tim Sandle

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Abstract

Cleanrooms remain a central focus of regulatory inspections and it is good practice for those working within pharmaceuticals and healthcare to assess regulatory trends. This task is difficult within Europe, where only broad overviews are released (due to data privacy restrictions) and it becomes complex when assessing output from U.S. FDA, given the hundreds of warning letters issued. To assist with this process, this article assesses recent FDA warning letters and draws out the main trends and significant non-compliances relating to cleanroom design, testing and operations.

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Critique

Clarity on GMP from PHSS, a critique of Guidance Note No. 1

Tim Coles

News

Ecolab's new sporicide balances effective disinfection with user acceptability

Lab Innovations hosts The Cleanroom Hub

EECO2's Mobile Energy Monitoring Unit (MEMU) eligible for Enhanced Capital Allowance (ECA) tax scheme

BioClean™ Isolator Sleeve/Glove System

Cherwell announces new microbiology product specialist

Customer satisfaction at Crowthorne Group

Another prestigious completion by CRC

Envair recognised as Major Equipment Supplier in Facility of the Year Award to Eli Lilly and Company

Sign up today for Cleanroom Guangzhou Exhibition 2019!

PMS: Industry experts combine to create safer intravenous delivery

Cleanzone trade fair experience enriched by numerous events

STERIS Launches ProKlenz® Foam High Performance Alkaline Cleaner and ProKlenz® RESTORE High Performance Acid - Based Cleaner

Events and Training courses

Life-lines