Clean Air and Containment Review
The journal to enhance your knowledge of cleanroom, clean air and containment technology


Issue 21: January 2015

Main Features

Practical experiences in particle deposition monitoring
Koos Agricola

Abstract

The rate of deposition of airborne particles determines the risk of product contamination and demonstrates the operational quality of a cleanroom. The particle deposition rate at a particular location and time depends on the deposition velocity and the concentration of particles. The concentration of particles larger than 10 μm cannot be measured easily; therefore the deposition rate of falling particles should be measured.

Specific particle deposition meters, that measure the particle size distribution and rate of particle deposition, have been available since the end of 2013. In the past, particle deposition measurements were complicated and expensive and were therefore only carried out in specific cleanroom applications or to investigate contamination problems. Nowadays it is easy to carry out particle deposition measurement in various cleanrooms where operator activities are important. The new instruments also make real time particle deposition measurements possible. Practical experiences with these instruments in various applications are described in this article.

Addressing rouge on stainless steel in biopharmaceutical manufacturing systems
Paul Lopolito

Abstract

This article is a guide on how to treat rouging or discolouration on stainless steel surfaces. The article starts with a description of the different types of stainless steel and how stainless steel develops a chromium-enriched corrosion-resistant layer by passivation either from the oxygen in the air or by chemical means. X-ray photoelectron spectroscopy (XPS) is used to measure the depth of the layer. When stainless steel corrodes, this shows as a discolouration that is known as rouge. Rouge can be anything from reddish brown to blue or black. The article describes three types of rouge that result from deposited oxidized metal particles, in-situ oxidization and high temperatures or steam. Finally the article explains how rouge can be removed and surfaces repassivated. Routine procedures for inspection and treatment are recommended.

A history of isolator and containment technology
Part 4: Transfer devices
Doug Thorogood

Abstract

The discussion in this part of the history of isolator and containment technology reviews the development and use of various devices that permit the aseptic transfer of components such as sterile vials, syringes, bottles and other types of container as well as the actual product itself into and out of the aseptic filling area of an isolator or RABS (restricted access barrier system).


Standards
ISO 14644 series of standards: Progress report
Gordon Farquharson

Life-lines

Regulatory reflections

WHO adopts ICH quality system philosophy
Dr Hans Schicht

Regulations that affect cleaning products
James Tucker

Award

Bill Whyte awarded Special Commendation by BSI
John Neiger

Book review

Review of 'Industrial Pharmaceutical Microbiology:
Standards & Controls - 2015 Edition' edited by Geoff Hanlon and Tim Sandle
James Filer

News

Nitritex, Bassaire, DOP Solutions, Clean Room Construction, Cleanroom
Istanbul 2015 Exhibition


Events and Training Courses



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