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


Issue 16: October 2013

Main Features

Cleanroom Lighting and LEDs
Graham Gould

Abstract

This article explains some of the important considerations when selecting luminaires for cleanrooms and controlled environments. It then goes on to describe the advantages of LED luminaires over traditional fluorescent luminaires, namely energy use and service life and compares the performance of the respective types.


The nature and environmental impact of control of floor level contamination
Gerry Prout

Abstract

The nature of particulate contamination in the operation of cleanrooms is reviewed; particulate of greatest significance and most numerous is less than 10 microns and emanates primarily from movement of personnel. Significant contamination at floor level results from carryover of foot- and wheel-borne particulate and is normally controlled by the use of peel-off adhesive mats or, increasingly, by polymeric contamination-control flooring. Previously reported research on control of contamination is briefly reviewed to illustrate the distribution of particle sizes at floor level and the efficiency with which they are collected by peel-off mats and by proprietary contamination control flooring. Polymeric flooring is shown to demonstrate significantly superior performance on particulate collection to peel-off mats for both viable and non-viable particulate and over a full range of particle sizes, especially on particulates less than 10 microns.

Research undertaken over the past ten years has reported on studies related to footwear types commonly in use in cleanrooms and their influence on control of particulate contamination. Footwear with smooth soles releases particles most efficiently to the control surfaces of both peel-off mats and polymeric flooring; other soling types with ridged or patterned soles behave less predictably. Polymeric flooring demonstrates superior performance to peel-off mats for all soling types; the efficiency of peel-off mats is influenced adversely by some soling types in use, which can render peel-off mats almost totally ineffective.

Comparative costs and ecological implications are reviewed by reference to an industrial case study. It is demonstrated that in a large installation requiring ten controlled entries, cost savings of as much a $300,000 can be achieved over a two-year period by the use of polymeric flooring in place of peel-off mats which have a high manufacturing and disposal cost. The installed area of the polymeric flooring, being 35 times greater than that of the ten mats combined, represents a substantially larger barrier against contamination. As polymeric flooring is disinfected with antimicrobial disinfectants, disposal poses no health hazard to humans or the environment compared with peel-off mats.

Key words: Cleanrooms, mats, polymeric flooring, particles, footwear, environmental impact.


Biological indicators peroxide vapour technology
Lynne Murdoch

Abstract

Biological indicators (BIs) have become the industry standard for verification of hydrogen peroxide vapour (HPV) decontamination efficacy. This white paper discusses BIs for use with HPV and some of the factors associated with inconsistent performance of BIs used to assess HPV bio-decontamination cycles.


Trends
Trends in healthcare cleanroom practice: single-use sterile disposable technology
Tim Sandle

Abstract

Medical devices, such as syringes, implants and components for aseptic processing including vessels, manifolds and connectors, are required to be sterile for the manufacture of many types of medicine and pharmaceutical product within cleanrooms. In the past, many of these items (such as stainless steel manifolds) were recycled and autoclaved. This way of working is now regarded as inefficient in terms of time and energy costs, as well as presenting occasional contamination control risks due to sterilising cycle inefficiencies.

The current trend in the biopharmaceutical industry, as well as with medical devices and parts of healthcare, is towards single-use sterile disposable systems which represent one of the biggest growth areas in relation to cleanroom technology. This article introduces the subject, gives examples of the types of system available, looks at the cost saving advantages, and describes the main methods of sterilisation

Standards
ISO 14644 series of standards: Expectations and updates in advance of the October meetings of ISO TC 209 and its Working Groups in Reno

Gordon Farquharson, Stephen Ward, Dick Gibbons, Richard Roberts and James Filer


Regulatory reflections
USP updates: cleanrooms and sterilization
Tim Sandle

Conference Report
GERPAC 2013
Tim Coles

Vital Vocabulary 
W, X, Y and Z are for...


News

Pharminox Isolation, CRC, DOP Solutions, Contec

Life-lines

In Memoriam

In Memoriam, Joe Ridge 1937 - 2013

Events and Training Courses


To access the full content of CACR in interactive pdf format, first enter the members section of the ICS website with your username and password.

To see the contents of all previous issues, please visit
www.cleanairandcontainment.com/journal-contents-list