Journal contents list

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Issue 25: January 2016

Main features

Airborne particle deposition in cleanrooms:

Relationship between deposition rate and airborne concentration

W Whyte, K Agricola and M Derks

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Abstract

This article is the second of a series that discusses the deposition of airborne particles onto cleanroom surfaces. It investigates the relationship between the airborne concentration of a range of cumulative sizes of particles and the particle deposition rate (PDR) onto cleanroom surfaces, through knowledge of the deposition velocity of particles in air. The deposition velocity of a range of cumulative particle sizes was obtained by means of experiments, theoretical calculations, and literature search and the influence of a number of variables found in cleanrooms on the deposition velocity was investigated. The use of the deposition velocity to calculate the amount of deposition on cleanroom surfaces, such as manufactured products, is discussed, along with its use in deciding the required ISO 14644-1 class of cleanroom; these subjects will be discussed in more depth in the final article of this series.

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Understanding the hydrogen peroxide vapour sanitisation process and introducing the MCHP concept, a personal account

Tim Coles

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Abstract

This article traces the history of hydrogen peroxide vapour as used for sanitising pharmaceutical isolators and similar volumes. From an early puzzle as to how the vapour could be so effective in deactivating resistant test organisms, the author moves forward through his own career to develop a clearer comprehension of the hydrogen peroxide vapour process. The term "micro-condensed hydrogen peroxide" (MCHP) is introduced as an aid to understanding how the process truly acts and this understanding helps to generate robust sanitisation cycles. The new knowledge can be applied to the many devices becoming commercially available for sanitising isolators.

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Lowering the risk of personnel induced contamination:

The use of robotics in aseptic processing

Sergio Mauri

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Abstract

One of the most problematic issues of aseptic manufacturing is the involvement of personnel. Human presence generates millions of particles every minute. Some of these particles are biologically active and can generate product contamination. Now, technology can create a revolution by removing human intervention from the aseptic manufacturing process to reduce its impact on product sterility. Stainless steel GMP robotic arms have been introduced to handle fill finish operations within a gloveless isolator. The advantage of this process, apart from sterility improvement, is the possibility of handling Highly Potent Active Pharmaceutical Ingredients (HPAPIs) like cytotoxic drugs in a flexible and cost-effective way. This article goes through all the main features of the gloveless robotic solution and describes a cluster tool concept for an advanced aseptic production facility.

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Pilot plant habitat for the development of regenerative closed loop life support systems, paving the way for deep space travel

Hosokawa Micron Ltd

Standards

Major revisions of ISO 14644 Parts 1 and 2 finally published

Gordon Farquharson

ICCCS

ICCCS needs members and members need the ICCCS

Koos Agricola

Life-lines

News

Nitritex introduces a new era of aseptic donning

Academy for Cleanroom Testing (ACT) seminars on changes to ISO 14644 Parts 1 and 2

New product from Ecolab contamination control set to revolutionise the transfer disinfection process

Second successive record year for Clean Room Construction

Cleanroom Guangzhou Exhibition to be repeated in 2016

Welcome to a new expert at Envair Lab

Events and Training Courses