The journal to enhance your knowledge of cleanroom, clean air and containment technology
Issue 18: April 2014
The differing requirements for gaseous decontamination in pharmaceutical cleanrooms and microbiological laboratories
AM Bennett, SR Parks and T Pottage
AbstractHow do you ensure that your clean room or isolator is free from microbial contamination? How do you ensure that your BSL3 laboratory or cabinet is free from the dangerous pathogen you are working with? In many instances liquid disinfection cannot be used to reach all parts of the space and is difficult to validate so gaseous decontamination is carried out as an alternative measure.
While there are numerous candidates for use as gaseous disinfectants including chlorine dioxide and ozone, in recent years the choice had been between hydrogen peroxide and formaldehyde. Hydrogen peroxide systems have long been used in pharmaceutical clean rooms and isolators with great success and are now being used more commonly in laboratories as concerns have grown about the carcinogenicity of formaldehyde vapour. In this short article the issues of moving a technology designed for the pharmaceutical sector into the laboratory sector will be discussed and the advantages and disadvantages of the two methods for use in the laboratory sector will be examined.
Diffuser performance in cleanrooms
EU GMP Grades B, C and D turbulently ventilated cleanrooms rely on effective airflow delivery to dilute and remove airborne contamination generated from occupants and equipment, so that the airborne particle counts are within the required internal and regulatory requirements. This article describes work undertaken within an actual Grade B cleanroom in China, to analyse airflow performance of different types of diffuser, including a new, specifically designed, cleanroom diffuser. These were compared under different air-change rates and also different numbers of active diffusers in order to assess the recovery time and recovery rate. The ultimate objective was to establish which diffuser and which arrangement provided the best dilution of particles using the lowest airflow, based on recovery time and recovery rate outcomes. Optimum results were achieved with the specifically designed, cleanroom diffuser.
A history of isolator and containment technology - Part 1: Early containment leading to flexible film isolators
This is the first of five papers that will describe the history and development of containment technology in the field of research, medicine and pharmaceutical applications. The paper commences with the development of containment for various purposes possible and practical. The paper goes on to describe how the experimental work in the late 1920s led to the development of metal and then flexible film isolators for use in veterinary research, human medicine and surgery. The notable contributions of Philip Trexler, known to everyone as Trex, from the 1930s right through to the 1960s, especially in patient care and treatment, are recorded.
Moment of change: CO2 based solutions for cleanroom textile and garment laundering
Richard Kinsman and Steve Madsen
Traditional cleanroom laundries and other service centres that launder textiles and garments and related apparel accessories worn in controlled environments are faced with high capital and operating costs, and create significant sustainability impacts (water, energy, chemical waste, discarded uniforms). These costs are in large part driven by the water-based infrastructure and processing steps needed to meet cleanroom garment standards. By replacing water-based methods with liquid carbon dioxide (CO2)-based cleaning methods, operational costs, capital infrastructure, and sustainability impact can all be significantly reduced - all while maintaining superior cleaning and disinfection standards. CO2-based textile laundering offers enormous potential to a variety of cleanroom and healthcare related markets, including pharmaceutical, biotech, semiconductor, aerospace, medical device, and nuclear laundries.
Revision to EU GMP Annex 15: Qualification and Validation
Pharminox, Ecolab, DOP Solutions, Validair, Dycem, Contec
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.