Contamination of the production area can affect the safety and stability of products, from automotive and aircraft parts to pharmaceutical products and medical devices. ISO is helping to reduce the risk by two International Standards for biocontamination control that hold promise for key business domains such as aerospace, automotive, health care, pharmaceutical and food industries, as well as many others.
"The new standards are the first complete, comprehensive International Standards on biocontamination incorporating elements from many individual national standards and specific product standards as well as text books on biocontamination," said Dick Matthews, Chair of ISO technical committee ISO/TC 209, Cleanrooms and associated controlled environments. "They provide a universal framework for critical industries worldwide to be used both internally and externally to control biocontamination in cleanrooms and other associated controlled environments."
ISO 14698, which is published in two parts under the general title, Cleanrooms and associated controlled environments - Biocontamination control, is designed to eliminate the hazards of contamination or minimize the likelihood of their occurrence in the production area and, in so doing, contribute to the creation of safe and stable products for the global market place.
Part 1 of ISO 14698 demonstrates how to establish a formal system of biocontamination control in order to assess and control factors that can affect the microbiological quality of the process and product. It specifies the methods required for monitoring risk zones and for applying control measures appropriate to the degree of risk involved.
Part 2 of ISO 14698 provides guidance on the evaluation and interpretation of biocontamination data. It will help users to estimate results in risk zones and trigger corrective actions before biocontamination problems arise.
Personnel involved in quality assurance, quality control and validation, as well as microbiologists within the life sciences and health care industries, will find the standards useful.
ISO 14698-1:2003 costs 116 Swiss francs and ISO 14698-2:2003 costs 67 Swiss francs. They are available from ISO national member institutes and from ISO Central Secretariat (see below). The new standards are the work of ISO technical committee ISO/TC 209, Cleanrooms and associated controlled environments.