High Quality Sterility Standards for Life Science Applications
Aug 04 2021
With four new quality levels under the BIO-CERT® label, Brand provides quality, reliability and simple selection for applications such as PCR, cell cultures and liquid handling. To achieve this, the life science experts at Brand worked closely with users to analyse the application requirements and define quality levels geared toward the respective application. The idea behind the new quality levels: not to offer as many ‘free from’ attributes in various combinations as possible, but rather exactly what is required for the respective application - and in a precisely defined and reliable format.
For example, sterility levels are not always the same. At Brand, the benchmark is clearly defined: sterility occurs when the requirements of ISO 11 137 are met. This standard clearly stipulates how many, or better yet how few, organisms are allowed to be present. In terms of pipette tips, for example, this translates to a maximum of one organism per million pipette tips. Brand certificates also transparently specify the method and irradiation intensity used to sterilise the product and the name of the external GLP laboratory that monitors the quality. This not only ensures reliable results but is also important for audits.
This high sterility standard, for example, is part of the quality level BIO-CERT® liquid handling sterile. This quality level also guarantees that products are free from ATP - which is required when users perform ATP measurements to monitor hygiene in compliance with the HACCP concept. This example demonstrates how different application-related attributes are bundled in the quality levels, thus making work easy due to reliably high quality and simple selection.
All BIO-CERT® products are manufactured in a cleanroom under controlled conditions at Brand in Germany. This process begins already with the use of ultra-pure granulates and extensive incoming goods inspections. For the production process itself, Brand has at its disposal one of the world’s largest cleanrooms for laboratory consumables. Products are manufactured according to current ISO standards (ISO 14 644-1 Class 5, 7 and 8) and therefore have virtually no particle contamination. The advantage is obvious: particles in consumable materials not only carry contaminants such as foreign DNA but they can also permanently disrupt sensitive laboratory experiments.
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