All labware has some extractable and leachable content. It is important to recognize that extractables and leachables are two different things. Extractables are organic compounds or metals removed from the material under extreme conditions, such as exposure to high heat or very high/low pH, whereas leachables are those that are removed under normal conditions of use. Sarina Bellows at Thermo Fisher Scientific examines the importance of E&L standards and their application for risk assessment during product selection and offers insight into relevant regulatory guidance and available E&L testing methods.
Extract:
‘E&L Standards: Empowering Confident Labware Choices’
Scientist across every discipline strive to design and conduct experiments that will deliver clear and meaningful results. Doing so demands meticulous attention to detail in assessing all aspects of the experimental setup, understanding the variables involved, and anticipating and minimising potential unknowns. Once critical but easy-to-overlook factor is the influence of the labware used.
One possibility, in particular, is the interference from extractables and leachables (E&L) that may be present due to the materials used to manufacture the labware, including both glass and plastic labware. While these chemical stowaways are often inert, it is crucial to be aware of their presence and be mindful of their potential impact on the experimental process. Testing and validation of labware is essential in establishing confidence in the quality and reproducibility of the experimental results that will be generated. This article examines the importance of E&L standards and their application for risk assessment during product selection and offers insight into relevant regulatory guidance and available E&L testing methods.
The Key Issue
All labware has some E&L content. It is important to recognise that extractables and leachables are two different things. Extractables are organic compounds or metals removed from a material under extreme conditions, such as exposure to high heat or very high/low pH, whereas leachables are those that are potential leachables, but not all extractables will become a leachable under each set of specific operating conditions. Everything from glass and plastic to packaging materials and even label inks can leach unwanted contaminants. Everything from glass and plastic to packaging materials and even label inks can leach unwanted contaminants.
Many of the additives used in plastics manufacturing including plasticiser, pigments, lubricants, stabilisers, antioxidants and slip agents, can be an extractable and, therefore, a leachable under certain conditions. It is important to note that nearly all products made from plastics, including food packaging, toys and medical supplies, requires the use of additives to ensure they deliver the needed properties of structural integrity, product performance, sterility and protection against environmental factors that would otherwise lead to degradation.
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