In both the medical and general scientific research communities, the importance of having contaminant-free lab equipment, instruments and products can’t be overstated. If any part of the testing chain is contaminated – pipette tips, vials, Petri dishes, assay plates, etc. – it can throw off all the data and make it unusable. Rather than take this risk, it’s important to ensure that all materials are made contaminant-free.
In particular, ensuring that materials are RNase free and DNase free is vitally important. These substances can degrade the very RNA and DNA samples being tested if they are present in or on any of the testing materials. For example, if a researcher is running a Polymerase Chain Reaction (PCR) to amplify their genetic sample for more accurate testing, they’ll need to provide RNase free PCR tubes, among other items. RNase contamination can come from innumerable sources, so all testing equipment and products must be properly sterilized and RNase free.
For RNase and DNase free products, disposables and consumables that are labelled as sterilized or sterilized processed, the sterilization processing must be validated to a Sterility Assurance Level (SAL) of 10 to the negative 6, meaning that contamination must statistically not exceed 1 per million devices or lower. To achieve this validation standard for medical devices, electron beam (E-beam) irradiation and Gamma sterilization are often used.
Companies that do not label their lab products as sterilized or sterilized processed will still need assurance and be able to provide their customers assurance that their lab consumables and disposables are contaminant free. In this case, processing their product to achieve a SAL of 10 to the negative 3 or one per thousand devices is acceptable with data and monitoring of manufacturing process is in place to assure this SAL is achieved on an ongoing basis.
And as important as it is to sterilize lab products, disposable and consumables, it is just as important to perform sterility testing and verification dose calculations to verify the effectiveness of the sterilization procedure.
For more information and to request a quote for lab product decontamination or medical device sterilization, please contact NUTEK online.