By Severin Heynen
If you need to absolutely guarantee that the tips you are using are sterile when they arrive on your lab bench then there are a few critical points to consider.
Sterile pipette tips must conform to ISO 11607
Tips may be labelled as ‘pre-sterile’ or ‘sterile’. What does this mean? Sterility, in the context of pipette tips, is the likelihood that one in a million tips is contaminated by a single organism and is defined by a sterility assurance level (SAL). The SAL and how to achieve this are described in regulatory standards as for example EN 556 and ISO 11607, which providers of products that are labeled as “sterile” need to conform to in order to be able to use such a label.
On the other hand, “pre-sterile” is a term that is not defined by any standards and is therefore thought to describe manufacturing processes that do not guarantee a SAL of 10-6. So look at the labels on your packages – ‘sterile’ or ‘pre-sterile’? If you are unsure about the quality, contact the supplier and ask what standards they are basing their sterility claim on.
The sterilization process has to be validated and the sterility has to be tested by an accredited laboratory. Accredited labs ensure full confidence and traceability in the results. Testing has to be done at the batch level to ensure the tips you are using are indeed sterile.
The packaging of sterile products is very important. Sterile products need a robust package construction that can withstand all manner of circumstances as it is transported from the manufacturer to the warehouse and finally from the warehouse to your lab bench. Furthermore, the package contents must maintain its sterility for the entire shelf life of the product. Without this, customers might receive sterilized products that are damaged during transportation and risk being contaminated. The customer will only realize this when they find that their samples are contaminated. And that is far too late.
In the final post in this series, we will look at how Tecan ensures the sterility of pipette tips when they arrive on your lab bench.