We make sure that our single-use systems are thoroughly sterilized by exposing them to gamma rays.
We follow a set of guidelines to confirm that gamma irradiation is suitable for all our single-use systems. Our products are treated with gamma ray doses between 25 and 40 kGy . This range ensures an extremely high level of cleanliness, with a Sterility Assurance Level of 10-6 (meaning there’s only a one in a million chance of finding a living microbe) on surfaces that come into contact with the product.
We also do regular Dose Audit testing by following the ISO 11137 guideline and we check for absolute sterility by using a special USP – direct inoculation method.
Additionally, we conduct ongoing checks for things like endotoxins (harmful substances from bacteria) and particles, and we monitor the gamma rays’ effects to make sure our single-use systems stay safe. Our exhaustive design testing gives you the peace of mind that every liquid single-use system will do its job perfectly, in harmony with cGMP biopharmaceutical processes.