Completely. It is Sterilised and comes in sterilisation packing that ensures the sterility is maintained to a level of the legal requirement for sterile products of 10(-6) and which has the instructions printed on the verso. The legal requirements on the level of sterility are set out in the EU Harmonised standards 556-1 and 556-2. In a nutshell any claim for a sterility assurance level (SAL) must follow these procedures. Aseptically manufactured or clean room manufactured is not a claim for sterility assurance level and is considered unsterile. All claims for a SAL must be in protective packaging in order to maintain the SAL level claimed. This is why the Midstream is individually packed and then sterilisation occurs of the entire kit after the product has been packed.