BioPure puresu single-use tube assemblies validation summary guide

puresu^® is a single-use assembly, available in a variety of custom configurations for use in bioprocessing. They comprise of single-use components including Watson-Marlow tubing, ReNu SU cartridges, BioPure connectors and gaskets, as well as a number of industry recognised third party supplies.

• Validation summary guide details manufacturing process.
• BioPure employ ISO 9001 quality management systems within their Horndean facility, UK.
• Assemblies are manufactured and packed in ISO 14644-1 Class 7 cleanrooms.

puresu^® assemblies can be provided double or triple bagged depending on customer requirements. These assemblies can also be provided in three categories

• Non-irradiated.
• Gamma irradiated to a minimum of 25 kGy with a certificate stating irradiation dose range.
• Gamma irradiated with a sterile claim of 10^-6 SAL per ANSI/AAMI/ISO 11137 (VDmax method).

Each assembly has a unique lot number which enables each component to be fully traced to its constituent materials.