puresu® is a combination of different components that can be customised to your requirements. Through a broad range of tubing and single-use components combined across an open architecture design, we work with you to create a sterile and dependable fluid path customised to your bioprocessing requirements.
- Sterile tube assemblies are available with a 10-6 SAL (sterility assurance level)
- Safe, flexible and quick turnaround backed with a robust supply chain.
- Complete product traceability.
- Large component library to choose from.
- Documented quality systems compliant with ISO 9001.
Each of our single-use assemblies are manufactured in-house and are lot traceable throughout our process. To ensure our single-use technology comes ready to use, and meets the requirements set by cGMP guidelines, lot traceability of each component can be made available as part of our detailed documentation.
Assembly and packaging are carried out in our ISO 14644-1 Class 7 Cleanroom manufacturing suite. Sterile tube assemblies are available with a 10-6 SAL and a two year sterility shelf life, validated in compliance with ANSI/AAMI/ISO 11137 VDmax 25 methodology.
We work with you to deliver a final design that is specific and reliable to your bioprocessing needs. To align with your requirements, puresu® single-use assembly packaging configurations may include non-irradiated, gamma irradiated (minimum 25 kGy) or gamma irradiated with a 10-6 SAL claim.
- Ideal for critical fluid path bioprocesses and customers unable to terminally sterilise.
- Supplied gamma irradiated with a sterile assurance level claim (10-6 SAL). Suitable for customers who require contamination risk mitigation.
Gamma Irradiated puresu®
- Suitable for customers who manage microbial control through bioburden reduction.
- Suitable for prototype evaluation and the application of alternative sterilisation methods.
We employ an open architecture approach to enable flexibility of your assembly designs. puresu® assemblies are available with the following:
- A range of fluid path components including Watson-Marlow Tubing products (ReNu SU cartridges, Pumpsil®, PureWeld® XL, BioPure tubing, BioPure tubing fittings, sanitary hose barbs, Bio-Clamps, valves and adaptors)
- Product options include: non-gamma irradiated, gamma irradiated (minimum 25kGy) or gamma irradiated with a sterile claim (10-6 SAL).
- Documented quality systems compliant with ISO 9001
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
- 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.