Phone: 1-888-755-4370 (toll free US only)
Phone: 1-215-526-2151 (worldwide)
Email: info@advantapure.com
Single Use Systems (SUS)
Single-Use / Disposable Process Systems For Pharmaceutical & Biotech Processing Applications
Eliminate production stoppages for sterilization, reduce the risk of contamination, and increase efficiency by incorporating single use systems from AdvantaPure. Single use systems, or SUS, simplify cleaning validations—use once and discard.
Each system is custom made using platinum-cured, Class VI silicone tubing and hose or AdvantaFlex® Class VI biopharmaceutical grade tubing for peristaltic pump applications. Add fittings, stoppers and container closures, filters, bags, bottles, labels and tracking options, and other components.
Single use systems are not intended for implantation or continuous steam applications.
KEY FEATURES
- Custom manufactured and assembled from a variety of components
- Reduces end-user assembly labor expense and time
- Reduces cross contamination risks
- Saves energy and resource costs by eliminating cleaning
- Reduces production downtime by eliminating certain cleaning validation requirements
- Provides flexibility and speed in facility design—system redesigns are implemented faster than with hard piping
- Less costly process development and design compared to systems of hard piping
- Assembled and packaged in a Class 7 (Class 10,000) ISO-certified clean room
- Available with validated sterility assurance of 10-6 per ISO 11137 method VDmax.
- Documented lot traceable with identification on bags
- Documented quality control
- Experienced engineers available for technical assistance
- Tubing and molded connections provide a single, animal-derived ingredient-free material contact surface
- Complete validation package available upon request
- Optional RFID tags easily attach to assemblies for identification purposes—provide reliable electronic data storage and current status of assemblies from inception to disposal
Silicone Tubing and Hose
Low-volatile grade, platinum-cured silicone tubing and braid-reinforced silicone hose is clean-room manufactured by AdvantaPure for pharmaceutical and biotech applications.
Both the tubing (called APST) and hose (APSH) have undergone extensive physical, chemical, and biological testing and meet USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, and 3A standards.
APST size range: .030" through 1" I.D. (.76mm through 25.40mm I.D.)
APSH size range: .063" through 1" I.D. (1.59mm through 25.40mm I.D.)
AdvantaFlex® BioPharmaceutical Grade Tubing
AdvantaFlex addresses the need for a flexible, translucent, sterilizable, heat sealable, weldable and moldable biopharmaceutical tubing for fluid processing. The unique properties of AdvantaFlex help it outlast similar tubing tested in peristaltic pumps by 6-10 times.
AdvantaFlex is ideal for aseptic tubing welds, as it eliminates costly aseptic connectors and multiple contact surfaces. The tubing is made from FDA-approved ingredients and meets various ISO and USP standards, including Class VI, as well as European Pharmacopoeia 3.2.2.1 standards.
Size range: 1/8" to 1" I.D. (3.18mm to 25.40mm I.D.)
Molded Manifolds
Single-use Molded Manifolds provide a seamless transition between tubing and connections for a continuous, leak-proof flow. Molded connections include Y, T, cross, reducer, Tri-Clamp®, and mini Tri-Clamp styles. Made from platinum-cured silicone or AdvantaFlex biopharmaceutical grade TPE, they allow for one material contact surface throughout the system. Connections sizes differ depending on style.
Size range: .188" to 1" I.D. (4.76mm to 25.40mm I.D.)
BioClosure® Systems - High Purity Container Closures
AdvantaPure's BioClosure Systems offer purity, secure seals, and versatility in design. Stoppers, caps, True Union and GL45 inserts, and other styles, available with or without tubing inserts, are manufactured from platinum-cured, Class VI silicone or AdvantaFlex biopharmaceutical TPE.
MORE ABOUT BIOCLOSURE® HIGH PURITY CONTAINER CLOSURES
| Connections |
 Barbed Fittingscome in Y, T, elbow, and reducer styles. Materials include polypropylene, polyethylene, and PVDF. Size range: 1/8" to 1" hose I.D. (3.18mm to 25.40mm hose I.D.) |
|
  Aseptic Connectorsreduce contamination risks and keep processing systems pure. Several easy-to-use styles are available. AdvantaFlex tubing can even be molded onto connectors (patent pending), reducing the risk of leaks associated with barbed fittings and eliminating cable ties and their risk of piercing bags or packaging. Note: Molding onto aseptic connectors and filters may involve R&D and lengthy lead times; call for details. |
|
| Clamps |
 Pinch Clampsof polypropylene or polyester squeeze tubing closed anywhere along a line. One piece construction. Sizes fit up to 3/4" tubing O.D. (19.05mm tubing O.D.) |
|
| Filters |
  Choose from a variety of styles, sizes, and manufacturers for your single use system. Like aseptic connectors, AdvantaFlex tubing may be molded onto filters (patent pending), reducing the risk of leaks asso- ciated with barbed fittings and eliminating cable ties and their risk of piercing bags or packaging.Note: Molding onto aseptic connectors and filters may involve R&D and lengthy lead times; call for details. |
| Bags |
 AdvantaPure can supply bags from a number of leading manufacturers. Let us know what you need. |
| Bottles |
 Laboratory and sampling bottles can also be incorporated into your system. Select from HDPE and other materials. For stoppers and container closures, see our BioClosure® Systems. |
Quick Connects
Tri-Clamp Connection Clamps
Download a printable version of our Single-Use Process Systems brochure. Single_Use_Systems.pdf (828KB)
BUILD YOUR SYSTEM FROM:
OPTIONS
DocuLink® - Manifold Identification System
DocuLink is our new silicone manifold identification system providing individual identification and tracking information directly on each manifold in the form of a silicone-encased label. Manifold information can be linked to an on-line data management site to provide easy document retrieval for audits and validations. READ MORE...
Gamma Irradiation Services
Have your single use system gamma irradiated before it arrives at your location and save the additional inventorying, transportation costs, and transit time.
Bagged and labeled products are picked up from AdvantaPure's facility and conveyed to a local gamma irradiation service provider. Using Cobalt 60 radiation, microorganisms and bacteria are destroyed while your single use system remains in its original packaging. Products are then returned to AdvantaPure for final inspection and shipment to your location.
A number of AdvantaPure's silicone and AdvantaFlex products, particularly those designed for single use, are available with validated sterility assurance of 10-6 per ISO 11137 method VDmax. Contact us for more information at 1-888-755-4370.
