Satorius Single Use Fexsafe Bioprocess Bags

Single-Use Bioprocess Bags

Single-use bio process bags for the preparation, storage and transport of biopharmaceutical solutions, intermediates and final bulk products. Also available is a complete range of aseptic transfer bags for the aseptic transfer of components into clean rooms, isolators or RABS and for contained transfer of potent powders. Single-use bio process bags from Sartorius Stedim Biotech provide a disposable alternative to traditional glass, stainless steel and rigid plastic carboys.

Flexel® Bags

The Flexel® bag range is designed for processing, storage, mixing and transportation of small- to large- volume biopharmaceutical solutions in our proven Palletank® containers. They are a single-use alternative to stainless steel vessels for many applications. Flexel®bags enhance process reliability as they reduce the risk of cross-contamination from batch to batch and from product to product. They eliminate the time and expense of CIP & SIP operations, thus optimizing your capacity utilization.

Flexsafe® Bags

The variety of Flexsafe^® bag sizes accommodates all bioprocessing applications. These single-use products made of our new S80 polyethylene film feature:

Excellent and reproducible cell growth
Consistent product quality; outstanding robustness
Complete assurance of supply all the way from resin, to film extrusion, to final bag assembly
Robust change management and proven business continuity plan

Consistent, reproducible extractables and leachables profile

Flexboy® 2D Bags

Flexboy® 2D Bags are available in bag chamber volumes between 5 mL and 50 L. They are supplied sterile and ready to use for an easy and convenient process implementation. The versatile range of Flexboy® Pre-Designed Solutions (PDS) allows for sterile filtration, storage and transfer of all biopharmaceutical fluids. Multiple configurations are provided for flexible incorporation in all process steps and are qualified against extensive biological, chemical,physical, extractable and cell growth testing.

MYCAP® Bottle Closures

Enhancing Aseptic Fluid Transfer in Bottles

MYCAP® closures are a one-piece, ready-to-use and single-use aseptic fluid transfer system for bottles.

Select from a diverse range of standard configurations purposefully designed for common applications. Or, capitalize on the generous design freedom and ever-expanding range of bottles to configure MYCAP® to your application specification.

Remarkably, the robust platinum-cured silicone seal never changes from design to design, despite the range of capabilities. MYCAP® is the first truly universal closure system.

MYCAP® expands capabilities, removes uncertainty and eases validation.

Available on Glass and all popular Plastic Bottles, Centrifuge Tubes and Containers
One-for-All Silicone Closure for Consistency from Drug Development to Final Filling
High Performance Closure Preserves Aseptic Processes
Highly Configurable to Meet Your Process Requirements

Ready-To-Use and Single-Use Prevents Contamination

Tubing | Dis-/Connectors

Process transfer systems & connectors for fast and reliable sterile connections | disconnections and sterile fluid transfer between two separate, pre-sterilised components in biopharmaceutical process operations.

Ready to use TuFlux® Transfer Sets

Ready to use TuFlux® Transfer Sets create process flexibility and guarantee safe and reliable transfers for all your fluids in all your process steps. Select your solution and benefit of the best assurance of quality and supply. All tubing and components are characterized and validated for their specific process conditions. We guarantee the best lead time and robust change control with at least 24 months of change notification at any time when selecting a standard solution.

Sterile Tubing Connectors

The sterile tube connectors are available as fully automated devices or as single use sterile connectors. Single-use sterile connectors allow fast and reliable connections between two process components in a sterile or non sterile environment. The fully automated devices enable connecting thermoplastic tubing, such as C-Flex®, Sanipure® and Pharmed®, in a sterile welding operation.

Sterile Tubing Disconnectors

The sterile tube disconnectors are available as a fully automated device with the BioSealer® or as single-use sterile disconnectors with the Clipster® aseptic disconnector. The single-use sterile disconnectors allow fast and safe disconnections of a transfer line made of silicone or thermoplastic tubing, in a sterile or non-sterile environment. The fully automated device enables disconnecting thermoplastic tubing, such as C-Flex®, Sanipure® and Pharmed®.

Tubing

Sartorius Stedim Biotech TuFlux SIL is a highly resistant platinum cured silicone tubing designed to facilitate fluid transfer in many pharmaceutical and biopharmaceutical applications such as media and buffer processing, filtration, fermentation and cell harvest.

TAKEONE® Aseptic Sampling System

Quick, Accurate, Reliable and Safe

Soft Parts Life Cycle

Soft Parts, also known as reusable parts, are components used on multiple batches in a production process. Reuseable parts present a risk of bioburden contamination which can be due to improper cleaning, improper assembly, damaged or worn parts and other reasons.

Regulatory Agencies demand a risk assessment on all equipment including validation of the number of uses, number of cleaning | sanitization cycles and a program to monitor and control the life cycle of equipment before replacement.

Security in Simplicity

The TAKEONE® is the first Pre-Assembled Aseptic Sampling device and is fully single-use. The inherent simplicity of the TAKEONE® removes risks of other sampling systems with complex life-cycles. Production processes with TAKEONE® are clean, simple and robust.

The pre-assembled and single-use TAKEONE® eliminates risk, reduces costs and saves time. TAKEONE® is the preferred aseptic sampling device for an effective microbial control and monitoring program.