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Final Sterile Filtration

There are multiple devices that appears to be used for sterile filtration.

Sterile filtration of drug products is a critical step in ensuring product sterility and drug safety for patients. Manufacturers must focus on ensuring sterility and maximizing product recovery, while meeting regulatory requirements. The design of an effective filtration system considers multiple filter options and process requirements, including the number of sterilizing filters, sampling needs, and whether pre-use post-sterilization integrity testing (PUPSIT) will be performed.   

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Two technicians in a sterile environment are operating a Mobius 2D and 3D single-use assembly system. They are dressed in full protective cleanroom suits, complete with hoods and masks, ensuring a contamination-free process.
Single-Use Assemblies

Mobius® 2D and 3D single-use assemblies and systems for sterile fluid management offer flexible manufacturing options for biopharmaceutical companies, from media and buffer preparation to final fill applications.

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Lab technician connecting a 2D bag assembly on a Mobius® container cart to a Mobius® mixer
Connection/Disconnection for Bioprocessing

Sterilized fluid transfer systems containing tubing, connectors, clamps, valves, and disconnectors provide a critical link between disposable fluid paths and the various steps in your aseptic process, whether that is plastic-to-stainless or plastic-to-plastic.

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A female scientist wearing protective goggles holds up a sterile drug product
Sterile Filters

Sterile filtration with disposable filters is a common operation in bioprocessing and part of every bioburden control strategy. Sterile filtration assures microbial safety of the drug for patients. Learn how to select the best sterilizing filter for your process step.

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Family shot of NovaSeptum® GO sterile sampling systems connector offerings and security tag, including TC Connector, Ingold® Connector, In-Line Butt End TC Connector, In-Line TC Connector.
Sterile Sampling

A closed sterile sampling method is increasingly preferred by regulatory authorities over traditional sampling methods, such as glass bottles or steam-in-place (SIP) stainless steel valves. The NovaSeptum® GO sterile sampling system is designed to provide you with the flexibility and safety you need when sampling at any point in your aseptic or sterile biomanufacturing process.

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Single-use Assemblies for Final Aseptic Filtration and Fill-Finish Operations

Single-use systems are increasingly being adopted into fill-finish processes to meet today's complex drug production demands. Single-use assemblies deliver improved process flexibility and productivity, increase operator and product safety, and reduce validation requirements and process turnaround time. These systems integrate multiple single-use components, including SU beta bags, sterile connectors, sterile filters, header bags, pump tubing, and filling needles, to create an optimized final filtration and filling system that is tailored to meet specific process needs. 

Benefits of implementing a single-use assembly into the final sterile filtration and filling process include:

  • Improved safety, efficiency, and productivity
  • Reduced cleaning, set-up and validation
  • Decreased risk of cross-contamination
  • Minimization of bottlenecks on the filling line

For optimal results, manufacturers can collaborate with single-use experts on the design of custom assemblies. An experienced partner can seamlessly integrate the right single-use solution into the final filtration and filling process, while leveraging the benefits of existing infrastructure. 

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