Fill4Sure single-use filling assembly with blue-tinted fill lines running to a row of filling needles.

Fill4Sure™

Custom Single-Use Filling Assemblies

Designed entirely around your drug product, Fill4Sure is a completely bespoke, single-use filling assembly that optimizes aseptic drug product filling and delivery while ensuring maximum efficiency and reliability.

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100% Custom
Dedicated Fill Lines
Risk-Mitigating Design
ISO Class 7 Cleanroom
100% In-Line Inspection

See How Fill4Sure Works

Questions about your fill-finish setup?

Connect with our team to discuss your application, requirements, and how Fill4Sure can support your fill-finish success.

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Fill4Sure Custom Single-Use Filling Assemblies: dedicated fill lines, custom needle engineering, RTU format.

Key Capabilities

Security, Efficiency, and Repeatability

Dedicated Fill Lines for Every Needle

Dedicated fill lines for each needle eliminate the need to perform line splitting, minimizing the risk of fluid-path bottlenecks, cavitation for sensitive drug products, and structural weak points in assembly integrity.

Aseptic RTP Transfer Into the Filling Environment

Fill4Sure allows you to aseptically port industry-leading RTP bags for the safe and efficient transfer of drug product into the filling environment.

Tubing Matched to Your Drug Product

With a diverse and precision-focused portfolio of tubing, Fill4Sure can integrate all tubing types to achieve specific drug product considerations and accuracy of filling.

Designed Around Your Drug Product’s Characteristics

Fill4Sure assemblies are designed entirely around and specifically for your drug’s chemical and physical product characteristics, ensuring your product gets The Best Home a Drug Can Get.™

ISO Class 7 Manufacture, 100% In-Line Inspection

All our assemblies are manufactured in an ISO Class 7 cleanroom with 100% in-line inspection, with tailored validation packages to fit your regulatory requirements.

Fill4Sure single-use filling assembly: a 2D bag with dedicated fill lines running to individual filling needles.

A Closer Look

Clear fill lines leaving the base of a filled 2D bag in a single row, each marked with a different colored band.
Dedicated Fill Lines
A filling needle joined to its tubing at a molded hub, with a green band at the connection.
Needle and Tubing Junction
Applications

What Filling Applications Does Fill4Sure Support?

Learn More About Applications
Biopharma Processes
  • mRNA Manufacturing
  • Monoclonal Antibodies (mAbs)
  • Plasmid DNA (pDNA)
  • Viral Vectors
Advanced Therapies
  • Cell Therapy
  • Gene Therapy
Custom Applications
  • Small, bench-top single-needle filling setups
  • Full commercial, multi-needle assemblies
  • Clinical trial batch filling
Assembly Design

Designed by Bioprocess Engineers, for Bioprocess Engineers

Sterile-Validated Components

Build your Fill4Sure drug product filling assemblies from a wide range of industry-leading components with our sterile-validated library.

Custom Ported RTP Bags

Maximize large-batch filling while retaining a Grade A filling environment with a number of custom RTP bag porting options.

Expert Consultative Support

Create a secure and fully optimized drug product filling assembly with SaniSure’s industry-leading engineering team to remove bottlenecks, increase output, and reduce risk.

Hotspot Background
Flexible 2D Bag Systems
  • Multi-layer structure with inert PE fluid contact layer offers very low extractables and leachables
  • Highly transparent film materials for enhanced visual inspection of process fluids
  • Available with and without bag vent port
Surge Bags Customized for 1–12 Filling Ports

For multi-line filling without the introduction of downstream line splitting.

Independent Fill Lines

High-throughput, multi-needle filling with superior fluid dynamics ensures the process pumps perform optimally for accurate drug product filling.

Silicone Overmolded Tubing Connections

Provide optimal fluid dynamics with a reduction in component-driven bug traps and turbulence.

Increased connection strength offers enhanced assembly integrity to ensure the drug products remain secure throughout prolonged filling operations.

Precision Peristaltic Tubing

Designed to integrate all tubing types to achieve specific drug product considerations and accuracy of filling.

Genuine OEM Replacement & Custom Single-Use Filling Needles

All needles are produced without adhesives or oils for minimal particle generation.

Designed to meet FDA and EU GMP standards.

Available as:

  • Non-irradiated
  • Gamma-irradiated to a minimum of 25 kGy
  • Sterile (SAL 10-6 per ANSI/AAMI/ISO 11137-2)

Needles can also be customized to provide specific nozzle configurations to remediate unfavorable drug product results during filling.

Component Lines

Fill4Sure
Components

Explore the SaniSure component lines every Fill4Sure assembly is built from.

Coil of clear single-use tubing.

Diversified Tubing Portfolio

Precision peristaltic tubing and silicone overmolded connections, matched to your drug product and fill accuracy. Explore tubing Single-use filling needles in a range of OEM replacement and custom nozzle configurations.

OEM & Custom Single-Use Filling Needles

Genuine OEM replacement and custom needles, made without adhesives or oils for minimal particle generation. Explore needles Single-use transfer assembly: tubing with inline connectors and clamps.

Transfer & Filter Assemblies

Single-use transfer and filtration sets for moving drug product into the filling environment. Explore assemblies
Frequently Asked Questions

Questions We Hear from Fill-Finish Teams

For anything not covered here, our filling specialists are a message away.

What is line splitting, and why does it matter in aseptic filling?

Line splitting is the practice of bringing drug product into a filling assembly on one line and dividing it downstream so that one branch feeds each needle. It matters because each split introduces the risk of fluid path bottlenecks, cavitation for sensitive drug products, and structural weak points in assembly integrity. Fill4Sure uses dedicated fill lines for each needle, which eliminates the need to perform line splitting.

How are Fill4Sure assemblies sterilized?

Fill4Sure assemblies are available as both gamma-sterilized and autoclavable to provide agility to end-users based on drug product modality.

Assemblies and needles are available non-irradiated, gamma-irradiated to a minimum of 25 kGy, or sterile to SAL 10-6 per ANSI/AAMI/ISO 11137-2.

Where are Fill4Sure assemblies manufactured?

All Fill4Sure assemblies are manufactured in an ISO Class 7 cleanroom with 100% in-line inspection, with tailored validation packages to fit your regulatory requirements.

Can Fill4Sure be used for bench-top and clinical batch filling as well as commercial scale?

Yes. Fill4Sure has been used for small, bench-top single-needle filling setups, for clinical trial batch filling, and for full commercial multi-needle assemblies.

Can filling needles be customized for a specific drug product?

Yes. Needles can be customized to provide specific nozzle configurations to remediate unfavorable drug product results during filling. All needles are produced without adhesives or oils for minimal particle generation, and are designed to meet FDA and EU GMP standards.

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Get More Information

We’d love to discuss how SaniSure can streamline your operations, reduce risks, and drive growth in your drug filling capabilities.

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