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.
100%
CUSTOM
UP TO 12 FILL NEEDLES
RISK MITIGATING DESIGN
SECURITY, EFFICIENCY AND REPEATABILITY
CUSTOMER-DRIVEN DESIGN PLACES YOUR DRUG FIRST
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.™
INDIVIDUAL NEEDLE FLUID LINES MINIMIZE TURBULENT INTERRUPTIONS AND PROBLEMATIC LINE SPLITTING
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.
MORE EFFICIENT FLUID TRANSFER
Fill4Sure™ allows you to aseptically port industry-leading RTP bags for the safe and efficient transfer of drug product into the filling environment.
ROBUST DRUG PRODUCT DELIVERY
Multi-position manifolds enable aseptic drug product separation into multiple fluid lines without the need for a 2D surge bag. For operations where drug product circulation is required for sustained product homogeneity, or the location of process pumps external of the filling environment a truly single-use manifold enables efficient drug product fluid paths.
EXCEPTIONAL FILLING ACCURACY
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.
SECURE MANUFACTURING
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.
APPLICATIONS
Fill4Sure™ has been used to meet the demands of even the most demanding modalities and workflows in bioprocessing, advanced therapies and custom applications.
Monoclonal Antibodies (mAbs)
Plasmid DNA (pDNA)
Viral Vectors
Gene Therapy
Full commercial, multi-needle assemblies
Clinical Trial Batch Filling
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.
- 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
- No animal-derived components
For multi-line filling without the introduction of downstream line splitting.
High-throughput, multi-needle filling with superior fluid dynamics ensures the process pumps perform optimally for accurate drug product filling.
Provide optimal fluid dynamics with a reduction in component-driven bug traps and turbulences.
Increased connection strength offers enhanced assembly integrity to ensure the drug products remain secure throughout prolonged filling operations.
Designed to integrate all tubing types to achieve specific drug product considerations and accuracy of filling.
All needles are produced without adhesives or oils for minimal particle generation.
Ensured to meet FDA and EU GMP standards through designed adherence.
Available as:
- Non-irradiated
- Gamma-irradiated to a minimum of 25 kGy
- Sterile (10⁻⁶ SAL per ANSI/AAMI/ISO11137-2)
Needles can also be customized to provide specific nozzle configurations to remediate unfavorable drug product results during filling.
FILL4SURE™ COMPONENTS
ADDITIONAL SINGLE-USE SOLUTIONS
Single-use, out-of-the-box bottle and carboy small-volume mixing platform.
Simultaneous bottle filling system for bioprocessing.
Automated roller bottle processing system for adherent cell culture stages.
GET MORE INFORMATION
We’d love to discuss how SaniSure® can streamline your operations, reduce risks, and drive growth in your drug filling capabilities.