Fill4Sure Custom Single-Use Filling Assemblies

Reliability by DesignHow Engineered Reliability Is Reshaping Single-Use Bioprocessing


How custom assembly design, vertical integration, and regulatory alignment are becoming one standard for single-use fluid management.

Custom assembly design, vertically integrated supply, and proactive regulatory alignment are converging into a single standard of performance for single-use bioprocessing assemblies in biopharmaceutical manufacturing – shifting reliability from something you verify after the fact to something engineered in from the start.

Mixed4Sure™ enables continuous mixing at all process volumes from 50 mL — 20 L. It also maintains mixing and fluid homogeneity during offload down to 50ml, which ensures the consistency of your drug is maintained down to the last drop. In downstream mixing steps, shear forces can have undesirable effects on your sensitive protein, such as degradation and aggregate formation. Mixed4Sure™ has been shown to create only ½ the shear forces of a comparable mixing system, and a magnitude of 4 lower than the forces leading to protein degradation.

FOR IMMEDIATE RELEASE

April 1, 2026SaniSure Launches PETG PharmaTainer™:
Cleaner by Design, Bioprocessing Bottles & Carboys Industry-standard PETG material meets industry-leading cleanliness, compliance, and RNase/DNase-free validation — now available for the full bioprocessing workflow.

Modernize vaccine and viral vector manufacturing with automated roller bottle processing that reduces contamination risk while meeting FDA and EU regulatory requirements.

10x simultaneous aliquoting solution streamlines up & downstream bioprocessing applications, media or buffer preparations, sampling, and drug substance filling. 
+/- 3% ACCURACY FOR PRECISION FILLING High-accuracy simultaneous bottle-filling in volumes ranging from 125 mL to 2 L, reduces hold-up volume and lowers your drug manufacturing footprint.


ONLY 1 VENT FILTER TO TEST We significantly reduce the effort and time required for vent filter integrity testing, minimizing this effort by a factor of 10 with our One Vent Hub solution.

RELIABLE AND SECUREUsing our PharmaTainer™ bottles ensures super clean processing. Our drop test-proven PharmaTainer is exceptionally strong and oustandigly clean: <1.7 % of the USP 788 limits with 0 detectable endotoxins.

This white paper explores critical contamination control strategies and advanced containment solutions to protect sensitive mRNA and gene therapies in GMP biopharmaceutical manufacturing environments.

Draw up to 10 samples with a single connection using configurable assemblies with a variety of container types and combinations.

Analytical Method Specific Containers

A wide range and mix of sampling containers means every sample is in the right container for the analytical method. Each assembly can be configured based on the specific unit operations’ sampling needs. 

Easy to Use

One2Sample manifolds and trays offer superior ease of use for drawing up to 10 samples with a single sterile connection. A wide range and mix of sampling containers reduces sample handling and preparation prior to analysis. Simplified handling reduces opportunities for sampling errors.

Comprehensive TR-1092 study demonstrates ClearGreen®Pure outperforms leading PVC competitors in weld integrity, burst pressure, and particulate cleanliness for commercial cell therapy manufacturing.

RNase/DNase-free PETG bottles and carboys with ultra-low particulate and endotoxin specifications for sensitive biologics and advanced modalities.

PETG PharmaTainer is a platform of ready-to-use, square PETG bottles and carboys that combine exceptional cleanliness, 10-6 sterility assurance, and comprehensive regulatory documentation for sampling, shipping, storage, and processing of biomanufacturing fluids from lab through commercial manufacturing.

The PETG PharmaTainer family mirrors the standard PharmaTainer platform but is optimized for PETG applications, enabling one-to-one replacement of incumbent PETG bottles with enhanced cleanliness and validation.

Discover how SaniSure delivered 70 custom assemblies in half the standard lead time, supporting vital viral vector manufacturing for a leading CDMO.

The RC-40 is a roller bottle cell culture system that fully automates all adherent cell culture stages-from inoculation, incubation, and media change.

Modernize vaccine and viral vector manufacturing with automated roller bottle processing that reduces contamination risk while meeting FDA and EU regulatory requirements.

As regulators and clients demand higher quality, faster timelines, and lower contamination risk, organizations relying on manual roller bottle processes face increasing pressure to modernize. Closed-system automation like the RC-40™ bridges the gap—offering a compliant, scalable solution without abandoning validated processes.

Download the GMP Compliance Checklist to benchmark your roller bottle operations and identify opportunities for improvement. Or, contact our technical team to explore how RC‑40 can address your specific compliance and efficiency challenges.

Gamma-irradiated 10 L PharmaTainer™ bottles were filled to nominal volume and frozen to -80°C for 2 days. The bottles were then dropped two times in a row onto a flat concrete surface from a height of 110cm.

After the contents were thawed, leak tests were performed on the sides, base, and closure. All bottles passed the drop test with only minor scratches!

This white paper reviews a comprehensive TR-1092 study, demonstrating that ClearGreen®Pure outperforms leading PVC competitors in weld integrity, burst pressure, and particulate cleanliness for commercial cell therapy manufacturing.

The rapid advancement of cell and gene therapies, particularly mRNA-based therapeutics, has created an unprecedented demand for nuclease-free manufacturing environments. Even trace amounts of DNase or RNase contamination can compromise critical materials and undermine therapeutic outcomes. 

Through detailed analysis of container manufacturing processes, rigorous enzymatic testing protocols, and extensive validation procedures, the paper demonstrates how advanced technologies like PharmaTainer™ establish new standards for contamination control in GMP environments. The comprehensive analysis spans innovative manufacturing technologies and validation protocols essential for maintaining nuclease-free conditions across manufacturing scales from 10 mL to 20 L, particularly benefiting mRNA vaccine and gene therapy applications. This technical resource provides biopharma manufacturers with crucial insights into maintaining product integrity through adv...

Challenges of the freezing processIn biopharmaceutical manufacturing, it is common to bulk-freeze biological drug substance (DS), with target storage temperatures ranging from -20℃ to below -65℃. These temperatures offer a number of benefits – they can stabilize the DS long-term, helping to maximize its shelf life, allowing for bulk storage until needed. Freezing can also help minimize the risk of potential microbial growth in bioburden-controlled DS, as well as circumvent cumulative stability of DS and drug product (DP).Th...

In biologics production, mixing operations are crucial for maintaining fluid homogeneity. However, shear stress during mixing can affect protein stability and quality attributes. Understanding how mixer design and process parameters influence shear force generation is essential for product integrity. Computational Fluid Dynamic (CFD) modeling during product development demonstrated that the Mixed4Sure™ Bottom Mount impeller design outperformed traditional stir bars. Subsequent laboratory evaluation using lysozyme as a protein model confirmed these findings. This session will highlight the importance of innovative mixer designs in optimizing protein formulation processes that will help you maintain product quality. During the session, the following key takeaways will be discussed: CFD modeling revealed superior mixing performance of the new impeller geometry Laboratory studies validated the CFD predictions The Mixed4Sure™ Bottom Mount demonstrated lower shear stress compared to conventional stir bars, indicating improved mixing performance in shear sensitive process steps.