Single-Use Filling Assemblies: Solutions and Design Considerations

With the increasingly diverse biopharmaceutical pipeline and the continuous emergence of personalized, high-demand products, traditional single-use filling solutions are facing new challenges. How to achieve flexible, efficient, and reliable filling under high standards has become a key focus across the industry.

Cobetter has launched Lifecube™ AF single-use filling assemblies. It has been successfully applied in multiple clinical and commercial filling projects. Cobetter continuously break through the boundaries of innovation, constantly optimizing and expanding the design forms of filling assemblies, and are committed to more precisely meeting your increasingly diverse and complex filling needs.

This article provides an in-depth analysis of single-use filling assembly solutions and key design considerations, supporting informed decision-making for your next pivotal project.

Design Considerations of Single-Use Filling Assemblies in Different Clean Room Environment

Single-Use Filling Assemblies IN ISO 5 Clean Room

Single-Use Filling Assemblies OUTSIDE ISO 5 Clean Room

The Composition and Design Considerations of Single-Use Filling Assemblies

The Composition of Single-Use Filling Assemblies

Bag Chamber: Standard size 5L, fully customizable

Design Consideration: minimize product holdup and residue, high recovery.

Hanging Hole: Standard 200mm hole

Multiple hole design, good compatibility, hole pitch can be customized.

Vent Filter: Optional

Balance the air pressure inside the bag during the filling process.
Protect oxygen-sensitive products by filling with nitrogen.

Inlet Connector: Cobetter Lifemeta™ AC aseptic connector

CPC AQG aseptic connector is the alternative.

Inlet Tubing

A. How to choose the size: evaluate the pumping rate based on the product properties, minimizing the occurrence of bubbles and strong vibrations as much as possible.
B. How to design the position inlet tubing: should be level with or slightly lower than the liquid level of the stable fed-batch.

Outlet Connector: 

A. Tubing ports: flexible design, lower holdup volume.

B. Boat ports: higher bottom support strength; the V-shaped vortex is easier for liquid outlet; high concentration viscosity friendly.

C. Dispenser: used for multi-branch filling; not restricted by the width of the bag chamber; can reduce the contact area between high-adsorption solvents and silicone.

Pump Tubing: Cobetter Lifemeta™ ST5P, excellent wall thickness control

We can also provide filling pump tubing of other main brands.

Filling Needle: Cobetter Lifemeta™ FCS

Filling needle can be customized, and is compatible with main-brand filling machines.

Particle Control Systematic Engineering of Single-Use Filling Assemblies

Process Control	Measures
Membrane material	Use Cobetter Topene™ blown film, which has a ultra clean inner surface, very low Leachable and Extractable
Components	Strict quality requirements for particulate matter control
Design	Inlet and venting ports are on the side, reducing the exposed area when welding
Environment	ISO Class 5 clean room, A-class clean bechtop, eliminate static electricity and reduce particle adsorption
Cleaning process	ISO Class 5 WFI flushing line
	ISO Class 5 Oven to dry, 3-layer package
Process inspection	Illuminance of the lamp inspection table 800-1000LUX + Darkroom inspection by UV

Design for Different Filling Technologies

1. (Radial) Peristaltic Pump

Advantages of Peristaltic Pump Filling

① In terms of filling weight and accuracy, it has the same performance as other forms of displacement pumps.
② Minimal product loss.
③ Filling assemblies are single-use, pre-sterilized and ready-to-use, reducing the cleaning and sterilization process. Due to the working principle of peristaltic pumps, the wear of pipelines during the filling process is unavoidable. The impact of pump tubing wear on filling stability has become one of the important considerations in the design of filling.

Thus, Cobetter conducted research on the stability of pump tubing filling. As showing in the following figure, based on the same filling parameters - 1.80mL filling volume, Cobetter Lifucube™ ST5P silicone pump tubing maintained high-precision filling stability in 3,000 cycles filling tests.

* Above data were tested by laboratory filling equipment

Single-Use Filling Solution Using Peristaltic Pumps 

2. Rotary Piston Pump

Advantages of rotary piston pump filling

• High filling accuracy, excellent stability, fast filling speed
• Suitable for small filling volumes <1 mL

However, the working principle of rotary piston pumps can induce protein aggregation, making them unsuitable for shear-sensitive products.

Single-Use Filling Solution Using Rotary Piston Pumps 

3. Linear Peristaltic Pump

The linear peristaltic pump utilizes the linear motion of multiple piezoelectric actuators to generate synchronous orthogonal displacements, producing a sinusoidal wave that reduces tangential forces. Consequently, particle shedding from the tubing is relatively minimized.

Advantages of linear peristaltic pump

• Suitable for accurately dispensing very small volumes, ranging from 12 to 450 µL 
• Ideal for applications such as ophthalmic drug filling

Single-Use Filling Solution Using Linear Peristaltic Pumps

From meeting stringent cleanliness and stability requirements to reducing product loss, as well as being flexible in responding to the diverse product characteristics, the design of Cobetter Lifecube™ AF filling bag solutions always focus on "customer value" and "technological foresight". Cobetter is committed to being your trusted partner in the final filling process.