Feature
- Ultra-clean process treatment：Full process washing with Water for Injection (WFI), precise drying in Class 100 clean oven, rigorous control of cleanliness and subvisible particulates throughout the manufacturing process
- High grade production environment：Produced in Class A laminar flow environment with Class C background, meeting the aseptic process requirements of biopharmaceuticals
- Strict quality control：Bacterial endotoxin and subvisible particulate matter levels exceed strict internal industry standards to reduce the risk of filling contamination
- Modular adaptable design：The product structure is modular and can be flexibly adapted to various commercial fill and finish equipment, with easy installation and no compatibility issues
- Full-process technical support：A professional technical team can provide an integrated service of process analysis, risk assessment, and precise product matching based on the actual formulation process of the customer
Application
- Filling processes for bulk and finished drugs in the biopharmaceutical/formulation field, compatible with various commercial single-use filling equipments.
Advantage
- Ultra-clean design with ultra-low visible particulate levels safeguards drug product quality
- Fully customizable design adapts to diverse process requirements
- DMF-filed LeKrius® film ensures an efficient, flexible supply chain, supports global drug registration and mitigates compliance risks with complete validation data
- Expert team delivers comprehensive end-to-end process assurance
Typical Design
- Dispenser design：Equipped with multi-channel structures (e.g., manifold design), it uniformly and synchronously distributes bulk liquid to multiple filling needles for high-efficiency filling
- Ship-shaped outlet design：Minimize residual liquid. By designing the outlet in a wedge-shaped/boat-shaped structure to guide the flow of the liquid, minimize the residue liquid at the outlet
- Folding design：The filling line is located at the lowest point of the bag through the “V”-shaped folding design of the bag body. The “V” fold serves to guide the flow of the liquid and reduce the fluctuation of the liquid level
- β-bag design：As a standardized transfer interface for isolators, it ensures that sterilized filling bags safely enter the isolator without breaking the aseptic barrier
Performance
LeKrius® single-use filling bags are validated via actual user data, demonstrating superior subvisible particulate control over competitors, effectively reducing the probability of visible particulate matter contamination during the filling process of bulk and formulation, ensuring formulation quality with core cleanliness metrics exceeding industry averages