Valbiopure
ValBiopure Single-Use Systems Bag.
Flexible, Reliable, Customizable
2D – 3D bag up to 3000 L
Manufactured in ISO 7 Cleanroom using high‑quality Renolit Infuflex® 9101 film (PE, EVOH) and Granuflex® 4301 ports (PE). Designed for safe storage and transport of fluids, fitting market‑leading totes, with strong customization options and 100% leak‑tested.
Flexible customization of sizes, tubings, joints, and filters for a variety of biopharmaceutical processes
Validation and Quality Assurance
- Manufactured in ISO 7 cleanroomISO 14644
- Quality system in according to ISO 3485
- Suitable for Gamma irradiation
- 100% 2D bags leak test.
Coming soon: 3D bags leak test - The materials which compose the ValBioPure bags comply with:
1. Biocompatibility requirements
(USP class VI and ISO10993)
2. REACH regulation and free
from animal derivates
3. Physico-chemical
test requirements fo
pharmaceutical containers (Ph.
Eur. 3.1 / USP <661.1>–<661.2>)
- The materials which compose the Biopure bags comply with:
- Endotoxin USP 85 / Ph. Eur. 2.6.14
- Biological reactivity test USP <87> / <88> (USP Class VI)
- Plastics USP 661.1
- Biocompatibility Tests ISO 10993-4/5/6/10/11
- Qualification studies ongoing:
- Extractable Study (USP 1665, USP 665 / BPOG Guidance)
- Physico-chemical material properties and Chemical compatibility chart
- Validation tests including:
- Mechanical Tests
- Connection Integrity Test
- Gamma Sterilization, Filling and Transport Resistance
- Resistance to Freezing Test up to -80°C
- Physicochemical Testing (USP <661.2>, Ph. Eur. 2.6.14, USP <788> and USP <790>)
- Shelf-Life Evaluation (Ongoing – accelerated testing – 40°C, 75% RH and real-time testing – 25°C, 60% RH)
Renolit Granuflex 4301:
PE port specifications
- Valmed brand-owned mold design
- High-precision injection molding technique
- The selected PE granule demonstrates lower leachable levels and high purity
- Strong uniformity and compatibility with film
- Customizable configuration including port arrangement, number and diameters
Renolit Infuflex 9101:
PE film specifications
- Made with five-layer coextruded film with a total thickness of 0.325mm and PE fluid contact layer
- The barrier film is made of ultra-pure inert PE inner and outer layers
- The high barrier properties combined with the oxygen barrier layer (EVOH) offer significant advantages in oxygen-sensitive products storage
- The selected film demonstrates ultra-low extractables and leachables level and excellent clarity
Discover the Valbiopure models
Flexible, Reliable, Customizable
Beyond Standard: Custom Designs Available
Our engineering process enables complete tailoring of bag geometry, assembly configuration, materials selection, and component integration to meet specific process requirements. Each solution is designed through a controlled process that integrates material expertise, precision tooling, and validated manufacturing methods.
Technical strengths
Extended Expertise in Custom Medical Devices
Our background in engineered medical components provides a robust foundation for developing customized SUS designs with attention to quality and physical performance.
Dedicated In House Tooling
Tooling for tailor-made bag shapes, is fully developed internally. This ensures precision, reproducibility, and short lead times during design iteration.
Flexible Manufacturing Assets
The integration of automated equipment with configurable manual workstations provides high adaptability for prototypes, small runs, and preseries production.
Example Custom Design
Pillow 2D bag
| Capacity | Up to 200 L |
| Film | Infuflex® 9101 |
| Ports | Granuflex® 4301; single-port or multi-port configuration |
| Sensors | Sensor integration available |
| Fixation | Rigid tubing for secure fixing |
| Tubing assembly | Customizable tubing assemblies |
| Filtration | Compatible with inline / dedicated filters |
Bag Assemblies
The bag chamber can be completed with tubing and end components according to the customer’s specifications.
Valmed performs the entire assembly process in-house within its ISO 7 cleanroom, without involving external subcontractors. This minimizes handling, reduces lead times, and ensures a controlled and streamlined workflow.
Variety of component selection:
- Tubing: TPE or silicone
- Connectors and disconnectors
- Fittings
- Pinch clamps
- Filters
- Sensors
- Customer specific request
Example of bag assemblies
We offer fully customized assemblies, enabling customers to leverage components and configurations they have already validated, or to integrate new tailored solutions.
Get in touch with the team
Our technical department is available to research and study flexible and innovative products in collaboration with the customer.