Purillex® 2D Bag Assemblies
Frequently Asked Questions (FAQs)
Frequently Asked Questions (FAQ)
What are Purillex® 2D Bag Assemblies used for?
Purillex® 2D Bag Assemblies are single-use bioprocess bags designed for sterile fluid handling, storage, and transfer in upstream, downstream, fill/finish, research, and analytical workflows. Typical applications include buffer and media preparation, bioreactor feed and harvest, intermediate product hold, chromatography feed, sampling, and final product transfer.
What sizes are available for Purillex 2D bioprocess bags?
Purillex 2D Bag Assemblies are available in volumes ranging from 25 mL to 50 L as standard configurations. Custom sizes and 3D bag formats up to 200 L are available upon request.
Are Purillex 2D Bag Assemblies sterilized?
Yes. Purillex 2D Bag Assemblies are sterilized using validated e-beam or gamma irradiation (up to 50 kGy depending on tubing selection) in accordance with ISO 11137 standards. Sterilization methods are selected to preserve material integrity and product compatibility.
Do Purillex 2D Bag Assemblies undergo leak testing?
Yes. Every assembly undergoes 100% seal-integrity testing using Z-Axis Z8 high-sensitivity air leak detection equipment. Testing verifies chamber weld integrity, port seals, and tubing-to-connector interfaces prior to release to ensure leak-free performance.
What regulatory standards do Purillex 2D Bag Assemblies support?
Purillex 2D Bag Assemblies support compliance with:
- USP <661> Plastic Packaging Systems
- USP <665> Plastic Components Used in Drug Manufacturing
- USP <788> Particulate Matter in Injections
- ISO 11137 Sterilization of Healthcare Products
Certificates of Conformance and extractables data packages are available upon request.
What material are Purillex 2D Bags made from?
Purillex 2D Bags are constructed from Renolit 9101, a five-layer medical-grade polyethylene/EVOH film. This multilayer structure includes ULDPE inner and outer layers with an EVOH barrier for oxygen and moisture protection, 97% clarity, low extractables, and durability at temperatures below –45 °C.
What tubing options are available?
Available tubing materials include:
- AdvantaFlex® TPE (weldable)
- AdvantaSil® silicone
- Additional tubing options upon request
Custom tubing lengths are also available.
What connector types are supported?
Purillex 2D Bag Assemblies offer vendor-agnostic connector compatibility, including:
- MPC
- MPX
- Luer (male and female)
- AseptiQuik® G
- Sanitary tri-clamp
- Customer-specified connectors
This flexibility allows seamless integration into existing bioprocess systems.
How do Purillex 2D Bags improve product recovery?
Purillex 2D Bags feature a Marlex® 9006 polyethylene canoe port and a tapered-edge chamber design that reduce hold-up volume and improve fluid evacuation. This design helps maximize valuable product recovery during critical manufacturing steps.
Where are Purillex 2D Bag Assemblies manufactured?
Purillex 2D Bag Assemblies are manufactured in the United States under an ISO 9001-certified quality system within a Class IV cleanroom environment to ensure traceability, cleanliness, and consistent performance.
Are extractables data and documentation available?
Yes. Certificates of Conformance (CoC) and extractables data packages are available upon request to support regulatory filings and validation requirements.
How do Purillex® 2D Bag Assemblies differ from standard 2D single-use bags?
While many 2D single-use bags focus primarily on containment, Purillex 2D Bag Assemblies are engineered for maximum product recovery, validated seal integrity, and flexible system integration.
Key differences include:
- Canoe port design to improve drainability
- Tapered-edge chamber geometry to reduce hold-up volume
- 100% seal-integrity testing on every assembly
- Over 80 off-the-shelf configurations
- Vendor-agnostic connector compatibility
These features help minimize product loss, reduce risk, and improve process flexibility.
What is the difference between 2D and 3D bioprocess bags?
2D bioprocess bags are flat, pillow-style single-use bags typically used for storage, sampling, and fluid transfer in small to mid-scale workflows.
3D bioprocess bags are designed to fit into rigid containers or totes and are often used for larger volume mixing or bulk storage.
Purillex offers:
- 2D bags from 25 mL to 50 L
- Custom 3D bag formats up to 200 L upon request
The choice depends on your required volume, handling method, and process configuration.
How do Purillex 2D Bags compare in drainability?
Standard 2D bags can leave residual hold-up volume due to port placement and flat weld geometry.
Purillex 2D Bag Assemblies incorporate:
- A Marlex® 9006 polyethylene canoe port
- Tapered-edge chamber design
This combination enhances fluid evacuation and helps maximize recovery of valuable product during upstream and downstream operations.
Do all single-use bag manufacturers perform 100% leak testing?
Not all manufacturers perform seal-integrity testing on every individual assembly.
Purillex 2D Bag Assemblies undergo 100% seal-integrity testing using Z-Axis Z8 high-sensitivity air leak detection equipment to verify:
- Chamber weld integrity
- Port seals
- Tubing-to-connector interfaces
This level of testing helps reduce the risk of leaks, contamination events, and batch loss.
How do Purillex 2D Bags compare in customization flexibility?
Many single-use bag suppliers require long lead times for custom builds.
Purillex provides:
- Over 80 off-the-shelf configuration combinations
- Multiple tubing and connector options
- Vendor-agnostic integration
- Custom 3D formats and expanded volumes available upon request
This allows teams to scale and adapt without extended custom development timelines.
How do Purillex 2D Bag Assemblies compare in regulatory support?
Purillex 2D Bag Assemblies support compliance with:
- USP <661>
- USP <665>
- USP <788>
- ISO 11137 sterilization standards
Manufacturing occurs under an ISO 9001-certified quality system in a Class IV cleanroom. Documentation packages, including Certificates of Conformance and extractables data, are available upon request to support validation and regulatory submissions.
Are Purillex 2D Bags compatible with existing bioprocess systems?
Yes. Purillex 2D Bag Assemblies are designed for vendor-agnostic integration, offering compatibility with commonly used connectors such as:
- MPC
- MPX
- Luer
- AseptiQuik® G
- Sanitary tri-clamp
This enables seamless integration into existing sterile fluid handling systems.
When should you choose a premium 2D bag assembly over a standard bag?
A premium 2D bag assembly may be appropriate when:
- Product value is high and minimizing hold-up volume is critical
- Process validation requires strong documentation support
- Leak prevention is essential to protect batch integrity
- Flexible connector configurations are needed
- Scaling from development to production is anticipated
Purillex 2D Bag Assemblies are designed to support these higher-performance requirements.