PVC tubing has long been integral to legacy advanced therapeutic workflows that rely on clarity, flexibility, and weldability, particularly in Cell and Gene Therapy (C & GT). As expectations for material purity and consistency increase, traditional PVC is being re evaluated.
Cole-Parmer® DEHP-Free, Gamma-Stable PVC Tubing is engineered to advance what PVC can deliver—offering a modern, DEHP-free, animal-derived-ingredient-free (ADI-free) alternative designed for today’s critical fluid pathways.
Why PVC is the Standard in Cell and Gene Therapy
PVC’s widespread adoption in C & GT and other bioprocessing workflows stems from a combination of performance characteristics that are difficult to replicate:
- Reliable welding and sealing for processing closed systems and decreasing contamination risks.
- Visual clarity to monitor flow and product quality.
- Mechanical stability through pinch valves, pump heads, and routing configurations.
- Decades of qualification history to reduce validation complexity.
These advantages made PVC the material of choice for fluid transfer, media movement, and the intermediate processing steps that keep modern cell culture and expression workflows running smoothly.
Limitations of PVC Tubing in Modern C & GT
Despite its long use in bioprocessing, traditional PVC formulations present several challenges for today’s aseptic, closed system workflows and evolving regulatory expectations.
- DEHP plasticizer concerns — DEHP can migrate under certain conditions, leading to leachables and extractables concerns and introducing potential cellular interference or toxicity risks.
- Animal Derived Ingredient (ADI) challenges — Some PVC resins and additives include ADIs, increasing unpredictability and requiring additional sourcing documentation.
- Post-gamma instability — Discoloration, embrittlement, or stiffness after irradiation can compromise weld quality, pump performance, and visual inspection.
- Limited compliance and testing data — Gaps in material traceability, extractables profiles, or ADI-free declarations slow validation and limit confident integration into closed-system assemblies.
Introducing Cole-Parmer® DEHP-Free, Gamma-Stable PVC Tubing: A Purpose-Built Vinyl Material for Advanced Therapies
Cole-Parmer DEHP-Free, Gamma-Stable PVC Tubing is engineered to meet the evolving demands of cell and gene therapy processes. It provides a cleaner, more dependable alternative to conventional PVC formulations by focusing on material purity, sterilization stability, and integration in controlled processing environments.
- Engineered to elevate the performance standard for PVC tubing
Developed specifically for critical closed-system workflows, this tubing reduces the risk of material-related process variability and degradation, improving the quality of high-value biologics. - Designed with next-generation raw materials
This formulation is Animal Derived Ingredient–Free (ADIF), using a non phthalate TOTM plasticizer. This reflects a modern approach to PVC formulation, reducing leachables and supporting a pure flow path across sensitive fluid transfer operations. - Optimized for biological processing environments
This tubing withstands the routing, pumping, and handling demands of biologic processing workflows while maintaining sample integrity from single-use assemblies to aseptic transfer.
Why Cole-Parmer PVC Outperforms Standard PVC
1. DEHP Free Formulation & Reduced Leachables—Cleaner, safer, more predictable
Cole Parmer PVC tubing is formulated without DEHP and instead incorporates TOTM (tris 2 ethylhexyl trimellitate), a modern non phthalate plasticizer known for its low migration characteristics and suitability for high purity processing. This shift away from legacy phthalates reduces the overall leachable burden and aligns the tubing with stringent material quality expectations.
2. Animal Derived Ingredient–Free—Supporting biologic purity
This formulation is Animal Derived Ingredient–Free across both resin and additives, enhancing consistency and traceability. This streamlines supplier documentation and global validation while reducing contamination and immunogenicity risks.
3. Gamma Stable Formulation—Reliable performance after sterilization
This PVC tubing is engineered to retain clarity, elasticity, and weldability following gamma irradiation, reducing the risk of material degradation throughout its lifecycle. Stable post gamma properties ensure consistent performance and support sterility in closed path, single use systems.
Sterilization:
- Gamma irradiation < 45 kGy
- E-beam
- Ethylene oxide (EtO)
4. Regulatory-Ready Documentation—Meeting modern single-use expectations
From controlled resin selection through tightly managed extrusion, Cole Parmer PVC tubing is supported by comprehensive documentation and traceability. This aligns with modern single use expectations and benchmark compliance standards, enabling faster qualification and integration.
Compliance:
- Biocompatibility: USP Class VI <87>, <88>, ISO 10993-5
- Endotoxins: USP <85>
- Extractables: USP<665>
- Hemocompatibility: ISO 10993-4
- Material characterization: USP <661.1>
- Particles: USP <788><665>
5. Validated Aseptic Welding and Sealing Compatibility—Ideal for closed systems
Validated compatibility with industry standard welders and sealers enables confident closed-system assembly and seamless integration into existing processes. Consistent weld strength and seal integrity reduce contamination and minimize process requalification burden, keeping critical operations on schedule.
Essential Applications for Cole-Parmer PVC Tubing
1. Cell Culture & Expression Workflows
Cole-Parmer PVC tubing plays a vital role in transferring media, supplements, and intermediates throughout culture operations. The tubing’s clarity and weldability performance make it ideal for building closed systems that must adapt to variable batch sizes.
- Bag to bag fluid transfer
- Media preparation and distribution
- Sampling loops and inline process steps
2. Cell Harvesting, Separation & Washing
Gamma-stable PVC tubing supports critical cell processing workflows by preserving elasticity and allowing the tubing to recover its shape under pinch points, routing constraints, and pump-induced stress. Stable post gamma properties protect flow continuity and minimize performance drift across multi step separation and washing sequences.
- Effluent transfer during wash steps
- Bioreactor feed and harvest lines
3. Media, Buffer & Intermediate Fluid Transfer
- Pump-driven buffer recirculation
- Scale-up media transfer and buffer delivery
Ready-to-Use Centrifuge Tube Assemblies
Cole-Parmer has ready to use, single use centrifuge tube assemblies that incorporate Cole-Parmer DEHP-Free, Gamma-Stable PVC Tubing to provide a consistent, high purity fluid path from the point of collection through sample preparation. Available in Labcon® tube and Falcon® tube configurations, these assemblies are built for closed system integration, helping standardize processing steps while maintaining process integrity.
These assemblies support: - Small-volume collection
- Intermediate sample handling
- Transfer into downstream process steps
By pairing Cole-Parmer PVC tubing with ready-to-use assemblies, operators can streamline setup, reduce handling variability, and maintain alignment with modern single-use workflow expectations.
FAQ
1. What makes PVC tubing a popular choice for Cell & Gene Therapy processing?
PVC tubing is widely used because it is weldable, sealable, highly transparent, and mechanically stable—making it ideal for closed systems, media handling, and intermediate process steps. It also has decades of qualification history, which simplifies standardization.
2. Why is DEHP free PVC tubing preferred in modern therapeutic workflows?
DEHP free PVC tubing reduces extractables and aligns better with current global expectations for material purity. Using a DEHP free plasticizer, such as TOTM, helps ensure cleaner transfer lines and more predictable system behavior.
3. What is TOTM, and why is it used instead of DEHP in PVC tubing?
TOTM (Tris(2 ethylhexyl) trimellitate) is a non phthalate plasticizer with a significantly lower tendency to leach compared to DEHP. It supports a cleaner extractables profile and is more compatible with advanced manufacturing processes.
4. What does ADI Free or ADIF mean?
ADI-Free, or ADIF, stands for Animal Derived Ingredient Free. In tubing, this designation indicates that the resin, additives, and processing aids are free of animal derived components. Removing ADIs streamlines documentation, minimizes origin related restrictions, and supports more efficient qualification in high purity biologic workflows.
5. Why is gamma stability important when choosing PVC tubing?
Gamma irradiation is a common sterilization method for single-use assemblies. Tubing that remains clear, flexible, and weldable after irradiation ensures reliable performance ensures product integrity.
6. How does Cole-Parmer’s PVC tubing reduce extractables compared to traditional PVC tubing?
Its TOTM-based, DEHP free, ADIF formulation minimizes plasticizer migration. Combined with controlled manufacturing and traceable materials, this results in a cleaner, more predictable extractables profile.
Setting a New Benchmark for PVC Tubing in Advanced Therapies
PVC remains foundational for fluid handling in cell and gene therapy and other critical operations, yet modern processes require cleaner, more consistent materials. Choose a DEHP-free, ADI-free, gamma-stable solution engineered for weldability and compliance. Explore our Cole-Parmer DEHP-Free, Gamma-Stable PVC Tubing to learn more.
