Paratubing (Peel Apart Tubing)
Our areas of expertise include arterial drills, neurovascular applications, wound management, laparoscopic surgery, ophthalmology, and biopsy devices.
TekniPlex Healthcare is a pioneer in the field of paratubing and has the technology to tightly control the tolerances on the bond strength between tubing. Having a tight process window on the tube-to-tube bond is the key factor in limiting process risks associated with a paratube configuration.
- Validation Services
The TekniPlex Healthcare validation approach has been used to satisfy FDA validation requirements in other device components. The robust approach for validation is supported by an ISO 13485 quality system for traceability and reproducibility when moving into production. The validation incorporates operation qualification (OQ) and production qualification (PQ) to document and prove the critical parameter range for production, and then simulate production runs. The validation can be fine-tuned to customer requirements according to their risk assessment. It also incorporates measurement systems analysis to satisfy measurement capability regulations and, in addition, features current part comparisons to ensure there is no change in quality or appearance to the customer’s production floor or end users. - Tight Process Controls
There are various methods and processes for bonding tubes together that result in varying levels of product consistency. TekniPlex Healthcare is able to tightly control the peel strength consistency while also controlling the inner and outer diameter of each individual tube line.
- Customized Solutions
The individual tubes inside the paratube can be engineered and customized to exact specifications, with customization options including configurations with up to 8 tubes bonded together, colors stripes, and texture can be added so that each tube can be identified easily and quickly for accurate installation onto the device, and up to 8 different colors can be used on the same paratube design. We can also make each tube from its own unique compound engineered to accommodate the fluid, gas or suction it’s meant to deliver and the tube ends can be separated to ensure efficient and secure bonding into the connecting ports or luers. - Repeatable, Uniform Peel Consistency
Ensuring consistent and stable bond strength along with tight dimensional and concentricity specifications is a tricky process and can cause many downstream application problems when done incorrectly. TekniPlex Healthcare’s process ensures consistent ID, OD, and concentricity after tube separation.
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