Determining the exact type of tubing to be used in medical devices is a crucial decision. It involves in-depth research and understanding of the applications of different types of tubing materials for medical rubber tubes. Designers are expected to go through performance, ingredients, sterility, documentation requirements, and other relevant specifications for choosing the best medical tubing material.

Regulations are indispensable components of the medical device industry. The domain includes products and substances that affect human bodies. As per the US FDA (Food & Drug Administration), it is verified that medical devices are safe to use and operate as per the instructions of the manufacturers. Additionally, it is crucial to use the medical grade tubing which is USP Class VI compliant tubing. The Santoprene medical tubing meets these USP Class VI medical tubing requirements.

Understanding Medical Tubing

Most medical devices are available with plastic tubing for gas or liquid transfer. For the best outcomes, it is recommended to take help from reliable medical grade santoprene tubing manufacturers.

As far as medical grade tubing is concerned, the oversight of the FDA can include everything -right from individual ingredients making up the rubber or plastic compound to detailed manufacturing processes. If you are searching for the best medical grade santoprene tubing suppliers, you can opt for medical grade santoprene tubing solutions to expect the best results.

• Understand the Tubing Company: To be assured of high-quality medical grade rubber tubing or medical grade oxygen tubing, you can inquire about the production processes, quality policies, standards, and safeguards used by the manufacturing unit. It should be followed by documented work and reliable manufacturing procedures.

While your medical device might not require tubing that is manufactured in a clean setup, you should still ensure maximum uniformity and precision.

• Understand the Materials Used: Ensure that the raw materials used for manufacturing medical grade tubes deliver ample traceability with important information about the manufacturing process. There are some companies manufacturing their own products. On the other hand, there are others that purchase these products to enter into the process of tubing. Whatever might be the process, you should ensure end-to-end traceability for every ingredient in the available formulation.
• Determine the Regulatory Documentation: Analyze in detail specific regulatory compliance required for medical tubings like medical grade tygon tubing and others. Some of the instances of such regulatory documentation are USP Class VI, UL listings, and so more. You should also look into the respective Material Safety Data Sheets.

The tubing supplier delivering access to medical-grade latex tubing or others should inform about the type of documentation being provided with the product. In some cases, some testing might be required on your part by some independent laboratory.

• Ensure Ingredient Approvals and Compatibilities: You should check whether or not the medical tubing you choose is manufactured with NSF, FDA, or other leading organization-compliant regulations or ingredients. You should also inspect the tubing specifications of the supplier for receiving in-depth information. You should also be aware of unacceptable or incompatible ingredients like phthalate and others.

Read More:- Benefits of Medical Grade Santoprene Tubing In The Medical Industry

Regulatory and Safety Compliance:

Biocompatibility of raw materials

• US Pharmacopeia (USP) Class VI
• ISO 10993-1 Biocompatibility:
  • ISO 10993-5 ”Cytotoxicity”
  • ISO 10993-6 “Muscle Implantation”
  • ISO 10993-10 ”Intracutaneous Irritation”
  • ISO 10993-11 ”Acute Systemic Toxicity”

Ability to withstand sterilization with minimal degradation:

• Steam (132°C) (up to 100 repeatable sterilizations) and autoclave
• Ethylene oxide
• Gamma radiation

Clearness (Heavy metallics, Extractables)

• Carcinogenic N-nitrosamines at levels below detection limits (1ppb)
• Passed the heavy metals test USP NF and EU monograph.
• Testing for skin sensitization.
• The Drug Master File was maintained with FDA.

Supply Security and Consistency

• Manufactured at Good Manufacturing Practices (GMP) site.
• ISO 9001:2015 certified for quality management.
• Specially designed manufacturing line to ensure product consistency, with worldwide availability.

At SantopSeal, We manufacture various seals and tubing from medical grade Santoprene. Our custom medical-grade Santoprene tubes and seals are USP class VI approved, RoHS regulated, and EU 2003/11/EC compliance.

We use medical grades of Santoprene ranging from 35 shores A to 90 shore A. The material we use is a Santoprene®. it is a proprietary thermoplastic elastomer developed by ExxonMobil Corporation. According to ExxonMobil “Santoprene medical-grade meets the USP (U.S. Pharmacopeia) Class VI requirement. Additionally, some ISO 10993 tests have been conducted, each medical grade Santoprene undergoes annual testing for cytotoxicity and heavy metals, and the Drug master file is maintained with the FDA”.

At SantopSeal, we use below listed Santoprene Medical grades in our products,

• Santoprene™ 8281-35MED
• Santoprene™ 8281-45MED
• Santoprene™ 8281-55MED
• Santoprene™ 8281-65MED
• Santoprene™ 8281-75MED
• Santoprene™ 8281-90MED

Conclusion

When you make use of medical tubing from reliable medical-grade santoprene suppliers, you can be convinced of the overall quality and compatibility of the crucial medical components.

Our experts at SantopSeal Corporation are considerate about detailing and perfection in every product that we process here. Being an extruded medical-grade Santoprene tubing manufacturer, we have varied experience and knowledge over the years in rubber products.

Please discuss your requirements with us. Contact us with your details or email us at info@santopseal.com or call us at (412) 444-1888 to request your quote today and learn about our medical tubing solutions.