Definitive Guide To Choosing The Best Santoprene Medical Grade Tubing

1
Definitive Guide To Choosing The Best Medical
Tubing
2

• 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.

3

• 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.
• Regulatory and Safety Compliance
• 1.) 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

4

• 2.) Ability to withstand sterilization with
  minimal degradation
• Steam (132C) (up to 100 repeatable
  sterilizations) and autoclave
• Ethylene oxide
• Gamma radiation
• 3.) 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.
• 4.) Supply Security and Consistency
• Manufactured at Good Manufacturing Practices
  (GMP) site.
• ISO 90012015 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.

5

• 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

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_at_santopseal.com or call us at [phone]
to request your quote today and learn about our
medical tubing solutions.