Description of the Material Used in Medical Flexible Hoses
We utilize platinum-cured silicone to create our medical-grade silicone hoses since it is the best type for medical and pharmaceutical use.
The main benefits of the material are:
Biocompatibility:
Platinum-cured silicone is exceptionally biocompatible, thus it's safe to contact medicines and bodily fluids.
High Purity:
There are no peroxide residues or other harmful by-products in the material, so there is no risk of contamination when moving fluids.
Few leachables and extractables:
Made to restrict chemicals from moving about, so that the media that is transferred stays clean and unharmed.
No smell and no chemicals that could hurt you:
Good for sensitive uses where even a little bit of contamination is not okay.
Transparency:
The clear shape makes it easy to see how the fluid moves, which improves process control and safety.
Platinum-cured silicone is cleaner, lasts longer, and is better able to handle repeated sterilization cycles than peroxide-cured silicone.
Ability to Sterilize
It is very crucial for medical and pharmaceutical tubing to be able to be sterilized well. Our Sterile Transfer Hose can be used with a lot of various sterilization methods without losing its strength or efficacy.
Ways to Sterilize That Are Supported:
Sterilization with an autoclave (steam) takes place at 121°C / 134°C.
Cycle Capability: More than 100 cycles without any damage
Keeps its flexibility and strength even after being used a lot.
Gamma rays:
Good for systems that are only used once or programs that have already been cleaned
Ethylene Oxide (ETO):
Works with delicate settings that need to be sterilized at low temperatures
After being cleaned, performance:
No cracking, hardening, or altering color.
It stays flexible and clear.
Stable chemical and physical properties
This makes sure that the system is reliable for a long time and cuts down on the need for regular replacements, which lowers costs.
Performance Data
|
Property |
Typical Value |
|
Material Type |
Platinum-cured silicone |
|
Hardness |
50–70 Shore A |
|
Tensile Strength |
≥ 8 MPa |
|
Elongation at Break |
≥ 400% |
|
Temperature Range |
-60°C to +200°C |
|
Sterilization Resistance |
100+ autoclave cycles |
|
Transparency |
High (visual flow monitoring) |
|
Extractables |
Extremely low |
|
Biocompatibility |
USP Class VI / ISO 10993 compliant |
Biopharmaceutical Process Hose File Support & Documentation
We offer full documentation support to suit the rigorous regulatory and validation needs of the medical and pharmaceutical industries:
There are Biopharmaceutical Process Hose Documents that you can get:
COA stands for Certificate of Analysis.
We check the quality and compliance of every batch.
MSDS: Material Safety Data Sheet
Full details about the composition, handling, and safety of the substance.
Biocompatibility Reports:
Following the rules specified by USP VI and ISO 10993 is one of these.
Documents for FDA Compliance:
When food and medical supplies touch, check for safety.
Traceability of Lots:
Full traceability from raw ingredients to finished goods, which makes sure that people are responsible and ready for audits.
Help with Validation:
Help with the validation steps that biotech and pharmaceutical businesses need to do.
With this level of documentation, audits and regulatory inspections will go smoothly.
FAQ
Q: What makes your silicone hoses truly "medical grade"?
A: Our hoses are manufactured using platinum-cured silicone and comply with stringent standards such as USP Class VI and ISO 10993. They are biocompatible, non-toxic, and suitable for contact with pharmaceutical fluids and medical applications.
Q: Can the hoses withstand repeated sterilization?
A: Yes, our medical grade silicone hoses are designed for repeated sterilization. They can endure 100+ autoclave cycles at 121°C or 134°C without cracking, hardening, or losing flexibility. They are also compatible with Gamma and ETO sterilization methods.
Q: Do the hoses release any substances that could contaminate fluids?
A: No. Our hoses feature extremely low extractables and leachables, ensuring that there is no contamination or impact on the purity of transferred liquids. This makes them ideal for sensitive pharmaceutical and biotech processes.
Q: What documentation do you provide for validation and compliance?
A: We provide a full set of documentation, including COA (Certificate of Analysis), MSDS, FDA compliance statements, biocompatibility reports (USP Class VI / ISO 10993), and complete lot traceability to support audits and validation processes.
Q: Can the hoses be customized for specific applications?
A: Yes, we offer full customization options including inner diameter, wall thickness, length, hardness, and packaging. We can also provide tailored solutions for specific pressure, temperature, or sterilization requirements.
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