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Medical Silicone Tubing Autoclave Ethylene Oxide Gamma Radiation Sterilization -60°C To 200°C

Medical Silicone Tubing Autoclave Ethylene Oxide Gamma Radiation Sterilization -60°C To 200°C

MOQ: 15M
Price: Base on BPT number and quntities
Payment Terms: T/T,L/C
Supply Ability: 1500000m/Year
Detail Information
Place of Origin:
China
Temperature Range:
-60°C To 200°C
Fda Compliant:
Yes
Sterilization Method:
Autoclave, Ethylene Oxide, Gamma Radiation
Material:
Silicone
Color:
Transparent
Country Of Origin:
China
Sterilized Times:
Wet Heat Sterilized Up To 60 Times.
Standard:
EP, USP, FDA, ISO
Packaging Details:
Double Pharma-grade LDPE bags+ Carton
Supply Ability:
1500000m/Year
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Product Description

Medical silicone tubing

 

Product Description

 

Medical silicone tubing is a versatile and essential component in various industries, particularly in biopharmaceuticals, due to its unique properties. It is often made from imported raw materials, ensuring high quality and consistency.

One of its key advantages is a low extract content, which guarantees enhanced biological safety for the transmission of sensitive materials like medicines, biopharmaceutical liquids, and intermediates. This is crucial for maintaining the purity and integrity of the substances being transported.

The tubing is exceptionally durable and resilient, capable of withstanding up to 60 cycles of wet heat sterilization. This makes it ideal for applications requiring frequent sterilization to prevent contamination. Furthermore, its smooth inner wall ensures high-precision filling and minimal residue, which is vital for accurate dosing and reducing product waste.

Medical silicone tubing also boasts long-lasting performance, with a peristaltic pump transmission time of 100-1000 hours. It meets stringent quality standards, including EP, USP, FDA, and ISO, and is manufactured in ISO class clean rooms.

 

Product Parameters

 

Material

Platinum-cured or Peroxide-cured silicone

Color

Translucent to clear

Sterilization Methods

Autoclave, Gamma Irradiation, Ethylene Oxide (EtO)

Operating Temperature

-50°C to 200°C(Higher temps possible for short-term use)

Hardness

50-70 Shore A

Chemical Resistance

Good to excellent for most aqueous solutions, alcohols, and some weak acids/alkalis.

Biocompatibility

Low extractables, does not support bacterial growth.

Regulatory Compliance

FDA 21 CFR 177.2600, USP Class VI, ISO 10993, EP 3.1.9

 

 

Product Features

 

1.Imported raw material.

2.Extract content is low, and has better biological safety.

3.Sterilized times: wet heat sterilized up to 60 times.

4.Meet EP,USP,FDA,ISO quality standard.

5.ISO class clean room workplace.

6.FDA DMF registration NO: DMF038279

7.Peristaltic pump transmission time is 100-1000 hours.

8.High precision filling silica gel tube inner wall smoothness, can achieve accurate filling and minimum residue.

 

Product Application

 

Pharmaceutical LDPE (low-density polyethylene) packaging bags are indispensable in the drug manufacturing industry, primarily for maintaining the sterility of sensitive materials. Their main application is the safe and sterile transfer and packaging of Active Pharmaceutical Ingredients (APIs) and finished drug products.

In pharmaceutical facilities, these bags are crucial for internal logistics. They are used to move sterile powders, granules, and other drug components between different processing stages, such as from a reactor to a filling line, without contamination. This is vital for aseptic manufacturing processes where environmental control is paramount.

The bags' clean and inert properties also make them ideal for the final packaging of sterile drug products, particularly those intended for injection. They ensure that the contents remain free from harmful particles, microorganisms, and chemical leachates, thus guaranteeing product safety and integrity until they reach their final destination or are used in a clinical setting.

 

Product Advantage

 

Medical silicone tubing is widely used across various fields due to its unique combination of flexibility, durability, and biological safety. Its primary application lies in the biopharmaceutical and medical industries, where it serves as a critical component for fluid transfer.

Specifically, it is perfectly suited for the transmission of pharmaceuticals, biological liquids, and intermediate products. Its low extractable content and superior biological safety ensure that the transported substances remain pure and uncontaminated. This is essential for applications like peristaltic pump systems, where the tubing's high-precision inner wall allows for accurate and efficient liquid dispensing with minimal residue.

Beyond pharmaceuticals, Medical silicone tubing is also utilized in general medicine and traditional Chinese medicine for liquid transmission. Its ability to withstand numerous wet heat sterilization cycles (up to 60 times) makes it a reliable choice for sterile environments, such as those found in ISO class clean rooms. By meeting strict quality standards like EP, USP, FDA, and ISO, Medical silicone tubing guarantees safety and performance for critical applications, ensuring the integrity of the product and the safety of the patient.