Product Specification

Tyvek sterilization bag

Product Description

Tyvek sterilization bags are advanced packaging solutions designed for the rigorous sterilization of critical components in the medical and pharmaceutical industries. They are constructed from a film, often HDPE, and Tyvek, a high-density polyethylene spunbond material. This combination provides a powerful barrier against microbial contamination while remaining breathable for effective sterilization.

Manufactured and packaged in a C+A Class or similar cleanroom environment, these bags are free from non-soluble micron particles. They can be sterilized using various methods, including pressure steam (autoclave), gamma ray, and EO (Ethylene Oxide). A built-in sterilization indicator confirms that the bag has undergone the process, and a bacterial endotoxin level of less than 0.25 EU/mL ensures a high degree of safety.

The unique material provides an excellent microbial barrier, allowing sterilized contents—such as rubber stoppers, aluminum covers, penicillin bottles, and syringe components—to maintain sterility for up to one year. Available in a range of standard and customizable sizes, Tyvek sterilization bags are a highly reliable and essential tool for ensuring the sterility of critical medical and pharmaceutical supplies.

Product Parameters

Product Features

1.C+AClass.

2.Sterilized by: pressure steam, γ ray (Gamma ray), EO and VHP etc.

3.HDPE flm without any additive.

4.Excellent micron-bio barrier and lower no-soluble micron particle.

5.Sterilized labe lindicator and printing.

6.Supporting special heat seal equipment.

7.Bacterial endotoxin<0.25EU/mL.

8.After sterilization, the contents can be placed for one year and stil reach the sterile condition.

9.Size: 400mm-1200mm, some sizes were supported to customized.

Product Application

Tyvek sterilization bags are specifically designed for the safe and effective sterilization of a wide range of medical and pharmaceutical components. Their primary use is in the sterilization of disposable rubber stoppers and aluminum covers, which are critical for sealing vials and bottles. They are also essential for sterilizing penicillin bottles, clean clothes, and filter elements before they are used in a sterile environment.

Furthermore, these bags are crucial for sterilizing individual items like canned needles and syringe components, ensuring they are sterile and ready for use in a medical setting. The material's unique properties allow steam, EO gas, and gamma rays to penetrate and sterilize the contents, while the film side creates a robust barrier.

After sterilization, the excellent microbial barrier of the Tyvek bag allows the contents to maintain sterility for up to one year. This long-term sterility is invaluable for supply chain management and storage, ensuring that critical components are sterile and safe when needed. Tyvek sterilization bags are a key tool in maintaining the high standards of sterility required in pharmaceutical and healthcare manufacturing.

Product Advantage

Tyvek sterilization bags offer numerous advantages for the sterilization of medical and pharmaceutical components. A key benefit is their exceptional microbial barrier, which effectively protects contents from contamination while still allowing various sterilizing agents to penetrate. This is crucial for applications that require a high degree of sterility.

These bags are highly versatile, compatible with a range of sterilization methods including pressure steam, gamma ray, and EO. The bags also feature a built-in indicator, providing clear visual confirmation that the sterilization process has been completed.

Moreover, Tyvek sterilization bags can maintain the sterility of their contents for up to one year after the sterilization process. This long-term shelf life is invaluable for logistics and inventory management. With a bacterial endotoxin level of less than 0.25 EU/mL and a manufacturing environment of C+A Class, these bags ensure a safe and highly reliable solution for critical medical and pharmaceutical supplies.