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Medical freeze-dried sterile polyethylene film and preparation method thereof

A polyethylene film and polyethylene resin technology, which is applied in the field of pharmaceutical freeze-dried sterile polyethylene film and its preparation, can solve the problems of cross-contamination of drugs, difficult cleaning, and difficult detection of drug residues, and achieve strong mechanical properties, The effect of low insoluble particles

Active Publication Date: 2018-08-10
ZIBO HUA ZHI LIN PACKING PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As high-risk drugs, the production quality requirements of sterile drugs and biological products are more stringent. For a long time, the freeze-drying production of the pharmaceutical production industry has used stainless steel plates to hold the products to be dried, which is difficult to clean and difficult to detect and determine the amount of drug residues. Safe residues can easily lead to cross-contamination of drugs, and there are major hidden dangers related to human life and health

Method used

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  • Medical freeze-dried sterile polyethylene film and preparation method thereof
  • Medical freeze-dried sterile polyethylene film and preparation method thereof
  • Medical freeze-dried sterile polyethylene film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] (1) Formula composition: 8 parts by weight of ultra-high molecular weight polyethylene resin with a melt index of 0.3 g / 10 min, and 2 parts by weight of metallocene polyethylene with a melt index of 0.3 g / 10 min.

[0039] (2) Mixing: Add the polyethylene resin of the above components into a mixer or blender, and mix for 15 minutes.

[0040] (3) Film making: Melt and blend uniformly mixed polyethylene resin through a film blowing machine. The temperature of the film blowing machine is controlled at 230°C, and extrusion blow molding is performed.

[0041] (4) Cutting film: Cut the roll film formed by extrusion blow molding according to the specification and size required by the customer.

[0042] (5) Packaging: The cut and formed polyethylene film is packed in more than two layers of pharmaceutical low-density polyethylene bags, and then packed in cartons or woven bags.

[0043] (6) Sterilization: use Co 60 γ-ray sterilization, the sterilization dose is 30KGy.

[0044]...

Embodiment 2

[0049] (1) Formula composition: 6 parts by weight of ultra-high molecular weight polyethylene resin with a melt index of 0.3 g / 10 min, and 4 parts by weight of metallocene polyethylene with a melt index of 0.3 g / 10 min.

[0050] (2) Mixing: Add the polyethylene resin of the above components into a mixer or blender, and mix for 15 minutes.

[0051] (3) Film making: Melt and blend uniformly mixed polyethylene resin through a film blowing machine. The temperature of the film blowing machine is controlled at 210° C., and extrusion blow molding is performed.

[0052] (4) Cutting film: Cut the roll film formed by extrusion blow molding according to the specification and size required by the customer.

[0053] (5) Packaging: The cut and formed polyethylene film is packed in more than two layers of pharmaceutical low-density polyethylene bags, and then packed in cartons or woven bags.

[0054] (6) Sterilization: use Co 60 Gamma-ray sterilization, the sterilization dose is 28KGy.

...

Embodiment 3

[0060] (1) Formula composition: 6 parts by weight of ultra-high molecular weight polyethylene resin with a melt index of 0.3g / 10min, 2 parts by weight of metallocene polyethylene with a melt index of 0.3g / 10min, and linear polyethylene resin with a melt index of 1.0g / 10min. 2 parts by weight of vinyl resin.

[0061] (2) Mixing: Add the polyethylene resin of the above components into a mixer or blender, and mix for 30 minutes.

[0062] (3) Film making: Melt and blend the homogeneously mixed polyethylene resin through a film blowing machine. The temperature of the film blowing machine is controlled at 190°C, and extrusion blow molding is performed.

[0063] (4) Cutting film: Cut the roll film formed by extrusion blow molding according to the specification and size required by the customer.

[0064] (5) Packaging: The cut and formed polyethylene film is packed in more than two layers of pharmaceutical low-density polyethylene bags, and then packed in cartons or woven bags.

[0...

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Abstract

The invention belongs to the technical field of high molecular materials and in particular relates to a medical freeze-dried sterile polyethylene film and a preparation method thereof. The medical freeze-dried sterile polyethylene film is prepared from the following raw materials in parts by weight: 6 to 8 parts of ultrahigh molecular weight polyethylene resin and 2 to 4 parts of metallocene polyethylene. The preparation method of the medical freeze-dried sterile polyethylene film comprises the steps of mixing, preparing the film, cutting the film, packaging and sterilizing. The polyethylene film provided by the invention has the characteristics of low temperature resistance, sterile performance, low insoluble particles, strong mechanical properties and the like, and can meet the freeze-dried production requirements of medicines, crude drugs, biological products, medical intermediates, chemical products and the like.

Description

technical field [0001] The invention belongs to the technical field of polymer materials, and in particular relates to a medicinal freeze-dried sterile polyethylene film and a preparation method thereof. Background technique [0002] Polyethylene material is widely used in the inner packaging of medicines, pharmaceutical intermediates and other products, and has excellent characteristics such as moisture resistance, low dissolution, and convenient transportation and use. [0003] In the production of pharmaceuticals, biological products, raw materials and pharmaceutical intermediates, many products are not resistant to high temperatures, so freeze-drying technology is used in the process of product drying involved in the production process. After the implementation of the new version of GMP, the country's supervision of pharmaceutical companies and the pharmaceutical market has become more and more stringent. As high-risk drugs, the production quality requirements of steril...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08L23/06C08J5/18B29C55/28
CPCC08J5/18B29C55/28C08J2423/06C08J2323/06
Inventor 高爱国刘树林倪华丽刘文臣
Owner ZIBO HUA ZHI LIN PACKING PROD CO LTD
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