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Plastic packaging material for injection powder and preparation process thereof

A technology for injection powder and plastic packaging, which is applied in the field of pharmaceutical packaging materials, can solve the problems of transparency, high heat-sealing temperature, impact resistance and environmental stress cracking resistance, inconvenient operation and transportation, and achieve tear resistance Excellent tensile strength, good impact resistance and environmental stress cracking resistance, excellent processability

Active Publication Date: 2015-12-23
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

The production and packaging of sterile raw materials and injection powders have always used stainless steel containers and glass materials, which are not only heavy, inconvenient to operate and transport, difficult to clean, high production costs, poor environmental performance, and more likely to lead to drug failure. Cross-contamination, one of the purposes of implementing GMP in my country is to prevent cross-contamination of drugs
In addition, the existing packaging materials still have defects such as poor toughness, transparency, thermal viscosity, high heat sealing temperature, and strong odor. Difference

Method used

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  • Plastic packaging material for injection powder and preparation process thereof
  • Plastic packaging material for injection powder and preparation process thereof
  • Plastic packaging material for injection powder and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The formula of embodiment 1 is as follows:

[0041] In terms of mass percentage, both the inner layer and the outer layer are made of the following components:

[0042]

[0043] In terms of mass percentage, the middle layer is made of the following components:

[0044]

[0045] The preparation process of the plastic packaging material for injection powder described in the present embodiment, the steps are as follows:

[0046] (1) Start the air-conditioning unit: make the film blowing area of ​​the production workshop reach B level cleanliness, and the bag making area and inner packaging area reach B+A level.

[0047] (2) Disinfection in clean area: Thorough disinfection is carried out according to GMP requirements.

[0048] (3) Purification of air or nitrogen: the air or nitrogen can reach the A-level standard after being purified.

[0049] (4) Mixing: Mix the above raw materials evenly.

[0050] (5) Film blowing: According to different formulations, the tempe...

Embodiment 2

[0053] The formula of embodiment 2 is as follows:

[0054] In terms of mass percentage, both the inner layer and the outer layer are made of the following components:

[0055]

[0056] In terms of mass percentage, the middle layer is made of the following components:

[0057]

[0058] The barrel temperature is 175±3°C, the die head temperature is 165±3°C, the heat sealing temperature is 240±3°C, and the inflation ratio is 1.2. Except for the above parameters, the preparation process of the plastic packaging material for injection powder described in this example is the same as that in Example 1.

Embodiment 3

[0060] The formula of embodiment 3 is as follows:

[0061] In terms of mass percentage, both the inner layer and the outer layer are made of the following components:

[0062]

[0063] In terms of mass percentage, the middle layer is made of the following components:

[0064]

[0065]

[0066] The barrel temperature is 165±3°C, the die head temperature is 165±3°C, the heat sealing temperature is 190±3°C, and the inflation ratio is 1.9. Except for the above parameters, the preparation process of the plastic packaging material for injection powder described in this example is the same as that in Example 1.

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Abstract

The present invention relates to a plastic packaging material for injection powder and a preparation process thereof, and belongs to the field of pharmaceutical packaging materials. The plastic packaging material has a three-layer structure comprising an inner layer, a middle layer and an outer layer. The inner layer and outer layer are made from the following components by weight: 5-15% of mVLDPE, 10-25% of mLLDPE, 25-45% of LLDPE and 40-60% of LDPE; and the middle layer is made from the following components by weight: 5-15% of mLLDPE, 20-40% of LLDPE and 45-75% of LDPE. The plastic packaging material provided by the present invention has good toughness, high transparency, low heat viscosity low heat sealing temperature and small odor, and performances superior to conventional polyethylene products; the plastic packaging material has excellent anti-impact resistance and resistance to environmental stress cracking at room temperature or even at a low temperature of -80 DEG C, excellent barrier properties and tearing strength. The invention provides a better securer choice with higher quality for aseptic pharmaceutical production and packaging.

Description

technical field [0001] The invention relates to a plastic packaging material for injection powder and a preparation process thereof, belonging to the technical field of pharmaceutical packaging materials. Background technique [0002] The national "Pharmaceutical Industry Twelfth Five-Year Development Plan" specifically pointed out: "Strengthen the development and application of new pharmaceutical excipients and pharmaceutical packaging materials, improve drug quality, improve drug performance, and ensure drug safety." After the implementation of the new version of GMP, the return visit unannounced inspection has quietly increased, and the drug regulatory department is slowly increasing the "active" unannounced inspection. Since 2014, the state has become more and more stringent in the supervision of pharmaceutical companies and the pharmaceutical market, and has increased the supervision and management and supervision responsibilities of pharmaceutical manufacturers. In 20...

Claims

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Application Information

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IPC IPC(8): C08L23/06C08L23/08B32B27/32
CPCB32B27/32C08L23/06C08L2205/025C08L2205/03C08L2205/035C08L23/0815C08L23/08
Inventor 高爱国刘树林倪华丽张占坤
Owner ZIBO HUA ZHI LIN PACKING PROD CO LTD
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