An article to understand medical packaging materials

"Asepsis" is the primary pursuit of medical packaging materials. In addition to meeting the basic performance of products, aseptic design, the use of aseptic materials and the use of materials are all considered factors in the production of medical packaging materials. Medical packaging materials specifically refer to materials used in the medical industry to manufacture and seal packaging systems and to ensure that the materials remain sterile throughout their intended use, including storage and transportation conditions.

Medical packaging materials can be divided into:

1. Packaging materials used to package medicines or medical devices (outer packaging of products, without direct contact with human body or drugs)

2. Packaging materials that can be taken, exposed to medical drugs or used as functional (such as moisture-proof, barrier, etc.) outer packaging materials.

Medical packaging materials that can be taken; Such packaging materials are mainly used as capsules, microcapsules and excipients. Commonly used materials are edible starch, gelatin, ethyl cellulose, polyvinyl alcohol and so on.

The function of capsule: The drug loaded with capsule is generally irritating powder or particle to the esophagus and gastric mucosa, or bad taste, easy to volatilize, easy to be decomposed by saliva in the mouth, and easy to inhale the medicine of the trachea. These medicines are packed into capsules to protect the drug's properties from being destroyed, as well as to protect the digestive organs and respiratory tract. Removing the capsule may result in drug loss, drug waste, and reduced effectiveness. In addition, some medicines need to be dissolved and absorbed in the intestine, and the capsule protects them from being destroyed by stomach acid.

By material type

Traditional packing materials include wax, glass, ceramic, paper (plate), rubber, metal, etc. Glass has a long history of product packaging, beer, tea, sour date juice and many other beverages packaging materials. In the field of medical packaging, glass packaging materials are widely used for injection, biological drugs, blood products, oral liquid packaging.

Glass has many advantages when used as medicine packaging

1, glass material has good barrier performance, can well prevent the invasion of oxygen and other gases inside the contents, and can prevent the volatile components of the contents to the atmosphere

2, glass bottle safety and health, good corrosion resistance and acid corrosion resistance

3, convenient to observe the condition of drugs in the bottle;

4, glass bottles can be used repeatedly, reduce the cost of packaging

Rubber packing material, good resistance to heat, sunlight, ozone, electrical insulation, impermeability to most common gases, good resistance to sunlight and odors, can be exposed to animals or vegetable oils or gasifying chemicals. Rubber packing material is used as container plug, gasket. Among them, Butyl Rubber is a common medical rubber materials.

In addition to the above traditional packaging materials, plastic packaging is playing an increasingly important role in the field of medicine. As a packaging material, plastic has many excellent characteristics, such as high strength, good barrier, light weight, easy to carry, transparent and so on, which has become the main material in modern medical packaging.

1. Plastic bottles for medical use. The actual application of plastic varieties are: polyethylene (PE), polypropylene (PP), polystyrene (PS), polyester (PET) and so on. PET is the material of medical plastic bottles in recent years. It is characterized by high transparency, can see whether the drug is spoiled, and excellent barrier moisture-proof performance, which is greatly conducive to the preservation of drugs. Easy to color or add some additives to meet special requirements (UV resistance).

2. Thin film, composite film. It is usually made into sachets for medical packaging applications. Plasma bagging is a typical example of compound film packaging of pharmaceuticals. Breathable film plays an important role in the packaging of bone-sticking drugs.

3. Bubble packaging of sheet and tablet is a new technology and a new stage of pharmaceutical packaging. The main materials used are aluminum foil, adhesive and plastic sheet. And plastic sheet and mainly with polyvinyl chloride (PVC) sheet and polyester (PET) sheet two. Polyvinyl chloride (PVC) sheet requires non-toxic formulation; The content of oxyethylene (VC) in PVC resin is less than 1X10-6. Polyester (PET) sheet is after PVC sheet, used for medical packaging sheet, and in some European countries prohibit PVC for disposable packaging; It has become a major medical packaging sheet.

4. Synthetic paper, non-woven synthetic paper, non-woven fabric (including spunbonded fabric) can breathe; But for medical packaging materials are usually also made into bacteria can not pass through the mesh; So that it has the function of blocking bacteria, used to manufacture surgical instrument packaging bag, paste medicine packaging, adhesive tape, bandages, etc.

Product introduction

The products are disposable products and sterilized packaging products with sterilization process indication labels. They are made of transparent or colored (usually blue, green, purple) PET/CPP composite medical film and medical dialysis paper through special technology (EN868-5), which can prolong the sterile storage time of sterilized articles. And through the color change of sterilization indication to identify the difference between before and after sterilization.

sterilization

At present, the main packaging materials of sterile barrier system include medical grade dialysis paper, eluting/coated paper, Tyvek, PE, PP, PET, PVC, etc. Different packaging materials are suitable for different packaging forms, corresponding to different sterilization methods and packaging contents. One commonly used material dialyzed paper, its role is to allow only a part of things to penetrate, prevent another part of things. What's allowed here is something like EO ethylene oxide or STEAM high temperature steam sterilization, bacteria are kept out.

Sterilization of modern medical drugs and devices consists of two aspects: one is that medical supplies are sterilized in the packaging, and the other is that the products remain sterile under the protection of the packaging. The scenarios involved include sterilizing disposable sterile medical devices after packaging by manufacturers, and sterilizing and storing reusable medical devices after packaging sealing by hospital disinfection and supply centers for next use. Compared with the traditional sterilization and packaging method, the modern sterilization mode strengthens the control of contamination risk in the whole process of transportation, storage and use of medical products, which significantly improves the safety of products.

Product introduction

1. Medical wrinkled paper is made of pure wood pulp, with the characteristics of porous arrangement, ethylene oxide, high pressure steam, and other sterilization medium bending into the sterilization package, penetration rate of 100%, after sterilization, medical wrinkled paper has an excellent antibacterial effect.

2. Aseptic storage time after sterilization is up to six months.

3. Soft paper, Yipak wrinkle paper is a kind of environment-friendly medical dialysis paper.

Note: USED FOR PRESSURE STEAM AND ethylene OXIDE sterilization, because of weak tear resistance, thin, suitable for the sterilization of light and no sharp instruments.

At present, there are four commonly used sterilization methods for packaging, and different sterilization methods are selected according to the different properties of materials.

Pressure steam sterilization

The packaging material should be able to withstand high temperature of 121℃ -135 ℃, air discharge, water vapor penetration and drying of the packaging material and contents;

Sterilization with ethylene oxide

Packaging materials need to allow the penetration and discharge of ethylene oxide gas (ventilation process);

Dry heat sterilization

Packaging materials need to withstand the high temperature of 160℃ -204 ℃ within 2-3 hours, without melting, burning or other reactions;

Sterilization by plasma

Packaging MATERIALS NEED TO withstand extreme VACUUM, do not absorb sterilizing agents, do not interfere with the sterilization cycle, and treat sterilized items without damage.