Medical films use high-quality, low-toxic or even non-toxic medical-grade raw materials, such as polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyurethane, etc. These materials need to pass biocompatibility tests to ensure they are harmless to the human body . In terms of production technology, the production of medical films usually involves advanced technologies such as multi-layer co-extrusion, precision stretching, and special coatings to improve its barrier properties, strength, transparency and other properties.
Ordinary packaging films are available in a wider range of materials, including polyethylene, polypropylene, polyester, polyvinyl chloride, etc. These materials are relatively low-cost, but do not necessarily meet medical-grade safety standards. The production process is relatively simple and mainly focuses on improving production efficiency and reducing costs.
The production environment needs to be carried out in a clean room, and the number of dust particles and microorganisms in the air, as well as the temperature and humidity conditions, are strictly controlled to ensure sterility during the production process. At the same time, strict quality control is carried out on raw materials, semi-finished products and finished products, including microbial testing, chemical residue testing, etc., to ensure that products comply with international standards such as ISO 11607, EN 868, ASTM, and certification requirements such as FDA and CE. The production environment requirements are relatively low and a clean room is not necessarily required, but there will also be certain quality control measures, such as appearance inspection, dimensional measurement, tensile strength testing, etc., to meet the basic requirements of ordinary packaging.
In addition to basic waterproof, moisture-proof and tear-proof properties, it also needs to have excellent barrier properties, as well as good sealing, transparency and sterilization resistance. Widely used in pharmaceutical packaging (such as blister packaging, liquid bottle packaging), medical device packaging (such as surgical instrument packages, catheter packaging), drug delivery systems (such as patches, transdermal drug delivery systems), etc., to ensure the safety of medical products sex and effectiveness. It mainly meets the needs of product protection, display, transportation and storage, and has relatively low performance requirements, such as basic waterproofing and moisture-proofing, printing adaptability, tear strength, etc. It is widely used in food packaging, daily necessities packaging, industrial product packaging, etc.
It is subject to strict regulatory supervision and must comply with the medical device regulatory requirements of various countries and regions, such as the European Union's Medical Device Directive (MDR), the US FDA's Center for Medical Devices and Radiological Health (CDRH) regulations, etc. At the same time, with the increase in environmental awareness, the recycling and biodegradability of medical films have also become important considerations. Although certain environmental regulations must be followed, compared with medical films, the regulatory requirements may be looser. With the development of global environmental protection trends, ordinary packaging films are gradually becoming recyclable and degradable to reduce the negative impact on the environment.
When using, special attention must be paid to aseptic operation to avoid contamination. After use, dispose of it safely in accordance with medical waste disposal regulations to prevent secondary harm to the environment and human body caused by medical waste. It is more flexible to use and does not require strict aseptic operation. After use, it is generally disposed of as domestic waste, but with the improvement of environmental awareness, consumers are encouraged to classify and recycle.