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Vinyl Bags Quality Standard
Sep 12, 2017

Medicinal polyethylene bag is a kind of polyethylene particles as raw materials, in a clean environment by blown film, cutting, heat sealing, vacuum packaging and other processes produced by the pharmaceutical packaging materials. Widely used in raw materials powder, food powder, chemical powder transport and temporary storage.

Medicinal bags because of its excellent low temperature performance and good chemical stability and electrical insulation and other properties, is widely used in raw materials powder, food powder, chemical powder transport and temporary storage. In addition, in the food industry, but also with cardboard, aluminum foil together constitute the food packaging containers, mainly blocking the role of liquid leakage and microbial invasion.

Quality standard for medicinal polyethylene bags

To effectively control the quality of pharmaceutical and food packaging materials, the State Food and Drug Administration in 2002, the development and promulgation of the corresponding drug packaging containers - medicinal low-density polyethylene film, bag quality standards (YBB00072005), to strengthen the Material physical, mechanical properties, chemical properties, safety control. Specifically includes the appearance, barrier properties, heavy metal content, dissolution content, microbial limit and other projects.

Medicinal Polyethylene Bag Microbiological Limits

The number of bacteria shall not exceed 1000 /

Production environment and process of medicinal polyethylene bag

The production process of medicinal bags is mainly divided into blown film, cutting, heat sealing bag, vacuum packaging.

Blown film: first open the workshop within the air purification system, and the workshop, the operator disinfection and sterilization, the operating environment to set the standard, the purified polyethylene particles at a certain temperature blowing film;

Cutting: Blown film obtained after the tubular film according to the size of the requirements of customers cut into different sizes of the film tube;

Heat sealing bag: sealing the film tube with heat sealing machine;

Vacuum packaging: sealed aseptic bags in accordance with a certain number of multi-layer vacuum packaging;

The essence of medicinal polyethylene bags is a plastic bag, although the traditional concept that the bag of the production process is very simple, low technical content. However, in order to meet the quality standards of the State Food and Drug Administration (FDA) standards and the GMP requirements for microbiological limits, the production process becomes complicated and requires that each production detail take into account the technical requirements for cleanliness and microbial limits.

For a long time, antibiotics and other sterile injection powder packaging are used glass or aluminum drums for packaging, but there are packaging fragile, difficult to recover, high cost, and the emergence of medicinal bags, just to solve the above Packaging problem. Pharmaceutical polyethylene bags first appeared in 1992, is by Shijiazhuang Yucai Pharmaceutical Packaging Materials Co., Ltd. and North China Pharmaceutical in the joint development of antibiotic sterile powder packaging, after a large number of experiments developed, named as - medicinal Low density polyethylene film bag. The emergence of medicinal bags to fill the gaps in the domestic, creating a package of antibiotics injection powder revolution.

 The following year, the Hebei Provincial Medicine Bureau for the Shijiazhuang Yucai awarded the country's first production license for medicinal bags. In 1994, the quality standards for medicinal polyethylene bags also appeared. Since then from 1995 to 2003, the state of the pharmaceutical bag production regulation gradually improved, the pharmaceutical bag has been controlled by the pharmaceutical low-density polyethylene bag registration card, into a direct contact with the pharmaceutical pharmaceutical low-density polyethylene bag Ⅰ Class registration certificate. Medicinal bags with its stable performance, simple, low prices and other advantages, and gradually recognized by pharmaceutical companies.

As a result, the manufacturer of medicinal bags has sprung up in the market of medicinal packaging materials.