How to achieve aseptic requirements for high-density polyethylene bottles

Medicine bottles are an important part of the circulation of medicines. The common pharmaceutical packaging is mainly plastic bottles and PTP aluminum foil, especially high-density polyethylene bottles, which can be used for the packaging of solid and liquid medicines. As a special commodity, medicine has high requirements for packaging, and sterility is the most basic condition. So, how can high-density polyethylene bottles meet the requirements for sterility?

Aseptic packaging is a method of sterilizing packaging in a sterile environment using instant ultra-high temperature sterilization technology. The sterile high-density polyethylene bottle can better maintain the ingredients of the medicine, extend the shelf life, inhibit bacterial contamination, and ensure the safety of medication. If the package contains bacteria, it will greatly shorten the shelf life of the medicine, seriously affect the efficacy of the medicine, and even cause a safety accident of the medicine. Therefore, the sterility of the drug package is the focus of the pharmaceutical companies.

child proof bottle

The sterility of high-density polyethylene bottles must first be derived from the sterility of the production environment. According to GMP requirements, the production of pharmaceutical packaging materials must be completed in a clean workshop. The clean workshop has Pressure difference, illuminance, noise, etc. have strict standards. From the production process to sorting to packaging, they must be strictly controlled to ensure that the entire production process is carried out in a sterile space.

Secondly, high-density polyethylene bottles will undergo secondary sterilization after the production is completed. The main sterilization methods used are ethylene oxide sterilization or cobalt 60 sterilization to ensure that they meet the requirements of the industry standard for microbial limits ( Inspect according to law (Chinese Pharmacopoeia 2015 Edition General Rules 1105, 1106), the number of bacteria must not exceed 1000cfu per bottle, the number of molds and yeasts must not exceed 100cfu per bottle, and each bottle of Escherichia coli must not be detected).

It is not a separate action for high-density polyethylene bottles to achieve aseptic requirements. It needs to be strictly controlled from the production environment, packaging, sterilization and other links in order to achieve true sterility. With the substantial increase in the production standards of the pharmaceutical industry, the industry's requirements for aseptic packaging will become higher and higher.