In the past, non-end-sterilized sterile powder bulk drugs used internal packaging often used antibiotic glass bottles or special aluminum barrels, rubber stoppers and other components as packaging materials, in order to rough wash these components, washing, finishing wash, dry Dry, sterilize, and then put the sterile powder into the bottle, cover with a rubber stopper, and finally sealed with a plastic stopper outside the stopper. Recently, this traditional packaging method is being challenged by the new packaging material, PMP.
Traditional packaging: high cost, high consumption, environmental pollution
Traditionally, the traditional packaging process is: in the non-sterile area, the antibiotic bottle is washed with tap water, followed by purified water. After dry control, it was moved into a control zone of 100,000 grades, washed with water for injection, and after drying, it was placed upside down on a tray, placed in a double-opening sterilizer, and sterilized at 180°C for 90 minutes. After the temperature dropped to 40°C, it was taken out in the Class 100 area, filled with medicines, and the washed and sterilized flipper rubber stoppers were sealed and sealed in stoppers outside the 10,000-class control zone.
In fact, the above packaging methods have many drawbacks in energy consumption, environmental protection, and production costs, especially in the quality control of pharmaceuticals. The general performance is:
The amount of cleaning water is as large as the rough washing process to consume tap water, the middle washing process consumes purified water, and the fine washing process consumes water for injection.
Large electricity consumption consumes electricity when preparing different grades of water; the electricity consumed during the sterilization process after cleaning is particularly large; and the air-conditioning purification system configured to maintain various levels of clean environment also consumes a large amount of electricity.
The large amount of pollutants, whether it is the cleaning of glass bottles and flip rubber stoppers, or the clearing process must consume a lot of water, and the sewage is easy to pollute the environment.
Large areas of sterile area and supporting non-sterile areas are needed. Cleaning and drying of glass bottles and overturning rubber stoppers require a certain area of sterile area matching the production capacity and supporting non-sterile areas. Aseptic area.
Waste manpower resources such as rough washing, mid-washing, fine washing, racking, sterilization, tapping, and sealing all require manpower that matches the production capacity. Cleaning personnel account for a large proportion of the total number of people required on the production line, resulting in serious waste of manpower. Resources.
The high cost of packaging materials GMP (Good Manufacturing Practice) clearly requires that packaging materials in direct contact with the sterile powder must not be reused. Therefore, glass bottles and overturned rubber stoppers can only be used once and eliminated, resulting in the cost of packaging materials in drug production. The proportion of total cost is too large. In particular, the State Food and Drug Administration has stipulated that since July 1, 2005, butyl rubber plugs must be used instead of natural rubber stoppers, since the price of butyl rubber plugs is much higher than the price of natural rubber stoppers. The cost of wood will increase further.
The volume and weight of glass bottles and overturned rubber stoppers account for a large proportion in the total production logistics, and it is prone to cause a large amount of traffic, which in turn increases transportation costs.
The quality of medicines is difficult to guarantee the possibility of bursting of glass bottles during heat sterilization. Small cracks that are not detected may cause microparticles to mix in medicines; there is also the possibility that exfoliated rubber stoppers may fall into the medicine. These will affect the quality of drugs and directly affect the safety of medications.
The Chinese Pharmacopoeia (2005 version of the Opinion Draft) requires that no foreign material be detected in the sterile powder, but the original packaging method cannot meet this requirement.
New Packaging: Triple Profits for Economy, Environment and Social Benefits
In the work practice, the author found that using PMP material as the internal packaging material of the raw material medicine can avoid the above deficiencies.
PMP material is a sterile, inert material that is produced under specific process conditions. The author first conducted a small packaging test on the PMP material as the inner packaging material of the drug. Has carried out the regular placement of quality certification and accelerated test stability inspection quality certification, inspection at the prescribed time, quality qualified. On this basis, the author applied the PMP material to the production: the PMP material was made into a tube, sealed layer by layer and transported to the pharmaceutical production plant. The packaging was removed layer by layer under different environmental levels and sampled according to GMP regulations. According to the State Food and Drug Administration's National Drug Packaging Containers (Materials) Standards (Trial)” YBB00342002, after inspection, bags are bagged at the required size, and after being filled with quantitative drugs, they are completely sealed and sent for inspection. District, after the inspection is qualified, packing, storage, transportation, to be divided into powder injection agent.
In production, PMP material as the inner packaging material of sterile powder bulk drugs that cannot be sterilized in the actual work has significantly reduced the water consumption, power consumption, and the amount of pollutants discharged, reduced the production work surface, and saved human resources. The product quality has been significantly improved, and the overall packaging cost of the product is reduced by approximately 3 yuan/kg compared to the cost of using natural rubber stoppers, and is reduced by approximately 7.8 yuan/kg compared with the use of butyl rubber stoppers.
The use of PMP materials as inner packaging materials for non-terminally sterilized sterile powders has great promotional value. This method also has an important enlightening effect on the field of packaging materials for sterile powdered bulk drugs that can be sterilized because PMP materials meet the requirements of circular economy, clean production, and environmental protection. However, what kind of material PMP material should be used as the inner packaging material should be determined through specific tests. The key is to ensure that the packaged drug does not undergo chemical and physical changes with the selected PMP film. To ensure that the internal quality of the drug is not affected, the drug is not contaminated, and its quality certification must be based on accelerated test stability as the most basic basis.
