Pharmaceutical aluminum-plastic blister packaging is widely used in the pharmaceutical industry for its beautiful appearance, good barrier properties, convenience in use, and convenience in carrying. It is the most important packaging for solid dosage forms such as pharmaceutical tablets and capsules. One way.
Aluminum foil for pharmaceutical packaging (also commonly called PTP aluminum foil) is one of the two major constituent materials of this packaging method, and its pinhole degree will directly affect the protection of the final packaging to the contents. Because the PTP aluminum foil pinhole is located in the blister area, which means that the drug is in direct contact with the outside air, the protective function of the drug package will be completely lost, which brings great risks to the producers and users of the drug. The risks are unacceptable to most drug manufacturers.
PTP aluminum foil pinholes are produced for two reasons: 1 pinholes produced during the production of raw aluminum foil used in the production of PTP aluminum foil; pinholes produced during the production of 2PTP aluminum foil. Since the generation of pinholes in the production process of PTP aluminum foil is relatively easy to control and avoid, the following discussion is mainly directed to pinholes generated during the production of raw material aluminum foil for PTP aluminum foil (hereinafter referred to as raw material aluminum foil).
Hysteresis problem of pinhole standard of a raw material aluminum foil
At present, the national standard for “aluminum and aluminum alloy foil†based on the production and inspection of raw material aluminum foil is GB/T3198-2003. The relevant standard for the standard of pinhole porosity of raw material aluminum foil is as follows: the diameter of the pinhole of the aluminum foil for medical packaging shall not exceed 0.3 mm, and shall not exceed 5/m2. (The above-mentioned aluminum foil for pharmaceutical packaging refers to the raw material aluminum foil used in the production of PTP aluminum foil.) This expression specifies two standard values ​​for the pinhole of the raw material aluminum foil: 1 pinhole diameter should not be greater than 0.3 mm2 pinholes with diameter less than 0.3 mm should not exceed 5 /m2. In the current industry standard YBB00152002 based on the production and inspection of PTP aluminum foil, the relevant regulations for pinhole porosity are as follows: 1 pinholes with a diameter greater than 0.3 mm are not allowed; 2 the number of pinholes with a diameter of 0.1-0.3 mm shall not exceed 1 (The number of pinholes less than 0.1mm is not specified). It is easy to see from the production process of PTP aluminum foil that the pinhole defects of the raw material aluminum foil cannot be eliminated in the subsequent production process. Therefore, it is not difficult to see from the above values ​​that the current "Aluminum and Aluminum Alloy Foil National Standard" has specified the pinhole standard. It has fallen far behind the provisions of "YBB00152002".
The difference between the pinholes of the two PTP aluminum foils and the raw material aluminum foil according to the test conditions specified by the standard
In the industry standard "YBB00152002" based on PTP aluminum foil, the detection condition of pinhole is required to be light in a dark room with zero ambient illumination, and the "aluminum and aluminum alloy foil national standard GB/T3198-2003" based on raw material aluminum foil. The pinhole detection conditions required in the case are performed under conditions of an ambient illuminance of 20 lx to 50 lx. For pinholes with a diameter of less than 0.1 mm, it can be clearly seen in the darkroom, but under ambient conditions of 20lx-50lx, it may not be visible at all. If the degree of influence of the two test conditions on the test results is taken into account, then the pinhole standard specified in the "Aluminum and Aluminum Alloy Foil National Standard GB/T3198-2003" cannot be used as a raw material for the pharmaceutical packaging manufacturer. standard.
With the continuous improvement of the production process of domestic raw material aluminum foil manufacturers, the overall quality of raw material aluminum foil is steadily improving. The internal control standards for pinholes of some enterprises have reached the requirements of YBB00152002; however, more companies produce aluminum foil products in pinholes. There is still a long way to go in terms of quality stability. I think the most fundamental reason for this is that only a complete production chain from billet to aluminum foil can facilitate the overall quality control of the aluminum foil production process and form a complete production and quality control system. At present, most of the raw material aluminum foil manufacturers do not have a blank production line, and the main production link of the pinhole, the blank, cannot be truly effective quality control, and can only passively avoid other occurrences in the subsequent rolling and slitting processes. Quality issues.
It can be seen from the above discussion that the pinhole control of PTP aluminum foil is a systematic project, which involves three steps of aluminum foil blank production, raw material aluminum foil rolling and PTP aluminum foil production. It is necessary to carry out effective quality control on these three links to maximize Reduce the occurrence of pinholes. As one of the best pharmaceutical packaging suppliers in China, Jiangsu Zhongjin Matai Pharmaceutical Packaging Co., Ltd. has 20 years of experience in PTP aluminum foil production and has a stable high-end pharmaceutical manufacturing enterprise customer base. We can do some of their practices. Get inspiration:
First, in agreement with the supplier on the acceptance criteria of raw material aluminum foil: the detection method and detection index of the raw material aluminum foil pinhole degree are uniformly implemented according to the standards stipulated by YBB00152002.
2. The pinholes found in the raw material aluminum foil in the sampling test (even within the allowable range) are judged for preliminary reasons. Once the blanking problem is determined, the sampling amount of the relevant batch of aluminum foil will be increased to better evaluate the The overall pinhole condition of the batch of aluminum foil.
3. Keep the production equipment clean and ensure that no hard particles adhere to the equipment guide rolls.
Fourth, in the PTP aluminum foil production process in-line sampling (due to the accuracy of the detection equipment, currently only detect large holes), can effectively find the larger diameter pinholes and linear pinholes not found in the sampling inspection . For other companies that lack online testing equipment, they can only rely on the naked eye.
5. Perform a full inspection on the cut-off sample (1 sample/1000 m).
6. Analyze, summarize, and evaluate the pinholes detected in the above process, and communicate with suppliers in time to analyze and improve.
Undoubtedly, under the existing conditions of most enterprises in the pharmaceutical packaging industry, even after the above strict control of the production and testing process of PTP aluminum foil, it is impossible to ensure the production of PTP aluminum foil with zero pinhole. What pharmaceutical packaging companies can do is to reduce the risk of packaging as much as possible and then reduce it.