Aluminum foil for pharmaceutical packaging (also commonly referred to as PTP aluminum foil) is one of the two major constituent materials of this packaging method. Its pinhole degree will directly affect the protection of the final package against the contents. Because if the pinhole of PTP aluminum foil is just in the blister area, which means that the medicine is in direct contact with the outside air, the protective function of the medicine packaging will be completely lost, which brings great risks to the producers and users of the medicine. This risk is unacceptable to most pharmaceutical manufacturers.
There are two causes for PTP aluminum foil pinholes: ① pinholes produced during the production of raw aluminum foil used in the production of PTP aluminum foil; ② pinholes produced during the production of PTP aluminum foil. Since the generation of pinholes in the production of PTP aluminum foil is relatively easy to control and avoid, the following discussion is mainly focused on the pinholes produced during the production of raw aluminum foil for PTP aluminum foil (hereinafter referred to as raw aluminum foil).
A lag of the pinhole standard of raw material aluminum foil At present, the national standard of "aluminum and aluminum alloy foil" on which raw material aluminum foil is produced and inspected is GB / T3198-2003. The relevant expressions of the standard for the pinhole degree of raw material aluminum foil are as follows: The pinhole diameter of aluminum foil for pharmaceutical packaging shall not be greater than 0.3mm, and may not exceed 5 per square meter. (The aforementioned 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 degree of raw material aluminum foil: ① the diameter of the pinhole must not be greater than 0.3mm ② the diameter of the pinhole less than 0.3mm cannot exceed 5 / m2². In the current industry standard YBB00152002, which is the basis for the production and inspection of PTP aluminum foil, the relevant regulations on pinholes are as follows: ① pinholes with a diameter greater than 0.3mm are not allowed; ② the number of pinholes with a diameter of 0.1 ~ 0.3mm must 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 aluminum foil cannot be eliminated in the subsequent production process. Therefore, it is not difficult to see from the above values that the current "National Standard for Aluminum and Aluminum Alloy Foil" on the pinhole degree standard has lagged far behind that stipulated in "YBB00152002".
The difference between the PTP aluminum foil and the raw material aluminum foil pinhole degree according to the standard detection conditions. In the industry standard "YBB00152002" based on the PTP aluminum foil, the detection condition of the pinhole degree is the light in a dark room with zero ambient illumination. The detection conditions of the pinhole degree required in the “National Standard for Aluminum and Aluminum Alloy Foil GB / T3198-2003” according to which the aluminum foil is based on are that the light is carried out under the condition that the ambient illumination is 20 ~ 50lx. For pinholes with a diameter of less than 0.1mm, they can be clearly seen in a dark room, but they may not be seen at all under the environment illumination of 20 ~ 50lx. If the degree of influence of the two test conditions on the test results is taken into account, the pinhole degree standard specified in the “National Standard for Aluminum and Aluminum Alloy Foil GB / T3198-2003” cannot be used as a raw material aluminum foil for pharmaceutical packaging manufacturers. standard.
With the continuous improvement of the production technology of domestic raw material aluminum foil manufacturers, the overall quality of raw aluminum foil is steadily improving. Some companies' internal control standards for pinhole degree have reached the requirements set by YBB00152002, such as Alcoa Shanghai; but more companies produce Aluminum foil products still have a long way to go in terms of pinhole quality quality stability. I think the most fundamental reason for this is that Alcoa Shanghai has a complete production chain from blanks to aluminum foil, which facilitates comprehensive quality control of the aluminum foil production process, and has formed a complete production and quality control system. While other raw material aluminum foil manufacturers do not have a billet production line, the main production link of pinholes-billets, cannot be truly effective in quality control, and can only passively avoid other quality in subsequent rolling and slitting processes. problem.
As can be seen from the above discussion, the pinhole control of PTP aluminum foil is a systematic project, which involves three links of aluminum foil blank production, raw aluminum foil rolling, and PTP aluminum foil production. All three links must be effectively quality controlled to maximize Ground pinholes are reduced. As the best domestic pharmaceutical packaging supplier, Jiangsu Zhongjin Matai Pharmaceutical Packaging Co., Ltd. has 20 years of experience in the production of PTP aluminum foil, and has a stable customer base of high-end pharmaceutical manufacturers. We can learn from their practices:
First of all, we reached an agreement with the supplier on the acceptance criteria of the raw aluminum foil: the detection methods and indicators of the pinhole of the raw aluminum foil are uniformly implemented in accordance with the standards specified by YBB00152002.
The second step is to make a rough judgment on the pinholes (even within the allowable range) found during the sampling inspection of the raw aluminum foil. Once it is determined that the blank is caused by the problem, the sample volume of the aluminum foil of the relevant batch 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 debris particles adhere to the equipment guide rollers.
4. Online spot check during the production of PTP aluminum foil (due to the lack of suitable testing equipment at present, mainly relying on naked eye observation), can effectively find pinholes and linear pinholes with larger diameters not found in the sampling inspection.
5. Carry out a full inspection of the cut-off sample (1 sample / 1000m).
Sixth, analyze, summarize and evaluate the pinholes detected in the above process, and communicate with the supplier in time to analyze and improve.
There is no doubt that under the existing conditions of most companies in the pharmaceutical packaging industry , even after the strict control of the PTP aluminum foil production and testing process described above, it is not possible to ensure the production of PTP aluminum foil with zero pinhole. What a pharmaceutical packaging company can do is to reduce and reduce the risks brought by packaging as much as possible.