Quality control of pharmaceutical packaging aluminum foil pinhole degree

Drug aluminum-plastic blister packaging, with its beautiful appearance, good barrier property and the ease of use, carry, and many other advantages, has been widely used in the pharmaceutical industry, is currently the drug tablet, capsule of solid dosage forms such as one of the major way of packing. Pharmaceutical packaging aluminum foil ( Usually also called inhibits PTP aluminum foil) As one of the two constitute materials of this kind of packing way, its degree of pinhole will directly affect the final packaging of content protection. Because it inhibits PTP aluminum foil pinhole if just in a bubble, also means that drug direct contact with the outside air, drug packaging protective function will complete loss of producers and users of the drug to bring huge risk, the risk is not acceptable for most drug makers. Inhibits PTP aluminum foil pinhole of two reasons: (1) production inhibits PTP aluminum foil use raw materials produced in the process of production aluminum foil pinhole; (2) inhibits PTP aluminum foil production process of pinhole. Due to inhibits PTP aluminum foil pinhole in the process of production is relatively easy to control and avoid the, the following discussion at inhibits PTP aluminum foil with the raw materials of aluminum foil ( Hereinafter referred to as the raw materials for aluminum foil) Production process of pinhole. A raw aluminum foil pinhole degree standard lag problem at present, the material of aluminum foil production and inspection according to the 'aluminium and aluminium alloy foil' national standard of GB/T3198 - 2003. The standard for raw aluminum foil pinhole degree of related statements are as follows: the pharmaceutical packaging aluminum foil pinhole diameter shall not be greater than zero. 3 mm, and no more than 5 / m22. （ The pharmaceutical packaging aluminum foil which inhibits PTP aluminum foil (foil) of materials This statement specifies the material aluminum foil pinhole degree of two values: 1) pinhole diameter shall not be greater than zero. 3 mm (2) the diameter of less than 0. 3 mm of the pinhole must not exceed 5 / m22. In current inhibits PTP aluminum foil production and inspection according to the industry standard in YBB00152002 rules to pinhole degree are as follows: (1) diameter greater than zero. Pinhole is not allowed to have 3 mm; (2) the diameter of 0. 1 to 0. 3 mm pinhole shall not exceed the number 1 ( For less than 0. 1 mm for the number of pinhole) 。 From inhibits PTP aluminum foil production process is very easy to see, the raw material of aluminum foil pinhole defects can not be eliminated in the subsequent production process. So from the above numerical isn't hard to see the 'aluminium and aluminium alloy foil national standard' of the regulations on degree of pinhole standard has significantly lagged behind the defined in 'YBB00152002'. 2 inhibits PTP aluminum foil with the raw material of aluminum foil pinhole degree according to the standard testing conditions stipulated difference in inhibits PTP aluminum foil on the basis of the industry standard 'YBB00152002' degree of pinhole test requirement is the environment in zero intensity of illumination light in the dark room, in the raw material of aluminum foil on the basis of 'national standard GB/aluminium and aluminium alloy foil T3198 - The required degree of pinhole test condition in 2003 'is in the environmental illumination for 20 ~ 50 lx under the condition of light. For diameter less than 0. 1 mm pinhole, can see clearly in the dark room, but under the condition of environment illumination for 20 ~ 50 lx, may be completely invisible. If considering the conditions of different from the two tests on the degree of impact test results, the 'national standard GB/aluminium and aluminium alloy foil T3198 - Pinhole degree to the standards set by the 2003 'cannot as drug packaging production enterprises of raw material of aluminum foil acceptance criteria. As domestic raw materials aluminum foil manufacturers the continuous improvement of production technology, raw materials of aluminum foil in the overall quality of improved steadily, some enterprises pinhole degree of internal control standards of the products has reached the requirements of the YBB00152002, such as Alcoa Shanghai; But more and more enterprises in the production of aluminum foil products in terms of the quality stability of the degree of pinhole is still a long way to go. I think it is one of the most fundamental reason is Alcoa Shanghai from blank to the entire production chain of aluminum foil, to facilitate the production process of aluminum foil to conduct a comprehensive quality control, has formed a complete production and quality control system. And other raw materials for aluminum foil manufacturers, most do not have blank lines, to the main produce pinhole link - Blank, can't be truly effective quality control, can only passively in the subsequent rolling, cutting process to avoid other quality problems. From the argument that inhibits PTP aluminum foil pinhole control is a system engineering, it involves the aluminum foil billet production, raw material of rolling aluminum foil, inhibits PTP aluminum foil production three link, must be conducted for the three links are effective quality control, to minimize the generation of pinhole.