Analysis on the measures to ensure the sealing qua

2022-08-01
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Analysis on the measures to ensure the sealing quality of high-volume injection plugs

the sealing quality of high-volume injection plugs is guaranteed by the following aspects: first, the quality of rubber plugs; The second is to reasonably determine the quality index after sealing; Third, the design structure of the rubber stopper pressing machine is advanced and reasonable to ensure the quality index after sealing. The following three aspects are analyzed

I. quality of rubber plugs

rubber plugs used in drugs in China are divided into natural rubber plugs and butyl rubber plugs. Most of the rubber plugs used before high-volume injection are natural rubber plugs, and a few use butyl rubber plugs are also wholly-owned enterprises or joint ventures. Because natural rubber plugs were eliminated internationally in the 1970s. China lags behind in the understanding of improving the quality of drug packaging materials. It only proposed to promote the application of butyl rubber plugs in the late 1990s. However, due to price factors and technical quality problems of domestic butyl rubber plugs, the promotion work has been hindered and has not been well implemented so far. With China's entry into WTO, China has become a member of the world trade organization. The technical quality of commodities must be in line with international standards in order to go abroad and carry out international circulation of commodities. Domestic experts and entrepreneurs strongly call for the elimination of natural rubber plugs and the use of butyl rubber plugs to ensure the quality of drugs. The reasons for elimination are: impure natural rubber composition, poor chemical stability, easy aging, poor shielding performance and sealing performance, containing impurities harmful to human body, overflow of additives in the rubber plug production process, affecting the drug quality and hidden dangers to human health. However, butyl rubber (synthetic rubber) solves the above problems due to its good air tightness and becomes a substitute for natural rubber plugs

at present, the call for the use of butyl rubber stopper for high-volume injections has attracted great attention of management departments at all levels. In 2004, the State Food and Drug Administration issued the notice on Further Strengthening the supervision and management of packaging materials and containers in direct contact with drugs (gsyjz [2004] No. 391). The basic requirements of the notice are:

1 The packaging materials and containers related to drugs listed in the "catalogue of drug packaging materials subject to registration administration" shall apply for registration in accordance with the provisions of the measures for the administration of packaging materials and containers in direct contact with drugs

2. According to the measures for the administration of packaging materials and containers in direct contact with drugs, the food and Drug Administration will formulate national standards for all drug packaging materials, and the production and use of drug packaging materials shall comply with national standards

3. The drugs packed with ordinary natural rubber plugs before January 1, 2005 and before December 31, 2004 shall be used up within the validity period of the drugs. Since january1,2005, applications for newly compiled and compiled national standard drugs, imported drugs, hospital preparations and applications for changing drug packaging materials will no longer be accepted for packaging with ordinary natural rubber plugs

the government management department has put forward tough management measures, and the pharmaceutical packaging materials industry standardization committee should organize to formulate a series of quality indicators related to butyl rubber plugs from the aspects of material, structural dimension, manufacturing quality, cleaning, silicification, etc. as soon as possible. Use industrial standards or national standards to guide and supervise drug packaging material manufacturers and users to implement standards, and ensure the quality of rubber plugs

II. Reasonably determine the quality index after sealing with a pressure plug

the quality index after sealing with a pressure plug includes two aspects: on the one hand, the sealing performance of the pressure plug after sealing, that is, the bottle mouth and the rubber plug are free of damage and oil stain, the T-shape of the bottle plug is close to the bottle mouth, there is no gap, and the qualification rate of the pressure plug is more than 99%. The sealing performance of plug sealing can be achieved in China. The second aspect is the oxygen content index of the drug after sealing. The latter attaches great importance to foreign countries. There are clear quantitative provisions on the oxygen content index of sealed drugs, which can only be sold after passing the strict test. For example, the joint venture or wholly-owned enterprise established in China by Fresenius of Sweden and Germany, whose oxygen content index of nutritional infusion drugs such as amino acid and fat emulsion is generally set at 5.5 ~ 7ppm, and can only be sold out of the factory after passing the strict test. Therefore, their infusion drugs account for more than 90% of the sales market in China and are also exported to foreign countries. However, the current situation of domestic infusion production is that there is no unified quantitative index for the oxygen content of easily oxidized drugs, and there is no detection requirement. The anti-oxidation measure adopted is to add a nitrogen filling process before filling or sealing. There are no regulations on the nitrogen filling amount, time and method. It is said that some of them added antioxidants during the preparation of liquid medicine, and even the nitrogen filling process was cancelled. If this is the case, the gap with foreign countries is too large and should be paid attention to. For the oxygen content index of easily oxidizable drugs, China's pharmaceutical experts are urged to make quantitative provisions in the Pharmacopoeia. The pharmaceutical factory and the packaging machinery design and manufacturing factory jointly implement the quality indicators specified in the Pharmacopoeia

after China's accession to the WTO, pharmaceutical units and packaging machinery manufacturers have attached great importance to drug quality standards. Although there is no clear oxygen content index for nutritional infusion, pharmaceutical units have consciously taken measures to seal and prevent oxidation of drugs. For example, Liu nitrogen filling protection of the nitrogen filling, filling and sealing linkage unit ordered by Guangdong Litai Pharmaceutical Co., Ltd. in Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd, It is required to fill the empty bottle with nitrogen before filling, and fill the bottle with nitrogen at the same time during filling. When sealing the butyl infusion bottle plug, it is required to vacuum - fill nitrogen - vacuum - seal the rubber plug. The whole linkage unit is required to work under the nitrogen protective cover. Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd. has designed and manufactured the linkage unit according to this requirement. This proves that China's equipment and drug manufacturers are advancing towards the world's advanced level. However, standards must be used to standardize and unify

III. The design structure of the rubber stopper pressing machine is advanced and reasonable to ensure the quality index after sealing

the design and installation of the rubber stopper pressing machine shall meet the requirements of drug production and process, be safe, stable, reliable, easy to clean and disinfect, easy to operate and maintain, and be able to prevent comparison errors and cross contamination. The material selection of rubber stopper pressing machine shall be strictly controlled

parts and components in self contact with rubber plug and purification medium shall be made of non-toxic, corrosion-resistant materials that do not change chemically with drugs or absorb drugs. The internal surface of the equipment and the surface of the working parts in direct contact with the rubber plug shall be flat, smooth, free of dead corners, and easy to clean and disinfect

the structure of the rubber stopper pressing machine should focus on the following two points: first, ensure that the rubber stopper does not produce particles during transportation; Second, there must be a vacuum pumping and nitrogen filling system to ensure the oxygen content of drugs after sealing

first talk about the rubber plug conveying device, which generally adopts the principle of oscillating conveying. However, no matter what advanced structure is adopted in the design and how the surface finish is guaranteed in the manufacturing process, the relative friction between the rubber plug and the mechanism during the conveying process can not be solved. If there is friction, particles may be generated. The solution of foreign machines is to add water for injection to flush the rubber plug when it is output from the outlet of the oscillating conveyor. Its function is to prevent the rubber particles generated by friction from being brought into the liquid medicine. At the same time, lubrication is added to the sealing of the pressure plug, which has a good pressure plug effect. At the request of users, Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd. has adopted the following structure to solve the friction problem between the rubber plug and the conveying device. That is, the conveyor belt is used for static conveying. Its working principle is to manually Orient (i.e. the T-shape is upward) and place the plug on the conveyor belt, and the rubber plug will follow 26 Power supply voltage: 220V (single-phase) conveyor belt is transported synchronously (statically, without relative friction) to the position of the plug pressing head at the fixed point of the plug pulling wheel. The plug pressing head absorbs the rubber plug through vacuum to complete vacuum pumping, nitrogen filling and plug sealing

the above two forms are designed to solve the possible particle phenomenon of rubber plug during transportation. With the progress of technology, more and better structural forms will appear in the future

talk about vacuum pumping and nitrogen filling system again. Nitrogen and vacuum system are the key measures to ensure the oxygen content index of easily oxidizable drugs, and the two important points to ensure the implementation effect of this measure are; First, when vacuuming and nitrogen filling, the pressure plug device and the bottle mouth must be kept in a closed state. The sealing is not smooth. The effect of vacuuming and nitrogen filling is not good; Second, the nitrogen pressure and vacuum pressure should be controlled to the set value. Both are indispensable. The structure and working principle of the machine is that when the glass bottle is aligned with the cork head, the self-contained sealing cover on the cork head contacts and compresses with the bottle shoulder to form a closed space, that is, the material, shape and manufacturing accuracy of the sealing cover should have reasonable requirements to ensure reliable sealing. The control procedure of the gas control system shall control the stroke (or time), times, vacuum pressure and nitrogen pressure of vacuumizing and nitrogen filling, and alarm and shut down if the requirements are not met

source: sunjinlian, Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd

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