According to the author's research and investigation, there are many opinions on the selection, configuration and process of oral liquid preparation equipment. According to the premise that the oral liquid preparation production process and equipment are reasonably configured, it is produced in non-sterile medicine, and its zui high cleanliness level. It is also only 100,000. It is usually used for the cleanliness of the exposure process of 300,000. At present, there are several problems in the production equipment and process of oral liquid preparation: (1) When preparing clean air in the sterilization and drying cabinet, 100 layers of laminar flow are still selected; (2) in the sterilization and drying control, still press The indicator of the antibiotic bottle to pyrogen "350 ° C for 5 min" or other control; (3) still wash the bottle according to the antibiotic bottle requirements (one super + three water three gas) or still use 0.22 μm filtration on the circulating water system.
With such a high configuration, is it necessary? The author feels that as long as the selection, configuration and process of oral liquid preparation equipment must conform to the reality of GMP and production process, it must also consider economics and rationality.
1 Discussion on the problems of the bottle washing machine used in the oral liquid and the process based on the commonly used oral liquid bottle has the national standard, namely "regulated oral liquid bottle" (type A and type C) (YY0056-91), while using the regulatory system Oral liquid bottles have been shipped to the factory according to the standard of medicine packaging materials. Therefore, the use of a set of antibiotic bottles (one super + three water three gas) seems to be a waste. Because the "one water and one gas" after the Zui in the antibiotic bottle (one super + three water three gas) is water for injection and clean air (0.22 μm), the antibiotic bottle cleaned by this method has been verified to have a cleanliness level of 10,000 and The corresponding indicator of the powder needle process. However, the index of oral liquid bottle cleaning is much lower than that of antibiotic bottle cleaning, and it does not need to be "one water and one gas" after the above. Therefore, from the perspective of saving water and improving productivity, the author believes that the oral liquid bottle washing machine only needs (one super + two water two gas) cleaning method is enough. Therefore, the pharmaceutical factory and the pharmaceutical machine manufacturer are reminded that the formation of the process and equipment should be based on the actual process requirements of the oral liquid preparation.
Some of the bottle washers equipped with oral liquid bottles still use the 0.22 μm filtration configuration in the circulating water system according to the antibiotic bottle requirements. The waste filter is configured in this way because the oral liquid is prepared by using purified water, and the dosing system is usually filtered by 0.45 μm, and the oral liquid preparation has a high cleanness process of only 100,000 grades. Therefore, from the configuration and process matching and saving operating costs, as long as the 0.45μm filter is used for circulation.
2 Discussion on the problems of tunnel sterilization dryer and process used in oral liquid GMP GMP oral liquid preparations are included in non-sterile medicines, and their production environment requirements: cleanliness of exposure process of non-zui terminally sterilized oral liquid medicines For the 100,000 class, the cleanliness of the exposure process of Zui's terminally sterilized oral liquid medicine is 300,000. However, many domestic pharmaceutical factories still have 100-level high-efficiency laminar flow when configuring an oral liquid bottle tunnel type sterilizer. This arrangement increases the operating cost and is not necessary. Because of the design process layout, the non-zui terminally sterilized oral liquid medicines are listed as 100,000 grades from the bottle washing section to the filling section, and the tunnel sterilizing dryer has collected air ducts of up to 100,000 grades. Meet the process requirements. Therefore, in terms of equipment configuration, the author believes that the end-sterilized oral liquid medicine for Zui does not have a high-efficiency filter directly into the clean indoor air or only the equivalent 100,000-class filter in ordering the tunnel-type sterilization dryer; Sterilized oral liquid medicines do not have high-efficiency filters or only sub-high efficiency filters when ordering tunnel-type sterilization dryers.
Process control for sterilization and drying of oral liquid bottles. Since the oral liquid bottle only needs to be sterilized and sterilized, it is not necessary to go to the pyrogen. So is it necessary to apply antibiotic bottles to the pyrogen for sterilization and drying at 350 ° C for 5 min? Or the sterilizing drying temperature of the ampule to the pyrogen is 300 ° C for 4 min? This is related to the economic and rationality of the configuration equipment in line with the actual requirements of GMP and production processes. According to the experience of the production of Dadu oral liquid preparation, it is generally considered that the temperature of the oral liquid bottle sterilization and drying is 250 ° C for 5 min, but it must be determined by process verification.
3 Discussion on the elimination of sterilization and drying process in the process of Zui terminally sterilized oral liquid For most of the oral liquid preparation products, the main sterilization type is Zui, and the Zui must be extinguished by the water bath steam sterilization cabinet ( Killed) bacteria are leaked before leaving the factory. Among them, since the drying process of the oral liquid bottle only serves as a sterilization and moisture control, and does not control the drying index, it is also liquid-filled thereafter. From this point of view, the drying process of the bacteria can be omitted, as long as the visible foreign matter and insoluble particles after washing the bottle can be controlled to meet the corresponding standards, and the "air blowing" process can be added at the end of the bottle washing machine to control the water content. Enter the filling process. Also, since the oral liquid agent Zui is finally treated by a water-bath steam sterilization cabinet (here is sterilization, not pyrogen sterilization), the author believes that the drying process of the oral liquid bottle can be omitted. It is reported that a number of oral liquid manufacturers in Guangdong and other production of oral liquid products can be passed GMP acceptance by the method of “saving the drying processâ€. Production practice shows that this method can work. Of course, this method needs to be monitored and coordinated by the corresponding agencies of the pharmaceutical factory QA to form a practical, energy-saving and reliable model, which can be truly applied to the production of Zui terminally sterilized oral liquid medicine.
With such a high configuration, is it necessary? The author feels that as long as the selection, configuration and process of oral liquid preparation equipment must conform to the reality of GMP and production process, it must also consider economics and rationality.
1 Discussion on the problems of the bottle washing machine used in the oral liquid and the process based on the commonly used oral liquid bottle has the national standard, namely "regulated oral liquid bottle" (type A and type C) (YY0056-91), while using the regulatory system Oral liquid bottles have been shipped to the factory according to the standard of medicine packaging materials. Therefore, the use of a set of antibiotic bottles (one super + three water three gas) seems to be a waste. Because the "one water and one gas" after the Zui in the antibiotic bottle (one super + three water three gas) is water for injection and clean air (0.22 μm), the antibiotic bottle cleaned by this method has been verified to have a cleanliness level of 10,000 and The corresponding indicator of the powder needle process. However, the index of oral liquid bottle cleaning is much lower than that of antibiotic bottle cleaning, and it does not need to be "one water and one gas" after the above. Therefore, from the perspective of saving water and improving productivity, the author believes that the oral liquid bottle washing machine only needs (one super + two water two gas) cleaning method is enough. Therefore, the pharmaceutical factory and the pharmaceutical machine manufacturer are reminded that the formation of the process and equipment should be based on the actual process requirements of the oral liquid preparation.
Some of the bottle washers equipped with oral liquid bottles still use the 0.22 μm filtration configuration in the circulating water system according to the antibiotic bottle requirements. The waste filter is configured in this way because the oral liquid is prepared by using purified water, and the dosing system is usually filtered by 0.45 μm, and the oral liquid preparation has a high cleanness process of only 100,000 grades. Therefore, from the configuration and process matching and saving operating costs, as long as the 0.45μm filter is used for circulation.
2 Discussion on the problems of tunnel sterilization dryer and process used in oral liquid GMP GMP oral liquid preparations are included in non-sterile medicines, and their production environment requirements: cleanliness of exposure process of non-zui terminally sterilized oral liquid medicines For the 100,000 class, the cleanliness of the exposure process of Zui's terminally sterilized oral liquid medicine is 300,000. However, many domestic pharmaceutical factories still have 100-level high-efficiency laminar flow when configuring an oral liquid bottle tunnel type sterilizer. This arrangement increases the operating cost and is not necessary. Because of the design process layout, the non-zui terminally sterilized oral liquid medicines are listed as 100,000 grades from the bottle washing section to the filling section, and the tunnel sterilizing dryer has collected air ducts of up to 100,000 grades. Meet the process requirements. Therefore, in terms of equipment configuration, the author believes that the end-sterilized oral liquid medicine for Zui does not have a high-efficiency filter directly into the clean indoor air or only the equivalent 100,000-class filter in ordering the tunnel-type sterilization dryer; Sterilized oral liquid medicines do not have high-efficiency filters or only sub-high efficiency filters when ordering tunnel-type sterilization dryers.
Process control for sterilization and drying of oral liquid bottles. Since the oral liquid bottle only needs to be sterilized and sterilized, it is not necessary to go to the pyrogen. So is it necessary to apply antibiotic bottles to the pyrogen for sterilization and drying at 350 ° C for 5 min? Or the sterilizing drying temperature of the ampule to the pyrogen is 300 ° C for 4 min? This is related to the economic and rationality of the configuration equipment in line with the actual requirements of GMP and production processes. According to the experience of the production of Dadu oral liquid preparation, it is generally considered that the temperature of the oral liquid bottle sterilization and drying is 250 ° C for 5 min, but it must be determined by process verification.
3 Discussion on the elimination of sterilization and drying process in the process of Zui terminally sterilized oral liquid For most of the oral liquid preparation products, the main sterilization type is Zui, and the Zui must be extinguished by the water bath steam sterilization cabinet ( Killed) bacteria are leaked before leaving the factory. Among them, since the drying process of the oral liquid bottle only serves as a sterilization and moisture control, and does not control the drying index, it is also liquid-filled thereafter. From this point of view, the drying process of the bacteria can be omitted, as long as the visible foreign matter and insoluble particles after washing the bottle can be controlled to meet the corresponding standards, and the "air blowing" process can be added at the end of the bottle washing machine to control the water content. Enter the filling process. Also, since the oral liquid agent Zui is finally treated by a water-bath steam sterilization cabinet (here is sterilization, not pyrogen sterilization), the author believes that the drying process of the oral liquid bottle can be omitted. It is reported that a number of oral liquid manufacturers in Guangdong and other production of oral liquid products can be passed GMP acceptance by the method of “saving the drying processâ€. Production practice shows that this method can work. Of course, this method needs to be monitored and coordinated by the corresponding agencies of the pharmaceutical factory QA to form a practical, energy-saving and reliable model, which can be truly applied to the production of Zui terminally sterilized oral liquid medicine.
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