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Weighing equipment should be based on different absolute accuracy, select the appropriate scale weighing range of platform balances, scales, or scales, weighing instruments dust should have a certain capacity, in order to comply with GMP, should be able to connect the printer to print in real time. For some little weight,[link widoczny dla zalogowanych], but because of small and large volume density of the material, the weighing equipment selection should pay special attention. If the connection can be through a variety of materials management and computer software connected to the material by reading the bar code real-time transmission of information to the materials management system is better. The installation of weighing equipment should be noted that vibration,[link widoczny dla zalogowanych], voltage, electromagnetic interference, humidity, temperature, the negative impact of such factors. Placed in special table, the best table on the corner of the room,[link widoczny dla zalogowanych], away from the vibration source, away from the air, doors and other places have a strong air current, the use of fluorescent lamps as light sources. In addition, in the weighing process,[link widoczny dla zalogowanych], the powder and the packaging of static friction between the weighing will bring many negative effects, we can appropriately increase the relative humidity, in addition to static equipment grounding or other devices to eliminate static electricity. Should be preheated before weighing instrument or for a long time to keep energized. 3.2 Under the settlement through the facilities of catching dust low-negative pressure air flow in the operating area are to produce a clean local environment. Thus, to avoid leakage of material in the weighing process and cross-contamination between drugs. This can be a weighing hood, laminar flow can be a car, or other form. 3.3 Other suppliers or manufacturers that they will use wooden pallets, these pallets should be prohibited from entering the clean area, under normal circumstances, clean the area of the tray should be dedicated, and in the vicinity of the weighing room cleaning and disinfection. Spoon a class of items should be selected for weighing raw materials do not react with the material, if possible, a set of tools for each specific material. Mop with the use of disposable cleaning cloth, rag, so as to reduce cross-contamination. Widow [References] [1] NickPhillips. WeighingandDispensing: DoitGongyitantaoyuXit. ngsheji ◆ Process and system design of a Right [DB / OL]. http}} deleted. pharmamanufacturing. com/articles/2007/099. html ,2009-11 an l8 [2] InternationalConferenceOilHarmonizationofte-chnicalRequirementsforRegistrationofPhar-maceuticalsforHumanuse. GoodManufacturingPracticeGuideforActivePharmaceutica1Ingre-dients: ICHQ7Es] [3] State Food and Drug Administration Drug Certification Center. EU GMP Guide for Pharmaceutical Received date :2009-1 Bu 27 Author: Wen Lijuan,[link widoczny dla zalogowanych], female, engineers, research direction: architectural design. (Continued from page 26) a longer process. However, we believe that by PAT in pharmaceutical research and development, production and quality control play and show the advantages of growing, PAT must be able to bring more security and higher quality drugs. [References] EllGuidanceforIndustry: PAT - AFrameworkforIn-novativePharmaceuticalDevelopment, Manufactu-ring, andQualityAssurance. FDA [2] Wan-Zhen Lu, Xiao-Li Chu. Near infrared spectroscopy (NIR) and process analytical technology (PAT) [J]. Modern scientific instruments, 2007,4:13 ~ 17 [3] Wang. PAT: through knowledge intensive approach to ensure quality [4] Liu Quan. Near-Infrared Process Analytical Technology in the pharmaceutical industry quality control of [5] Liang Yi. GMP Guide [M]. Beijing: Chinese Medical Science and Technology Press, 2003.246 [6] D. ChristopherWatts, Ph. D. PAT: ProcessAnalyti-calTechnology Received Date :2009-10-09 Description: Rongxiao Yang (1984 a), Male, China Pharmaceutical University, Graduate School of International Pharmaceutical Business, research direction: up drugs at home and abroad, quality management and supervision . Electrical and Information 5 2010 251 29 General Administration
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