Control of microbial contamination in pharmaceutic

e707004304 · Wysłany: Śro 11:36, 09 Mar 2011

Drug control of microbiological contamination

Production plant, processes, jobs should be put by the production and air cleanliness level called for plant, equipment, containers and other cleaning procedures, should include: clear put methods, procedures, when every question asked, the use of detergents or disinfectants , cleaning tools, cleaning and storage locations. Uniform selection, style, and wearing a manner that air purification and production operations and meet the requirements of the degree level. And shall not be mixed. Pharmaceutical production personnel should be health records, personal hygiene should be the same time, requirements and provisions, in particular opponent's health. 2.4 The implementation of certification systems in the pharmaceutical production and quality management experience in the need to strengthen the anal Du Jinghui - permit implementation of the work. Authentication is proving that any procedure, process, equipment, materials, activities or systems can really lead to expected results to ensure that the documented events. GMP norms of the current basic requirements for validation pharmaceutical production validation should include plants, facilities and equipment installation confirmation, Operational Qualification, Performance Qualification, the production process validation, product validation and the main production equipment is changed. And the production of a certain period after the re-verification. Validation of pharmaceutical manufacturing processes include air purification systems,[link widoczny dla zalogowanych], process water systems,[link widoczny dla zalogowanych], production processes and changes, equipment cleaning, the main raw material change; key equipment. Validation of sterile pharmaceutical products including sterilization equipment, liquid filtration and encapsulation (repackaging) system. 2.5GMP Microbiology Applied Microbiology Detection technology methods to monitor drug efficacy and safety of pharmaceutical microbiology is the basic task of quality assurance. Microbiological testing in drug development and quality control plays an important role. Microbiological techniques in the implementation of GMP is an important and indispensable means of monitoring the establishment and development, it is not only a non-sterile pharmaceutical products from raw materials to an effective method of monitoring microbial limit is detected in sterile aseptic pharmaceutical production level of assurance of reliable measures. 3 According to Pharmacopoeia requirements of the samples for microbial limits. Increase the control of microbial contamination of pharmaceutical drugs in order to ensure the strength of the entire production, storage and use of quality. Eliminate potential hazards to health caused by pollution,[link widoczny dla zalogowanych], according to the nature and use of drugs means. The drugs are divided into two categories: one is to require sterilization of drugs, including injections and infusion agent for the body cavity, severe burns, ulcers, bleeding and other ophthalmic preparations for sterility of sterile preparations, including the required gas bacteria, anaerobic bacteria and fungi. During which the sterilization of drugs,[link widoczny dla zalogowanych], including commonly used in I: 1 服 topical agents and general agents, agents generally do not require this part is absolutely sterile, allowing a certain limited number of microorganisms present. But also provides disease-causing bacteria may not have suspected the existence. China Pharmacopoeia of the viable count of non-sterile preparations were determined, including bacteria, fungi (yeast) number determination; control bacteria examination, including E. coli, Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa inspection. On Pyrogen injection determination to do so. Evaluated by the determination of drugs by microbial contamination and the extent of damage. Hygienic quality control of drugs. Diagnosis and treatment of rectal trauma management bears the shield of new Zheng Zhou Yahao 2 Abstract Objective To discuss the anorectal trauma diagnosis and treatment. Methods We reviewed the January 1990 ~ May 2004 asked the 25 patients were treated in our hospital of anorectal injury, (Anoreetalinjury, ARI) of the clinical data. Results 1 died, 4% mortality rate, complication rate of 24% in 7 cases. Including the perianal wound infection, anal stenosis, rectal fistula, rectal perineal fistula, abdominal infection and the infection cut El toxic shock and death in 1 case. Conclusion Early diagnosis, prompt treatment and the importance of associated injuries, is to reduce mortality and prevent complications ARI key. Key words diagnosis and treatment of anorectal injury CLC number: R657.12 Document code: A Article ID :1812 -5859 (2005) 06-0030-03 anus and rectum due to the protection of the pelvis, usually very rare injury, and its The incidence of abdominal injuries accounted for about 0.5% a 5.5% t · 1. But if not promptly diagnosed units may be of: 1 Jinggu County of Simao City People's Hospital of Surgery, (Yunnan 666400) 2 Simao tL Hospital of Thoracic Surgery (Yunnan 666500) Author: Du Jinghui, the Presidency, the attending physician. Serious infectious complications, usually rectal injury mortality 0% to 10% and complication rate of 10% to 45%, this paper information on their treatment in our hospital to make a report. 1 General Information 1.1 clinical data from 1990 January 1 May 2004 were treated in our hospital of anorectal injury (Anoreetalinjury,[link widoczny dla zalogowanych], ABI) 25 cases of iatrogenic injury, except