兽药粉针剂无菌质量控制浅谈

从人员、设备、物料、方法、环境五个方面阐述兽药无菌粉针剂产品的无菌控制方法,从而防止无菌粉针剂生产中的微生物污染。     

诺氟沙星微生物限度检查方法的研究

微生物限度检查法是检查非规定制剂及原料、辅料受微生物污染程度的方法,检查项目包括细菌数、真菌数、酵母菌数及控制菌情况.但具有抑菌成分的药品由于其抑菌活性的干扰,常规检查结果不能真实地反映出药品中污染微生物的情况,必须先消除供试品中的抑菌活性,再根据<中国药典>规定的方法进行检查,并对所采取的检查方法进行验证,以确认抑菌活性的消除和检查方法的可靠性.具有抑菌作用的各个药品的抑菌效果不同,因此适合的微生物限度检查法也不同.试验对诺氟沙星胶囊微生物限度检查方法进行了进一步的研究,试图找到一种可以消除诺氟沙星胶囊在试验条件下抑菌作用的新方法.     

无菌药品生产企业核心区微生物污染调查与分析

对8家无菌药品生产企业的核心生产区(即动态A/B级)环境进行调查并分析。本文对无菌药品生产企业核心区微生物污染进行调查与分析。     

冰鲜鸭中主要腐败菌来源及菌相分析

研究了生鲜鸭肉产品在生产和冷藏过程中相关腐败微生物多样性和动态变化。通过对不同生产过程中环境对胴体表面造成的交叉污染进行分析,为在线控制微生物生长提供数据和理论基础,达到降低微生物污染,提高产品保质期的目的。     

新疆某肉牛屠宰场微生物污染关键点检测分析

为了对新疆某肉牛屠宰场肉牛的屠宰加工、排酸及分割过程中微生物污染状况进行调查研究,为控制屠宰加工企业微生物污染,并提高牛肉及其产品的卫生质量,试验采用GB/T 4789.2—2008及GB/T 4789.3—2008的方法,分别选取屠宰过程中牛胴体排酸前后各部位的分割牛肉、操作工人的手、刀具、操作台、传送带、围裙、包装袋等进行菌落总数和大肠菌群两项微生物指标的测定,同时调查各车间空气的微生物污染状况。结果表明:该屠宰场在牛的屠宰及分割过程中存在不同程度的微生物污染。合理的胴体排酸条件既可以提高肉品质又可有效降低微生物污染程度,牛胴体排酸前后大肠菌群数分别为(1.57±0.18)log MPN/cm2、(0.87±0.10)log MPN/cm2,且差异显著(P0.05)。对于倒吊排酸胴体而言,下部位分割肉微生物污染高于上部位分割肉。屠宰场在屠宰及分割生产线上胴体表面和分割肉微生物污染仍然比较普遍,除去肉牛自身的污染外,刀具、工人的手、操作台和传送带及车间环境是胴体微生物污染的重要污染源。因此,高档牛肉及制品的生产更加需要严格的卫生管理、规范的生产操作和规范化的操作环境。     

种蛋的污染、腐败变质及控制措施

一个种蛋是一个幼小生命的起源，它富含各种营养成分。在种蛋生产、孵化过程中，如果微生物污染并侵入种蛋内部，则可以其丰富的营养成分为基质而大量增殖。最终导致种蛋腐败变质、胚胎死亡或孵出弱雏。生产实践中，完全避免种蛋的污染往往是不容易的。因而严重制约了雏鸡质量和孵化场的经济效益的提高，所以必须采取有效的综合措施，把种蛋的污染和腐败变质控制在最低限度。 　　一种蛋的抗菌因素 　　1健康种鸡可以通过机体的免疫功能和输卵管的自净排菌作用，保持生殖器官尤其是卵巢处于无菌状态，使种蛋在形成过程中免遭微生物的污…     

降低牛细管冻精细菌数的技术措施

牛冻精中细菌数超标,不仅使冻精质量下降,影响母牛受胎效果,而且容易引发母牛生殖疾病,造成屡配不孕,影响母牛繁殖生产和身体健康.在牛冻精生产过程中,由于精液被灌装到无菌的塑料细管内并且被密封,避免了精液的污染机会.精液巾细菌数偏高,往往是精液在灌装到细管前受到污染的.因此,加强精液的采集和精液在灌装前的处理这两个环节的工作尤为重要.笔者从事牛冷冻精液生产十余年,通过对冻精生产这两个环节的不断改进,取得了理想的效果,细菌数明显降低,80%的冻精细菌数控制在每剂量在50个以下.现将采取的措施加以总结,供同行参考.     

生鲜乳中致病微生物污染来源、危害与消减措施

生鲜乳中致病微生物污染严重影响乳及其制品的质量安全。本文分析了致病微生物的污染来源,并对生鲜乳中可能携带的对消费者健康有影响的37种病原微生物综合其致病性和耐药基因传播进行危害分析,明确了需优先管控的致病微生物风险排序,为我国生鲜乳全产业链中致病微生物认知、防控、风险评估提供技术参考。同时结合我国生鲜乳不同生产模式,提出影响消费者健康的致病微生物消减措施：养殖环节要加强饲料、牛舍和牛体的微生物控制;挤奶环节加强挤奶工具、挤奶员工、和药浴时的微生物控制;贮运环节要加强储存和运输过程中的微生物控制。这些针对性防控策略建议,将促进相关方及时跟进生鲜乳质量安全控制,降低乳制品消费风险。     

对于手术过程中保持无菌环境的思考

实施手术之前,器械和物品都要灭菌消毒,手术人员要洗手、消毒、穿戴无菌手术衣和手套,手术区也要消毒和铺盖无菌创巾,这些措施为手术提供了一个无菌操作环境.但是,在手术过程中,如果不注意保持这种无菌环境,则会使已经灭菌和消毒的物品或手术区域受到污染,导致伤口感染的发生,有时可使手术失败,甚至影响病畜的生命.本人以在动物医院实践所得体会,对手术过程中保持无菌环境的问题做出几点思考,愿与同行讨论.     

病死动物无害化处理的技术规程及方法

在动物养殖环节中不可避免的会发生死亡现象,病死动物(家畜禽)尸体处理不当,会对环境造成污染,也能威胁人类健康。所以要采取无害化处理,将病死动物对环境和人类的危害降到最低。1技术规程运尸人员应穿戴工作服、口罩、胶鞋及手套,尸     

Investigations into the use of respiratory masks for reducing the MRSA-exposure of veterinarians visiting regularly pig herds--first experiences

The study presents first experiences on the controlled use of respiratory masks against Methicillin-resistant Staphylococcus aureus (MRSA) in a multi-person veterinary pig practice. Seven veterinarians entered the trial (five wearing masks, two wearing no masks) after the veterinarians had performed a decolonisation protocol. The pig herds were visited regularly by the veterinarians during the study period. The five "trial" veterinarians wore gloves and respiratory masks for at least 30 days and 30 farm visits. The two "control" veterinarians wore gloves only. Nasal swabs were collected at a seven day interval. Swabs and ten masks per "trial" veterinarian were bacteriologically tested for MRSA including MLST- and spa-typing. The study showed a high MRSA-exposure for the veterinarians, since 68% of the masks were tested positive for MRSA. However, four vets stayed MRSA-negative while using the masks. Only one of the"trial" veterinarians became positive after two weeks. After the masks were not worn any more, two veterinarians returned to colonisation soon again. The two "control" veterinarians turned positive after 26 and 54 days, respectively. The high finding-rates of MRSA in the masks proof an enormous risk of nasal colonisation during routine work.The results of our study do not proof the potential of respiratory masks to prevent nasal colonisation of veterinarians with MRSA. However, there are no hints, that the proper use of masks could be a risk factor for becoming colonised. Further details of the proper use of masks and the quantification of their protective potential need further studies on a larger scale.     

Postoperative integrity of veterinary surgical gloves

A multicenter, prospective study was performed to document the incidence of defective gloves postoperatively in veterinary surgery and to correlate defects with a variety of influencing factors. Gloves were collected after surgical procedures performed by the small animal clinical services at two veterinary teaching hospitals and one institution's student surgery laboratories. Gloves were evaluated for defects using electrical resistance testing. The overall incidence of glove defects was 23.3%. Significantly more defects occurred in gloves used for nonsoft-tissue procedures and in gloves worn on the nondominant hand. Eighty-four percent of all defects occurred in procedures lasting >60 minutes. No differences were detected in the brands of gloves used nor among surgeons of different experience levels. The individuals performing the surgery were not able to accurately predict the presence of a defect in their gloves. Surgeons should remain alert for possible glove defects and consider measures such as changing gloves every 60 minutes or double-gloving to minimize potential complications.     

冷冻饮品微生物污染风险分析和防治措施研究进展

冷冻饮品行业近年来发展迅速,但冷冻饮品消费市场不断扩大的同时,也暴露了微生物污染等一些突出问题。利用近年来冷冻饮品的食品安全抽检结果,本文对冷冻饮品的微生物污染进行风险分析,并结合冷冻饮品的生产工艺特点提出微生物污染的防控措施,为提升我国冷冻饮品食品安全水平提供参考。     

Bacterial contamination of gloves worn by small animal surgeons in a veterinary teaching hospital

This prospective study investigated bacterial contamination of surgical gloves during small animal surgical procedures and factors associated with glove contamination. The outer surface of surgical gloves was sampled and cultured after completion of surgical procedures. Bacterial presence and numbers were recorded. Of 78 gloves sampled from 39 surgical procedures, bacterial contamination was noted in 16/78 (21%) gloves from 12/39 (31%) procedures. There was no difference in contamination of left or right hand glove [7/39 (18%) versus 9/39 (23%)], respectively (P = 0.78). There was no impact of glove type of left hand (P = 0.41), right hand (P = 0.44) or either hand (P = 0.26) contamination, or of surgical time (P = 0.71), dominant hand (P > 0.13), surgery type (orthopedic versus soft tissue versus neurological) (P > 0.42) or surgical wound classification (P > 0.11) on the incidence of contamination.     

重组溶葡萄球菌酶对奶牛乳房炎和子宫内膜炎常见病原菌的体外杀菌试验

从患乳房炎和子宫内膜炎奶牛的奶或子宫黏液中分离菌株,鉴定后选取金黄色葡萄球菌105株、表皮葡萄球菌20株、大肠埃希氏菌20株、链球菌38株(其中停乳链球菌8株,无乳链球菌30株)和牛源多杀巴氏杆菌5株,在体外用重组溶葡萄球菌酶、苯唑西林、氨苄西林、庆大霉素按照微量肉汤稀释法进行了杀菌试验。结果表明,重组溶葡萄球菌酶对奶牛乳房炎和子宫内膜炎分离的金黄色葡萄球菌和表皮葡萄球菌具有良好抑杀效果,对链球菌(包括无乳链球菌和停乳链球菌)和牛源多杀巴氏杆菌具有一定的抑杀效果,对大肠杆菌作用较差;苯唑西林、氨苄西林、庆大霉素都有一定量的耐药菌株产生,而重组溶葡萄球菌酶对苯唑西林、氨苄西林、庆大霉素耐药菌株同样具有良好抑杀效果。     

Risk factors for Listeria monocytogenes contamination in French laying hens and broiler flocks

The objective of this study was to identify potential risk factors for Listeria monocytogenes contamination in French poultry production. Eighty-four flocks of layer hens kept in cages and 142 broiler flocks were included in this study. For each production type, a questionnaire was submitted to farmers and fecal samples were taken to assess the L. monocytogenes status of the flocks during a single visit to the farm. Two logistic regression models (specific to each production) were used to assess the association between management practices and the risk of L. monocytogenes contamination of the flock. The prevalence of L. monocytogenes-positive flocks was 30.9% (95% CI: 21.0; 40.9) and 31.7% (95% CI: 24.0; 39.4) for cage-layers and broiler flocks, respectively. For layer flocks, the risk of L. monocytogenes contamination was increased when pets were present on the production site. When droppings were evacuated by conveyor belt with deep pit storage, the risk of L. monocytogenes contamination decreased significantly. Feed meal was found to be associated with a higher risk of L. monocytogenes contamination than feed crumb. For broiler flocks, the risk of L. monocytogenes contamination was increased when farmers did not respect the principle of two areas (clean and dirty) at the poultry house entrance. A first disinfection by thermal fogging and the absence of pest control of the poultry house before the arrival of the next flock was found to increase the risk of contamination. When litter was not protected during storage and when farm staff also took care of other broiler chicken houses, the risk of L. monocytogenes contamination increased significantly. In the case of the watering system, nipples with cups were found to decrease the risk of contamination.     

Influence of milking technique, milking hygiene and environmental hygiene parameters on the microbial contamination of milking machines

It was the aim of this study to investigate the effect of various factors of the milking technique, milking hygiene and environment on microbial contamination of the milking machine. In 31 dairy herds, the degree of bacterial contamination was examined by taking swabs at four locations (teat cup liner, claw, short and long milk tube) before the milking procedure was started using a standardized protocol (DIN ISO 6887-1:1999). Furthermore, the total germ count was determined in the first milk entering the bulk tank as well as in the bulk tank milk following milking. For each farm, the quality of the milking process and the condition of the milking machine as well as of various environmental factors were recorded. A subjective evaluation of the status of the milking cluster or other parts of the milking machine ("good" or "moderate-poor") gave more information about bacterial contamination than the determination of age and type of material used. A temperature of the rinsing water of < 42 degrees C increased the contamination with Pseudomonas spp. and coliform bacteria. Milking clusters kept out of the cluster pick-up between milking had a higher risk of microbial contamination. Various methods of teat cleaning before milking or of postmilking teat disinfection did not affect the contamination of the milking machine and the bulk tank milk with environmental bacteria. Furthermore, type of bedding material affected bacterial contamination of milking clusters and bulk tank milk. In conclusion, our results suggest that the microbial contamination of the milking machine is not only influenced by the sanitation pro-     

Survey of Intraoperative Bacterial Contamination in Dogs Undergoing Elective Orthopedic Surgery

Objective

To investigate the frequency, source, and risk factors of intraoperative (IO) surgeon and patient bacterial contamination during clean orthopedic surgeries, and to investigate the relationship between IO contamination and surgical site infection (SSI) in dogs.

Study Design

Prospective clinical study.

Sample Population

Client‐owned dogs undergoing stifle surgery (n = 100).

Methods

IO cultures were taken in each case from surgical foot wrap, peri‐incisional skin, surgical gloves, and the surgical team's hands. The environment (operating room [OR] lights, computers, scrub sink faucet, anesthesia gurney, and radiology table) was sampled every 5 months. Bacteria were identified and the contamination of each case was categorized. All gloves from the surgical team were collected and tested for perforations using a water infusion test. Cases were followed for at least 8 weeks to determine the presence or absence of SSI. Perioperative variables were evaluated for association with IO contamination and SSI.

Results

Bacterial isolates were yielded from 81% of procedures from 1 or more sources; 58% had positive hand cultures, 46% had positive glove cultures, 23% had positive patient skin cultures, and 12% had positive foot wrap cultures. Staphylococcus spp. was the most commonly recovered bacteria. There was no apparent association between IO contamination and SSI. The highest level of environmental contamination was associated with the scrub sink faucet, followed by the radiology table, anesthesia gurney, and OR computers. The IO glove perforation rate was 18%.

Conclusion

Clean orthopedic procedures commonly had clinically insignificant bacterial contamination. In our study, bacteria responsible for SSI did not appear to colonize the patient in the OR.     

Risk factors for Salmonella enterica subsp. enterica contamination in French broiler-chicken flocks at the end of the rearing period.

Broiler-chicken are often Salmonella carriers. However, these bacteria are responsible for major food-borne human infection, in which poultry-meat products are frequently implicated. In order to prevent Salmonella spread during the slaughtering process, control measures should be implemented at the farm level to reduce the prevalence before slaughtering. The objective of this study was to identify the risk factors for Salmonella contamination in French commercial broiler flocks at the end of the rearing period. A prospective study was carried out in 1996 and 1997 on 86 broiler flocks located in western France. The Salmonella status of the flocks was assessed by means of litter swabs and dust samples analyzed with classical bacteriological methods. Sixty flocks (70%) had at least one contaminated environmental sample and were classified as Salmonella-contaminated flocks. Logistic regression was used to assess association of managerial practices, general hygiene and results of environmental Salmonella recovery, with the odds that the flock itself would be Salmonella-contaminated at the end of the rearing period. Salmonella contamination of the house before placing day-old chicks and the Salmonella contamination of day-old chicks were significantly related to Salmonella contamination of the flock at the end of the rearing period. The risk for Salmonella contamination of the flock was increased when feed trucks parked near the entrance of the change room and when feed meal, instead of small pellets, was provided at the start.     

Risk assessment strategies for Europe: integrated safety strategy or final product control: Example of Listeria monocytogenes in processed products from pork meat industry

The European regulation 2160/2003 of November 17th, 2003 clearly shows the European strategy of zoonosis monitoring and control as an integrated approach, including the entire food production chain with a first application to Salmonella control in different animal species. This regulation is the consequence of a risk assessment performed with a "farm to fork" philosophy. European strategy is scarcely different from the American strategy, despite the fact that both were achieved by a quantitative risk assessment, as for instance, in the USA the control of Salmonella in eggs is supposed to be completed by refrigeration. Nevertheless, the EU will still have a final product control approach towards future regulations on microbiological criteria for foodstuffs. The final production monitoring and control with HACCP (93/43/EC) and microbiological criteria is the only one available for L. monocytogenes in foodstuffs. The purpose of this paper is to discuss alternative control strategies for L. monocytogenes in pig production including integrated risk assessment. In France, most of the food-borne outbreaks associated with L. monocytogenes in delicatessen were due to one particular group of strains belonging to serovar 4b and presenting a particular RFLP/PFGE (Restriction Fragment Length Polymorphism/Pulsed Field Gel Electrophoresis) profile. The outbreak itself is always associated with the initial contamination of a RTE ("ready to eat") product and re-contamination by inappropriate handling after cooking. Consequently, in most cases the RTE product is subject to inadequate refrigeration during an excessive shelf-life. The responsibility of the food industry and the consumer is clearly engaged during this scenario of foodborne diseases. The question is how to avoid the introduction of this particular strain of L. monocytogenes in the food chain. In a study we tried to evaluate the risk of pig carcass contamination at slaughterhouse level and to identify the main risk factors associated with the infection of live pigs. In most cases inappropriate cleaning and disinfection of surfaces were associated with the contamination of raw meat, but in some cases the introduction of epidemic strains in the food chain was also associated with primary production. Feeding with soup in piggeries seemed to select a particular microbial ecology associated to L. monocytogenes contamination of live pigs. The possible strategies that may be used to control L. monocytogenes in live pig production are not yet developed sufficiently to be included in the EC regulation but should be discussed in more detail.