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    美国药典USP1117对培养基配制及质量控制的要求(二)

    日期:2023-10-25 | 中海生物行业综合 | 浏览:849 次

    Media Storage培养基存储

    It is prudent to consider how the manufacturer or supplier transports and stores media before distribution to the end user.Manufacturers of media should use transport and storage conditions that minimize the loss of moisture, control the temperature, prevent microbial contamination, and provide mechanical protection to the prepared media.

    培养基的生产商或供应商在培养基销售给最终用户前的运输和存储方式是需要慎重考虑的。培养基生产商所采用的运输和存储条件应最大程度降低水份损失、保证温度的控制、防止微生物污染,提供对已制备培养基的物理保护。

    Media should be labeled properly with batch or lot numbers, preparation and expiration dates, and media identification.Media should be stored according to the manufacturer's instructions. Media prepared in house should be stored under validated conditions. Do not store agar at or below 0°, as freezing could damage the gel structure. Protect stored media from exposure to light and excessive temperature. Before prolonged storage, agar plates should be placed into a sealed package or container to retard moisture loss.

    培养基应标记批号,制备时间和有效期,以及培养基识别信息。培养基应根据生产商说明进行存储。公司自己制备的培养基应在经过验证的条件下存储,不要将琼脂培养基存储在等于或低于0℃条件下,因为结冻可能对胶质结构造成损伤。存储期间培养基应避光,避免超温。如果需要长期存储,琼脂平板应放在密封的包装或容器中以减少水份损失。

    Remelting of an original container of solid media should be performed only once to avoid media whose quality is compromised by overheating or potential contamination. It is recommended that remelting be performed in a heated water bath or by using free-flowing steam. The use of microwave ovens and heating plates is common, but care should be taken to avoid damaging media by overheating and to avoid the potential injury to laboratory personnel from glass breakage and burns. The molten agar medium should be held in a monitored water bath at a temperature of 45° to 50° for not more than 8 hours. Caution should be taken when pouring the media from a container immersed in a water bath to prevent water from the bath commingling with the poured sterile media. Wiping the exterior of the container dry before pouring may be advisable.

    固体培养基只能再融化一次,以避免培养基由于过热或潜在污染造成质量问题。建议在热水浴中或使用自由流动蒸汽融化培养基。使用微波炉和加热盘也是常见的,但需要注意避免因为过热造成培养基损伤,避免因玻璃仪器破裂和烧伤引起化验室人员受伤。熔化的培养基在40~45℃水浴中存放不超过8h。将培养基从浸在水浴中的容器中倒出时要特别注意,避免水浴用水混入倒出的无菌培养基中。最好在将容器从水浴中取出后、倾倒前,将容器外表面擦干。

    Disposal of used cultured media (as well as expired media) should follow local biological hazard safety procedures.

    使用过的培养基处理(和过期的培养基)需要按照生物危害安全程序处理。

    Quality Control Testing质量控制检测

    Although growth media can be prepared in a laboratory from individual components, many laboratories, for ease of use, use dehydrated media or purchase commercially prepared media in plastic plates or glass containers. Manufacturers of media attempt to standardize raw materials from biological sources, but must constantly deal with unavoidable differences in raw materials obtained from natural sources, and therefore, lot-to-lot variability of media must be considered. In addition, the performance of media prepared in a laboratory or by a manufacturer is highly dependent on preparation and storage conditions.Improper media preparation can cause unsatisfactory conditions for microbial growth or recovery and unreliable results.

    虽然培养基可以采用各组份配制而成,但许多化验室为了方便,采用培养基干粉或采购商业制备的成品培养基。培养基生产商会尽量采用同一生物来源的原料,但这些原料不可避免会有差异,因此需要考虑到培养基批次之间的差异。另外化验室制备的或者生产商制备的培养基的性能很大程度上取决于制备条件和存储条件。培养基制备不当会导致微生物生长或恢复不理想,从而导致不可靠的结果。

    Therefore, quality control tests should be performed on all prepared media, including media associated with swabs or media in strips and other nontraditional formats. Tests routinely performed on in-house prepared media should include pH, growth promotion, inhibition, and indicative properties (as appropriate), and periodic stability checks to confirm the expiration dating.

    因此,需要对所有制备的培养基进行质量控制检测,包括与擦拭棉签相关的培养基、条状培养基和其他非传统方式培养基。一般公司自制培养基检测应包括pH值、促生长试验、抑制试验和指示特性试验(如需要),并进行定期稳定性检查以确认有效期。

    When in-house prepared microbiological media are properly prepared and sterilized using a validated method, the growthpromotion testing may be limited to each incoming lot of dehydrated media, unless otherwise instructed by the relevant compendial method. If the media preparation procedure was not validated, then every batch of media should be subjected to growth-promotion testing. Test organisms may be selected from the appropriate compendial test chapter. In addition, microorganisms used in growth-promotion testing may be based on the manufacturer's recommendation for a particular medium, or may include representative environmental isolates (but these latter are not to be construed as compendial requirements).

    如果公司采用经过验证的方法进行培养基制备和灭菌,则促生长试验可以是只针对购入的每个培养基干粉批次,除非相关药典方法另有要求。如果培养基制备程序未经验证,则所制备的每批培养基均需要进行促生长试验。检验用菌种可以从药典相应的检测章节中选择。另外,用于培养基促生长试验的菌株可以采用生产商推荐的品种,或包括有代表性的环境隔离物(但后者不构成药典要求的内容)。

    Expiration dates on media should have supporting growth-promotion testing to indicate that the performance of the media still meets acceptance criteria up to and including the expiration date. The length of shelf life of a batch of media will depend on the stability of the ingredients and formulation under specified conditions, as well as the type of container and closure.

    培养基的有效期应有促生长试验支持,在培养基有效期内及到有效期时,该培养基应仍符合可接受标准。一批培养基有效期的长短取决于各成份和配方在规定条件下的稳定性,以及容器和密封的形式。

    When a batch of media does not meet the requirements of growth-promotion testing, an investigation should be initiated to identify the cause. This investigation should include a corrective action plan to prevent the recurrence of the problem. Any batch of media that fails growth-promotion testing is unsuitable for use. [NOTE—Failed growth-promotion test results may not be used to negate positive test results.]

    如果培养基的促生长试验失败,则应启动调查程序寻找原因。该调查程序应包括纠正措施以防止相同问题重复发生。所有促生长试验失败的培养基不得用于检测。注:促生长试验失败可能会导致阳性检测为阴性。

    Some reagents are used for diagnostic purposes to help support identification of microbial organisms, e.g., Gram stain and oxidase test reagents. These may have attributes that can be quality control tested similar to microbiological media. Select the correct quality control standard microorganisms, following the manufacturer's instructions, and perform the testing before unknown sample diagnostic testing. All relevant diagnostic reagents should be subjected to incoming quality confirmation before use.

    有些试剂盒用于鉴别微生物种类,例如革兰氏染色和氧化酶检测试剂。这些试剂具有与微生物培养基类似的进行质量控制测试的特性。选择正确的质量控制标准微生物,按照生产商指示,在未知样品诊断检测前进行测试。所有相关的试剂盒均进行进厂质量确认才可使用。

    Special care should be taken with media that is used in sterility tests (see Sterility Tests á71ñ for requirements) and in environmental monitoring studies. Media used for environmental monitoring of critical areas should preferably be double-wrapped and terminally sterilized. If terminal sterilization is not performed, media should be subjected to 100% pre-incubation and inspection before use within a critical area. [NOTE—Growth-promotion testing for this media must be performed after the preincubation stage.] This will prevent extraneous contamination from being carried into controlled environments and will prevent false-positive results. A raised agar level for surface contact plates should be verified.

    用于无菌检测(见71无菌检测)和环境监控的培养基需要特别注意。用于关键区域环境监控的培养基最好双层2,并采用最终灭菌方式。如果无法进行最终灭菌,则在使用前应进行100%预培养并检查(注:该培养基的促生长试验必须在预培养阶段后进行)。这样能防止由于携入受控制环境中所产生的额外污染,防止假阳性结果。接触碟培养基厚度应进行确认。

    原文链接:https://mp.weixin.qq.com/s/w0epoMAzc3IMpqFAtGV0vA


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