培养基的停滞实验

仲夏秋夜云

youngzhou 发表于 2013-2-28 14:57
我们以前也遇到过这个问题，有些培养基有效期一年，买回来就过了几个月了，使用时间很短，所以经常要做效 ...

我现在不确定这个楼主问的是不是这个问题

圆and缘

纯国产的企业没听说过这个概念

seamen

仲夏秋夜云 发表于 2013-2-28 15:01
我现在不确定这个楼主问的是不是这个问题

不是这个问题，我找了些资料  和大家分享

seamen

3.5 positive controls: Refers to the sterility test controls that may be used to define a "false negative" test result. An absence of growth of test challenge micro-organisms in the growth promotion, validation or "stasis" tests would result in a "false negative" test finding and an invalid test result.
3.6 stasis test: Also referred to as an inhibition test, which is performed to ensure that there are no inhibitory substances remaining in the product and that the media is still capable of supporting the growth of micro-organisms at the end of the sterility test incubation period. This test is not mandatory but it may be useful to confirm the inactivation of antimicrobial substances in products where a marginal test methodology is employed routinely, after an initial successful test validation.
---来自新加坡《STERILITY TESTING》201301版 @仲夏秋夜云 @youngzhou

seamen

5.5 positive controls: Refers to the sterility test controls that may be used to define
a "false negative" test result. An absence of growth of test challenge microorganisms
in the growth promotion, validation or "stasis" tests would result in a
"false negative" test finding and an invalid test result.
5.6 stasis test: Also referred to as an inhibition test, which is performed to ensure
that there are no inhibitory substances remaining in the product and that the
media is still capable of supporting the growth of micro-organisms at the end of
the sterility test incubation period. This test is not mandatory but it may be
useful to confirm the inactivation of antimicrobial substances in products where
a marginal test methodology is employed routinely, after an initial successful test
validation.

---来自PIC无菌检验指南

seamen

Monitoringthe efficacy of test media at the end of the incubation period (stasis test)

483. The stasistest is not mandated by the Pharmacopoeias but is recommended as part of GoodLaboratory Practice (GLP) in relation to method validation and a quality systembased on ISO 17025. It is particularly important for antibiotics, slow-releasesterile products and for direct inoculation methods where validity of the testdepends on the use of an exact amount of product (ie, marginal methodology).

484. The stasistest is intended to demonstrate that the media inoculated with the testpreparation will support growth for the full incubation period. For example, itis necessary to show that anaerobiosis is maintained in the Medium 1 to allowthe late development of slow-growing anaerobes. It is also necessary todemonstrate that growth promoting qualities of media are retained and thatpreservative inhibitors remain stable for the full test period.

485. The stasistest will be included in referee testing (see clauses 101 and 105).

486 Afterincubation of the media has been completed in accordance with the instructionsgiven in clauses 475-479:

· addto representative vessels containing Medium 1 that has been incubated at 30 –35°C, an inoculum of viable spores of an anaerobic bacterium eg, Clostridium sporogenes ATCC 19404;

· addto representative vessels containing Medium 2 that has been incubated at 20 –25°C an inoculum of viable cells of a fungus, eg, Candida albicans ATCC 10231;

NOTE: Acceptablechallenge organisms are listed in Table 5. The list is not exclusive; othermicro-organisms may be suitable.

487. In each casethe number of organisms in the inoculum is to be not more than 100 CFU (seeAnnex I Guidance on Obtaining SmallNumbers of Vegetative Organisms and Spores).

488. The vesselsare returned to their previous temperature and incubation continued. Thecontainers of product should all show growth of the added organisms within 48hours. If conspicuous growth is not apparent within 5 days for both bacteriaand fungi the test is considered invalid. Invalid stasis tests may be repeatedonce. If conspicuous growth is not obtained at the second attempt the testmethod should be modified and revalidated.

489. If the mediaare found to support growth of the test micro-organisms then this test need notbe applied to every sample. It should be repeated periodically on the relevantcategories of products or when product is reformulated. Every 12 months isrecommended.

490. Periodicallythe strains referred to above may be supplemented with appropriate strains ofmicro-organisms collected from the manufacturing environment.

---来自TGA《TGA guidelines for sterility testing oftherapeutic goods 》

seamen

感谢丁香园的zhulikou431老师

仲夏秋夜云

stasis test: Also referred to as an inhibition test, which is performed to ensure that there are no inhibitory substances remaining in the product and that the media is still capable of supporting the growth of micro-organisms at the end of the sterility test incubation period.
这个……还是一个有效性为目的的检验啊

朗老

仲夏秋夜云 发表于 2013-2-28 13:37
这个问题我刚看到，是这样的。我原来的那家美资企业是做这个的……
首先搞清楚老美当初为什么要做这个，一 ...

顶一个，学习了

molo

模拟培养温度培养后再做。以证明培养结束后培养基的质量依然能够满足实验目的

普子

貌似仲夏秋夜云 就清楚了

sun-40

大概明白了啥叫停滞实验

shevchenkozy

就是用完再整个促生长 也不知道为啥叫停滞实验

热血青年

PI 012-3 Recommendation on Sterility Testing
PI 012-3 关于无菌检查法的建议

5.6 stasis test: Also referred to as an inhibition test, which is performed to ensure that there are no inhibitory substances remaining in the product and that the media is still capable of supporting the growth of micro-organisms at the end of the sterility test incubation period. This test is not mandatory but it may be useful to confirm the inactivation of antimicrobial substances in products where a marginal test methodology is employed routinely, after an initial successful test validation.
5.6 停滞试验：也称为抑制试验，进行该试验是为了确保产品中没有抑制生长物质残留，并且在无菌检查培养期结束时培养基仍能够支持微生物的生长。该试验不是强制性的，但在初始验证成功后常规利用边际检验方法学的情况下，该试验可能有助于确认产品中抗菌物质的失活。

现在已经不用这个名词了，改为”促生长试验“