USP,EP、中国药典干热灭菌条件对照表

更新时间:2023-07-13 12:10:37 阅读：评论：0

小学二年级数学应用题

EU,USP及ChP对干热灭菌/除热原条件对照表

EP 6.0		唯一英文 USP32-NF27		中国药典2010
Dry heat sterilisation. （附件1-2）	2.6.14. BACTERIAL ENDOTOXINS （附件1-2）	1211 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES 附件2-1	85 BACTERIAL ENDOTOXINS TEST 附件2-2	灭菌方法	内毒素检测方法
For this method of terminal sterilisation the reference conditions are a minimum of 160 °C for at least 2 h. Other combinations of time and temperature may be ud provided that it has been satisfactorily demonstrated that the process chon delivers an adequate and reproducible level of lethality when operated routinely within the established tolerances. The procedures and precautions employed are such as to give an SAL of 10− 6 or better. Dry heat at temperatures greater than 220 °C is frequently ud for sterilisation and depyrogenation of glassware. In this ca demonstration of a 3-log reduction in heat resistant endotoxin can be ud as a replacement for biological indicators (5.1.2).	Apparatus Depyrogenate all glassware and other heat-stable apparatus in a hot-air oven using a validated process. A commonly ud minimum time and temperature is 30 minutes at 250 °C. If employing plastic apparatus, such as microtitre plates and pipette tips for automatic pipetters, u apparatus shown to be free of detectable endotoxin and of interfering effects for the test. NOTE: In this chapter, the term ‘tube’ includes all types of receptacles, for example microtitre plate wells.	A typical acceptable range in temperature in the empty chamber is ±15 when the unit is operating at not less than 250. A microbial survival probability of 10–12 is considered achievable for heat-stable articles or components. An example of a biological indicator for validating and monitoring dry-heat sterilization is a preparation of Bacillus subtilis spores. Since dry heat is frequently employed to render glassware or containers free from pyrogens as well as viable microbes, a pyrogen challenge, where necessary, should be an integral part of the validation program, e.g., by inoculating one or more of the articles to be treated with 1000 or more USP Units of bacterial endotoxin. The test with Limulus lysate could be ud to demonstrate that the endotoxic substance has been inactivated to not more than 1/1000 of the original amount (3 log cycle reduction).	APPARATUS AND GLASSWARE Commonly ud minimum time and temperature ttings are 30 minutes at 250.	干热灭菌条件一般为160～170℃×120min以上、170～180℃×60min以上或250℃×45min以上，也可采用其它温度和时间参数。总之，应保证灭菌后的产品其SAL≤10-6。干热过度杀灭后产品的SAL应≤10-12， 250℃ 45min的干热灭菌也可除去无菌产品包装容器及有关生产灌装用具中的热原物质。细菌内毒素灭活验证试验是证明除热原过程有效性的试验。一般将不小于1000单位的细菌内毒素加入待去热原的物品中，证明该去热原工艺能使内毒素至少下降3个对数单位。细菌内毒素灭活验证试验所用的细菌内毒素一般为大肠杆菌内毒素（ Escherichia coli endoxin ）。	检测用玻璃器皿去热原温度在250℃，30分钟以上。
结论
对去热原温度和时间组合没有明确要求，对温度下限有要求。	对温度和时间有要求，同USP，ChP.	对去热原温度和时间组合没有明确要求，对温度下限有要求	对温度和时间有要求，同EP，ChP.	旺旺英语对去热原温度和时间组合有建议要求，没有强制要求。psychologist	对温度和时间有要求，同EP，USP.

附件1 -1

EP6.0 5.1.1. METHODS OF PREPARATION

OF STERILE PRODUCTS)

Dry heat sterilisation. For this method of terminalspdb sterilisation the reference conditions

are a minimum

of 160 °C for at least 2 h. Other combinations of time

and temperature may be ud provided that it has been

satisfactorily demonstrated that the process chon delivers

an adequate and reproducible level of lethality when

operated routinely within the established tolerances. The

procedures and precautions employed are such as to give an

SAL of 10− 6 or better.

Dry heat sterilisation is carried out in an oven equipped with

温床forced air circulation or other equipment specially designed

for the purpo. The sterilir is loaded in such a way that

a uniform temperature is achieved throughout the load.

Knowledge of the temperature within the sterilir during

surgeon

the sterilisation procedure is usually obtained by means of

temperature-nsing elements inrted into reprentative

rails

containers together with additional elements at the

previously established coolest part of the loaded sterilir.

The temperature throughout each cycle is suitably recorded.

Where a biological asssment is carried out, this is obtained

using a suitable biological indicator (5.1.2).

Dry heat at temperatures greater than 220 °C is frequently

ud for sterilisation and depyrogenation of glassware. In

this ca demonstration of a 3-log reduction in heat resistant

endotoxin can be ud as a replacement for biological

indicators (5.1.2)

附件1-2 2.6.14. BACTERIAL ENDOTOXINS

The test for bacterial endotoxins is ud to detect or

quantify endotoxins of gram-negative bacterial origin

using amoebocyte lysate from horshoe crab (Limulus

polyphemus or Tachypleus tridentatus). There are

3 techniques for this test : the gel-clot technique, which

is bad on gel formation ; the turbidimetric technique,

bad on the development of turbidity after cleavage of an

汉翻英

endogenous substrate ; and the chromogenic technique,

bad on the development of colour after cleavage of a

synthetic peptide-chromogen complex.

The following 6 methods are described in the prent

chapter :

Method A. Gel-clot method: limit test

Method B. Gel-clot method: mi-quantitative test

Method C. Turbidimetric kinetic method

182 See the information ction on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 6.0 2.6.14. Bacterial endotoxins

Method D. Chromogenic kinetic method

Method E. Chromogenic end-point method

Method F. Turbidimetric end-point method

Proceed by any of the 6 methods for the test. In the event

of doubt or dispute, the final decision is made bad upon

method A unless otherwi indicated in the monograph.

The test is carried out in a manner that avoids endotoxin

contamination.

Apparatus

Depyrogenate all glassware and other heat-stable apparatus

in a hot-air oven using a validated process. A commonly ud

minimum time and temperature is 30 minutes at 250 °C. If

employing plastic apparatus, such as microtitre plates and

渤海大学研究生学院pipette tips for automatic pipetters, u apparatus shown

to be free of detectable endotoxin and of interfering effects

for the test.

NOTE: In this chapter, the term ‘tube’ includes all types of

receptacles, for example microtitre plate wells.

indicators (5.1.2).

附件2-1

1211 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES

This informational chapter provides a general description of the concepts and principles involved in the quality control of articles that must be sterile. Any modifications of or variations in sterility test procedures from tho described under Sterility Tests 71 should be validated in the context of the entire sterility assurance program and are not intended to be methods alternative to tho described in that chapter.

Within the strictest definition of sterility, a specimen would be deemed sterile only when there is complete abnce of viable microorganisms from it. However, this absolute definition cannot currently be applied to an entire lot of finished compendial articles becau of limitations in testing. Absolute sterility cannot be practically demonstrated without complete destruction of every finished article. The sterility of a lot purported to be

sterile is therefore defined in probabilistic terms, where the likelihood of a contaminated unit or article is acceptably remote. Such a state of sterility assurance can be established only through the u of adequate sterilization cycles and subquent aptic processing, if any, under appropriate current good manufacturing practice, and not by reliance solely on sterility testing. The basic principles for validation and certification of a sterilizing process are enumerated as follows:

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