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media-fill run

Russian translation: серия тестов на асептичность методом симуляции процесса с использованием стерильной среды

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19:09 Nov 26, 2001
English to Russian translations [PRO]
/ control of medicinal products
English term or phrase: media-fill run
Method of media-fill runs may be used to evaluate the process of aseptic production.
psven
Russian translation:серия тестов на асептичность методом симуляции процесса с использованием стерильной среды
Explanation:
Т.е. вместо компонентов реального продукта в контейнеры или производственную линию закладывают стерильный материал и потом проверяют, насколько он заражён на выходе. Такие тесты проводят в определенной периодичности и результаты строго документируют. На Гугле, действительно, про это много, а вот в русскоязычных публикациях я не нашла, поэтому надо ещё подумать над формулировкой.

One of the process validations used to determine aseptic processing of
pharmaceutical products is called the Media Fill Test.
This test utilizes sterile culture media instead of actual product.
This media is put through the same procedures and conditions as in the
actual processing operation. Parameters might include filling and closing
operations, process environment and human interaction, among others.
The test is also performed under an established „worst case" scenario.

Selected response from:

xxxH.A.
Grading comment
Большое спасибо, я примерно так и думал, но не мог
найти ссылки в которой бы этот метод был бы четко описан.

4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +3прогон контейнера по упаковочной линии без фактического заполнения его медпрепаратомSabina Norderhaug
4 +1серия тестов на асептичность методом симуляции процесса с использованием стерильной средыxxxH.A.
4дополнениеxxxH.A.
4Sorry- typo above. Should be "aseptichnosti"shifrak
4sm.nizheshifrak
4New referenceSabina Norderhaug


  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
sm.nizhe


Explanation:
Seriya testov dlya mikrobiologicheskogo podtverzhdeniya aseptochnosti napolneniya


See, e.g., Merck:
http://www.merck.de/english/services/chemdat/catalogs/mibio/...

shifrak
United States
Local time: 14:12
Native speaker of: Native in EnglishEnglish, Native in RussianRussian
PRO pts in pair: 9
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
прогон контейнера по упаковочной линии без фактического заполнения его медпрепаратом


Explanation:
Используется для оценки качества, стерильности, факторов, вызывающих сбои на линии по стерильной упаковке медпрепаратов.

Следующий текст был реконструирован Гуглом. Старый линк: biz.chollian.net/~sjkim01/DATA/ODV008.htm

The performance of media fill runs is a standard industry practice for the purpose of:

* simulating aseptic assembly operations of sterile product without actual product fill;

* prompting the need for evaluation of the assembly operation when positive contaminated units result during a media fill run;

* identifying environmental and human caused operational deficiencies and any other causes for discrepancies and their correction;

* validating the aseptic assembly process.

Recent industry and FDA discussions have focused on the question of media fill contamination rates and the adequacy of statistical methods for determining acceptable sterility assurance levels (SALs). This is based on the percentage of filled media units that are found to be contaminated.

FDA's Guideline On Sterile Drug Products Produced By Aseptic Processing references a media fill contamination rate of .1% in two separate instances. Currently, contamination rates >.1% are expected to prompt industry to:
* investigate thoroughly records of the processes, equipment, environment and personnel associated with the failed media fill;
* identify the causes and correct the problems; and,
* revalidate with three additional media fill runs.
However, the result of a media fill contamination rate <.1% (even as low as the incidence of one contaminated unit out of any number of units) in a media fill should be regarded by an aseptic operator as sufficient reason to:
* investigate (e.g. speciate and identify the possible origins of the organisms in the contaminated unit(s), considering potential developing trends over many media fills, etc.)
* evaluate results to determine the need for an expanded investigation to identify contamination causes and make corrections if possible.
Although the Guideline On Sterile Drug Products Produced By Aseptic Processing states that FDA recognizes the scientific and technical limits of validation, it should be noted that there are also limits in the degree of confidence with which one can state that observed contaminated units in any media fill represent the true contamination rate. Although the degree of confidence in perceiving the true contamination rate increases as the total number of units in a media fill increases, it must also be recognized that there can never be absolute certainty that an observed incidence of even one contaminated unit is the actual number of such units in any given media fill. Some media fills, statistically, will not accurately represent the true contamination rate. The guideline associates a 95% confidence probability with a media fill run totaling 3000 units. Therefore, the chances are that in 20 media fill runs, one of the runs will not accurately represent the true contamination rate.
In summary, true values of the contamination rate of any media fill can only be known to a degree of probability. It is thus never definitely known whether the result (i.e. contamination rate) of any particular media fill is actually a true value or not. To err on the side of patient safety would be for each contaminated unit to be investigated and corrective action taken if necessary.



    Reference: http://biz.chollian.net/~sjkim01/DATA/ODV008.htm
Sabina Norderhaug
PRO pts in pair: 138

Peer comments on this answer (and responses from the answerer)
agree  protolmach: Great reference and comment!
8 mins
  -> Спасибо

agree  Natametzger
36 mins

agree  xxxH.A.: м.б. для фармацевтических процессов эта формулировка более конкретна, чем моя
1 hr
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
Sorry- typo above. Should be "aseptichnosti"


Explanation:
Just a typo

shifrak
United States
Local time: 14:12
Native speaker of: Native in EnglishEnglish, Native in RussianRussian
PRO pts in pair: 9
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
New reference


Explanation:
Нашла тот же текст на сайте FDA - Food and Dgug Administration.

http://www.fda.gov/cder/hdn/hdn395.htm
see HUMAN DRUG CGMP NOTES March, 1995


    Reference: http://www.fda.gov/cder/hdn/hdn395.htm
Sabina Norderhaug
PRO pts in pair: 138
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
серия тестов на асептичность методом симуляции процесса с использованием стерильной среды


Explanation:
Т.е. вместо компонентов реального продукта в контейнеры или производственную линию закладывают стерильный материал и потом проверяют, насколько он заражён на выходе. Такие тесты проводят в определенной периодичности и результаты строго документируют. На Гугле, действительно, про это много, а вот в русскоязычных публикациях я не нашла, поэтому надо ещё подумать над формулировкой.

One of the process validations used to determine aseptic processing of
pharmaceutical products is called the Media Fill Test.
This test utilizes sterile culture media instead of actual product.
This media is put through the same procedures and conditions as in the
actual processing operation. Parameters might include filling and closing
operations, process environment and human interaction, among others.
The test is also performed under an established „worst case" scenario.




    Reference: http://www.merck.de/english/services/labor/l_uba/emibio/news...
xxxH.A.
PRO pts in pair: 54
Grading comment
Большое спасибо, я примерно так и думал, но не мог
найти ссылки в которой бы этот метод был бы четко описан.

Peer comments on this answer (and responses from the answerer)
agree  Milana_R
2 days 22 hrs
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
дополнение


Explanation:
слово «серия» можно опустить, т.к. "run" означает сам процесс проверки - он длится по 16-18 часов.

xxxH.A.
PRO pts in pair: 54
Login to enter a peer comment (or grade)




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