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  3. Medical: Pharmaceuticals

revendication (stérile / low bioburden)

English translation: claimed (to be sterile / to have a low bioburden)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:revendication (stérile / low bioburden)
English translation:claimed (to be sterile / to have a low bioburden)
Entered by: Drmanu49

09:48 Dec 17, 2020
French to English translations [PRO]
Medical - Medical: Pharmaceuticals / vaccines
French term or phrase: revendication (stérile / low bioburden)
This is from an inspection report of a vaccine production site. Really not sure about 'revendication' here and how to translate it properly.

"En mode HPV, attendu la revendication stérile, les locaux de filtration stérilisante (117), préparation de milieu stérile (135), couloir (112) et autres locaux de stockages passent en grade B."

>>> In HPV mode, as sterility is expected ??

Le bulk est filtré stérilement et adsorbé sur l'adjuvant aluminium (AI(OH)3), avec une revendication stérile.

>>> "which is claimed to be sterile"?

I also found this later on in the text "Il est noté que pour le process HZ-su, attendu la revendication low bioburden, seules des simulations à l'eau pour vérifier la bonne pratique comportementale sont réalisées."
Sylvia Avila Cacho
France
Local time: 06:52
claimed (to be sterile / to have a low bioburden)
Explanation:
IMO

For the Submission of Documentation for Sterilization ... - FDA
www.fda.gov › media › download
PDFTraduire cette page
This level of sterility assurance should be demonstrated for all parts of the drug product (including the container and closure, if applicable), which are claimed to be ...
Selected response from:

Drmanu49
France
Local time: 06:52
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3claimed (to be sterile / to have a low bioburden)
Drmanu49
4claim
Conor McAuley
3sterility requirement/assurance level
SafeTex


  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
claimed (to be sterile / to have a low bioburden)


Explanation:
IMO

For the Submission of Documentation for Sterilization ... - FDA
www.fda.gov › media › download
PDFTraduire cette page
This level of sterility assurance should be demonstrated for all parts of the drug product (including the container and closure, if applicable), which are claimed to be ...


Drmanu49
France
Local time: 06:52
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1131
Grading comment
Selected automatically based on peer agreement.
Notes to answerer
Asker: Thanks! Glad to know my first instinct wasn't completely wrong :)


Peer comments on this answer (and responses from the answerer)
agree  Bashiqa
57 mins
  -> Thank you.
agree  EirTranslations
2 hrs
  -> Thank you.
agree  philgoddard
5 hrs
  -> Thank you Phil.
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
claim


Explanation:
Found in any decent FR>EN dictionary and on the internet. Production premises must be sterile.

--------------------------------------------------
Note added at 1 hr (2020-12-17 11:18:20 GMT)
--------------------------------------------------

I wasn't being rude, I was just making a statement. You are interpreting tone where there is none. No need to be so sensitive.

It couldn't mean anything else, even in this context, so by default, even apart from anything else, "claim" is the answer.

Admittedly the original is poorly-worded, but you'll get used to that in time.

--------------------------------------------------
Note added at 1 hr (2020-12-17 11:24:53 GMT)
--------------------------------------------------

You're the one who is arguing, I am stating facts.

Conor McAuley
France
Local time: 06:52
Native speaker of: English
PRO pts in category: 12
Notes to answerer
Asker: No need to be rude. I know a revendication is a claim, but was not completely sure in this context as there aren't any hits for "revendication sterile" on Termium or any other online termbases and only a few hits on Google, most if not all being unrelated to vaccine production. As a translator you should know that context is everything. Have a great day!

Asker: Ok then, well I have better things to do than argue with someone on here, so back to work with me. Ciao!

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3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
sterility requirement/assurance level


Explanation:
Hello
I think that the two French sentences given in the question have to be resolved differently. The first sentence is more like a requirement and the second one is an assurance (similar to "claim") but "assurance" is the right jargon for me.
Note Sterility Assurance Level (SAL) in the second reference


    https://www.btb.termiumplus.gc.ca/tpv2alpha/alpha-fra.html?lang=fra&i=&index=enr&srchtxt=STERILITY%20REQUIREMENTS
    https://en.wikipedia.org/wiki/Sterility_assurance_level
SafeTex
France
Local time: 06:52
Native speaker of: Native in EnglishEnglish
Notes to answerer
Asker: thank you!

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