Glossary entry

Croatian term or phrase:

finalni bulk

English translation:

final bulk

Added to glossary by Mira Stepanovic
Oct 12, 2013 16:34
10 yrs ago
1 viewer *
Croatian term

fialni bulk

Croatian to English Other Chemistry; Chem Sci/Eng
Testiranje sterilnosti fialnog bulka i gotovog proizvoda antitoksina za otrov europskih zmija (konjskog) otopine za injekciju provodi se prema metodi Ph. Eur. 07/2010 opisanoj u PKK. Navedena metoda je u potpunosti prema europskoj farmakopeji te je bilo potrebno provesti njezinu verifikaciju prema Ph. Eur. 07/2010.
Proposed translations (English)
4 final bulk
2 vial bulk
Change log

Sep 21, 2014 14:45: Mira Stepanovic Created KOG entry

Discussion

Proposed translations

16 hrs
Selected

final bulk

http://www.bioreliance.com/sterilitytesting.aspx
BioReliance offers the following tests under GLP or GMP:
Direct Inoculation Sterility for Final Bulk
Direct Inoculation Sterility for Final Vials
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Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria respectively.

https://www.google.rs/search?q=final bulk&ie=utf-8&oe=utf-8&...

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Note added at 16 hrs (2013-10-13 09:30:48 GMT)
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Ph. Eur. = Pharmaeuropa
http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...
(Pharmeuropa 22.3, 07/2010)
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 Rabies vaccine : NIH potency assay performed on 1 out of 10 lots derived from one final bulk
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• In vivo testing carried out on Final bulk products
(FBP) instead of Final products
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• A final bulk/lot that is representative of the current production method

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Note added at 1 day15 hrs (2013-10-14 08:28:22 GMT)
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http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...
A.3.5.2.4 Sterility
The sterility test should be performed using at least 10 ml of each final bulk for bacterial and mycotic sterility, in accordance with the recommendations of Part A, section 5, of the revised General requirements for the sterility of biological substances (Requirements for biological substances, No. 6) (22), or by a method approved by the NRA.
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A.3.5.2.5 Specific toxicity
Each final bulk is tested for specific toxicity in at least five guinea pigs, each weighing 250350 g, that have not been used previously for experimental purposes.
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4 KudoZ points awarded for this answer. Comment: "Thank you"
2 hrs

vial bulk

Perhaps, I am not sure this time...
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Reference comments

7 hrs
Reference:

fialni bulk?

http://www.proz.com/kudoz/english_to_russian/automation_robo...

http://www.patent-de.com/pdf/DE602004011553T2.pdf

ovo objašnjenje s ruskog možda bi moglo biti logičnije, a u prilog govori i ovaj patent, tj. da se radi o "bulk vial" ... nekoj bočici u kojoj se drži pripravak "u rinfuzi" ... "bulk vial" ima puno spominjanja na netu

... kako su ovi došli na "fialni bulk" ... fialna rinfuza, rinfuza u fiali?

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Note added at 7 hrs (2013-10-12 23:59:40 GMT)
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http://www.poslovni.hr/hrvatska/lijekovima-u-rinfuzi-ustedje...
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