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a sterilizzazione terminale

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19:40 Feb 24, 2012
This question was closed without grading. Reason: No acceptable answer

Italian to English translations [PRO]
Science - Medical: Pharmaceuticals / filling
Italian term or phrase: a sterilizzazione terminale
This is from a media fill protocol.

"I media fills vengono programmati e definiti per simulare i processi relativi ai prodotti a riempimento asettico o sottoposti a trattamento termico e non sono intesi per validare il riempimento di prodotti a sterilizzazione terminale'

Terminally sterilised products (i.e. sterilised in their containers)?
Alexander Chisholm
Local time: 19:06
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Summary of reference entries provided
liz askew

Discussion entries: 1





  

Reference comments


12 mins peer agreement (net): +2
Reference

Reference information:
Symbiosis Pharmaceuticals
www.symbiosis-pharma.com/
The sensitivity of certain biological, pharmaceuticals and biotechnology drugs to terminal sterilisation by steam autoclaves, dry heat ovens, ethylene oxide and ...

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Note added at 13 mins (2012-02-24 19:53:45 GMT)
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PHARMACEUTICAL TECHNOLOGY Cleaning Aseptic Fill Areas
www.texwipe.com/files/pdfs/.../cleaning_aseptic_fill_areas....
File Format: PDF/Adobe Acrobat - Quick View
For pharmaceuticals that cannot be given terminal sterilization at the end of production, the alternative of aseptic fill is available, requiring sterile materials ...

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Note added at 14 mins (2012-02-24 19:54:46 GMT)
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Guidance for Industry
www.fda.gov/downloads/Drugs/.../Guidances/ucm072180.pdf
File Format: PDF/Adobe Acrobat - Quick View
Products Terminally Sterilized by Moist Heat. Processes ... http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma... and/or ...

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Note added at 20 mins (2012-02-24 20:01:35 GMT)
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Validating and Monitoring a Form-Fill-Seal Operation ...
www.pmpnews.com/.../validating-and-monitoring-form-fill-sea...
16 Nov 2000 – Validating and Monitoring a Form-Fill-Seal Operation ... their systems or use stand-alone units to monitor parameters and keep them in check. ... printing of the top web and equipment for automated filling or product loading.

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 58
Note to reference poster
Asker: Many thanks. If someone wants to post an answer I can close the question and award the points.


Peer comments on this reference comment (and responses from the reference poster)
agree  dandamesh
6 mins
agree  Rachel Fell
13 mins
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