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  3. Medical: Pharmaceuticals

mono-format line

Portuguese translation: linha de formato único

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:mono-format line
Portuguese translation:linha de formato único
Entered by: Gabriella

11:55 Aug 25, 2013
English to Portuguese translations [PRO]
Medical - Medical: Pharmaceuticals / Assuntos regulatórios
English term or phrase: mono-format line
4.6 - Frequência dos testes de envase de meio de cultura

A qualificação inicial do desempenho (nova oficina de envasamento, novo formato, alteração significativa do equipamento ou do processo): pelo menos 3 MFTs compatíveis por formato, levando em consideração a a natureza das modificações (ver Dossiê do Controle de Modificação) e as indicações nas seções acima.

• qualificação periódica:

− mono-format line: at least 3 compliant media fill tests per year
− multi-format line: at least 4 compliant media fill tests per year, with at least 1 compliant media fill test per year for each end of the format range
− freeze-dryer: use of each freeze-dryer for at least 1 compliant media fill test/year
− workshop for final sterilising filtration during fractionation: at least 1 compliant MFT per flow per year.
Gabriella
Brazil
linha de formato único
Explanation:
Seria uma linha de produção de um formato só.
Selected response from:

Martin Riordan
Brazil
Local time: 06:30
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1linha de formato único
Martin Riordan


  

Answers


22 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
linha de formato único


Explanation:
Seria uma linha de produção de um formato só.

Martin Riordan
Brazil
Local time: 06:30
Native speaker of: Native in EnglishEnglish
PRO pts in category: 32

Peer comments on this answer (and responses from the answerer)
agree  Claudio Mazotti
49 mins
  -> Obrigado, Claudio!
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