fialni bulk
English translation: final bulk
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| 16:34 Oct 12, 2013 |
| Croatian to English translations [PRO] Chemistry; Chem Sci/Eng | |||||||
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|  Selected response from: Mira Stepanovic Serbia Local time: 13:31 | ||||||
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| Summary of answers provided | ||||
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| 4 | final bulk |
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| 2 | vial bulk |
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| fialni bulk? |
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| Discussion entries: 1 | |
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Answers
2 hrs confidence: 
vial bulk Explanation: Perhaps, I am not sure this time... |
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16 hrs confidence:
final bulk Explanation: 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 --- 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&... -------------------------------------------------- Note added at 16 hrs (2013-10-13 09:30:48 GMT) -------------------------------------------------- Ph. Eur. = Pharmaeuropa http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=... (Pharmeuropa 22.3, 07/2010) --- Rabies vaccine : NIH potency assay performed on 1 out of 10 lots derived from one final bulk --- • In vivo testing carried out on Final bulk products (FBP) instead of Final products --- • A final bulk/lot that is representative of the current production method -------------------------------------------------- Note added at 1 day15 hrs (2013-10-14 08:28:22 GMT) -------------------------------------------------- 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. --- A.3.5.2.5 Specific toxicity Each final bulk is tested for specific toxicity in at least five guinea pigs, each weighing 250350 g, that have not been used previously for experimental purposes. |
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Reference comments
7 hrs |
| Reference: fialni bulk? Reference information: 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? -------------------------------------------------- Note added at 7 hrs (2013-10-12 23:59:40 GMT) -------------------------------------------------- http://www.poslovni.hr/hrvatska/lijekovima-u-rinfuzi-ustedje... |
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