Oct 21, 2010 17:16
13 yrs ago
9 viewers *
español term

Test de suciedad

español al inglés Medicina Medicina: Farmacia validation report
I'm translating the validation results for phenylephrine hydrochloride. There is a list of tests in one column and specifications in the next column.
1. Descripción (Next column: polvo blanco cristalino...)
2. Identificación
3. Aparencia solución
4. Pérdida por desecación
5. Acidez o alcalinidad
6 Sustancias relacionadas (impurezas C, desconocidas, totales)
7. Microbiologia (bacterias, hongos y levaduras, E Coli)
...
11. Tamaño partícula (next column: >850 um. Max. 2%)
12. ***Test de suciedad*** (next column: cumple test)

I have looked up the pharmacopoeia monograph for phenylephrine and can't find any ref to "test de suciedad"
http://www.sinoapi.com/Pharmacopoeia/bp2009/BP61-76-7.pdf
Any ideas welcome!

Discussion

Travelin Ann Oct 28, 2010:
No problem, Emma, glad to help.
Emma Goldsmith (asker) Oct 28, 2010:
Thanks for your help Ann As you can see my points should be for you :)
Travelin Ann Oct 21, 2010:
Happy if I could help :)
Emma Goldsmith (asker) Oct 21, 2010:
impurities Looking again at the link I gave in my question, I now see that "impurities" appears at the bottom, separately from "related substances" and their impurities. So I think you're on the right track after all, Ann, and it is "impurities" :)
Emma Goldsmith (asker) Oct 21, 2010:
purity/impurity Hi Ann, purity sounds like the opposite of impurities, which is already on the list. I also thought of "contamination", but again microbiological contamination is already on the list. Thanks for the idea anyway, and maybe someone will prove me wrong on this :)
Travelin Ann Oct 21, 2010:
Purity test? Not my field, but there are a number of relevant hits for purity test pharmaceuticals
http://www.chromforum.org/viewtopic.php?t=3091&view=previous...

Proposed translations

2 días 47 minutos
Selected

purity test

In pharmaceutical purity testing, quantitative densitometric analysis is often used instead of pharmacopoeial semi-quantitative TLC methods or in testing of ...
linkinghub.elsevier.com/retrieve/pii/S0165993606001269 - Similar

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Note added at 2 days47 mins (2010-10-23 18:04:54 GMT)
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Chiral purity test of bevantolol by capillaryelectrophoresis and ...by PH Long - 2006 - Cited by 5 - Related articles
purity testing, chiral stability testing of pharmaceutical formulations and in pharmacokinetic and clinical studies. (Fillet et al., 1995). ...
www.springerlink.com/index/576VV34507U4544H.pdf - Similar
Pharmaceutical Stability Testing to Support Global Markets - Google Books ResultKim Huynh-Ba, Kim Huynh-Ba - 2009 - Medical - 268 pages
Pharmaceutical Stability <1150> This chapter states that the monograph ... the three types of purity tests: (1) a chromatographic purity test coupled with a ...
books.google.com/books?isbn=1441908889...
Heparin identification test and purity test for OSCS in heparin ...In this study, we developed rapid and robust methods as identification test for heparins and as a purity test for OSCS in pharmaceutical heparins by using a ...
www.journaltocs.hw.ac.uk/articleHomePage.php?id=1900855...
Identification and purity test for ergonovine and methylergonovine ...by TG Alexander - 1962 - Cited by 2 - Related articles
17 Sep 2006 ... Alexander, T. G. (1962), Identification and purity test for ergonovine and methylergonovine. Journal of Pharmaceutical Sciences, ...
onlinelibrary.wiley.com/doi/10.1002/jps.2600510724/abstract

Saludos,
eski
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1 KudoZ points awarded for this answer. Comment: "Thanks for your help, Eski. This was a tricky term, because it isn't even used in Spanish. I offered the client "impurity test" (trying to reflect the Eur Ph)and "cleanliness test" (closest to the Spanish). The client eventually chose "dirty test". I said that I did not agree. I think "purity test" could be the most reasonable, and the points should go to Travelin Ann as she suggested it first. However, I have awarded you 1 point as a consolation prize !! "
1 hora

particulate matter test

This might be in the form of a visual inspection.
Note from asker:
Thanks Giovanni. This is a possibility, but particle size has already been covered in the preceding item on the list, so I'm not convinced. :(
Something went wrong...
12 horas

Soil test

This is probably a colour strip test for checking it has been sterilised
ISO/TS 15883-5:2005 - Washer-disinfectors -- Part 5: Test soils ...
ISO/TS 15883-5:2005 includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ...
www.iso.org/iso/catalogue_detail.htm?csnumber=41175 - Cached -
Ensuciar artificialmemnte el instrumental de una
carga difícil de limpiar con una de las
preparaciones decritas en EN 15883-5 (dejar
secar 1 hora o más). El hecho de utilizar al
mismo tiempo tests industriales permite hacer
controles periódicos entre dos validaciones
(TOSI®, LOAD check®, SOIL test®).


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Note added at 14 hrs (2010-10-22 07:59:09 GMT)
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Emma, but we are talking about "soiled" which means "dirty". Think about the uses of the word "soil", it just doesn't mean "earth" One can "soil clothes" with tomato juice, for example

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Note added at 15 hrs (2010-10-22 08:31:55 GMT)
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Unfortunately, there is no way of testing the sterility of an individual tablet or solution. Test indicator strips are wrapped around the batch to be sterilised and if it changes colour it means that it fulfilled the sterilisation conditions, i.e. sterile contents and the autoclave, steriliser is functioning correctly.
I'll leave it at that as I don't seem to be able to explain it very well

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Note added at 1 day18 hrs (2010-10-23 11:41:56 GMT)
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[DOC]
STERILISATION GUIDANCE FOR PRIMARY CARE AND COMMUNITY SETTING
File Format: Microsoft Word - View as HTML
Cleaning efficiency should be detected using a standard 'soil test'. ..... Sterilisation, disinfection and cleaning of medical equipment: guidance on ...
www.manchester.nhs.uk/document.../SterilisationNov08.doc - Similar
Curriculum Online - Materials and Equipment
Autoclave bags, Forceps, Pooters. Backed blades, Growth tray and boxes, Pressure cooker ... Aseptic wash solutions, Hydrochloric acid (concentrated), Soil test kit box for ... Sterilise the agar and the dishes at 121 °C for 15 minutes. ...
www.curriculumonline.ie/.../Materials_and_Equipment/ - Cached - Similar
[PDF]
SEFTON PRIMARY CARE TRUST TITLE: Decontamination of Medical ...
File Format: PDF/Adobe Acrobat - Quick View
possible, all re-useable medical instruments requiring sterilisation will be undertaken ... to using the autoclaves, if there are no forthcoming study days available. .... 6.5.4 Cleaning efficiency should be detected using a standard 'soil test' ... sterilizer is compatible with the equipment to be processed, ...
www.sefton.nhs.uk/.../023_Decontamination Policy.pdf - Similar
Cole-Parmer Digital Gauge, Cole-Parmer Antifoam Probes, 15 Psi W
Buy "Lamotte® Soil Test Kits" products like Garden test kit, Soil texture test ... Buy "Sterilmatic Sterilizing Equipment" products like Benchtop sterilizer ...
www.coleparmer.com/1/3/indexb514.html - Cached
[PDF]
Decontamination of reusable Medical Devices Policy
File Format: PDF/Adobe Acrobat - Quick View
Transport of Contaminated Instruments & Associated Equipment .... Chemical indicator strips show that sterilising conditions have been achieved at that point; .... It is recommended that a soil test and a residual protein .... bag or plain top and either a heat sealing machine or autoclave tape is then required to ...
www.southstaffshealthcare.nhs.uk/work/policies.../C.YEL.ic....
[PDF]
INFECTION PREVENTION
File Format: PDF/Adobe Acrobat - View as HTML
“The DAC Universal is an extremely efficient autoclave, which can handle the complete process for turbines and contra angles between each ... cleaning, lubrication and sterilisation processes of the ... an excellent cleaning performance for the soil test ... Cross-contamination potential with dental equipment ...
https://www.wh.com/imperia/md/content/.../dac_broschyr_eng_2...
Autoclave / Sterilizer, Sturdy-LTE- All American- Hirayama ...
21 Aug 2007 ... We can offer the top quality Autoclave / Sterilizer, Sturdy-LTE- All American- ... Tester GMO Kit Goniometer Grain Testing Equipment Granule Tester Grinder ... Media, Microwave, Steam Sterilising Tray Stirrer Stomacher Super ... Salt Meter Sampling Water Shakling Water Bath Soil Test Kit Soil Tester ...
www.manufacturer.com/.../i5100394-Autoclave + Sterilizer, ...



Note from asker:
Thanks David. This sounds feasible, but I think test soils are done on medical devices, not on pharma solutions?
I quite agree that this does not refer to earth here :) But my doubt remains as to whether this test is performed on instruments (following sterilisation), not tablets
Something went wrong...

Reference comments

2 horas
Reference:

cleanliness testing?
Note from asker:
Thanks Liz. I offered this to the client as you will see in my answer to Eski.
Peer comments on this reference comment:

agree alcocer
1 día 7 horas
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