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03:44 Dec 7, 2011 |
German to English translations [PRO] Tech/Engineering - Medical: Pharmaceuticals / estriol/testosterone production plant - Risk Analysis | |||||||
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| Selected response from: Marga Shaw United Kingdom Local time: 09:04 | ||||||
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Summary of answers provided | ||||
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4 | balance room |
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3 +1 | separate weighing room |
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Discussion entries: 4 | |
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balance room Explanation: "Although referred to here as a "balance room," this can be any suitable area which ... The balance room should be small enough to allow proper and economical ..." www.epa.gov/ttnamti1/files/ambient/pm25/qa/balance.pdf "Thus, if a method of direct weighing is used, the substance ought to be added to .... balances, precise to ±0.001 g, are available for your use in the balance room. ..." www.csudh.edu/oliver/demos/bal-use/bal-use.htm |
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Notes to answerer
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separate weighing room Explanation: Weighing of starting materials usually should be carried out in a separate weighing room designed for that use. http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/cap3... This 350 sq.ft. metal-free clean laboratory has two laminar flow work stations, two fume hoods, a Millipore ultrapure water system, a separate weighing room with two Sartorious balances (Genius analytical balance and Expert top-loading balance), an Analab closed environment evaporation system, two centrifuges, an ultrasonic bath, two Savillex acid stills, five temperature-controllled hot plates, and miscellaneous other items (including Parr bombs). http://myweb.uiowa.edu/mreagan/mkr-facilities.htm "Weighing of starting materials usually should be carried out in a separate weighing room designed for that use." (3.13 EU GMP Guideline). This explicit requirement for a weigh-in area reflects the importance of the process. In addition to the requirements regarding layout, surfaces, etc., the rooms should also be separate from the other rooms in the production area. During the planning phase, the location of the weigh-in process should be established depending on the defined material and personnel flows. Permanent weigh-in in multi-functional rooms is thus not recommended. This is understandable, as the weigh-in system must be very precisely defined with balances and processes, in order to prevent cross-contamination, mix-ups or confusion. http://www.gmpua.com/World/GMPManual/daten/autorenteil/kapit... [Both are specialists in their own field and benefit from having automated manufacturing equipment and high performance packaging lines. Additionally, Waltrop has a dedicated areas for hormone bulk production and hormone packaging.] http://www.nextpharma.com/de/news/2006/newsletter_0306.html |
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