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yxfbbiedtj · Wysłany: Wto 4:02, 15 Mar 2011

Amendment to the Chinese Pharmacopoeia Sterile international comparison of experimental methods to reconcile

Fresh liquid medium in the same together with the liquid to continue to foster the total number of days {14 ± 7) days of the amendments highlighted. The time when bacterial growth. Only when the operator sets the following four conditions can be repeated experiment ① environmental factors: in the training did not prepare the error during the observation period; ② In the experiment, significant operational errors; ③ in the negative control in the growth of microorganisms; @ pollution seedlings determined. Is considered contaminated by bacteria in the sterile test material or equipment and meters, and repeated tests in early trials with the same amount. Double sampling without the operating environment which is extremely stringent requirements and 7 sampling of inoculation ■ , the pressure of oxygen do five strains,[link widoczny dla zalogowanych], including one as a positive control. 2 glance to mold repair 』1. Rear provides the test of load Hey Each flag of mourning past inoculation】】 m F memory objects to all 1ml13 [but not more than half of the contents 20ml Mourning 50mg J} I injected a guest, or more liquid containers can be less than 25ml in water or isopropyl fan delete borers acid sample pan fan of ten disposable device control block more scenting agents. emulsion or suspension may be cut or minimum of not less than 025g emulsifying ointment leopard sample volume. Pharmacopoeia different countries, the Chinese Pharmacopoeia whatever amount to take out only two,[link widoczny dla zalogowanych], without making provisions of the Japanese Pharmacopoeia. The amendment provides: polycarbonatef diameter 04m) rolilelraC) cline a tetracycline topiramate ... cyclin dimethylamine Penicillium Ring Cable Cable oxaeillinsodium oxacillin sodium colislinmethanexuIesodium prime enemy sodium et3 ~ hmmycinladoblonate A milk-yee, erythromycin oleatldomycin bamboo pick enzyme neomycin kita at amtinlartt ~ tt ~ ~ tartar minced meat white ADM pieillinoxaeillln ampicillin oxacillin ampiciIliuclo + x ~ illm ampicillin penicillin o-chloro cYcI extension cable Wu】】 ... Jtrale ILt bared a nitrate or tetracycline eye ointment care of non-intestinal large volume injection system for Jing Jing solid pension system at least in the 100 samples 1,005,091 containers, container 500 or more than 2 ∞ Selector container more than 200 the following ten container 4 4 ~ 5O a disposable device) the minimum sample volume of 50 ten container t0% or 4 large container storage clamor to step 10 2O a pit 2% or 5% or 2 devices l0 ten containers of containers of 20% or 4 per package of 2% or 101 ten packing,[link widoczny dla zalogowanych], packaging, sampling volume and pass rate: based of a batch of injections for the overall, for the N branch, which contaminated part of the P said, O sub-group that is not contaminated, then: P + Q = I.Q: 1 P when the sampling volume of a Q for the failure rate or said such a group with a detection rate of the sample = IO0 pieces. Part of pollution P 5%. Not the same sample volume. The positive detection is different slaughter Table: Different sampling volume and tone detection rate of sampling efficiency of {}} Mi out with fortune f, ga will not 々 Fortunately, Bei rate nQ = ll-PitP = 1 for a 1095l】 05095O052095: 13902500915O903015095: 085730】 426077O33tO095: 05987041) 1305904t20095 = 03585064t50360 Zion is only 9.75%. no cell was 010 units. The amendment to take 10 out of its orange-positive rate of 4013%. failure rate of 041, so the sample size of Chinese Pharmacopoeia 8 sterile device is worth improving,[link widoczny dla zalogowanych], sterile plant in Japan, there are three l shown) the first membrane device must be removed. cut into 2 or 4 half-half to release the cultured medium, and the Chinese Pharmacopoeia same. devices do not need to remove the membrane, pump device directly to the culture medium. This reduces the pollution of a King fan will be: a second device in the assembly of the gasket aging. spillage within the incubation time phenomenon; third device is a disposable sterile system. opportunity to both reduce pollution. fork does not spill phenomenon. but the price is more expensive; the amendment did not have specific provisions of sterile devices. So. Choose one according to the conditions and the international harmonized standards in order to reach agreement. suggest that the Chinese Pharmacopoeia, especially In the culture time and the sample size to be improved,[link widoczny dla zalogowanych], I Received :2000 -03-14)