4.05 Microbiological Examination of Non-sterile Products

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Potato dextrose agarInfusion from potatoes200 gGlucose20.0 gAgar15.0 gPurified water1000 mLAdjust the pH so that after sterilization it is 5.6±0.2 at 25°C. Sterilize in an autoclave usinga validated cycle.Sabouraud-dextrose brothGlucose20.0 gMixture of peptic digest of animal tissue and pancreatic digest of casein (1:1) 10.0 gPurified water1000 mLAdjust the pH so that after sterilization it is 5.6±0.2 at 25°C. Sterilize in an autoclave usinga validated cycle.Enterobacteria enrichment broth-MosselPancreatic digest of gelatin10.0 gGlucose monohydrate5.0 gDehydrated ox bile20.0 gPotassium dihydrogen phosphate2.0 gDisodium hydrogen phosphate dehydrate8.0 gBrilliant green15 mgPurified water1000 mLAdjust the pH so that after heating it is 7.2±0.2 at 25°C. Heat at 1009C for 30 min and coolimmediately.Violet red bile glucose agarYeast extract3.0 gPancreatic digest of gelatin7.0 gBile salts1.5 gSodium chloride5.0 gGlucose monohydrate10.0 gAgar15.0 gNeutral red30 mgCrystal violet2 mgPurified water1000 mLAdjust the pH so that after heating it is 7.4±0.2 at 25°C. Heat to boiling; do not heat in anautoclave.MacConkey brothPancreatic digest of gelatin20.0 gLactose monohydrate10.0 gDehydrated ox bile5.0 gBromocresol purple10 mgPurified water1000 mLAdjust the pH so that after sterilization it is 7.3±0.2 at 25°C. Sterilize in an autoclave usinga validated cycle.MacConkey agarPancreatic digest of gelatinPeptones (meat and casein)Lactose monohydrateSodium chlorideBile saltsAgarNeutral red14/2917.0 g3.0 g10.0 g5.0 g1.5 g13.5 g30 mg
Crystal violet1 mgPurified water1000 mLAdjust the pH so that after sterilization it is 7.1±0.2 at 25°C. Boil for 1 min with constantshaking then sterilize in an autoclave using a validated cycle.Rappaport Vassiliadis Salmonella enrichment brothSoya peptone4.5 gMagnesium chloride hexahydrate29.0 gSodium chloride8.0 gDipotassium hydrogen phosphate0.4 gPotassium dihydrogen phosphate0.6 gMalachite green36 mgPurified water1000 mLDissolve, warming slightly. Sterilize in an autoclave using a validated cycle, at atemperature not exceeding 115°C. The pH is to be 5.2±0.2 at 25°C after heating andautoclaving.Xylose, lysine, deoxycholate agarXylose3.5 gL-Lysine5.0 gLactose monohydrate7.5 gSucrose7.5 gSodium chloride5.0 gYeast extract3.0 gPhenol red80 mgAgar13.5 gSodium deoxycholate2.5 gSodium thiosulfate6.8 gAmmonium iron (III) citrate0.8 gPurified water1000 mLAdjust the pH so that after heating it is 7.4±0.2 at 25°C. Heat to boiling, cool to 50°C andpour into Petri dishes. Do not heat in an autoclave.Cetrimide agarPancreatic digest of gelatin20.0 gMagnesium chloride1.4 gDipotassium sulfate10.0 gCetrimide0.3 gAgar13.6 gPurified water1000 mLGlycerol10.0 mLHeat to boiling for 1 min with shaking. Adjust the pH so that after sterilization it is 7.2±0.2at 25°C. Sterilize in an autoclave using a validated cycle.Mannitol salt agarPancreatic digest of casein5.0 gPeptic digest of animal tissue5.0 gBeef extract1.0 gD-Mannitol10.0 gSodium chloride75.0 gAgar15.0 gPhenol red25 mgPurified water1000 mLHeat to boiling for 1 min with shaking. Adjust the pH so that after sterilization it is 7.4±0.2at 25°C. Sterilize in an autoclave using a validated cycle.15/29
Page 3 and 4: dehydrated medium or from the ingre
Page 5 and 6: Transfer a suitable amount of the s
Page 7 and 8: described in section 4. Incubate al
Page 9 and 10: with an established specification f
Page 11 and 12: 4-1-3 Quantitative test4-1-3-1 Sele
Page 13: hours.4-7-3 InterpretationGrowth of
Page 17 and 18: 17/29
Page 19 and 20: Change to read as follows:4.06 Ster
Page 21 and 22: Incubate portions of the media for
Page 23 and 24: If appropriate, transfer a small qu
Page 25 and 26: visual examination, 14 days after t
Page 27 and 28: 6.09 Disintegration TestChange to r
Page 29: cell is immersed in a water bath, a

4.05 Microbiological Examination of Non-sterile Products

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