4.05 Microbiological Examination of Non-sterile Products

More documents

Recommendations

Info

8. Minimum number of items to be testedThe minimum number of items to be tested in relation to the size of the batch is given inTable 4.06-3.Table 4.06-3. Minimum number of items to be testedNumber of items in the batch*Parenteral preparationsMinimum number of items to be tested foreach medium, unless otherwise justified andauthorised**– Not more than 100 containers 10 per cent or 4 containers whichever is thegreater–More than 100 but not more than 500containers–More than 500 containersOphthalmic and other non-injectablepreparations10 containers2 per cent or 20 containers (10 containers forlarge-volume parenterals) whichever is theless– Not more than 200 containers 5 per cent or 2 containers whichever is thegreater– More than 200 containers 10 containers– If the product is presented in the form ofsingle-dose containers, apply the schemeshown above for preparations forparenteral useBulk solid products–Up to 4 containers– More than 4 containers but not more than50 containers–More than 50 containersEach container20 per cent or 4 containers whichever is thegreater2 per cent or 10 containers whichever is thegreater* If the batch size is not known, use the maximum number of items prescribed**If the contents of one container are enough to inoculate the two media, this column givesthe number of containers needed for both the media together.26/29
6.09 Disintegration TestChange to read following part under Apparatus:Disks-The use of disks is permitted only where specified or allowed. Each tube is providedwith a cylindrical disk 9.5±0.15 mm thick and 20.7±0.15 mm in diameter. The disk is madeof a suitable, transparent plastic material having a specific gravity of between 1.18 and 1.20.Five parallel 2±0.1 mm holes extend between the ends of the cylinder. One of the holes iscentered on the cylindrical axis. The other holes are centered 6±0.2 mm from the axis onimaginary lines perpendicular to the axis and parallel to each other. Four identicaltrapezoidal-shaped planes are cut the wall of the cylinder, nearly perpendicular to the ends ofthe cylinder. The trapezoidal shape is symmetrical; its parallel sides coincide with the ends ofthe cylinder and are parallel to an imaginary line connecting the centers of two adjacent holes6 mm from the cylindrical axis. The parallel side of the trapezoid on the bottom of the cylinderhas a length of 1.6±0.1 mm, and its bottom edges lie at a depth of 1.5-1.8 mm from thecylinder’s circumference. The parallel side of the trapezoid on the top of the cylinder has alength of 9.4±0.2 mm, and its center lies at a depth of 2.6±0.1 mm from the cylinder’scircumference. All surfaces of the disk are smooth. If the use of disks is specified, and a deskto each tube, and operate the apparatus as directed under Procedure. The disks conform todimensions found in Fig.6.09-1. The use of automatic detection employing modified disks ispermitted where the use of disks is specified or allowed. Such disks must comply with therequirements for density and dimension given in this chapter.27/29
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 and 14: hours.4-7-3 InterpretationGrowth of
Page 15 and 16: Crystal violet1 mgPurified water100
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: visual examination, 14 days after t
Page 29: cell is immersed in a water bath, a

4.05 Microbiological Examination of Non-sterile Products

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?