In 2006, the United States Pharmacopeial Convention published a revised Chapter 61, and introduced a new Chapter 62, that cover the Microbiological Examination of Nonsterile Products. These chapters will become effective in May 2009, and are harmonized with the European Pharmacopeia and the Japanese Pharmacopeia.
BD has reviewed and revised, where applicable, the labeling, formulations and performance testing for the media that are specified in these new chapters. We stand ready to assist you with the transition to these new testing requirements. You can use these media now, secure that you are meeting today’s requirements for the USP, EP and JP as well as those of the harmonized requirements of the future.
Below are the media required for compliance with the new USP chapters.
These media meet today’s requirements for the USP, EP and JP as well as the harmonized requirements of the future.
USP CHAPTERS <61> and <62>
BD MEDIA FORMULATIONS
|
| TEST |
MEDIA |
CAT # |
DESCRIPTION |
TYPE |
FILL VOL |
PACKAGING |
| Test for Escherichia coli |
MacConkey Broth |
215177 |
MacConkey Broth |
Bottle |
100mL |
10 each |
| 220100 |
Dehydrated |
500g |
1 each |
| MacConkey Agar |
215197 |
MacConkey Agar |
Plate |
100mm style |
1 each |
| 297064 |
Plate |
100mm style |
1 each |
| 212123 |
Dehydrated |
500g |
1 each |
| 212122 |
Dehydrated |
2kg |
1 each |
| 275300 |
Dehydrated |
10kg |
1 each |
| 211387 |
Dehydrated |
500g |
1 each |
| 211390 |
Dehydrated |
5lb |
1 each |
| 211391 |
Dehydrated |
25lb |
1 each |
| Test for Bile-tolerant Gram-negative Bacteria |
Violet Red Bile Glucose Agar |
215198 |
Violet Red Bile Glucose Agar |
Plate |
100mm style |
20 each |
| 215053 |
Plate |
100mm style |
100 each |
| 218661 |
Dehydrated |
500g |
1 each |
| Mossel Enterobacteriaceae Enrichment Broth |
292627 |
EE Broth Mossel |
Bottle, wide mouth |
90mL |
10 each |
| 256620 |
Dehydrated |
500g |
1 each |
| 297005 |
Dehydrated |
500g |
1 each |
| Test for Salmonella spp. |
Rappaport Vassiliadis Salmonella Enrichment Broth |
215199 |
RVS Soy Broth |
K Tube |
10mL |
10 each |
| 214943 |
Dehydrated |
500g |
1 each |
| Xylose-Lysine-Deoxycholate Agar |
221192 |
XLD Agar |
Plate |
100mm style |
20 each |
| 221888 |
Plate |
100mm style |
30 each |
| 221284 |
Plate |
100mm style |
100 each |
| 278850 |
Dehydrated |
500g |
1 each |
| 278820 |
Dehydrated |
2kg |
1 each |
| 278830 |
Dehydrated |
10kg |
1 each |
| Test for Pseudomonas aeruginosa |
Cetrimide Agar |
297882 |
Pseudosel™ Agar Cetrimide |
Plate |
100mm style |
10 each |
| 285420 |
Cetrimide Agar Base |
Dehydrated |
500g |
1 each |
| Test for Staphylococcus aureus |
Mannitol Salt Agar |
221173 |
Mannitol Salt Agar |
Plate |
100mm style |
20 each |
| 221271 |
Plate |
100mm style |
100 each |
| 211407 |
Dehydrated |
500g |
1 each |
| 211410 |
Dehydrated |
5lb |
1 each |
| 293689 |
Dehydrated |
25lb |
1 each |
| Test for Clostridia |
Reinforced Medium for Clostridia |
215192 |
Reinforced Medium for Clostridia |
Bottle, screw cap/septum |
100mL |
10 each |
| 218081 |
Dehydrated |
500g |
1 each |
| Columbia Agar |
215191 |
Columbia Agar |
Plate |
100mm style |
20 each |
| 211124 |
Dehydrated |
500g |
1 each |
| 211125 |
Dehydrated |
5lb |
1 each |
| 211126 |
Dehydrated |
25lb |
1 each |
| Test for Candida albicans |
Sabouraud Dextrose Broth |
215193 |
Sabouraud Dextrose Broth |
Bottle, screw cap/septum |
100mL |
10 each |
| 238220 |
Dehydrated |
100g |
1 each |
| 238230 |
Dehydrated |
500g |
1 each |
| 238210 |
Dehydrated |
2kg |
1 each |
| Sabouraud Dextrose Agar |
221180 |
Sabouraud Dextrose Agar |
Plate |
100mm style |
20 each |
| 221278 |
Plate |
100mm style |
100 each |
| 292336 |
Plate, BD™ Sterile Pack |
100mm style |
100 each |
| 211584 |
Dehydrated |
500g |
1 each |
| 211585 |
Dehydrated |
5lb |
1 each |
| 210940 |
Dehydrated |
100g |
1 each |
| 210950 |
Dehydrated |
500g |
1 each |
| 211661 |
Dehydrated |
2kg |
1 each |
| 210930 |
Dehydrated |
10kg |
1 each |
| Microbial Enumeration Tests |
Soybean-Casein Digest Broth |
299107 |
Trypticase™ Soy Broth |
Bottle, serum |
100mL |
10 each |
| 299416 |
Bottle, screw cap/septum |
100mL |
10 each |
| 299113 |
Bottle, screw cap/septum |
500mL |
10 each |
| 211768 |
Dehydrated |
500g |
1 each |
| 211771 |
Dehydrated |
5lb |
1 each |
| 211772 |
Dehydrated |
25lb |
1 each |
| 290612 |
Tryptic Soy Broth |
Bottle, wide mouth |
90mL |
10 each |
| 290613 |
Bottle, wide mouth |
100mL |
10 each |
| 211824 |
Dehydrated |
100g |
1 each |
| 211825 |
Dehydrated |
500g |
1 each |
| 211822 |
Dehydrated |
2kg |
1 each |
| 211823 |
Dehydrated |
10kg |
1 each |
| Soybean-Casein Digest Agar |
221185 |
Trypticase™ Soy Agar |
Plate |
100mm style |
20 each |
| 221283 |
Plate |
100mm style |
100 each |
| 222205 |
Plate, BD™ Sterile Pack |
100mm style |
100 each |
| 299099 |
Bottle, screw cap/septum |
500mL |
10 each |
| 211043 |
Dehydrated |
500g |
1 each |
| 211046 |
Dehydrated |
5lb |
1 each |
| 211047 |
Dehydrated |
25lb |
1 each |
| 236940 |
Tryptic Soy Agar |
Dehydrated |
100g |
1 each |
| 236950 |
Dehydrated |
500g |
1 each |
| 236920 |
Dehydrated |
2kg |
1 each |
| 236930 |
Dehydrated |
10kg |
1 each |
| Potato Dextrose Agar |
297945 |
Potato Dextrose Agar |
Plate |
100mm style |
100 each |
| 299906 |
Bottle, screw cap/septum |
500mL |
10 each |
| 213300 |
Dehydrated |
100g |
1 each |
| 213400 |
Dehydrated |
500g |
1 each |
| Buffers and Solutions |
Phosphate Buffer pH 7.2 |
257385 |
Phosphate Buffer pH 7.2 (Stock Solution) |
Bottle, crimp/stopper |
100mL |
25 each |
| 214973 |
Phosphate Buffer pH 7.2 |
Bottle, screw cap/septum |
500mL |
10 each |
| 211544 |
Dehydrated |
500g |
1 each |
| Buffered Sodium Chloride-Peptone Solution pH 7.0 |
257086 |
Buffered Sodium Chloride-Peptone Solution pH 7.0 |
Bottle, crimp/stopper |
100mL |
25 each |
| 257087 |
Bottle, crimp/stopper |
500mL |
10 each |
|
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