Pharmaceutical


Microbial Limit Test <61>
Product Number PEP-013
Price:   $153.00
Availability:  Available

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PEP-013-1 Microbial Enumeration USP<61> - Sample 1


Description

This PT is supplied to simulate product testing. The sample is a vial containing a small Vitroid™ (media containing possible organisms). It is the colored disk on top of the cotton ball. The yellow beads are desiccant.

The sample is provided in duplicate.

The samples may contain any of the 5 organisms listed in Table 1: USPC General Chapter <61>.


Sample Preparation

Allow the vial to warm to room temperature.

Transfer the Vitroid™ to a suitable container for hydration. Assume the tablet weighs 500mg for dilution and calculation purposes. It actually weighs less than 50mg. The Vitroid™ will dissolve completely in as little as 100µL of buffer solution.

Allow the Vitroid™ to completely dissolve it takes approximately 15 minutes, mix well either by vortexing or inverting the sample 5-10 times.

Continue as directed by General Chapter <61>. Incubate at 30º-35ºC for 18-24 hours using Soybean-Casein Digest Agar or Soybean-Casein Digest Broth.


Reporting Instructions

Report total aerobic microbial count as cfu.



PEP-013-2 Microbial Enumeration USP<61> - Sample 2


Description

This PT is supplied to simulate product testing. The sample is a vial containing a small Vitroid™ (media containing possible organisms). It is the colored disk on top of the cotton ball. The yellow beads are desiccant.

The sample is provided in duplicate.

The samples may contain any of the 5 organisms listed in Table 1: USPC General Chapter <61>.


Sample Preparation

Allow the vial to warm to room temperature.

Transfer the Vitroid™ to a suitable container for hydration. Assume the tablet weighs 500mg for dilution and calculation purposes. It actually weighs less than 50mg. The Vitroid™ will dissolve completely in as little as 100µL of buffer solution.

Allow the Vitroid™ to completely dissolve it takes approximately 15 minutes, mix well either by vortexing or inverting the sample 5-10 times.

Continue as directed by General Chapter <61>. Incubate at 30º-35ºC for 18-24 hours using Soybean-Casein Digest Agar or Soybean-Casein Digest Broth.


Reporting Instructions

Report total aerobic microbial count as cfu.



PEP-013-3 Microbial Enumeration USP<61> - Sample 3


Description

This PT is supplied to simulate product testing. The sample is a vial containing a small Vitroid™ (media containing possible organisms). It is the colored disk on top of the cotton ball. The yellow beads are desiccant.

The sample is provided in duplicate.

The samples may contain any of the 5 organisms listed in Table 1: USPC General Chapter <61>.


Sample Preparation

Allow the vial to warm to room temperature.

Transfer the Vitroid™ to a suitable container for hydration. Assume the tablet weighs 500mg for dilution and calculation purposes. It actually weighs less than 50mg. The Vitroid™ will dissolve completely in as little as 100µL of buffer solution.

Allow the Vitroid™ to completely dissolve it takes approximately 15 minutes, mix well either by vortexing or inverting the sample 5-10 times.

Continue as directed by General Chapter <61>. Incubate at 30º-35ºC for 18-24 hours using Soybean-Casein Digest Agar or Soybean-Casein Digest Broth.


Reporting Instructions

Report total aerobic microbial count as cfu.



strammel@rt-corp.com