1. 51 to 80 - Microbiological, Animal Feed, Biologics, Dietary Supplements, Food & Perishables, Hemp & Cannabis, Industrial, Microbiology, Pharmaceutical, PT Scheduled Studies, Topicals & Cosmetics, USP Proficiency Testing Program
USP <61> and <62> PT Pharmaceutical Product for Bioburden
U.S. Pharmacopeia USP PT Program Schedule
| 2023 PH | ||
| Study Number | Study Opens | Study Closes |
| PH-0123 | Jan. 16, 2023 | March 17, 2023 |
| PH-0523 | May 15, 2023 | July 14, 2023 |
| PH-0923 | September 15, 2023 | November 17, 2023 |
| PH-0124 | January 15, 2024 | March 17, 2024 |
USP Harmonized Compendial Methods
| United States Pharmacopeia (USP) | Ph. Eur, EP | JP | NSI Catalog Item | Harmonized Description |
|
USP <61> |
<2.6.12> |
JP <35> Microbial Limit Test |
PHPT-022 |
Microbial Enumeration of Non-sterile Products |
|
USP <62> Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms |
<2.6.13> |
JP <35> Microbial Limit Test |
PHPT-015 |
Test for Specified Microorganisms in Non-sterile Products |
Product Details
PHPT- 039, <61>/<62> Bioburden
Quantitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <61> or equivalent. Samples are provided as two single-pellet vials plus two vials of talc powder. Each vial of talc contains 10 grams per vial. Participants will follow provided step-by-step instructions to prepare each sample for plating onto suitable microbiological media. Participants will then quantify the microorganism present in the sample.
Qualitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <62> or equivalent. Samples are provided as a panel of five single-pellet vials plus five vials of talc powder. Each vial of talc contains 10 grams per vial. Participants will follow provided step-by-step instructions to prepare each sample for plating onto suitable microbiological media. Participants may report qualitative results of either present or absent for their samples. Three of the five samples will contain microorganisms and therefore be positive. Participants are asked to identify a positive sample by indicating present and identify a negative sample by indicating absent.
The positive microorganism may be any of the following species Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis, Salmonella enterica Typhi, Escherichia coli and Salmonella enterica Abony.
A negative sample will be sterile and not contain any microorganisms.
