Tests for Specified Microorganisms <62>
SIAL/PEP025 - Proficiency Testing Material
Product Type: Chemical
| application(s) | pharmaceutical |
| format | matrix material |
| matrix | Vitroid™ |
| packaging | set of 1 ea |
| Quality Level | 100  |
| storage temp. | −20°C |
| suitability | suitable for (suitable for 62 per USP) |
| Application: | Tests for Specified Microorganisms under USP 62, pharmaceutical proficiency testing material is used to test Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella enterica typhimurium, Salmonella enterica Abony and Candida albicans microorganisms in pharmaceutical products. Have any questions? Explore our FAQs .For more information on this product, please contact our PT Service Team . |
| Features and Benefits: | We have a vast portfolio of environmental PT schemes with "fit-for-purpose" samples to help you meet the needs of the laboratory. Our proficiency testing (PT) program is a benchmark to: • provide staff with an insight into their laboratory′s performance, to verify the accuracy and reliability of their testing process • provide a comparison of performance with that of other laboratories, nationally and internationally • test and educate staff, provide a better understanding of the impact of incorrect results and identify areas where there may be problems • provide an independent evaluation of laboratory performance • demonstrate to clients, colleagues and accreditation bodies that there is a commitment to quality |
| General description: | Tests for Specified Microorganisms under USP 62 proficiency testing material is produced in accordance with ISO/IEC 17043:2010. The PT portfolio allows our test components to offer significant performance data to monitor and prove competency to customers, accreditation bodies or both. Supelco® Pharmaceutical Proficiency Testing scheme is mainly designed to meet the needs of the pharmaceutical industry. The pharma PT samples allow laboratories to demonstrate their competence in following compendial USP methods of analysis. They can be used to assure accreditors or auditors that the lab processes are followed accordingly. Our pharmaceutical PT scheme covers products under categories such as Chemical Tests and Assays, Physical Tests and Determinations and Microbiological Tests. Type of PT Scheme: Pharmaceuticals Analyte/s: Values of analytes vary lot to lot. All information regarding the use of Tests for Specified Microorganisms under USP 62 proficiency testing standard can be found in the reporting packet which will be available to download at PT Portal . |
| Legal Information: | Supelco is a registered trademark of Merck KGaA, Darmstadt, Germany |
| Legal Information: | Vitroid is a trademark of Sigma-Aldrich Co. LLC |
| Other Notes: | Are you new to Supelco® Proficiency Testing? Be sure to register your account details in the PT Portal before placing your order. This will provide access to data entry, reporting packets and final reports. Registrations will be approved shortly after your order is placed. For further questions, write to us at ptservice@milliporesigma. When placing your order online, please indicate your study preference under the ′your reference′ column. Available studies can be viewed at the bottom of the page. Click here to learn more about Quick-Turn Studies (on-demand proficiency tests that are offered depending on lot availability). The Quick-Turn results are released within 48-72 hours whereas scheduled study reports are released within 21 days.Proficiency testing samples are presented as single blind. No values for the samples are released until the testing period concludes. Proficiency Testing Schedule (2022-2023) Pharma PHARM22-2 April 6 - May 20, 2022 PHARM22-4 October 5 - November 18, 2022 PHARM23-2 April 5 – May 19, 2023 PHARM23-4 October 4 – November 17, 2023 Quick-Turn Study (on demand proficiency test that is offered depending on lot availability) |
| Preparation Note: | Description • The sample includes a vial containing a tablet (media containing a specific organism). • The samples contain one of the following organisms from USP General Chapter <62>: Staphylococcus aureus Pseudomonas aeruginosa Escherichia coli Salmonella enterica, typhimurium Salmonella enterica, abony Candida albicans. Sample Preparation • Dissolve the Vitroid™ in 100 mL of an appropriate solution. • This is to be considered your sample for test. • Perform presence/absence tests for each of the possible organisms on the prepared samples. Reporting Instructions • If presence occurs, report ′1′. • If no presence occurs, report ′0′. • Contact the PT Service Group if you have any question or if you have an unexpected result. |
| Storage and Stability: | Please refer to sample label for expiration date, specific storage temperature, and specific storage conditions. |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 1 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | −20°C |
| UNSPSC | 12352200 |
| Components | Candida albicans Presence/Absence; Escherichia coli Presence/Absence; Pseudomonas aeruginosa Presence/Absence; Salmonella enterica, abony Presence/Absence; Salmonella enterica, typhimurium Presence/Absence; Staphylococcus aureus Presence/Absence |