Microbial Enumeration Test PT
SIAL/PEP013 - Proficiency Testing Material
Product Type: Chemical
| agency | suitable for USP 61 |
| application(s) | pharmaceutical |
| format | matrix material |
| packaging | pkg of 3 × 1 ea |
| Quality Level | 100  |
| storage temp. | −20°C |
| Application: | Microbial Enumeration Test proficiency testing material is used for the quantitative enumeration of microbial species in pharmaceutical industry. 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: | Microbial Enumeration Test 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 All information regarding the use of Microbial Enumeration Test 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<SUP>®</SUP> Proficiency Testing? Be sure to <a target="_blank" href="https://supelco-pt.com/pt-participant/lab_applicant/add">register your account details</A> in the PT Portal before placing your order.<BR/>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.<WBR>com.<BR/><BR/>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.<BR/>Click <a target="_blank" href="https://supelco-pt.com/faqs">here</A> 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.<BR/><BR/>Kit containing three samples testing the principles of the harmonized < 61> chapter. Instructions are included with kit.<BR/><BR/><b><u>Proficiency Testing Schedule (2022-2023)</u></b><BR/><BR/><b>Pharma</b><BR/>PHARM22-2 April 6 - May 20, 2022<BR/>PHARM22-4 October 5 - November 18, 2022<BR/><BR/> PHARM23-2 April 5 – May 19, 2023<BR/>PHARM23-4 October 4 – November 17, 2023 <BR/><BR/> Quick-Turn Study (on demand proficiency test that is offered depending on lot availability) |
| Preparation Note: | 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. • Each sample may be presented with a unique cap color to help distinguish between the different material batches provided: Sample 1 - Clear Cap Sample 2 - Red Cap Sample 3 - Blue Cap Sample Preparation • Allow the vial to warm to room temperature. • Transfer the Vitroid™ to a suitable container for hydration. Assume the tablet weighs 500 mg for dilution and calculation purposes. It weighs less than 50 mg.The Vitroid™ will dissolve completely in as little as 100 μL of buffer solution. • Allow the Vitroid™ to completely dissolve. It takes approximately 15 min, mix well either by vortexing or inverting the sample 5-10 times. • Continue as directed by General Chapter <61>. • Incubate at 30 ºC - 35 ºC for 18 - 24 hours using Soybean - Casein Digest Agar or Soybean-Casein Digest Broth. • Recommended dilution: 1 to 10 Reporting Instructions Report total aerobic microbial count as CFU. |
| 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 | 41116107 |