Sterility PT
SIAL/PEP016 - Proficiency Testing Material
Product Type: Chemical
application(s) | pharmaceutical |
format | matrix material |
packaging | pkg of 3 × 1 ea |
Quality Level | 100 ![]() |
suitability | suitable for (suitable for 71 per USP) |
Application: | Sterility pharmaceutical proficiency testing material is used in the pharmaceutical analysis for any microbial growth identification. Have any questions? Explore ourFAQs ![]() 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: | Sterility 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 Sterility 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 ![]() 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 ![]() 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 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 colored tablet to buffer water and let sit for 15 min, the tablet will slowly dissolve. After 15 min gently shake the sample until the tablet dissolves completely. You may also use your media to hydrate. It is suggested to use no more than 100 mL for hydration. If 100 mL is used a minimum sampling size is no less than 1 mL. • This is to be considered your sample for test. This sample may be diluted up to 1:5. • Further dilution may dilute out the organisms. Reporting Instructions • If growth occurs report ′1′. • If no growth occurs report ′0′. • Contact ptservice@milliporesigma. |
Storage and Stability: | Please refer to sample label for expiration date, specific storage temperature, and specific storage conditions. |
RIDADR | UN3373 - class 6.2 Biological substance, Category B |
WGK Germany | WGK 1 |
Flash Point(F) | Not applicable |
Flash Point(C) | Not applicable |
UNSPSC | 41116107 |
Components | Growth (Report 0 or 1) 0.00 - 1.00 |