Documents
Recommended Products
Agency
suitable for USP 61
Quality Level
packaging
pkg of 3 × 1 ea
application(s)
pharmaceutical
format
matrix material
storage temp.
−20°C
1 of 4
This Item | PEP016 | PEP002 | PEP009 |
|---|---|---|---|
| format matrix material | format matrix material | format matrix material | format matrix material |
| agency suitable for USP 61 | agency - | agency - | agency suitable for USP 645 |
| packaging pkg of 3 × 1 ea | packaging pkg of 3 × 1 ea | packaging ampule of 4 × 1 g | packaging ampule of 3 × 100 mL |
| storage temp. −20°C | storage temp. - | storage temp. - | storage temp. - |
General description
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.
Application
Have any questions? Explore our FAQs.
For more information on this product, please contact our PT Service Team.
Features and Benefits
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
Preparation Note
- This PT is supplied to simulate product testing. The sample is a vial containing a small VitroidTM (media containing possible organisms). It is the colored disk on top of the cotton ball. The yellow beads are desiccant.
- Each sample is presented with a unique cap number to help distinguish between the different material batches provided.
Sample Preparation
- Allow the vial to warm to room temperature.
- Transfer the VitroidTM to a suitable container for hydration.
- Dissolve Vitroid in buffer solution.
- This sample is a single disc and the possible concentration range is quite broad; it may be necessary to analyze the sample in a dilution series buffer solution.
- Allow the VitroidTM 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.
- Report total aerobic microbial count as the 1 to 10 dilution.
Storage and Stability
Other Notes
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.com.
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.
Kit containing three samples testing the principles of the harmonized < 61> chapter. Instructions are included with kit.
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)
Legal Information
Storage Class Code
6.2 - Infectious substances
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
Already Own This Product?
Documents related to the products that you have purchased in the past have been gathered in the Document Library for your convenience.
Difficulty Finding Your Product Or Lot/Batch Number?
How to Find the Product Number
Product numbers are combined with Pack Sizes/Quantity when displayed on the website (example: T1503-25G). Please make sure you enter ONLY the product number in the Product Number field (Example: T1503).
Example:
Additional examples:
705578-5MG-PW
PL860-CGA/SHF-1EA
MMYOMAG-74K-13
1000309185
enter as 1.000309185)
Having trouble? Feel free to contact Technical Service for assistance.
How to Find a Lot/Batch Number for COA
Lot and Batch Numbers can be found on a product's label following the words 'Lot' or 'Batch'.
Aldrich Products
For a lot number such as TO09019TO, enter it as 09019TO (without the first two letters 'TO').
For a lot number with a filling-code such as 05427ES-021, enter it as 05427ES (without the filling-code '-021').
For a lot number with a filling-code such as STBB0728K9, enter it as STBB0728 without the filling-code 'K9'.
Not Finding What You Are Looking For?
In some cases, a COA may not be available online. If your search was unable to find the COA you can request one.
Customers Also Viewed
Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.
Contact Technical Service