Merck
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PEP013

Supelco

Microbial Enumeration Test PT

Proficiency Testing Material

NACRES:
NA.24

Agency

suitable for USP 61

Quality Level

packaging

pkg of 3 × 1 ea

application(s)

pharmaceutical

format

matrix material

storage temp.

−20°C

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.

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

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.

Other Notes

Are you new to Supelco® Proficiency TestingͰ 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.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

Supelco is a registered trademark of Merck KGaA, Darmstadt, Germany
Vitroid is a trademark of Sigma-Aldrich Co. LLC

Storage Class Code

6.2 - Infectious substances

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

新产品

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Origin

Enter Lot Number to search for Certificate of Origin (COO).

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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