Quality Control for Pharmaceutical Microbiology

Confidence in the quality of your pharmaceuticals

In the pharmaceutical industry, regulatory compliance is paramount. When it comes to pharmaceutical quality control, robust, validated protocols are key to ensure safe release of high-performing pharmaceutical products. Let us help you ensure the safety of your products and customers while meeting pharmacopeia requirements.

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Key applications for quantitative quality control

Growth Promotion:

Ensure your culture media supports the growth of relevant microorganisms to confidently test for sterility and  environmental monitoring programs. 
Bacillus subtilis ATCC® 6633™Quanti-Cult: 10 tests/kit R4731221
Quanti-Cult Plus: 100 tests/kit R4711221
Aspergillus brasiliensis ATCC® 16404™Quanti-Cult: 10 tests/kit R4731100
Quanti-Cult Plus: 100 tests/kit R4711100
Candida albicans ATCC® 10231™Quanti-Cult: 10 tests/kit R4731503
Quanti-Cult Plus: 100 tests/kit R4711503
Staphylococcus aureus ATCC® 6538™Quanti-Cult: 10 tests/kit R4737016
Quanti-Cult Plus: 100 tests/kit R4717016
Pseudomonas aeruginosa ATCC® 9027™Quanti-Cult: 10 tests/kit R4735210
Quanti-Cult Plus: 100 tests/kit R4715210
Clostridium sporogenes ATCC® 19404™Quanti-Cult Plus: 100 tests/kit R4711700

 

Method Suitability:

Validate your method to ensure detection of microorganisms in the final product - trust in the quality of your sterile pharmaceuticals.
Bacillus subtilis ATCC® 6633™Quanti-Cult: 10 tests/kit R4731221
Quanti-Cult Plus: 100 tests/kit R4711221
Aspergillus brasiliensis ATCC® 16404™Quanti-Cult: 10 tests/kit R4731100
Quanti-Cult Plus: 100 tests/kit R4711100
Candida albicans ATCC® 10231™Quanti-Cult: 10 tests/kit R4731503
Quanti-Cult Plus: 100 tests/kit R4711503
Staphylococcus aureus ATCC® 6538™Quanti-Cult: 10 tests/kit R4737016
Quanti-Cult Plus: 100 tests/kit R4717016
Salmonella enterica subsp. enterica serovar Typhimurium ATCC® 14028™Quanti-Cult Plus: 100 tests/kit R4716000
Salmonella sp. serovar Abony NCTC 6017Quanti-Cult Plus: 100 tests/kit R4716007
Escherichia coli ATCC® 8739™Quanti-Cult: 10 tests/kit R4737085
Quanti-Cult Plus: 100 tests/kit R4717085
Pseudomonas aeruginosa ATCC® 9027™Quanti-Cult: 10 tests/kit R4735210
Quanti-Cult Plus: 100 tests/kit R4715210
Burkholderia cepacia ATCC® 25416™Quanti-Cult Plus: 100 tests/kit R4715220
Burkholderia cenocepacia ATCC® BAA-245™Quanti-Cult Plus: 100 tests/kit R4715221
Burkholderia multivorans ATCC® BAA-247™Quanti-Cult Plus: 100 tests/kit R4715222
Clostridium sporogenes ATCC® 11437™Quanti-Cult: 10 tests/kit R4731703
Quanti-Cult Plus: 100 tests/kit R4711703
Clostridium sporogenes ATCC® 19404™Quanti-Cult Plus: 100 tests/kit R4711700

 

Microbial Limits Testing:

Assess which microorganisms and how many are present in non-sterile pharmaceuticals raw materials and products.
Candida albicans ATCC® 10231™Quanti-Cult: 10 tests/kit R4731503
Quanti-Cult Plus: 100 tests/kit R4711503
Staphylococcus aureus ATCC® 6538™Quanti-Cult: 10 tests/kit R4737016
Quanti-Cult Plus: 100 tests/kit R4717016
Salmonella enterica subsp. enterica serovar Typhimurium ATCC® 14028™Quanti-Cult Plus: 100 tests/kit R4716000
Salmonella sp. serovar Abony NCTC 6017Quanti-Cult Plus: 100 tests/kit R4716007
Escherichia coli ATCC® 8739™Quanti-Cult: 10 tests/kit R4737085
Quanti-Cult Plus: 100 tests/kit R4717085
Pseudomonas aeruginosa ATCC® 9027™Quanti-Cult: 10 tests/kit R4735210
Quanti-Cult Plus: 100 tests/kit R4715210
Burkholderia cepacia ATCC® 25416™Quanti-Cult Plus: 100 tests/kit R4715220
Burkholderia cenocepacia ATCC® BAA-245™Quanti-Cult Plus: 100 tests/kit R4715221
Burkholderia multivorans ATCC® BAA-247™Quanti-Cult Plus: 100 tests/kit R4715222
Clostridium sporogenes ATCC® 11437™Quanti-Cult: 10 tests/kit R4731703
Quanti-Cult Plus: 100 tests/kit R4711703
Clostridium sporogenes ATCC® 19404™Quanti-Cult Plus: 100 tests/kit R4711700

Quanti-Cult Plus

Access video demo: Thermo Scientific™ Quanti-Cult Plus™

In compliance with harmonized pharmacopeia requirements, Quanti-Cult Plus kits provide certainty in the quality control of your pharmaceutical microbiology processes. With the convenience of refrigerated storage and enhanced safety with a simple two-vial system, we'll show you how simple it is to use the Quanti-Cult Plus kits.

QC for Pharmaceutical Microbiology brochure

QC for Pharmaceutical Microbiology brochure

The Quanti-Cult™ two-vial system offers ease of use, enhanced safety with no organism handling and complete traceability of ATCC® Licence Derivative and NCTC cultures. Find out about the benefits and available strains for our Quanti-Cult Plus and Quanti-Cult products.

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Download pharmaceutical microbiology manual

Pharmaceutical microbiology manual – your complete guide

From raw materials to finished product, our complete, end-to-end workflows means that you can confidently get compliant and stay compliant, with the assurance of our product quality and expertise every step of the way.

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Pharmaceutical microbiology resource library

Explore the Pharmaceutical Microbiology resource library

Let us help you navigate the challenges of producing and quality testing your sterile and non-sterile pharmaceuticals, vaccines and biotechnology products. Visit our pharmaceutical resource library for the latest updates and recommendations.

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Learn more about our full range of solutions

Raw materials

Environmental monitoring

Aseptic process control

Microbial identification

Sterility testing

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ATCC Licensed Derivative
*The ATCC Licensed Derivative® Emblem, the ATCC Licensed Derivative® word mark and the ATCC catalog marks are trademarks of ATCC. Remel Inc. is licensed to use these trademarks and to sell products derived from ATCC® cultures. The identity, purity, and authenticity of the Licensed Products are exclusively the responsibility of Remel Inc., and not ATCC.