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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.
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 6017 | Quanti-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 6017 | Quanti-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 |
SmartNote: Growth Promotion Testing for Pharmaceutical Microbiology
Industry expert Dr. Tarun Chugh explores the fundamental principles, regulatory requirements, methods, and best practices associated with the Growth Promotion Test (GPT) within the context of pharmaceutical microbiology in our latest SmartNote. He also discusses key considerations for conducting and interpreting GPT results, emphasizing the importance of this test in maintaining the quality and safety of pharmaceutical products.
How ISO 17034 accreditation equates to high quality, consistent reference materials
Following a three-year program of continual improvement, Thermo Fisher Scientific Microbiology has become an official accredited reference material (RM) producer, supplying our customers with trusted certified reference material (CRM) and assuring high quality, consistency, regulatory compliance and confidence in results.
In our new SmartNote, we will look at what ISO 17034 is and why it matters, outline the intensive accreditation process, and explain how our QC products give our customers the added level of regulatory confidence they need.
Maximizing pharmaceutical quality: The essentials for robust growth promotion testing
Stream our webinar to learn more about:
- Key growth promotion testing standards, including ISO 17034 and choosing the right quality control organism strains
- Evidence-based growth promotion best practices
Featured speaker: Dr. Tarun Chugh (Ph.D., Microbiology) is a Pharmaceutical professional with more than 32 years of rich experience in Microbiology Quality Control and Quality Assurance Department. Presently CEO of SIMco Pharma Consultancy and working at Ahmedabad.
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.
Quanti-Cult Plus for Pharmaceutical Microbiology brochure
The Quanti-Cult Plus™ two-vial system offers ease of use, enhanced safety with no organism handling and complete traceability of ATCC® Licensed Derivative and NCTC cultures. Find out about the benefits and available strains for our Quanti-Cult Plus Quality Control Microorganisms.
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.
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.
Learn more about our full range of solutions
Raw materials | Environmental monitoring | Aseptic process control | Microbial identification | Sterility testing |
Resources
*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.