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Thermo Scientific™ microbiology solutions are designed to address the unique needs of the pharmaceutical and biotechnology industries. We deliver a range of validated solutions for the pharmaceutical microbiology laboratory, supporting the production and quality assurance of sterile pharmaceuticals, vaccines, and biotechnology products.
We understand patient safety is paramount and ensuring regulatory compliance is non-negotiable. With our commitment to bringing more to pharmaceutical microbiology—from raw materials to finished product, and from environmental monitoring to microbial identification and media fills—you can confidently rely on our product quality and expertise every step of the way.
Biopharmaceuticals
For biologic pharmaceuticals “the process is the product”. Biologics present unique and complex challenges, from both technical and regulatory perspectives. The biologic manufacturing process relies on strict compliance across many key aspects from the quality of the raw materials through to sterility of the facilities, equipment and personnel. |
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Learn more about our range of products that can support you from sterility testing for raw materials to finished product, environmental monitoring and media fills in our capabilities brochure or browse workflow specific topics below.
Environmental Monitoring programs can be very useful in understanding the evolution of different contaminants over time. An effective program enables understanding the impact of your contamination control strategy, such as the effectiveness of your cleaning and disinfection or changes in personnel or training.
Trending of environmental monitoring data will quickly highlight changes and support you in eliminating potential contamination threats. Explore resources and products to support your environmental monitoring program:
- Brochure: Environmental Monitoring Solutions
- SmartNote: Notes on Compliance - Environmental Monitoring
- EU GMP Annex 1: Changes and impact to environmental monitoring needs
- Video: Environmental monitoring and media fill: Theory and practical (Part 1 and 2)
- Sell sheet: Triple Wrap Plates
Media fills play a critical role in the validation of aseptic manufacturing processes
A thoroughly-designed media fill program is key to ensuring that all elements of your process meet the strict aseptic requirements needed in biopharmaceutical manufacturing.
Learn how to stay in total control of this demanding process and what products are available to support you:
- Video: Environmental monitoring and media fill: Theory and practical (Part 1 and 2)
- EU GMP Annex 1: New standards for aseptic process fills
- Brochure: BioProcess Containers
- Video:
Robust sterility testing protocols are essential to protecting patient safety and keeping manufacturing on time and on budget.
Sterility testing is a crucial part of pharmaceutical manufacturing, and the consequences of non-compliance can be fatal.
Learn more about this crucial step in the product release process and explore the products available to support:
- SmartNote: Notes on compliance - Creating robust sterility testing processes
- Pharmaceutical Microbiology Resource Library ›
- EU GMP Annex 1: Changes and impact to sterility testing requirements
- Membrane Filtration and Direct Inoculation Workflows
- Sell sheet: Bottled Media
Growth promotion testing of culture media is an important part of microbiological testing in support of pharmaceutical quality.
The growth promotion test is a quality control requirement that confirms the ability of a new batch of media to support growth of a predetermined selection of representative microorganisms.
All media used in a cGMP facility should be tested, including media for microbial limits, environmental monitoring and sterility testing.
- Webinar: Growth promotion testing - Comply with Pharmacopoeia needs
- Sell sheet: Quanticult (QCO) sell-sheet
Sterile Pharmaceuticals
The need for sterile manufacturing in the pharmaceutical industry has steadily grown in recent years.
Keeping up to date with new standards and evolving regulatory requirements can be a challenge. However, the selection of the proper solutions can help address the regulatory and process related challenges and improve pharmaceutical plant operations.
Learn more about our range of products that can support you from sterility testing for raw materials to finished product and environmental monitoring in our capabilities brochure or browse workflow specific topics below.
Environmental Monitoring programs can be very useful in understanding the evolution of different contaminants over time. An effective program enables understanding the impact of your contamination control strategy, such as the effectiveness of your cleaning and disinfection or changes in personnel or training.
Trending of environmental monitoring data will quickly highlight changes and support you in eliminating potential contamination threats. Explore resources and products to support your environmental monitoring program:
- Brochure: Environmental Monitoring Solutions
- SmartNote: Notes on Compliance - Environmental Monitoring
- EU GMP Annex 1: Changes and impact to environmental monitoring needs
- Video: Environmental monitoring and media fill: Theory and practical (Part 1 and 2)
- Sell sheet: Triple Wrap Plates
Growth promotion testing of culture media is an important part of microbiological testing in support of pharmaceutical quality.
The growth promotion test is a quality control requirement that confirms the ability of a new batch of media to support growth of a predetermined selection of representative microorganisms.
All media used in a cGMP facility should be tested, including media for microbial limits, environmental monitoring and sterility testing.
- Webinar: Growth promotion testing - Comply with Pharmacopoeia needs
- Sell sheet: Quanticult (QCO) sell-sheet
Robust sterility testing protocols are essential to protecting patient safety and keeping manufacturing on time and on budget.
Sterility testing is a crucial part of pharmaceutical manufacturing, and the consequences of non-compliance can be fatal.
Learn more about this crucial step in the product release process and explore the products available to support:
- SmartNote: Notes on compliance - Creating robust sterility testing processes
- Pharmaceutical Microbiology Resource Library ›
- EU GMP Annex 1: Changes and impact to sterility testing requirements
- Membrane Filtration and Direct Inoculation Workflows
- Sell sheet: Bottled Media
Non-Sterile Pharmaceuticals
The manufacturing of non-sterile pharmaceuticals presents a unique challenge when it comes to microbiological control. Unlike sterile products, which are manufactured using aseptic techniques, non-sterile products are not subject to the same level of control. As a result, there is a greater risk of microbial contamination during the manufacturing process.
To ensure patient safety, it is important to have effective microbiological control measures in place during the manufacture of non-sterile pharmaceuticals.
Environmental Monitoring programs can be very useful in understanding the evolution of different contaminants over time. An effective program enables understanding the impact of your contamination control strategy, such as the effectiveness of your cleaning and disinfection or changes in personnel or training.
Trending of environmental monitoring data will quickly highlight changes and support you in eliminating potential contamination threats. Explore resources and products to support your environmental monitoring program:
- Brochure: Environmental Monitoring Solutions
- SmartNote: Notes on Compliance - Environmental Monitoring
- EU GMP Annex 1: Changes and impact to environmental monitoring needs
- Video: Environmental monitoring and media fill: Theory and practical (Part 1 and 2)
- Sell sheet: Triple Wrap Plates
All non-sterile products (raw ingredients and finished goods) need to be screened for specified objectionable organisms or pathogens.
This test method has defined procedures for the detection Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia species, Salmonella species and/or Candida albicans.
- Product Overview: Microbial Limits Testing (MLT)
- Specified organisms workflows
Microbial Limits Testing (MLT) is used to determine whether a non-sterile pharmaceutical product complies with an established specification for microbial quality.
This is an important series of tests designed to limit the likelihood of any adverse incident occurring as a result of a high level of microorganisms being present in a non-sterile product. By setting limits on the numbers of bacteria present in the product under test you inherently reduce the likelihood of this occurring.
- Product Overview: Microbial Limits Testing (MLT)
- Membrane Filtration and Plate Count Workflows
Burkholderia cepacia complex (Bcc) is among the top three microorganisms on the FDA’s objectional list and has caused the recall of multiple non-sterile products.
Bcc refers to a 21-species strong group of water-borne opportunistic pathogens that can grow in preserved aqueous oral liquids or topical products. Testing is recommended for inhalation use products or aqueous preparations for oral, oromucosal and nasal use.
- SmartNotes: USP 60-compliant?
- B.cepacia complex workflow
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.
USP 60 Culture Media Formulations and QC Organisms for Burkholderia cepacia Complex
Simplify your lab workflow with non-sterile microbiological examination testing for B. cepacia complex (Bcc).
The comprehensive product portfolio covers the full workflow requirements for all non-sterile pharmaceutical B. cepacia product testing requirements: prepared culture media, dehydrated culture media and supplements, quality control organisms including B.cenocepacia ATCC BAA-245 and B.multivorans ATCC BAA-247, along with a full range of diagnostic products.
Pharmaceutical microbiology categories
Maintain high-quality standards with Thermo Scientific™ culture mediaformulated from our very own derivatives. As original manufacturers of animal-derived peptones and vegetable-derived Veggietones™ we have complete control of the process from start to finish. So you can rest assured knowing that the media that reaches your benchtop has been rigorously tested for quality and consistency
You won’t have to think twice about meeting testing guidelines with our extensive range of regulatory compliant Thermo Scientific prepared culture media. We provide a range of formulations designed to meet relevant US, EU, and JP pharmacopoeias, as well as FDA and ISO requirements for bioburden and purified water testing.
Sealed, Sterile, Secure
Designed for your most sterile environments, Thermo Scientific™ Triple Wrap Plates feature the latest in quality-assurance technology. From see-through triple wrapping to 2D barcoding and guaranteed longer shelf life—all available in high volume lot sizes—it’s the obvious choice for superior environmental monitoring.
Avoid delays and reduce the risk of contamination in the validation of your aseptic manufacturing process with prepared Thermo Scientific culture media in bioprocess containers (BPCs). With validated and compliant Animal Derived Component Free (ADCF) and Tryptone Soya Broth variants, this ready-to-use liquid media requires no mixing and no sterilization. Simply connect, and the BPCs will take care of the rest.
Ensure consistent microbiology testing for pharmaceutical materials with quantitative quality control test microorganisms. Reduce the risk of contamination with ready-to-rehydrate, gel-preserved organisms in the Thermo Scientific™
Quanti-Cult™ two-vial system, and provide complete traceability with ATCC®-derived* organisms and Custom Environmental Isolates from your own facility for use in Growth Promotion Testing.
Labs are constantly looking for new ways to cut costs, without sacrificing quality. That’s why our microbiology portfolio provides a number of affordable ways to accomplish your goals, including Thermo Scientific™ RapID™ Systems for cost-effective, manual identification of a broad spectrum of microorganisms.
Maintain safety while setting quality standards
Ensure consistent microbiological evaluation of pharmaceuticals, for effective, high-performance products. Reduce the risk of contamination with quantitative quality control microorganisms derived from authentic, high-quality ATCC®* cultures, in a safe, ready-to-rehydrate vial.
Related products:
*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.
Style Sheet for Global Design System
Style Sheet for Komodo Tabs