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Pharmaceutical Microbiology
Bringing more to drug manufacturing microbial safety
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 qualily 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 phannaceutical 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.
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.
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Featured bioproduction webinars
Microbial control of isolators and cleanrooms
Learn how to successfully perform on-site validation for settle plates and contact plates used in environmental monitoring during pharmaceutical manufacturing. Learn more about the Triple Wrapped Irradiated Plates. Designed for most regulated environments, they feature the latest in quality-assurance technology It's the superior choice for environmental monitoring.
Designing a media simulation trial program
In this exclusive webinar we'll explore important factors to consider when designing a media simulation trial program, and examine how these factors can be used to establish a risk-based matrix. You will also learn how single-use technology can aid safe and simple validation of aseptic manufacturing processes.
Featured videos
BioProcess containers: safe and simple validation with single use technology
Watch this animation to see our culture media in bioprocess containers for media fill trials. Ready-to-use and easy to connect. View brochure
Triple wrapped irradiated media for use during drug and vaccine manufacture
View brochure for more information about Triple Wrap Plates for environmental monitoring.
*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.
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