Downloadable Pharmaceutical QC Resources for HPLC and Bacterial Testing
Up-to-date access to application notes, white papers, infographics, and more.
Sartorius offers a variety of high-tech solutions for quality control laboratories. Learn how to better reduce errors and increase productivity as well as improve the safety of biopharmaceuticals. Sartorius has the answer to all your questions. Whether you are an analytical chemist or a biologist, we can help make your lab safer and more efficient. Our solutions are validated for use in regulated environments.
Cubis® II Resources for Pharmaceutical Quality Control
The Cubis®️ II balance is a high-tech solution from Sartorius for weighing in regulated environments. Designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA). The Cubis II balance, with pharma package, contains all the technical controls to support full compliance with common regulations.
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Cell-Based Therapies – Be on the Safe Side
Microbial contamination in Advanced Therapy Medicinal Products (ATMPs) endangers patient safety, but traditional growth-based QC-release takes too long. Our solutions enable you to obtain QC Results within 3 hours, allowing you to ensure non-contaminated ATMPs prior to treatment.
Benchmarking of the Microsart® AMP Mycoplasma kit
The traditional growth-based method of mycoplasma detection requires a cultivation time of at least 28 days before a contamination can be ruled out with certainty. In comparison, Nucleic Acid Amplification Techniques (NAT) reduce time to results to just hours.
Continuous Microbial Air Monitoring in Clean Room Environments
Environmental monitoring is an important part of quality assurance for the production environments of sterile pharmaceutical products.
Next Generation Cellular Therapeutic Technologies: Rapid Detection of Bacterial Contamination
Sterility testing is a critical component of the release testing for any cell therapy product. The current compendial sterility test takes 14 days before contamination can be ruled out with certainty, which is too long for short shelf life cellular therapeutics.
The Sterisart®️ Septum Enables Reliable Sampling from a Closed System Sterility Testing Unit
In this study, the closed system sterility testing device, Sterisart®️ septum version, was evaluated for the recurrent sterile extraction of samples. The results demonstrate that even after more than 100 repeated septum sampling events, which far exceeds any foreseeable sampling requirements, the septum remains intact and the growth media contained in these canisters remains sterile. The Sterisart®️ septum allows easy inoculation and sampling, and enables the coupling of the conventional closed system sterility testing with rapid detection methods.
Infographic: Microbiological QC Biopharma Production Process
Sartorius offers intelligent solutions for Microbiological QC throughout the biopharma production process, from process development to final fill and finish. Learn more by filling out the form below to download this free infographic.