Pharmaceutical Quality Control and Testing
Field-Proven Products Designed to Meet Your Stringent Requirements
To ensure your product is safe, effective and pure, you need to rely on optimal quality and compliance at all times.
In compliance with international guidelines such as ICH Q10 and Q9 for effective ‘Pharmaceutical Quality Systems’ and ‘Quality Risk Management,’ our test kits, assays and solutions offer the highest level of confidence so you can mitigate risks to near zero – test after test.
Our solutions minimize risk of contamination during handling of tools (such us filters), decreasing time-to-result with rapid microbial detection methods, well-designed continuous air monitoring products and closed sterility testing devices to ensure desired product quality is met for final product release.
For analytical quality control, our Octet® GxP package includes tools such as IQ/OQ, PQ and software validation support that make Octet® instruments ideal for regulated quality control (QC) labs.
Addressing the Challenges of Quality Control Labs in Vaccine Manufacturing
Different vaccine types against COVID-19 and other diseases are currently being manufactured and offered to the global population. To ensure the safety, efficacy, and quality of these vaccines, a meaningful combination of quality test methods need to be in place that comply with the principles of proper manufacturing practices, including proving the consistency of the manufacturing process.
Our solutions for quality control testing are designed to give you the best tools to meet the challenges you face every day, ensuring your results meet the required levels of safety and compliance. Sartorius offers intelligent solutions for unmet needs.
Take a look at a typical cell-based vaccine manufacturing process and see where our products and services can help you overcome your quality control challenges.
Explore QC testing solutions throughout the process by Clicking on the + symbol.
Ensure your compliance with demanding requirements of international regulations. Our products and solutions are aimed at providing full compliance and reliability to all international standards and requirements like GMP, EU 2017/745 MDR, ISO 10993, ISO 13485, USP, JP and EP. From personnel training and equipment qualification to calibration and microbiological studies, we provide confident compliance for every step along your laboratory workflow.
Rapid detection kits based on real-time PCR for mycoplasma, bacteria and fungi provide highly specific, sensitive, and compliant results in only 3 hours.
The Octet® label-free, Bio-Layer Interferometry (BLI) platforms allow QC labs to implement straightforward methods which greatly simplify the testing process. The high-throughput capability and flexibility of the Octet® RH16 and RH96 systems allow for design of experiments (DOE) that enables rapid development of robust assay methods for assessing critical quality attributes (CQAs).
Protecting the security and integrity of electronic records (ER) is essential for compliance. Cubis® II lab balances and Octet® BLI instruments include 21 CFR Part 11 software with audit trails.
The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles are incorporated into the Cubis® II balance, offering a full form of compliance to adhere to all necessary data integrity regulations.