Raw Material Testing
The source of biological raw materials for pharmaceutical use is very wide, and it mainly includes animals, plants and microorganisms. The three major pollution factors that affect their quality and safety include microbiological, chemical and parasite contamination. No pharmaceutical product can be manufactured without establishing the identity, purity and quality of its raw materials to ensure the product is suitable for its intended use. The presence of an incorrect material in a manufacturing process could compromise safety. When the raw material testing is performed successfully before the pharmaceutical manufacturing process, it not only helps to ensure the quality of the final product, but also minimize material costs and production time. With the rapid development of science and technology, relevant quality standards and detection technologies have reached a high level.
The testing of raw materials starts with checking packages and labels. After visual inspection, raw materials are moved to a sampling booth to avoid contamination and operator exposure. Once in the sampling booth, the container is opened and a sample is extracted. After sampling, the containers must be properly and securely closed before leaving the sampling booth to prevent contamination.
Raw Material Testing at Creative Animodel
Creative Animodel provides raw material testing services for biological products and the pharmaceutical industry. Our services comply with the testing requirements of regulatory agencies, such as United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). We also provide custom services according to customers’ specific requirement and methodology.
■ Identity of Raw MaterialsChromatographic analysis (HPLC, GC, LC)Elemental analysisMass spectrum (MS)Thermodynamic property analysisPolarimetryX-Ray diffraction (XRD)■ Purity of Raw MaterialsSpectrophotometric analysis (FTIR, UV/VIS)Metals analysis (AA, GFAA, ICP)Trace metals analysisDrying/gravimetric analysisViscosity testing■ Quality of Raw MaterialsResidual solvent testingHeavy metals testingPharmaceutical water testingMicrobial limits testing
In addition to services mentioned above, Creative Animodel offers comprehensive biosafety testing services to ensure the quality and safety of raw materials, such as sterility testing, mycoplasma detection, viral testing, residual DNA testing, and endotoxin detection.
Our team of well-trained and highly qualified professionals performs testing for all phases of biological product development from conception to market. Whether our customer needs raw material or finished product testing, property or quality testing, Creative Animodel has rich experience and knowledge to deliver timely and accurate results. Please feel free to contact us to learn more details about our services.