In addition to in-house microbiological assays, our QC Microbiology team performs environmental monitoring of our controlled manufacturing areas.
[QC Micro_1]: Bioburden, growth promotion, endotoxin testing, TOC analyzer, conductivity meter testing, BSC and incubation chambers. [QC Micro_2]: In-house microbial ID and isolate testing. [QC Micro_3]: Environmental monitoring laboratory.
Our QC Chemistry teams support the compliance of your products by providing quality control analysis services as part of validation and release of production batches.
[QC Chem_1]: Compendial laboratory for density and pH measurements, Karl Fischer moisture content analysis, freezing point osmolality, vapor pressure testing. [QC Chem_2]: Viscosity testing and UV spectophotometer measurements. [QC Chem_3]: Assay reagent preparation area.
Our Separation Science team analyzes the characterization of the molecule for impurities and potency to ensure product integrity.
[SeparationSci_1]: HPLCs, UPLC, CAD. [SeparationSci_2]: SEC MALS detectors, RI detectors.
QC Sample Receiving
QC Sample Receiving
Our QC sample management team ensures that received samples are logged and securely maintained under the appropriate conditions prior to testing.
[QC Sample]: QC sample receiving area.
Our ICH-compliant stability programs determine the quality of drug substance or drug product over time via traditional and accelerated shelf-life stability studies.
[QC Stability_1]: GMP stability storage conditions: 25°C ± 2°C / 65%RH ± 5%RH, 30°C ± 2°C /, 65%RH ± 5%RH, 40°C ± 2°C / 75%RH ± 5%RH, 5°C ± 3°C, -20°C ± 5°C, -70°C ± 10°C [QC Stability_2]:GMP stability storage conditions: 25°C ± 2°C / 65%RH ± 5%RH, 30°C ± 2°C / 65%RH ± 5%RH, 40°C ± 2°C / 75%RH ± 5%RH, 5°C ± 3°C, -20°C ± 5°C, -70°C ± 10°C
QC Raw Materials
Our QC Raw Material team ensures that the correct material has been received and confirms the material integrity.
[QC RawMaterials]: FTIR, FT-NIR, Quadra-Chek.