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
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.