Our quality control team
We have dedicated quality control experts across microbiology, chemistry, R&D, and stability.
Microbiology
Our specialists can test for sterility, bacterial endotoxins, and microbial bioburden using a variety of test methods. Hydrogen peroxide vapor decontamination isolator units are used for microbiological testing purposes, alongside a photometric reader for kinetic turbidimetric bacterial endotoxin testing and a biological safety cabinet for support tests. Our QC microbiology laboratory also has a biochemical identification system allowing species-level identification of microorganisms and performs the environmental monitoring program for our manufacturing facility.
Chemistry
Our team is experienced in testing to BP, EP, and USP monographs, using high-performance liquid chromatography (HPLCs) and ion chromatography (IC) dedicated to QC activities, as well as inductively coupled plasma optical emission spectroscopy (ICP-OES), Fourier-transform infrared spectroscopy (FT-IR), and UV-Vis spectroscopic methods. Physical and wet-chemistry testing can be used to perform sub-vis particle count, auto-titration, pH, density, polarimetry, conductivity and refractive index.
R&D
We have HPLCs dedicated to development use, including diode-array detection and UHPLC capability. Our Linear Ion-Trap Mass Spectrometer, ICP-OES and ion chromatography instrumentation can further support your research and innovation needs. Our team maintains close relationships with partner laboratories, which are MHRA and FDA accredited, to take care of any special analytical requirements.
Stability
We have fully-validated stability storage facilities available for key ICH climatic zones – 25° C/60% relative humidity (RH), 30° C/65% RH, 30° C/75% RH, and 40° C/ 75% RH – with sample tracking using Labware LIMS v8. Our team uses advanced chemical techniques, from HPLC, to titrimetry, UV, liquid particle counts and general wet chemistry to evaluate chemical and physical characteristics to determine your product’s stability needs. We also provide full study management and reporting as needed.
