Analytical and Regulatory Support
GMP Analytical Laboratory
Microsphere’s GMP (Good Manufacturing Practices) analytical laboratory is vital to ensure the quality and compliance of our clients’ products.
Through the implementation of gold standard instruments; Analytical Science and Technology (AS&T); and with the support of our 15 professionals who are completely dedicated to this unit, Microsphere’s laboratory has always respected client specifications and received regulatory approvals.
Some of our GMP analytical laboratory services include:
- Inhalation testing in controlled environments (T. rH)
- Third party laboratory service
- Familiarization / optimization, development, transfer and validation
- Stability testing according to ICH-guidelines
- Cleaning verification and validation
- In-Process Control (IPC) and QC Release
Our Capabilities
Chromatography
- HPLC/UHPLC detectors SWD/DAD/RID/ELSD
- GC Headspace with FID (Agilent / Thermo Fisher)
Spectroscopy
- FT-IR
- UV-VIS (Shimadzu)
Particle size & shape
- Laser diffraction (Malvern Mastersizer)
- DLS - Dynamic Light Scattering (Nanophox & Helos Sympatec)
- Bulk and Tapped density (Erweka)
- Sieving
- Angle of repose (Copley Scientific)
Wet chemistry
- Volumetric and Coulometric Karl-Fischer titration (Metrohm)
- TOC (Shimadzu)
- Standard laboratory equipment for wet chemistry
Thermogravimetry
- Loss On Drying thermobalace (Mettler-Toledo)
- Vacuum Oven
Specific drug testing
- NGI - Next Generation Impactor
- DUSA - Dosage Unit Sample Apparatus
- ACI - Andersen Cascade Impactor
- MSLI - Multi Stage Liquid Impinger (Copley Scientific)
- Dissolution test (Sotax)
Approved by
