QC LAB
In order to continually ensure the quality of product, CMS QC Laboratory follows the GMP and GLP operating systems based on ICH Q7A.
In our plant, we operate two QC laboratories which have a total of 80 instruments including Chromatography, Spectrometer, Titration and 30 different types of instruments.
For advanced analysis, highly sophisticated analytical instruments in SK's Corporate R&D Center (located in the same site with our QC lab) such as 500 MHz NMR, XRD/XRF, ICP, MASS, DSC, TGA equipments are utilized freely. With all this advanced and wide range of analytical instruments and GMP standard operating procedures, a world class quality control service is being provided.
Organization
- 28 experienced analysts
- Service of 24 hours/day and 365 days/year
Facilities:
- New Dedicated Building: Area 826.3 m2 , Total Floor Area 2215.1 m2
- Air Handling Unit: HVAC system for Micro Lab (Class 100,000) & CNC area for chemical laboratory Building Automation System (BAS): Continuous control & monitoring of parameter (Temperature, Humidity, Differential pressure, Airborne particle)
Quality Control
- Approximately 10,000 samples are tested annually
- Approved documents of specifications and 1500 analytical testing methods for 150 products, 450 raw materials and in-process controls.
Laboratory Control Program for QC Test Based on SOP
- 50 SOPs for quality control
- 66 SOPs for equipment qualification, operation, maintenance
Analytical Instruments (QC Lab)
- Following table is list of the various QC dedicated instruments. (All of the instruments are qualified according to their qualification programs)
- For advanced characterization, highly sophisticated analytical instruments in SK's Corporate R&D Center (located in the same site) such as 600 MHz NMR, XRD/XRF, ICP, MASS, DSC, TGA equipments are utilized freely.
Instruments in QC Lab
| Equipment | Manufacturer | Number | Comment |
|---|---|---|---|
| HPLC | Agilent | 8 |
Injector: Autosampler Detector Type: UVD(7), DAD(1) and RID(1) |
| Shimadzu | 9 |
Injector: Autosampler Detector Type: UVD(9) and DAD(1) |
|
| GC | Agilent | 8 |
Injector: PTV-Inlet(1), Headspace Sampler(1), Autosampler(6),Detector: FID(6) |
| Shimadzu | 5 |
Injector: Autosampler(6) Detector: FID(6), TCD(1) |
|
| Potantiometric Titrator | Metrohm | 2 | |
| Volumetric K/F | 1 | ||
| Coulomeric K/F | 1 | ||
| Halogen moisture analyzer | Mettler | 1 | Capable of reading to 0.01 mg |
| Balance | Mettler | 7 | Capable of reading to 0.01 g ~ 0.001 mg |
| Furnace | Barnstead international | 2 | |
| pH meter | Mettler | 2 | |
| Viewing Booth | X-rite | 1 | |
| Conductivity Meter | 3 star | 1 | |
| FT-IR | Jasco | 1 | |
| UV-Vis | Shimadzu | 1 | |
| Polarimeter | Jasco | 1 | |
| Jasco | Hunterlab | 1 | |
| Vacuum Oven | Precision | 3 | |
| Melting Point Apparatus | Buchi | 2 | |
| Stability Chamber | Labfine | 2 | |
| Bio Safety Cabinet | Vision Science | 1 | |
| Incubator | Vision Science | 2 | |
| Furnace | Vision Science | 1 |
Instruments in R&D center
| Classification | Instrument | Manufacturer |
|---|---|---|
| Organic/Inorganic Element Analysis |
ICP-AES | GBC |
| X-Ray Fluoroscence | Philips | |
| Atomic Absorption Spectroscopy | PerkinElmer | |
| Elemental Analyzer | Calro Erba | |
| N/S Analyzer | Antek | |
| Cl/S Analyzer | Mitsubishi Chemical | |
| Combustion-IC | Combustion-IC | |
| Sulfur Analyzer | LECO | |
| Spectrometer | FT-NMR Spectrometer | Bruker GmbH |
|
FT-IR Spectrometer - IR Microscope |
ThermoNicolet | |
| Near Infrared Spectroscopy | Foss NIRSystems | |
| Thermo Gravimetric Analyzer-IR | ThermoNicolet | |
| Gas chromatography - MSD | Agilent | |
| HPLC - MSD | Hewlett packard | |
| High Resolution-MS | Micromass | |
| Infrared & Raman Spectroscopy | Bruker GmbH | |
| MALDI-TOF | Micromass | |
| X-Ray Diffractometer | MAC Science |
