Quality Control
Quality Control
The main features of the Quality Control set-up at the facility are as follows :
- Classified Laboratory set-up as per GLP / WHO, c-GMP
- Strict Standards for Specifications, Sampling Plans, Test Procedures
- Separate Entries for Men & Materials at all Levels
- Automated Ultramodern RO-EDI Water Treatment Plant with Closed Circulation Loop
- SOP driven Activities
- Sampling and Dispensing of Actives and Excipients separately under RLAF
- Core Area Air Classification – 0.3 micron HEPA / EU-13
- Untouched Manufacturing & Packing Operations
The facility is fully equipped with all the required modern quality control equipment as follows :
Microbial Testing
- Horizontal Laminar Flow Unit
- Pass Box – Static
- Bacteriological Incubators (3 Nos.)
- Zone Reader – Digital
- Colony Counter
- Electric Loop Sterilizer
- Autoclaves – Automatic (2 Nos.)
- Microscope
Stability Testing
- Humidity Chambers – 21CFR Compliant (2 Nos.)
Chemical Testing
- Various Glassware of Required Specifications
- Laboratory Precision Oven
- Vacuum Oven
- Constant Temperature Water Bath
- Glass Door Refrigerators (2 Nos.)
- Sonicator
- Orbital Shaker
- Magnetic Stirrers
- Polarimeter
- Heating Mantle
- Viscometer
- Muffle Furnace
- UV Cabinet for TLC
- Distilled Water Plant
- Analytical Weighing Balance
- Moisture Balance
- Refractometer
- pH Conductivity Meter
- Bursting Strength Apparatus
- Calorimeter
- Cylomixer
- Centrifuge
- Bulk Density Apparatus
Instrumental Testing
- UV Visible Spectrophotometer- CFR Compliant
- High Pressure Liquid Chromatography (HPLC) with Auto Sampler – CFR Compliant (2 Nos.)
- Infrared Spectrophotometer
- Auto Titrator with Karlfischer Attachment
In-Process Testing Equipment
- Tablet Hardness Testers (3 Nos.)
- Friability Testing Machines (3 Nos.)
- Tablet Disintegration Apparatus (3 Nos.)
- Dissolution Test Apparatus
- Melting Point Apparatus – Digital
- Leak Test Apparatus
- Lacquer Porosity Test Apparatus