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Home  ::  Manufacturing  ::  Indrad Plant  ::  Facilities  ::  Quality Control Facility  
 

 

Quality Control Facility ::

Major Instruments ::

  • TOC Analyzer
  • Gas Liquid Chromatograph with Head Space with Auto Sampler attachment to estimate very trace level (ppm) of organic volatile /toxic solvents to meet ICH guidelines
  • Total Organic Carbon analyzer with SSM for Cleaning Validation of manufacturing equipment to ensure that product is practically free (ppb level) from previous product.
  • Ultra Pure Water Purification system for HPLC grade water (TOC< 10 ppb and particles < 0.22 micron, Endotoxin < 0.001 cfu/ml.)
  • Video Microscope for monitoring the crystallinity of Insulin products.
  • Fourier Transform Infra Red Spectrophotometer to ensure total identity/ genuineness of the product.
  • Slit to Agar to monitor Viable Count / Area monitoring to ensure that the Production, QC and Stores areas are meeting international standards.
  • Steri Test, a closed concept membrane filtration system for sterility testing to reduce the rate of false positive results.
  • Automatic Glass Ware Washing and Drying Machine to ensure right quality of cleanliness of the glass wares.
  • High Performance Liquid Chromatographs - 6 Nos.
  • High Performance Liquid Chromatographs with Low Temperature cooling and Auto sampler attachments for very precise and accurate analysis of Insulin products

Other Instruments ::

UV / Visible And IR Spectrophotometers  3
Metrohm Auto Titrator   2
High Performance Thin Layer Chromatograph  1
Atomic Absorption Spectrophotometer 1
Electronic Micro And Semi Microbalances 6
Met One Particle Counter For Non Viable Count 1
Coulter Counter For Suspended Particle Analysis 1
Dissolution Test Apparatus  6
Disintegration And Friability Testers 3
Digital Conductivity, TDS And  Ph Meters 6
Digital Polarimeter    1
Auto Clave, LAF, DHS, Depyrogenator  6


 
 
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