Plant Infrastructure

Manufacturing Area – Hormones / Steroids

TWO SEPRATE BLOCKS OF MANUFACTURING FOR HORMONES & STEROIDS

  • Glass Line Reactor of 630 Lt capacity

  • SS Reactors ranging from 0.35 KL to 1.25 KL

  • Clean Room Area of Class 1,00,000

  • From gram to Kilo Level Capacity Manufacturing Area

  • ANFD (Agitated Nutsche Filter Dryer)

  • Air Mist Shower

  • HEPA Filters of 0.3 micron in Powder processing Area

  • Provision of BIBO (Bag in bag out) filters

  • Rota cone Vacuum Dryer

  • Large Rooms and Corridors for easy man and material movement

  • Mfg. area is designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions.

  • Dedicated Micronization Area

  • Total 3 Clean Room Areas

  • Glass Assembly from 50 Lts. to 200 Lts. for Small Volume Products

Quality Control Laboratory

List of Major Instruments:

  • * HPLC System from Shimadzu

  • * GC with Head Space and Auto Sampler & PDA Detector

  • * UV Spectrophotometer

  • * FTIR

  • * Polarimeter

  • * Karl Fischer

  • * Micro Balance

  • * Potentiometer

  •   Biosafety Cabinet

  •   IR Moisture Balance

  •   Elga Water Purification system

(Note: * All Equipment’s are 21 CFR Complaint)

List of Major Instruments in Microbiology Lab:

Fully Independent In-house Microbiology lab. with,

  • BOD Incubator
  • Bacteriological Incubator
  • Laminar Air Flow
  • Autoclave (*Horizontal & Vertical)

  • * TOC Analyzer (Shimadzu)

  • Microscope
  • Colony Counter
  • Biosafety Cabinet

(Note: * All Equipment’s are 21 CFR Complaint)

Effluent Treatment Plant (ETP)

  • Well Equipped ETP Plant with Primary, Secondary and Tertiary Treatment to achieve Latest Statutory Guidelines.
  • Multiple Effect Evaporator to treat high COD Effluent.
  • Kill pots provided to neutralize the drug potency with sodium hypochloride.
  • ETP Plant is well equipped to achieve Zero Liquid Discharge.

EHS Program

  • Ensuring Personnel Safety is of priority.
  • Effective Safety & EHS Training.
  • Personal Protective Equipment made available.
  • Effective Fire Hydrant System with Site-Emergency Plan
  • Situated less than 1 km away from the Government Hospital
  • 500 Kva Back-up Diesel Generator connected to all Key Equipment’s to ensure minimal down time.

Quality Assurance

  • Validation Master Plan
  • Equipment qualification
  • Process validation
  • Cleaning validation
  • HVAC validation
  • Water system validation
  • Analytical validation
  • Change Control, Deviation, OOS Management
  • Effective GMP Training to all Employees
  • Periodic Internal Audits