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AMPOULES

Compact line for manufacturing & filling of terminally sterilized / aseptically processed product in ampoules.

Area Classification

  Ampoule Washing & Sterilization Area : Grade D
  Manufacturing Area  
   
Facility dedicated for diluents
: Grade D
   
Aseptically processed Products
: Grade C
  Ampoule Filling & Sealing Area  
   
Facility dedicated for diluents
: Grade A/C
   
Aseptically processed Products
(WITH ONLINE PARTICLE COUNTER)
: Grade A/B
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Production Capacity Per Annum

  • 75 million – Diluents: SWFI / Sodium Chloride [FACILITY- I]
  • 75 million aseptic / terminal [FACILITY - III]

 Highlights

Two compact filling lines for Ampoules, of which, one line is solely for diluents, namely Sterile Water for Injection and Sodium Chloride Injection and the other line for terminally sterilized and aseptically processed products.

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VIALS - Liquid & Lyophilized

Compact line for liquid filling in Vials and lyophilized products in Vials, with aseptic fill / finish technology.

Area Classification
  Manufacturing Area : Grade C
  Vial Washing and Sterilization Area : Grade D
  Vial Filling & Stoppering Area
(WITH ONLINE PARTICLE COUNTER)
: Grade A/B
  Cap Sealing Area : Grade A/C
  Compact line for liquid filling in Vials and lyophilized products in Vials with aseptic fill / finish technology.  
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Production Capacity Per Annum
  Vial (Liquid) : 2 to 10 ml. – 15 million
  Vial (Lyophilized)  : 2ml. – 7.5 million
        10 ml. – 3.75 million
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PFS - STERILE PRE-FILLABLE GLASS SYRINGES

Dedicated M/c for manufacturing & filling of terminally sterilized / aseptically processed product in PFS/CARTRIDGES

Area Classification
  Manufacturing Area : Grade C
  PFS Filling & Stoppering Area : Grade A/B
Production Capacities Per Annum
  PFS : 4.5 million
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CARTRIDGES

Dedicated machine for aseptic filling of liquid in Sterile Cartridges.
Area Classification
  Manufacturing Area : Grade C
  Cartridges Filling & Stoppering Area : Grade A/B
       
Production Capacities Per Annum
  Cartridges : 1.5 million

QUALITY CONTROL

Complete Support For:
  • Analysis of Raw materials, Packing materials, In Process, Finished product, Microbiological etc.
  • Control sample storage
  • Stability and Documentation
  • Environmental Monitoring
  • QC section is equipped with 3 Sterility Rooms
  • QC has separate LAL testing room and micro testing room with dedicated PALs
  • Dedicated stability chambers for different Temperature / humidity conditions
  • Dedicated walk-in incubators for environmental monitoring and sterilitytesting / media fill
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GMP

 All the three lines are independent of each other starting from issue of primary packing materials i.e. vials, ampoules, PFS etc. to the exit of finished goods in each line. These lines are equipped with dedicated AHU’s, Pre and Post Autoclaves, washing machines, depyrogination tunnel, filling and sealing machines, screening machines from Brevetti, labeling and packaging machines.
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Special Features of The Facility

  • Box in Box type model with Unidirectional layout and segregated man material movements
  • Man entry in core area through secondary change facility
  • Material entry through double door interlocking hatch
  • Classified areas are erected with prefabricated modular partitions and filling areas have SS panels
  • All classified areas have terminal HEPA filters of H14 Grade
  • Joint less Epoxy flooring in all critical areas
  • Electronic Access control for core areas
  • Dedicated areas for sampling and dispensing of RM with segregated MAL & PAL
  • Provision of cool / cold storage areas for intermediate goods & finished goods
  • Complete facility has 100 % power backup
  • HVAC of all CLASSB FILLING AREAS + all critical LAFS / Incubators ARE CONNECTED TO ups
  • BMS for aseptically processed areas

QUALITY POLICY

  • Quality is of extreme importance in Sovereign and must be supported by the employees at all levels and in all functions
  • Quality is imbibed in every aspect : Services, Processes, methodologies and work environment.
  • Quality is built in to process : we must ensure consistency  through continuous improvement and adherence to established company policies and standards.
  • We are committed to creating value for all our customers by continually improving our systems and processes, through innovation, investment and up gradation.
  • Deliver products of Sovereign quality, the first time and every time.

ENVIRONMENT, HEALTH & SAFETY POLICY

We are committed to manufacture and supply injectable preparations in Ampoules, Vials (liquids, lyophilized), Cartridges and Pre-filledSyringes with due respect to environment, health & safety aspects.

We shall comply with the relevant Environment, Health, Safety legislation and other requirement

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