Capabilities


Production of parenteral pharmaceuticals, usually in the form of lyophilized vials, makes up the core function of Ausia BioTech’s manufacturing services. Our facilities are housed in a 40,000 m2 compound, specially designed to meet GMP requirements. It contains three completely separate manufacturing areas with independent water treatment systems, allowing aseptic filling, freeze drying, labeling and inspection operations to be complete in a precise and efficient manner. Daily production volume is up to 1 million vials.


Process and Equipment



Formulation


  • 4 formulation tanks with total capacity up to 3000L
  • Automatic on-line weighing systems
  • ISO 7/8 Grade C Room Classification
  • Liquid filtration performed in a closed system

Vial washing


  • 8 linear vial washing/drying machines
  • Vials are depyrogenated using sterilizing tunnels
  • Rubber stoppers are washed and sterilized on-site to meet endotoxin, bioburden and particulate requirements.

Aseptic Filling


  • 8 high-speed filling & stoppering lines that can fill 8, 10, or 12 needles at a time.
  • All filling operations are done in a Class 100 Grade A curtained area with Grade B background.
  • Each product can have its own pump/pipe pieces
  • Vial sizes are ranged from 2 ml to 50 ml.
  • Daily filling volume is up to 972,000 vials and the output of the fastest filling machine at approximately 550 VPM.
  • Environmental monitoring is performed before, during and after the filling process.
  • Fill-weigh is checked manually every 30 minutes during filling.
  • HEPA filters are recertified semi-annually and Smoke studies are performed annually in Grade A/B area.

Lyophilization


  • 18 lyophilizers from 20m2 to 45m2.
  • Capacity is depended on vial diameter
  • 22mm(7ml/10ml): 2250 vials / m2
  • 13mm(2ml): 4450 vials / m2
  • One of our production facilities employs automatic loading and unloading system that connects filling, freeze-drying and capping operations.
  • HEPA filters are recertified semi-annually and Smoke studies are performed annually in Grade A/B area.

Vial Capping


  • 10 high-speed capping machines that cap 13mm or 22 mm vials.
  • All capping operations are done in a Class 100 Grade A curtained area with Grade B background
  • Environmental monitoring is performed before, during and after the capping process.
  • HEPA filters are recertified semi-annually and Smoke studies are performed annually in Grade A/B area.

Our emphasis on Environmental control and Quality


  • The liquid filtration system has one titanium filter, one 0.45um and two 0.22um hydrophilic high-performance cartridge filters. Between Grade B and Grade C cleanrooms, a pass box is installed to house one 0.22um filter for liquid and two 0.22um for compressed air. As a result, these filters are disassembled in the Grade C environment and assembled in the Grade A environment.
  • Rubber stopper processing system involves “zero transfer and zero interruption”. Stopper washer/sterilizer is located on the upper floor. Controlled by PLC, finished stoppers are unloaded and dropped down through a stainless steel pipe to the lower floor insides a vibration hopper attached to a capping machine.
  • Separate HVAC system for Grade A/B areas to archive better control of air velocity, volume and exchange rates. In the critical areas of cleanrooms, air is supplied from the top and returned through wall ducks on the bottom in a “∧” manner.

 
Connect with us
© Copyright 2012, AusiaBio Technoleghy, All rights reserved.   www.ausiabio.com   www.ausia.net   浙ICP备12005543号