INFRASTRUCTURE

API PRODUCTION BLOCKS


Separate lines to manufacture 2 products simultaneously
Production block is self sufficient with dedicated services
Can cater to wide range of processes and products
"" Dedicated AHUs to prevent cross contamination
"" Isolator barrier technology is used for safety and minimizing operator exposure levels
 
Equipment

Reactors (GL, SS) (22.6 KL in total)

ANFD
Isolators
Sifters
Millers
Dedicated HVAC system
Blenders
Vacuum tray driers etc.
 
FORMULATION BLOCK (to be commissioned by Jun 09)
As per cGMP guidelines
Can cater to a wide range of processes / products including Lyophilized injections, Liquid injections, Tablets and Capsules
Dedicated AHUs to supply temperature / humidity controlled filtered air as per requirement
 
Equipment (Injections)
 

Lyophilizers
Isolators
LAFs
Water System
Pure Steam Generator
HVAC System
HPHV Steam Sterilizer with Bung Processor
Sterilization and Depyrogenation Tunnel
Vial - Filling, Sealing, Inspection, Labeling and Packing line etc..

 
Equipment (Tablets & Capsules )
 
Isolators
Tablet Granulating / Processing equipment
Tablet Compressing machine
Tablet Coating machine
Capsule Processing, Filling, Labeling, Packing line etc.

 

QA/QC BLOCK
Dedicated QA /QC block
Wet Lab, Instrumentation Lab, and Microbiology Lab are fully equipped to carry out intermediate, in-process, and final product analysis
Qualified team to maintain cGMP compliance and documentation

Equipment
 
PLCs
GCs / GC with Headspace
IR & UV Spectrophotometers
FTIR
TOC Analyzer
LBPC
Polarimeter
Mili-Q-Water System
On-line Air-borne Particle Counter
Clean Room Validation Equipment etc.