A unique manufacturing system specially
designed for anticancer drugs.
Our capabilities are designed to handle SMALL and LARGE MOLECULES, SOLVENT BASED FORMULATION and LIPID BASED FORMULATION for development, clinical and commercial supply.
equipped to handle Liquid and Lyophilized vials from 2 ml to 100 ml with filling lines designed to manufacture products with short holding time and minimize shear stress.
DEDICATED AREAS for THAWING
STATIC AND DINAMIC
TEMPERATURE CONTROL
DURING MANUFACTURING
CRYOGENIC LYOPHILIZERS
ENABLE A VERY ACCURATE AND EFFICIENT TEMPERATURE'S MANAGEMENT DURING EACH STEP
AUTOMATIC LOADING e ULOADING SYSTEM (ALUS)
DESIGNED FOR A RAPID INTRODUCING OF THE VIALS
THE LYO CHAMBER TO MINIMIZE PRODUCT'S EXPOSURE TO ROOM TEMPERATURE
100% CCIT BY FMS
VISUAL INSPECTION
MANUAL, SEMI-AUTOMATIC AND AUTOMATIC
SECONDARY PACKAGING available for Commercial supply and DEDICATED COLD STORAGE AREAS for DS, mAb, toxin and finish product (+2/+8°C; from -20°C up to -80°C) .
Our manufacturing equipment are designed to handle Cytotoxic and High Potent products under isolators for development, clinical and commercial supply.
DEDICATED HVAC SYSTEM
ORGANIC SOLVENT BASED FORMULATION
CLASSIFIED ENVIRONMENT
with controlled microbiological level
WIP
for isolators and equipment
For tablets, minitablets, capsules
WET GRANULATION
DRY GRANULATION
DRY BLENDING
FILM COATING
DEDUSTING
METAL CHECK
WEIGHT SORTING
PRIMARY PACKAGING
for Liquid Filled Hard Gelatine Capsules
PREPARATION OF OILY SOLUTIONS AND SUSPENSIONS
IN-LINE HOMOGENIZER
TEMPERATURE CONTROL DURING COMPOUNDING AND FILLING
IN-LINE BANDING
SEALING
100% LEAK TEST
VISUAL INSPECTION
PRIMARY PACKAGING
Batch size
from 1,000 to 250,000 units.
