|
Total
containment under isolator for the compounding and from the
depyrogenation oven to the lyophilizer without human intervention in
class A:
•
Aseptic compounding in class A/B
•
Dry heat oven for the depyrogenation of the vials
• Batch sizes: max 8,000 vials and 20,000 syringes
•
Aseptic filling: vials and syringes
• Possibility
of N2 before and after the filling
•
Capping in class A (Lyoseal®,
Flip Off)
•
Lyophilization: vials and syringes.
Lyophilizator: 3m2,
loading and unloading under isolator, explosion proof. CIP, SIP
Analytical
laboratory: HPLC, IR, UV, Karl Fisher…
Highly
potent and biotech products:
•
cytotoxics
•
peptides
•
proteins
•
monoclonal antibodies
•
vaccines
•
nanoparticles
•
emulsions |