Automated parenteral manufacturing line for vials under barrier isolation.

 

 

DRUG PRODUCT

Vial Filling & Lyophilization

Vial Filling, Capping and Lyophilization Under Barrier Isolation
The automated vial-filling line at Cook Pharmica has an annual capacity of 15 million vials and is fully enclosed in a barrier isolator, ensuring an aseptic filling environment. The line is flexible, accommodating either time-pressure filling or filling by peristaltic pump. For products that require lyophilization, there is a 250 sq ft lyophilizer integrated into the vial line within the barrier isolator. This setup allows for automated vial loading and unloading, and for the establishment of a simple and practical process. The product and component pass-throughs and unidirectional flow further reinforce Current Good Manufacturing Practices (CGMP) and processes.

Quick Capability Reference

Product Types Large molecule, small molecule, vaccines
Vial Sizes 2-20 mL
Filling Speed 50-150 vials per minute, depending on vial size
Annual Capacity 15 million units
Lyophilization Capacity 250 sq ft
Manufacturing Scale Commercial and clinical
Other Features Automated lyophilizer loading and unloading, capper under barrier isolator, cool zone sterilization (tunnel), integrated material transfer chamber, recirculation capabilities for suspensions, 100% nondestructive weight control

 



FDA commercial approval

 

Vial Line Tour

Vial filling and lyophilization video