Sterile manufacturing tolerances and throughput capacity
18,000
units per hour max fill
OEB 5
containment threshold
72 hrs
analytical release time
Aseptic Liquid Vials
Automated nested syringe and vial lines running at speeds up to 18,000 units per hour with continuous particle monitoring and restricted access barrier systems.
Lyophilized Vials
Integrated automated loading and unloading freeze dryers with precise thermodynamic shelf control and automated CIP/SIP sterilization cycles.
High-Potency Solid Dosage
Rigid isolators and closed barrier systems capable of OEB 5 compounds under negative differential pressure for highly active compounds.
The four-stage tech transfer protocol
Analytical Validation
Pilot Scale-Up
Media Fills
Commercial Release
Method transfer, HPLC method verification, and baseline impurity profiling against pharmacopeial standards.
Bridging laboratory scale parameters to full commercial batch equipment under strict parameter mapping.
Executing three consecutive successful aseptic simulation runs prior to clinical or commercial batch authorization.
In-house chromatographic and mass spectrometry testing delivering verified certificates of analysis within 72 hours.
Evaluate line availability and changeover schedules
Connect directly with our technical operations group to review batch slot allocations and facility master files.