The ISOGEN facility is a 200,000+ sq. ft., fully contained, advanced aseptic processing facility for potent and non-potent compounds. It’s being built from the ground up with leading-edge technology, engineering and best practice methodology. Higher quality—greater speed—better systems.

Key Facility Features Include:

Flexibility - Peak capacity utilities planning controls cost by minimizing facility foot print while ensuring peak productivity is never limited by utilities. This facility houses:

• A central component prep area complete with washing systems, autoclaves, depyrogenation oven and stopper processor.
• 7 segregated filling suites
  • Isolated Nested Syringe Filling Line - 300/min with E-beam tub sterilization
  • Isolated Vial Filler/Lyo Line – 30/min with 2m2 Lyophilizer
  • Isolated Vial Filling Line – 30/min
  • Isolated Vial Filling/Lyo Line – 100/min with 7m2 Lyophilizer with automatic loading system
  • 3 Additional open suites for unspecified Syringe, Vial/Lyo expansion capacity
  • 2 Vial Inspection, labeling, packaging and sample retention suites.

Advanced Barrier Containment & Suite Segregation – Each suite is a standalone manufacturing facility with the ability to contain a potent compound. Each individual suite is a Grade C (Class 100,000) that houses a Grade A (Class 100) isolator system. Both the rooms and isolators have HEPA filtered returns, and can be gas sterilized (VHP) for complete cleaning and decontamination. The Grade C suite provides for secondary containment in the event of an isolator breach.

Integrated Single Use Product Contact Fluid Path – All primary product contact surfaces tubing, tanks, pumps filters etc will be fully disposable single use fluid paths wherever possible. They will be validated as a part of the Tech Transfer Service provided by ISOGEN Pharmaceutical Sciences.

Unidirectional Work Flow – Products, supplies and personnel enter from a central spine corridor and exit through a Decon Airlock to the circulation corridor.

Vial Exterior Decontamination Post Filling – Each vial can be rinsed after filling and capping using an integrated rinse system that simultaneously cleans the entire outside of the vial while protecting the overseal from moisture.

Integrated Waste Management – Managed directly by Isogen.