Processess - Test and Demonstration Area
The Containment systems test and demonstration area is located in Building 5 of the ILC Dover Campus.
- Test Stand (shown prior to test upgrade)
- 2 Vessels
- 2 Discharge Ports
- 9 Charge Ports
- "SMEPAC" Test Area
- Encapsulates 1/2 of total test stand
- Class 100,000 installation
- 1st Floor — 16'x16'x8'
- 2nd Floor — 12'x16'x8'
- Fixed ladder access and hoist pass thru between floors eliminates eliminates outlier contamination transfer
- Airlock for personnel entry
Independent third party support
- Clean room validation and certification
- Third party Test procedure
- Federal standard 209
- ISO 14644
- FDA guidelines for industry's sterile drug products produced by aseptic processing. Current good manufacturing practices — September 2004
- Containment Verification Testing
- OSHA Technical manual
- Best industrial hygiene practices
- ISPE good practice guide, assessing the particulate containment performance of pharmaceutical equipment — 2005 Edition
- Clean room validation and certification
Used for new product development design verification, training and factory acceptance testing.







