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 ½ 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
Used for new product development design verification, training and factory acceptance testing.
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