They characterized by its reliability and easy handling. The storage tanks are equipped with a sterile air filter and a dispensing system. The complete system can be sterilized with self-produced steam before production is started. The equipment is semi or fully automatic with quality surveillance.
A number of optional equipment is available for different quality standards and system design.
· Fully automatic function and surveillance.
· Unique separation system.
· Maximal operational safety.
· High flexibility
· Pure Steam production possible
· Space saving, easy to install
AUTOMATION and OPTIONS
· Semi- or fully automatic function.
· Automatic start/stop on signal from WFI tank.
· Discharge of sub-standard distillate during start operation and stop.
· Automatic surveillance & alarms of critical process values.
FACTORY ACCEPTANCE TESTING
All AQUA-NOVA stills are production FAT tested at our factory before delivery. The tests are documented and the produced distillate quality is verified by an independent laboratory.
The software is developed as per GAMP specifications. When ordered, full Pre IQ and OQ documentation will be supplied with the machines, including calibration documents.
The standard delivery documentation consists of:
· Authorized pressure vessel drawings with material and weld certificates.
· Mechanical component documentation and manuals.
· Electrical and instrument documentation and manuals.
Machine installation, operation and service manual.