OLDER EQUIPMENT DECOMISSIONING
NEW EQUIPMENT START-UP AND COMISSIONING
This customer
purchased three new sterility testing isolators to replace its two older transfer isolators and one workstation isolator. Therefore, a decommissioning of the old equipment
and a new equipment startup and commissioning were performed. The job was accomplished in four weeks by one
field service representative.
Decommissioning
Inspection: visual and functional defects were described in detail
in the service report. No parts were
replaced this time, and no troubleshooting was performed at this point since
equipment is to be dismantled and stored in a crate.
HEPA
filter test: integrity testing of all inlet and exhaust
HEPA filters as well as the two half-suit cartridge filters; preparation of
test certificate.
Calibration of the pressure controller and the pressure monitor;
preparation of test certificate.
Printing of all test labels to be affixed onto the three
isolators.
Ammonia
leak-test of all three isolators and
visual check of the half-suits.
Dismantling of the two half-suit workstation: sections were
disassembled from the isolators, either shrink-wrapped or bubble-wrapped, then
put aside (RTP ports, controller, HEPA filter housings, doors, ventilation assemblies,
canopy, utility panels); isolator floor shrink-wrapped and deposited on the
floor; tubular structure was taken apart in sections, each shrink-wrapped. All parts were loaded into a custom-made crate
by carpenters, as follows: floor first, then all smaller assemblies, then in a
second level all the tubular structure. Each of the two transfer isolators were wheeled into their individual
crates.
Sign-off: signatures obtained
on all reports/certificates; remittance of originals to the customer.
Start-Up
Uncrate new isolators; move the parts into the laboratory with
the help of riggers; lift the chambers onto the lower stand using the lifting
devices shipped into a separate crate.
Assemble all three isolators: mount all parts and
components; connect all cables and pneumatic connections.
Perform mechanical, electrical, and function checks.
Finalize password list for all levels.
Execute
Site Acceptance Test (SAT) protocol
including calibration of all sensors (temperature, pressure, humidity, scale,
H2O2, air velocity and mass flow) and HEPA filter integrity test; preparation
and placement of all labels.
Customer training for operators, managers, administrators, and maintenance personnel.
Close protocol and all reports.
