|Designed as a "carrousel" with pre-formed baskets mounted
between the "rings" of the carousel. (baskets are stamped out of
standard perforated S/S stock). No center spray bar. Sprays located on top
||A complete drum with material transfer guides. Direct Spray center
nozzle shaft, nozzles on the outside of the inner drum and the inside of
the outer drum.
|Efficiency of Particulate Reduction Level was up to 76% on the old
cassette design. No Direct Impact Cleaning. No CIP or SIP.
"Screen" effect masks water jets directed by rinsing nozzles.
Problem with residual silicone deposits in dead "legs" of
carrousel and "cone."
Efficiency of Particulate Reduction Level is up to 98% on the
patented system when using Direct Impact Cleaning, CIP and SIP. High
pressure sprays provide the essential shearing action needed to remove
all deposits, particulates and pyrogens.
|Uniform silicone distribution not possible due to restrictive
cassette design. Stopper mass does allow proper silicone surfactant
action to insure a smooth distribution along all stopper surfaces.
||Uniform silicone distribution by gently separating the stoppers and
cycling them through the silicone solution. The stoppers get
individually "wetted" with emulsion. Repeatable and therefore
validatable silicone film is consistently applied to the stopper
|Drying process does not eliminate clumping because of cassette
containment. Causes moisture to be trapped in the stopper mass. Drying
by HEPA filtered air. No centrifuge cycle possible in the cassette
||Drying process uses gentle movement of stoppers from product carrier
to product carrier. Maximum surface exposure with 0.2 micron
sterile filtered drying air.
|Cooling of mass of stoppers in each cassette needs longer cycle time.
||Cooling of intermittent shifted stoppers more effective with shorter
Moisture Content with LOD method not better than 0.045 % .
||Final Moisture Content with LOD method is 0.015%
|Pyrogen reduction is very restricted by "screen" effect and
very inconsistent within the mass of stoppers in each cassette. Lack of
shearing action with less than 12 nozzles allows pyrogens to remain on
stopper surfaces, in blind stopper holes and on interior surfaces of the
carousel, cassettes and the pressure vessel.
||Log 4 Pyrogen reduction guaranteed in the open drum design through
shearing action applied through the high pressure jets on the stoppers.
Direct spray impact cleaning of all mirror finished surfaces by more
than 42 nozzles. This CIP cycle assures the maximum reduction of
Load/unload > 40 minutes
Load/unload 15 minutes