We say a true
Class 100 Dry heat sterilizer depyrogenizer because we can guarantee Class 100 over the
entire temperature range from heat up to cool down--not just at room
temperature or during the sterilization/depyrogenation phase.
All of ICOS ovens meet or exceed the latest
cGMP requirements:
• The entire
frameworko of the dry heat oven is built in tubular 304 SS.
• The
chamber and the doors of a standard oven are polished to a roughness average
(RA < 20 micro inches, which exceeds the
industry standard execution)• The ovens are enclosed with removable panels with built in
access doors 304 SS, having 180 grit (RA 36-45 micro inches) satin finished.
· Excellent heat distribution due to the jacket applied at the chamber’s
bottom. The temperature deviation of the Icos depyrogenizer, in the chamber does not exceed ±3-4°C.
HEPA
filters on the recirculation wall have a gasketlees vacuum sealing system which
eliminates particle shedding and filters’ gasket maintenance.
The HEPA filters installed the recirculation wall of the ICOS Dry
heat sterilizer are “precured” and tested with specially designed equipment
custom manufactured by ICOS.
They are specially designed as per ICOS specification, and are the only ones
worldwide which can guarantee Class 100 conditions during the entire cycle and
not only at room temperature.
The doors are sealed with a patented system
which
· Improves the bond between the seal
profile and the sealing surface
· In
the event of a leak due to seal wear whether inward or outward, the contamination
is drawn away from the loaded chamber by the vacuum system.
· Extends duration of the door gaskets
up to three to four times due to lack of mechanical stress.
· Allows
maintaining constant pressure in the chamber of the dry heat oven and accordingly constant
temperature.
· The
recirculation air of the dry heat sterilizer is distributed across the chamber
uniformly by means of the air inlet wall which has fixed perforations. On the
outlet wall the perforations increase in size from the top to the bottom in
order to maintain constant air velocity across the chamber. Once the unit is
built, it does not need further adjustment of the air flow across the chamber.
· In
ICOS dry heat sterilizers there are no deflectors which have to be adjusted (bent)
constantly.
All standard ICOS equipment is furnished with 21 CFR part 11