SD Series - Dry heat sterilizer
ICOS PHARMA designs and manufactures a wide range of Class 100 static depyrogenation sterilizers (ISO 14644-1 class 5) to meet the most challenging pharmaceutical requirements.
The depyrogenation process is aimed at the reduction in the level of pyrogens, with the use of hot air in temperature which range from 250°C up to 300°C. The high performance Class 100 oven solution ensures an even distribution of hot air for the entire cycle including large loads, with the installed HEPA filters preventing cross contamination.
from 330 litres / 12 cu.ft
to 10.000 litres / 353 cu.ft
- The machine body and jacket are completely made of AISI 316L stainless-steel.
- AISI 316L stainless steel piping is connected with ASME tri-clamp connections.
- The machine body is insulated with ceramic material and with an external cladding of stainless steel.
- The HEPA filters abate the level of particle contamination in the chamber
- Particular care is used to eliminate heat transmission points.
- Specially designed filter retention system to minimise thermal stress.
- Adjustable temperature ramp, sterilization plateau, cooling temperature, chamber pressure, cooling time are all available.
- Unifor automatic chamber pressure and temperature control.
- Chamber with rounded internal angles and TIG welded smooth seams.
- Automatic pneumatic door locking mechanism.
- Chamber provided with a double bottom for even temperature distribution.
Complete layout versatility
Available with a choice of three types of doors: swing-out, horizontally sliding and vertically sliding, with the goal to always guarantee the door tightness, regardless of unit dimensions.
Machines equipped with special product holding trays and handling trolleys, can be also interfaced with the isolation technology.
Compliance and guidelines:
The SD Series is in compliance with the following latest Norms and Directives: cGMP; GAMP; FDA; EN 1822; ISO 14644/1/2; CFR’s including 21 CFR parts, 201, 211 and part 11 available as option; EUROVENT; Technical Reports “Parenteral Drug Association”; 2004/108/CE, 2006/95/CE ; plus other local and international standards as applicable.