Introduction:
The Dry Heat Sterilizer is used in Pharmaceuticals and Biotechnology for sterilization and depyrogenation of glassware, containers, vessels, machine and components.
At MACHINFABRIK, with over 200 installations world-wide, we can offer you systems that comply with the most exacting international regulatory requirements for your critical process needs.
Our Dry Heat Sterilizers are available in two options - Class 100 and Class 10,000. We also give you a wide range of choices on the chamber capacity, loading configurations and process control and recording.
The
DHS finds application for humidity sensitive materials such as glassware
and metal containers that can be sterilized by steam sterilizers but cannot
depyrogenate the load.
At MF, we assure the performance of DHS meeting the following specifications.
· STERILIZATION: Reduction of microbial spore forms up to 12 log
reduction.
· DE-PYROGENATION: Denaturing of microbial endotoxins in the material.
Technique:
The
DHS operation is based on hot air recirculation technique.
The centrally placed load is subjected to hot air circulation by means
of an impeller and heater bank arrangement.
Centrally placed impeller ensures circulation via heater bank spaced in
the recirculation zone.
Clean air for recirculation is sucked via the Pressure module through
a pre filter and high retention HEPA filter (99.997%
efficiency)
The efficiency of DHS depends on the velocity and circulation pattern
of air within the sterilization zone.
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Features:
·
The inner chamber is fabricated from S.S. 316 or S.S. 316L and is fully
welded to ensure a crevice free and easy to clean environment.
· Compliance with USFDA,UKMCA norms.
· Temperature Uniformity +/- 5 degree Celsius guaranteed within
the chamber for the entire cycle.
· STERILIZATION efficiency of 12 log reduction.
· HEPA filter of 99.97% performance for clean air.
· Extended shaft motor for chamber recirculation.
· Positive Pressure throughout the cycle for 100% Sterile integrity
of the load.
· Automatic plc controlled cycle with user-friendly operator interface
for visual monitor and control over the entire cycle.
· Blind Temperature Controller for overshoots temperature condition.
· From the point of view of chamber safety, the heater bank and
fan motor are electrically interlocked.
· Door Interlocking to prevent simultaneous opening of both doors.
· Door Process lock to prevent opening of doors when process is
on.
· "Sterile door lock" to prevent sterile door opening
unless the sterilization cycle has been successfully completed.
· Circulation Blower or heater malfunction alarm.
· Automatic Fh Calculator with facility for control in case of
heat labile materials.
· On-line printing [alpha-numeric and graphical ] for process documentation.
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Applications:
· Glassware (Containers such as ampoules, vials etc.).
· Metal trays.
· Containers and metal material.
· Machine and accessories used in production.
· Various types of humidity sensitive material.
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Optional Features:
Thyristor controlled operation : For efficient control of heater bank, thyristorised operation via PLC can be optionally provided giving an advantage of better temperature control and uniformity.
Class 100 DHS :
With a view to comply with the latest G.M.P. & U.S. FDA standards, we put to test the technical expertise of our dedicated engineers to successfully developed the CLASS-100 Sterilization Systems.
· High temperature HEPA filters (0.3 micron, performance 99.97%) are installed in the circulation loop to ensure Class-100 environment in the chamber.
· Differential pressure indicators for monitoring performance of HEPA filter bank.
· Improved filter seating arrangement for maximum filter surface.
· New baffle design for uniform airflow and temperature uniformity between the top-bottom and sides of the sterilization chamber.