Introduction:
For terminal sterilization of specific products the conventional steam sterilization method is rendered ineffective as the load within an ampoule or a pouch is always subjected to the risk of deformation or destruction due to pressure imbalance wrt to the chamber pressure.
The
conventional autoclaves fail to provide the necessary pressure balancing
for loads in sealed pouches or ampoules. To overcome this drawback, Machinfabrik
has conceptualized the rapid cooling autoclave. The exhaustive research
at Machinfabrik resulted in not just successful pressure balancing for
the enclosed product but A machine built to comply with all international
regulations like ASME, USFDA, EN285, ISO and HTM 2010.the machine design
is such that can adapt to a wide product range from glass ampoules, bottles
or pvc pouches.
Technique:
The constructional difference from a conventional autoclave is the design ensures automatic regulation of counter pressure using compressed air from a dedicate air reservoir. The over pressure not only accelerates steam evacuation from the chamber but also provides necessary counter pressure to ensure chamber integrity. After complete exhaust of the steam and marginal cooling of the load, an atomized water spray from a sprinkling manifold cools down the load.
The
technique initiates with mechanical air removal from within the chamber
utilizing a vacuum system followed by steam injection that comprises the
sterilization cycle. The purpose of vacuum creation is to prevent any
existence of air pockets that can hamper the steam penetration and hence
the sterilization process.
Features:
At Machinfabrik our autoclaves are built to the highest level of quality assurance to meet custom defined requirements.
1.The machine design is in compliance to ASME sec viii .
The machine functionality in Compliance to the HTM2010 &EN285 standards
accepted worldwide.
The control standards for the machine in compliance with the GAMP4
2.Assured cooling down load temperature to 60 deg.c in 6 minutes &
+/- 0.5 deg.c temperature uniformity throughout the sterilization chamber.
Baffle arrangement within the chamber to ensure uniform distribution of
steam in the chamber.
3.The chamber if required can be provided with a skid framework &
A flush mounted SS panel is provided on the sterile side to isolate it
from the non sterile side.
4. PLC based control system for comprehensive automatic monitor and control
of the process.
5.Safeties
Safety Valves for Chamber and Jacket.
Door Obstruction- the door will not open when the chamber is pressurized.
Both doors will not operate simultaneously to protect the integrity of
sterile chain.
0.01 micron clean air filter for exhaust of the chamber from vacuum condition.
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Applications:
Garments, machine parts ,machine accessories,containers.
Culture media,laboratory waste.
Bulk drugs.
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Optional Features:
Steam Generator:
HPHV can be provided with an optional Steam Generator for independent and economic operation.
The Steam Generator is made of SS304/316 as per requirement. (36 kW)
Restricted upto a chamber size of 900 X 900 X 1200
SCADA(Supervisory Control and Data Acquisition):
Supervisory control
and data acquisition system is a software that can be
operated with an desk top PC or a laptop.
The obvious advantage that a SCADA system offers as against the conventional
PLC-OPI system is remote monitoring and control over the entire system;along
with a gamut of other facilities such as :
Continuous process status indication.
Mimic representation.
Meport generation of process performance
Trending facility
Online alarm facility
Alarm history facility
Increased security level
Recipe selection
SIP(Sterilization
In Place):
We can provide the equipment with an additional cycle of "sterilization
in place" of the clean air filter.