Introduction:
Today's pharmaceutical market demands exacting temperature/pressure control, process automation and system documentation.
The Steam Sterilizer from Machinfabrik is the most appropriate to meet these demands and can be used for a wide range of applications - sterilization of machine parts, sterile dresses, glassware, vessels, filters, liquids, etc.
With over 20 years of experience in the field of Sterilization and Dis-infection our team of trained and dedicated Engineers have developed a product which can comply with all international regulations like ASME, USFDA, EN285, ISO and HTM 2010. All systems are designed, manufactured and tested with this objective in mind.
Steam Sterilizers are available in two basic models - Gravity Displacement Systems and Vacuum Sterilizers. While Gravity Displacements Systems are suitable only for sterilization of liquids [in open containers], Vacuum Sterilizers are more commonly used and can sterilize not only liquids but also a wide variety of other materials / components.
Technique:
Steam Sterilizers with vacuum - 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
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Features:
Customized chamber sizes ensure flexible loads and load patterns.
Single or double door options to suit your specific installation requirements.
Cabinet enclosure for GMP installation.
Contamination Seal to prevent cross-flow of air between the clean and
un-clean area.
Loading / unloading carts and trolleys for easy and convenient operation.
Mechanical Vacuum Pump for pre-pulsing [for air removal] and post sterilization
vacuum drying.
0.2 bacteria retentive, sterile air filter for vacuum break. [Optional
SIP facility can be provided]
In-built test programs - Vacuum Leak Test, Pressure Leak Test and Bowie-Dick
Test for higher process assurance.
Automatic Fo Calculator with facility for control in case of heat labile
materials.
Automatic air detector device for on-line air detection.
On-line printing [alpha-numeric and graphical ] for process documentation.
Sampling valve for Pure Steam and Chamber condensate.
"Sterile door lock" to prevent sterile door opening unless the
sterilization cycle has been successfully completed.
Vacuum tight validation ports for insertion of temperature sensors for
thermometric testing.
Steam quality-testing ports.
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Applications:
Garments, machine parts, machine accessories, containers.
Culture media, laboratory waste.
Bulk drugs.
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Optional Features:
1) Steam Generator:
The
steam sterilizer 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 up to a chamber size of 900 X 900 X 1200
2) SCADA(Supervisory
Control and Data Acquisition):
To meet the increasing demands of stringent process control Machinfabrik
now presents the steam sterilizer with the state of the art SCADA system.
Supervisory control and data acquisition system is software that can be
Operated with a desktop PC or a laptop. The obvious advantage that a SCADA
system offers as against the conventional PLC-operator interface system
is remote monitoring and control over the entire system; the user can
monitor and exercise control over the entire cycle at the convenience
of his desk, along with a gamut of other facilities such as:
Continuous process status indication
Mimic representation.
Report generation of process performance
Trending facility
Online alarm facility
Alarm history facility
Increased security level
Recipe selection
3) SIP(Sterilization
In Place):
We can provide the equipment with an additional cycle of "sterilization
in place" of the clean air filter.