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[China]
Trade Verify
Address: B631, HUAFANG INTERNATIONAL MANSION, No.178 CHENGBEI STR., ZHANGJIAGANG, JIANGSU, PRC, 215600
Contact name:Juliet
ZHANGJIAGANG MEDPHARM MACHINERY LTD. |
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Verified Suppliers
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Feature | Benefit |
Unique non-stick door gasket | Specially formulated to eliminate sticking and to avoid door jamming,FDA food grade silicon. |
Air-actuated gasket | Minimize steam exposure and extend working life. |
Whisper-quiet air compressor optional | Minimize noise,eliminate need for air supply,supply constant air pressure to gasket |
Side-mounted control | Avoids steam exposure to electronics and extends touchscreen life |
Counterbalanced sliding door | Simplifies one button,lifts by motor |
One style solenoid valve used throughout sterilizer | Simplifies maintenance,non-proprietary valve reduces cost |
Integrated post-vac drying cycle | Vacuum drying phase eliminates steam and removes moisture from the load((i.e. reduces wet-packs) |
Pressure gauge calibration | Permits periodic calibration to maintain accuracy,extend component life |
Customizable design | All sliding door sterilizers are custom made to exact configuration,functionality and options |
Automatic power door operation | Powered door operation allows 1 finger open/close operation.The door can be manually operated in the event of power loss. |
Specification
The Autoclave Sterilizer Machine shall have minimum of the
following alarms and safety features, but not limited to:
High Temperature over shoot alarm
Too long time to create vacuum
Vacuum pump trip alarm
Utility failure alarm
All the motors shall be provided with overload relay.
During the sterilization period if the chamber temperature falls below the set temperature,
the sterile hold period counting will stop. The counter shall restart again once the set
temperature is reached.
Description
1.cGMP compliance
This autoclave sterilizer machine is horizontal with sliding horizontal opening double door,
horizontal chamber type (rectangular chamber with smooth round corners and jacket)
with fully automated operating system.The entire construction including all components
shall be fully compliant with cGMP requirements.
2.Contamination seal
A stainless steel flush mounting shall be fitted between the sterilization chambers and the
sterile area wall to avoid any cross flow of air between the sterile and non-sterile side.
3. Vacuum pump
The sterilizer equipped with a water-ring type vacuum pump.
4. Steam condenser
Vendor shall provide a steam condenser made of AISI 304 fitted in
the exhaust/vacuum line to
condense the steam before entering the vacuum pump.
5.Validation port
The chamber equipped with two validation ports with dummy &
adaptor for insertion of
multiple temperature sensors (minimum upto 16 temperature sensors).
The equipment has a provision on the steam feeding pipe which
allows the installation of
an appropriate device (Client’s scope) for the execution of steam quality tests (non condensable
gas test, superheated gas test and dryness test).
6.Air Intake Filter
The sterilizer has a sterilizing grade hydrophobic air intake
filter of 0.22micron pore size for
vacuum break. The air intake filter shall be placed on the sterile side of the sterilizer. Option shall
be provided to sterilize the filter and perform integrity check. Relevant RTD for process control
and monitoring inside the filter housing shall be provided.
Applications
The Autoclave sterilizer Machine shall be suitable for handling the
following materials:
Glassware
Metal Trays
Containers and metal materials
Machine and accessories used in production
Basic biopharmaceutical products which can withstand heat
treatment at high temperatures.
Clean room Garments
Lab Fermentors/Bio-Reactors
Silicon braided tubes etc.
Competitive Advantage
Minimum sterilization requirements selectable as minimum F0
target.
Sterilization control selectable on time basis (with or without
F(T,Z) calculation) or F(T,Z) basis.
