Water Shower Pharmaceutical Autoclave Sterilizer With Printers Or Recorder For Process
Description
It adopts super heated water as the sterilizing medium to spray products for heating and sterilizing. The soft bag is at the swing status during the sterilizing process with the forced convection of spray water to result in the uniform heating, which improve the sterilizing quality, shorten the sterilizing time and avoid the re-contaminate the IV solution as unclean cooling water during the cooling process.
Features
* Energy exchanged through a highly effective plate heat exchanger, saving your energy
* Superheated pure water as the sterilizing agent circulating inside the chamber, avoiding recontamination
* Special technique of pressure balancing is adopted in the sterilization process, which guarantees that bottles won't explode.
* The chamber is manufactured under strict quality and safety standards.
* Safe, reliable airproof door, easy to be operated
* Reliable, nice pipeline system, convenient for maintenance
* Stainless steel loading carts, suitable for different requirements
* Stable and reliable PLC & background computer monitoring system
* Powerful and multifunctional control software adjustable for different kind medicine solutions.
* As a standard GMP verification interface has been equipped, GMP validation can be conducted conveniently.
Specifications
| Model | SY-3.0 |
| Door number | Single door |
| Door type | Motorized Hinge Door |
| Chamber / Jacket material | AISI 304 / Carbon steel |
| Chamber volume | 3.0 M3 |
| Chamber Size | 1000*1500*2000mm |
| Overall Size | 2600*2200*2340mm |
| Net Weight | 3600kg |
| Steam | 350Kg/cycle |
| Water | 1440Kg/cycle |
| Power(KVA) | 7KVA |
Bio-challenge Test
The steam sterilization process in pharmaceutical industry, when chanllened with Geobacillus sterothermophilus Biological indicator spore vial,spore population of NLT 10-6 spores/vial,should reduce bacterial load by mean of Sterility Assurance Level(SAL)10-6 on incubation of the loaded biological indicator, if growth is observed,then the sterilization cycle parameters to be reviewed.
Applications
- Sterilization of filled containers of HDPE/LDPE bottles, PVC multi-layer pouches or glass bottles.
- Terminal sterilization of large volume infusion solution in glass bottles, plastic bags.
Programs
- Customer can choose the more suitable operating parameters (time,temperature, pressure, etc.) to fit the widest variety of load and relevant packaging (e.g. glass, PVC, etc.).
- Autoclave job parameters can be changed by the Operator according to the need. Different jobs can be stored and retrieved at any time for an easy and quick autoclave set up.
- Reproducibility of cycles and process parameters enables Customers to perform easy and full validation.
- Autoclaves come, as a standard, with a service cycle for water drainage to be used according to Customer experience/internal procedures to renovate the water on a periodical basis.
- Since the lower sector of the cylindrical chamber is filled with process water, autoclaves do not require any external tank for process water storage upon cycle completion.
Applicable Standards & Guidelines
Sterilizers are designed, manufactured and tested in compliance with PED European Directive for construction of pressure vessels, according to UNI EN ISO 9001and UNI EN ISO 13485 Quality Management Systems procedures, following cGMP requirements .
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