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 .
