Autoclave

Technical Specification

Model：Stellar STM 06

1. General

   The sterilizer is strictly designed and manufactured in accord with GMP technical Standard. It has passed ISO9001 quality management qualification standard and ISO13485:2003 Certificate of Quality Management System for Medical Devices. The relevant data and curve can be saved and printed automatically. This autoclave is suitable for pharmaceutical factory, hospital, scientific research institute and other units to sterilize and dry asepsis clothes, rubber goods, metal instruments, culture medium, etc.

2. Size & Utilities

   Design pressure	0.245Mpa
   Working Pressure	0.22Mpa
   Design Temperature	139℃
   Working Temperature	134℃
   Heat Equilibrium	≤±1℃

   Vacuum	-0.095Mpa
   Steam Source Pressure	0.4-0.6Mpa
   Water Source Pressure	0.1-0.3Mpa
   Compressed Air Pressure	0.5-0.7Mpa

   Model	Overall Size D*W*H(mm)	Chamber Size D*W*H(mm)	Steam (kg/cycle)	Compressed Air (m³/cycle)	City water (kg/cycle)	Power (Kw)	N.W (kg)
   STM-06	1245*1300*1880	1050*680*850	30	0.1	200	2.0	1100

3. Structure and performance features
   • The jacket is designed wrapping around the chamber in order to avoid steam condensation and to facilitate proper temperature distribution. The chamber is heated uniformly and prevents material from non-uniform heating.
   • The chamber is made of SUS316L with mechanical and chemical treatment to create shiny, beautiful and corrosion proof chamber surface. Two stainless steel rail guides in the chamber is provided as tracks for the loading cart.
   • The insulating layer is made by aluminum silicate which is the best insulating material. The equipment is and chamber are rectangular with stainless steel decorating cover.
   • The autoclave is designed as pass-through (double door) or single door autoclave. If double door, both doors cannot be opened simultaneously.
     • The door seal is the inflatable type, pressurized with compressed air and can withstand the chamber temperature and pressure.
     • The doors have a safety mechanism to prevent opening of the door when the chamber is hot or pressurized or when the autoclave is in operation.
     • Sterilization cycle can start only after the door is fully closed and locked.
   • Pipeline system is consisted of air filter, vacuum pump, pneumatic valve and etc.
     • Air filter for is using PALL brand. The performance is excellent with no medium break or contaminated load.
     • The autoclave include a liquid ring vacuum pump to obtain vacuum in the chamber.
   • Control system: PLC+ HMI control + Micro-printer. Electric system adopts domestic or imported components whose performance is stable and reliable.
     • When automatic controller is during circumstances, the machine security device ensures the chamber pressure equalized to atmospheric pressure and allows the loading door to be opened.
     • During maintenance or emergency manual operation can be access through the use of control unit to test the components and to troubleshoot.
     • The master controller system can set the user name and password with different level of user access for manager, users, and technicians with triple interface function. This ensures safety and prevents improper operation or modification to the program.
     • Touch screen with user friendly display comes with work process parameter display. Interface has the following functions:
       Display shows the process of sterilization cycle, time, pressure, temperature, two-door airtight state, the running records, printing, etc. The machine comes with Malaysian Language as an option to accommodate the users.
     • The autoclave has an E-Stop mechanism designed to stop all physical movement of the equipment immediately.
   • The GMP confirming connecter fixed can provide the GMP validation for the customer freely.
   • Built in steam generator technology is the latest in the market. Heaters are installed to the jacket chambers to heat up and produce steam that is transferred to the chamber during sterilization.
4. Process flow

   The autoclave control with optional automatic operation or manual operation.

   The equipment operate and control the following process cycle:

   • Bowie Dick cycle
   • Chamber leak test cycle
   • Sterilizing program for textiles, such as clothes and medical packages.
     
     • Dynamic pre-vacuum:
       Vacuum is created to remove air in the chamber to replace steam into the chamber. This way the air is removed from the chamber with no heat build-up on the material and eliminates air pocket.
     • Pressure pulsing:
       The aim is to provide rapid removal of non-condensable gases and condensates and to pre-heat the material prior to sterilization.
     • Sterilization:
       Steam injected into the chamber until sterilization temperature and pressure is increased. When the correct pressure and temperature are obtained in the chamber, sterilization time begins.
     • Drying:
       Vacuum in the chamber is created and the start drying time starts during the set point and time counts while vacuum is still being made. Throughout the drying process, the jacket is kept at working pressure with hot steam. The deep vacuum and heat transferred from the chamber walls helps better drying of the material.
     • Cooling:
       Once sterilization is done slow vacuum is done until the pressure drops to 1.100 mbar. While the vacuum pump is still running vacuum break valve opens to prevent drop of pressure and thus accelerating the cooling process. The phase ends when cooling ending temperature is reached.

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