Tunnel Drying Sterilizer and Depyrogenation 320℃ (Class 100 Type)

ETS-01

The main purpose of this machine is to dry, sterilize, cool and convey of vials & ampoules to take advantages of the hot air circulation being sanitized under the fixed high temperature heating and time to completely arrive at bacteria sterilization and depyrogenation.

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The drying, sterilization, cooling, and transportation of the washed and clean vial, ampoule, oral liquid, and glass bottles adopt hot air circulation principle. Under a certain temperature and time, the bacteria of the products can be completed sterilized and depyrogenated by the high temperature heating method with conveyor transportation.
Adopting 99.97% and 99.997% high-efficiency & high-temperature-resistant HEPA filter for the area of bottle inlet, drying sterilization and sterilized dust-free cooling. Keeping the cleanliness of the tunnel inside within CLASS 100 to prevent product pollution, and adopting SCR control for the electrical system to make the curve of current output appears linear, and then the uniformity of temperature distribution will be better. Under a normal adjustment status, the internal temperature of each point is within plus or minus 5°C while the equipment is testing heat distribution under no-load status in sterilization.

Features

The design of equipment’s structure is using the materials of high temperature resistance, and adopts DOP (Di-Octyl Phthalate) or PAO (Poly Alfa Ollefin) test (99.97%) to the following places: bottle inlet, drying sterilization area and sterile dust-free cooling area. Therefore, when the temperature and time reach to a certain status, and the materials of bottles and appliances are all having the features of high temperature resistance and unbreakable, the bacteria of products can be completed sterilized and depyrogenated.
The 0.3μm high efficiency & high temperature resistance HEPA filter keeps the cleanliness of tunnel chamber within Class 100 to prevent product pollution, and adopts SCR control for the electrical system to make the curve of current output displaying as linear status, and the temperature can be distributed averagely.
When the equipment is tested under no-load condition and normal regulation, the heat distribution at each internal point is within ± 10°C when sterilizing. Calculating the lowest temperature of FH or FP value when the temperature is set at 250°C.
Calculating the required sterile time depends on various temperature, normally when the lowest temperature reaches 250°C and continuing at least 30 minutes, then the heat can be depyrogenated, however, most users are using the way of overkill to depyrogenate.
During sterilization, the temperature of heat distribution at each point inside is within ± 10°C. When the temperature is set at 250°C, the FH or FP value of the lowest point temperature is usually calculated, and the required sterilization time is calculated according to different temperatures. Generally, when the lowest point temperature reaches 250°C, and lasts at least 30 minutes. Remove the heat source, but most users use the OVERKILL method to remove the heat source.

Applications

For the sterilization on Pharmaceutical vials & ampoules .

Specification

Material: The whole machine is manufactured by SUS 304 and SUS 316L stainless steel.
Operating Temperature: 280 ~ 320°C. (MAX 350°C.)
Filter in inlet area: Efficiency is 99.97% ; High temperature resistant achieves 250°C.
Filter in heating and sterilizing area: Efficiency is 99.97% ; High temperature resistant achieves 398°C.
Filter in cooling area: Efficiency is 99.97% ; High temperature resistant achieves 250°C.

Equipment Arrangement

Matching with:
- Automatic Ultrasonic Bottle Washing Machine (For Vial & Ampoule)
http://www.gmp-equipment.com/en/product/ERVW.html

- Automatic Bottle Washing Machine (Rotary Type)
http://www.gmp-equipment.com/en/product/ABWM.html

Construction & Structure

This machine structure all designed by high temperature-proof materials. The HEPA filter adopts high efficiency DI-OCTYL phthalate test up to 99.97% absolute filter makes the chamber clean and keeps within Class 100 to prevent articles from contamination.

Design Characteristic

Tunnel Drying Sterilizer and Depyrogenation (Class 100 Type) adopts hot air circulation principle, and transported by conveyor via high temperature heating method.

Documentation

The complete procedure of the equipment: bottle feeding -> preheating -> sterilizing -> cooling and automatic rolling out the bottles.
PLC control, touch screen interface, easy to operate.

The control system uses SCR module being coordinated with that of temperature controller PID auto tuning and allows of current output curves appearing linear status to make the chamber temperature heat distribution more uniform. Under a normal regulation, the heat distribution is in the acceptance range of within ± 5℃ at a test of running free.

Functional specification (FS)
Design specification (DS)
Installation Qualification (IQ)
Operational Qualification (OQ)
Operation manual
Maintenance manual
Material certification
Control loop drawing
Instrument list
Electrical schematic
P & ID drawing
Machine structure drawing

Performance

Special thanks to the following Pharmaceutical and Biotechnology factories for purchasing our equipment to build biotech pharmaceutical factory that meets PIC/S GMP international standards.