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ECMC - Model APWR-01 -Superheated Water Sterilizer for Pharmaceutical Applications
The Superheated Water Sterilizer, developed by ECMC (E CHUNG) from Taiwan, is an advanced sterilization solution designed specifically for airtight containers. Utilizing a process of circulating hot water through sanitary mercury and a heat exchanger, this autoclave ensures precise temperature regulation and distribution throughout the sterilization period. The heat exchanger conforms to stringent US FDA standards, employing either double tube plate designs or plate heat exchangers. Tailored for pharmaceutical and biotech manufacturing, ECMC's autoclaves meet multiple international standards such as cGMP, current EU and US requirements, ensuring compatibility with demanding engineering practices. Over 48 years, ECMC has perfected its manufacturing processes, employing superior materials and technology to meet the needs of a global clientele. This device is especially critical in the sterilization of large and small volume parentals, providing consistent performance in line with good manufacturing practices.Autoclave Superheated Water Sterilizer is a highly efficient sterilization process for airtight containers.
The hot water circulates using sanitary mercury and passes through the heat exchanger. The heat exchanger uses industrial steam and cooling water.
Circulating mercury of this autoclave is designed with a high-efficiency circulation effect, and the temperature rises consistently during heating. The temperature of the autoclave is ideally distributed during the sterilization period. The heat exchanger conforms to the US FDA double tube plate design or adopts plate heat exchanger.
Our plant assure sterilization in conformity with good manufacturing practices for LVPs, SVP etc. and in accordance with the cGMP issued by FDA. In short, excellent engineering coupled with efficient manufacturing.
The process water is circulated through sanitary pumps via heat exchanger, industrial steam or cooling water is admitted to the external heat exchanger.
Circulation Pump is designed for high circulation performance, temperature rise averagely during heating and optimal temperature distribution during sterilization.
In order to comply with FDA standards, external heat exchanger is using double-tube sheet heat exchanger or plate heat exchanger.
- The panel of the autoclave use HMI touch screen control.
- Program Flow: HMI control. Easy operation. Providing three sterilization programs or customized specifications as requirements.
- Simple & Safe operation: The automatic program provides complete and safe control to ensure safe operating condition. Also, temperature recorder is continuously monitoring and recording the sterilization process.
- For medical equipment, syringes, sterile clothing.
- For instrument, solution, clothes, rubber, wrapped or unwrapped material sterilization.
- For the membrane container, PE、PVC or PP materials sterilization.
- For ampoule & vial bottles, glass bottle sterilization.
- Sterilization chamber in SUS 316, SUS 316l and SUS 316Ti stainless steel.
- Piping and valves directly connected with chamber in stainless steel.
- Chamber piping all valves and fittings are sanitary class.
- Insulation by Glass wool.
- Automatic temperature controller.
- Automatic temp. Recorder - 6 points or 12 points.
- Sealed Door Packing: Use heat-resistant silicon rubber material ring packing.
- Absolute air vent filter for prevention of sterilized product contamination.
- One door or pass through type double doors.
- Single wall (cylindrical chamber) or double walls (parallelepiped chamber) body.
- All control and safety components are adapted to the higher temperature and pressure.