LTWG Sterile Isolator

Simple Description

The LTWG sterile isolator is a device or system that is equipped with Class A ventilation and can completely isolate its internal environment from the external environment (such as the clean room or operator in which it is located).
It is used for the aseptic production and testing of sterile / highly toxic (live) drugs and drugs with poor stability, including laboratory sterility testing and routine testing of final product quality control.
Suitable for pharmaceutical, food and fine chemical industries. Comply with GMP and FDA requirements.

Working Principle

• In a closed environment, through the fan filter unit (high efficiency filter, HEPA) to achieve the specified number of clean air changes, so that the internal environment of particles and microorganisms is continuously controlled.
• And by adjusting the proportion of the exhaust valve, the pressure gradient of each section inside the isolator is realized.
• The positive pressure mode mainly protects products and processes, and is used for aseptic operation of the inner cavity.
• The negative pressure mode mainly protects the operator from external harmful substances, and protects the operator during the purification process, which is used for the highly toxic operation of the internal cavity.

Features

• VHP sterilization equipment can be integrated.
• Laminar air supply is used inside the cavity, and the air manifold is strictly controlled to ensure the purification level. Real-time monitoring and automatic control of pressure, temperature, humidity and wind speed inside the cavity.
• Continuous transfer is possible, suitable for large-scale sterility testing.
• According to customer needs, customize various non-standard sizes.
• Waste can be quickly transferred out of the work area through RTP, AB valve or continuous bag to ensure the clean environment inside the isolator

Technical Parameters

• Cavity clean level: A level.
• Equipment material: inner cavity 316L, the rest 304 stainless steel.
• Inlet filter: H14 high efficiency filter.
• Return air filter: H13 or H14 high efficiency filter.
• Sterilization method: VHP sterilization.
• Cleaning method: water gun cleaning or manual wiping.
• Illumination in the cavity:≥300Lux.
• Noise: Test ≤65db at Im from the front of the device.
• Glove ring center height: 1150mm.
• Customization needs to provide: inner cavity size requirements, shape requirements.
• Isolator seal form: air seal.
• The sealing level of the isolation room is tested strictly in accordance with the ISO 14644-2 standard.