Starttek | Pharmaceutical Isolator
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Your safety is our priority

Containment Isolator

FEATURES

  • OEB 4 or OEB5

  • Chamber Integrity: ISO10648-2

  • H14 cylinder HEPA filters (PUSH-PUSH)

  • Continuous liner bag system for a material safety transfer

  • Siemens PLC control with HMI

  • Automatic control and operation

  • Real-time monitoring the differential pressure, humidity, temperature

  • Critical process parameters can be stored and printed.

  • 21 CFR Part 11 compliance

  • Air change ＞24 times/h, turbulent flow

  • Can be installed in background Class D

  • Power Supply: AC220V or 380V/50Hz

  • Pressure range: -80Pa~-50Pa

 

OPTIONS

  • Laminar flow

  • Bag-In-Bag-Out(BIBO) H14 HEPA filters

  • Explosion-proof

  • The vibration-free platform for precision weighing

  • WiFi controlled glove integrity tester (GIT-WLAN)

  • Wooden Mock-Up

Aseptic Isolator

FEATURES

  • Class A, ISO5, Aseptic environment.

  • Integrated VHPS® decontamination system.

  • Special liquid transfer technology for continuous and aseptic filling.

  • Real-time monitoring of the velocity, differential pressure, humidity, temperature. 

  • Temperature is adjustable to minimize the influence on products.

  • Critical process parameters can be stored and printed.

  • Power Supply: AC 380V/50Hz

  • Siemens PLC control with HMI

  • The leakage rate is less than 0.5% /vol/hour at 2 times the working pressure

  • LED lamp, more than 300 Lux

 

OPTIONS

  • Rapid Transfer Ports (RTP) technology for safe transfer.

  • Particle counter

  • Air sampler

  • H2O2 high & low concentration sensors

  • H2O2 portable sensor for operator safety

  • WiFi controlled glove integrity tester (GIT-WLAN)

  • Wooden Mock-Up

Documentation

  • Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11.

  • FAT, SAT, IQ, OQ Training.

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