Sterility Test Isolator

Sterility test isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity.

It is ( laminar flow aseptic isolator) composed of stainless steel and toughened glass.

It is Class A inside.

The system is equipped with Siemens (PLC) for fully automatic control.

All the sterility test isolators meet the GMP requirements.

Product Features

  1. Built-in Vaporized Hydrogen Peroxide (VHPS) generator: Used for bio-decontamination which can reach 6-log Sterility Assurance Level.
  2. Safe VHPS Levels: The VHPS residual concentration is less than 1ppm after aeration.
  3. Optimized Leak Prevention: Leakage rate is less than 0.5%/vol/hour under 2 times working pressure test.
  4. Adjustable Pressure Range: -80Pa to +80Pa pressure customization.
  5. User-friendly Interface: 12.1” IPC with NetSCADA.
  6. Integrated Sterility Test Pump: Enhancing efficiency.
  7. Regulatory Compliance: Comply with GMP, USP, EP, and 21 CFR Part 11 electronic records and signature requirements.
  8. Enhanced Safety Features: Interlock Systems, Alarm Records, and Audit Trails.
  9. Low Noise Operation: ≤65dB(A) when in pressure hold stage.
  10. Compressed Air Supply: 0.4MPa ~ 0.6MPa clean and dry.
  11. Power Supply: 380±38V, 50±5Hz, 25A (HTY-1800G4 / HTY-1800AG4).

Options

Air Sampler, Particle Counter

High / low concentration sensor
Portable concentration sensor for operator safe
WiFi-controlled glove integrity tester (GIT-WLAN)

Wooden Mock-Up

Services

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

FAT, SAT, Training

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