Protect the boundary. Preserve the process.

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Sterile Test Isolator for Biopharma

Biopharma application: An enclosed testing environment for repeatable aseptic manipulation and controlled material transfer.

  • Automatic leak detection: Inflate the chamber to check whether the system remains airtight. Sterilization begins only when the airtightness requirement is met. Otherwise, continue inflation and repeat leak detection until the required condition is satisfied.
  • High-efficiency flash evaporation: A high-precision constant-temperature system ensures 0 decomposition during hydrogen peroxide evaporation, allowing 100% of the hydrogen peroxide to form vapor.
  • Rapid residue removal: The hydrogen peroxide decomposer quickly and thoroughly breaks down hydrogen peroxide in the space as well as residues on surfaces.
  • Sterilization process recording: Automatically detect sterilant concentration and plot the sterilization process curve.
  • Door interlock: Equipment doors cannot be opened during operation.
  • Antimicrobial chamber surfaces: The inner chamber surfaces receive an antimicrobial treatment with sterilizing and antimicrobial effects, leaving microorganisms nowhere to harbor on the inner surfaces permanently.
  • Computerized validation software: The system provides audit trails, electronic signatures, and data integrity functions.
  • Bottom-loading design: The bottom-loading transfer chamber has a compact structure, a small footprint, and is easy to operate.
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Sterile test isolator with glove ports and integrated controls
Stainless-steel sterile test isolator installed in a cleanroom
Operator using the control screen on an installed sterile test isolator
Glove-port working chamber inside a sterile test isolator

Negative Pressure Isolator for Biopharma

Biopharma application: Active containment for potent or hazardous processes, configured around material, waste, and decontamination flows.

  • The negative pressure isolator ensures that harmful toxic substances inside the operating chamber do not leak outside.
  • Chamber negative pressure is automatically adjusted to the set value, with an emergency response function. If internal pressure loss or leakage is detected, the system automatically responds and adjusts to ensure airflow enters the isolator from the background room, preventing toxic substances from spreading.
  • A practical, compact structure with high cost-effectiveness.
  • An optional disinfection and inactivation system provides disinfection treatment.
  • An optional waste-liquid collection module with a breathing function prevents toxic substances from escaping and polluting the environment.
  • Exhaust air passes through two layers of filtration for improved discharge safety.
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Multiple negative pressure isolators arranged in a clean production room
Stainless-steel negative pressure isolator with control panel
Full negative pressure isolator installed on a production floor

Negative Pressure Dispensing Booth for Biopharma

Biopharma application: ISO 5 unidirectional airflow for contained weighing, dispensing, and sampling operations.

  • Touchscreen PLC intelligent control with three-level password protection for operating-system security.
  • Air supply through a flow-equalizing membrane maintains the airflow pattern beneath the membrane and provides a more pronounced laminar flow effect.
  • A dedicated exhaust filtration system prevents contamination of the surrounding environment.
  • Air velocity sensors and differential pressure gauges monitor filter service life in real time.
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Compact dispensing booth in a blue-floor cleanroom
Negative pressure booth with integrated weighing area
Wide negative pressure dispensing booth with stainless-steel work zone
Twin dispensing booths in a controlled production area

Airborne Particle Counter for Biopharma

Biopharma application: Portable particle measurement for cleanroom verification, reporting, and point-of-use investigation.

Airborne particles scatter light when illuminated, a phenomenon known as light scattering. Scattering depends on particle size, light wavelength, particle refractive index, and the light absorption characteristics of the particles. For scattered-light intensity and particle size, particle counters follow a basic principle: the intensity of light scattered by a particle increases as its surface area increases. Measuring scattered-light intensity therefore allows particle size to be inferred. This is the basic operating principle of a light-scattering particle counter.

Remote particle counter unit on an assembly bench
Portable airborne particle counter with touchscreen
Remote airborne particle counter instrument and sampling connection

Biological Air Sampler for Biopharma

Biopharma application: Multipoint viable-air sampling for routine environmental monitoring across controlled spaces.

  • Numerous micropores in the sampling inlet reduce dust and microbial overlap, reducing microbial counting errors.
  • Sampling volume can be freely set from 0.01–2.0 m³.
  • The LCD displays parameters including sampling volume and sampling time.
  • Sampling volume, sampling time, and other parameters can be stored in groups, with capacity for up to 256 groups of data.
  • A distinctive design that is easy to use.
  • Petri dishes are easy to replace: remove the sampling head to change the dish (standard universal φ90X15 Petri dishes).
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Biological air sampler with protective sampling head
FKC air sampler with removable head and culture-dish components
Portable biological air sampler with controls

Clean Environment Online Monitoring System for Biopharma

Biopharma application: Continuous cleanroom data collection, alarming, reporting, and connection to wider production systems.

Product advantages:

  1. A powerful software system compatible with sensors from domestic and international brands, including lighthouse, METONE, and PMS, with free lifetime upgrades.
  2. Open data interfaces enable seamless connections with users’ MES/SCADA and other systems.
  3. Comprehensive functions for compliance with 21CFR, part11 regulations.
  4. Powerful user management with permission settings for more than 1000 users.
  5. Switch between real-time and historical data curves.
  6. Remote, around-the-clock real-time monitoring data reports.
  7. Remote instrument calibration is fast and flexible, without disassembly or return to the factory.
  8. HJCLEAN software includes free lifetime upgrades.
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Fixed environmental sampling unit in an active cleanroom installation
Clean environment monitoring control interface
Online microbial monitoring point installed above a clean work area
Environmental monitoring components deployed across a cleanroom

Glove Integrity Tester for Biopharma

Biopharma application: In-situ glove-leak testing with portable operation and audit-ready record control.

  • Online in-situ testing without disassembly avoids cross-contamination and damage during removal.
  • A high-precision pressure-drop method with high sensitivity and good repeatability.
  • A wireless, portable design with built-in power and air supplies for flexible movement.
  • Complies with multiple standards, including ISO, GMP, and 21 CFR Part 11.
  • Intelligent data management supports audit trails and electronic records.
  • A user-friendly interface, simple operation, and low maintenance costs.
  • Network management of multiple devices supports centralized data management.
  • High-capacity, low-power energy management enables more than 10h of continuous operation on a single charge.
  • Includes a self-check function.
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Glove integrity tester connected to an isolator glove
Portable glove integrity tester connected to an isolated glove
Pressure hoses and connection details for glove integrity testing