TL-NP-MISG22 Negative pressure sterile production isolator

Working Principle

Negative pressure isolators are mainly used in pharmaceuticals (processes such as filling, weighing, feeding, crushing, tableting, drying, filling, etc.), cosmetics, biological product research, and physical/chemical science experiments. They provide turbulent airflow, creating negative pressure in the work area through high-pressure exhaust fans, preventing cross-contamination of air inside and outside, ensuring personnel and environmental safety.

(NP series negative pressure isolators are installed in ordinary environments)

Performance Features

1

Can meet the highest standard protection requirements in the pharmaceutical industry

2

Complies with OEB5 protection level for operators (OEL <1μg/m³)

3

Can provide customized professional design according to customer process needs, configuring different glove operation ports, half-suits, or robots to achieve various operations under closed conditions

4

Air handling system uses safely replaceable double-layer PUSHPUSH HEPA filters or bag-in/bag-out HEPA filters

5

Equipment operation controlled by logic controller, human-machine interface operation is simple, can perform all operations

6

Material entry/exit methods can be configured with transfer chambers, sleeve systems, and rapid transfer ports (RTP)

7

Interlock function between chamber doors

8

Inner surface polished and brushed treatment, roughness <0.4Ra

9

Internal R≥15 radius corner structure, easy to clean, no dead corners

10

Door sealing methods can choose between inflatable sealing and mechanical compression sealing

11

Isolator equipped with emergency mode processing system: When isolator seal rings or gloves rupture, chamber pressure will quickly rise, isolator automatically triggers alarm while adjusting fan frequency, increasing exhaust air volume, closing intake valve, ensuring crack wind speed above 0.5m/s to prevent high-activity substances from leaking, protecting operator and laboratory environment safety

12

Optional glove integrity tester, gloves can be safely replaced online

13

Optional: Bag clamp tool set (PE bag, sealing clip, and packaging tools)

14

Isolator can be configured with high-precision air suspension platform, meeting high-precision weighing requirements (above 1/10,000 weighing accuracy)

15

Cleaning design meets CIP (Cleaning in Place) and WIP (Washing in Place) cleaning requirements, usually using WIP form, configured with water/air spray gun

16

Operation chamber interior uses ≥3mm thick 316L stainless steel material, if anti-corrosion requirements exist, titanium or surface PTFE coating can be used

Safety Note: This equipment design complies with the highest safety standards, equipped with multiple safety protection measures, ensuring operator and environmental safety during high-activity substance handling processes.

Application Areas

High Activity Laboratory

Weighing
Dispensing
Sampling
Solution Preparation
Analysis
Moisture Titration
Infrared Scanning

API Bulk Drug

Centrifugation
Filtration
Drying
Mixing
Crushing
Weighing
Dispensing

Solid Dosage Forms

Granulation
Drying
Mixing
Tableting
Coating

Main Safety Features

OEB5 Level Protection

Negative Pressure Turbulent Flow Design

Emergency Processing System

Chamber Door Interlock

Cleaning in Place

High Sealing Performance

Technical Specifications

Power Supply

220V/380V 50Hz

Air Change Rate

≥15 times/hour

Chamber Material

SUS316L Stainless Steel

Protection Level

OEB4 or OEB5

Airflow Pattern

Turbulent Flow

Operating Noise

<65dB(A)

Negative Pressure Maintenance Power

1000W

Operation Chamber Pressure

-50Pa ~ -150Pa

Chamber Sealing

Complies with ISO10648-2 Standard

Internal Roughness

<0.4Ra

Internal Radius Corner

R≥15

Internal Material Thickness

≥3mm

Note: The above technical specifications are standard configurations, can be customized and adjusted according to specific customer requirements.

Customization Options

Operation Configuration

Glove Operation Ports
Half-suit Operation
Robot Operation
Multiple Specification Combinations

Filtration System

Double-layer PUSHPUSH HEPA
Bag-in/Bag-out HEPA Filters
Safely Replaceable Design
Online Monitoring System

Material Transfer

Transfer Chamber System
Sleeve System
Rapid Transfer Port (RTP)
Bag Clamp Tool Set

Monitoring and Control

Glove Integrity Tester
Pressure Real-time Monitoring
Wind Speed Monitoring
Logic Controller