详情描述

The Comprehensive Stability Test Chamber for Pharmaceuticals is specifically designed for the industry to conduct stability tests on drugs to determine their shelf life and influencing factors. The major advantages of this series include ensuring stable and reliable testing conditions, an extended service life, and the ability to control temperature, humidity, light intensity, and ultraviolet intensity simultaneously with a single unit.

This product complies with the long-term, intermediate, and accelerated tests in the 2020 National Pharmacopoeia, GMP, FDA, ICH, and other relevant standards. It also meets the 40°C, 20% R.H. low humidity test for special drugs such as large-volume parenterals.

Product Features

Controller: Microcomputer P.I.D. Liquid Crystal Display Controller

Including: set value, measured value, date, running time

Microprinter paper records with adjustable print frequency

The controller features built-in data recording, allowing real-time recording of equipment operation data onto a USB drive, with adjustable recording frequency; even during power outages, data will not be lost.

RS485Communication interface connects to the computer for real-time data recording

Lighting UV Method: Top LED light board with computerized dimming, equipped with a luminometer.

Complies with the 2020 edition of the pharmacopoeia.GMPRequirementsICH1QBGuiding Principles

Temperature and Humidity Control

Air Conditioning Method: Forced ventilation, internal recirculation, balanced temperature and humidity control

Air Circulation Device: Blower Fan Circulation

Heating Method: Fin-Type PID Heating System

Humidification Method: Ultrasonic PID Humidification System

Cooling Method: Fin-Type Air Cooling System

Centralized control and monitoring

A single computer can connect to multiple devices of the same series simultaneously, up to 50 devices.

Safety Protection

Studio Independent Temperature Protection

Humidification System Water Supply Protection

Cooling unit overload protection

Humidity and Temperature Upper/Lower Limit Deviation Alarm System

Mobile WeChat Mini Program Alarm

Industry Standards

Meets GMP, ICH, and the requirements of the 2020 National Pharmacopoeia.

Manufacturing Execution Standard (Technical Conditions): GB/T 10586-2006

After-sales service

From the date of acceptance, one-year warranty and lifetime repair service.

Supply 3Q verification scheme documents and implementation services (optional) that meet national standards.

Structural Components

Microcomputer P.I.D. Liquid Crystal Display Controller

Electronic humidity sensor

Original Imported Pt100 Temperature Sensor

Low-energy consumption, heat-resistant refrigeration compressor

Environmentally friendly refrigerant

Mini Printer

Mobile remote control system, SMS alarm system (optional)

Box: Cold-rolled steel electrostatic powder coated

Inner Box: SUS304 Mirror Polished Stainless Steel

Shelf: Can support at least 304 stainless steel SUS50KG

Exterior Door: Equipped with key lock

Observation Window: Large hollow glass (optional)

Mobile casters: 4 swivel wheels with lockable feature

White and UV LED light sources

 

Technical Specifications

Note: This power rating is the result measured after the equipment has stabilized.

 

Index

Model

   

 

KHYW-160

KHYW-260

KHYW-360

KHYW-460

KHYW-660

KHYW-960

KHYW-1360

Temperature Control Range

0-65

Temperature fluctuation/Uniformity

±0.5/±2

Humidity Range/Deviation

20~95%RH/±3%RH

Humidity Fluctuation

≤±5%RH

Parameter adjustment method

Balanced temperature and humidity control method

Meets testing standards

ICH Q1BInstructions, Cool White Light ≥1.2x10  lux.hr  Near-ultraviolet fluorescence ≥200w.hr/

Light intensity range

0-10000lux±300luxAdjustableUVANear-ultraviolet light0-50w/㎡)

Light Source

LEDCool white light6500k, in compliance withISO10977,Ultraviolet light wavelength range:320~400nm

Dimming Method

Programmable0~100Dimmable to infinite levels

Refrigeration System

Totally enclosed, high-temperature-resistant compressor

Control System

Programmable Color LCD Integrated Controller

Sensor

Temperature:pt100Platinum Resistance Thermometer     Humidity: Electronic high-precision humidity sensor

Data Output Method

Mini Printer Printing andUDisk data export

Power Supply

220v±10%  50Hz

Input Power

500

600

680

800

850

1300

1500

Volume

140

220

300

430

660

830

1280

Internal DimensionsmmW*D*H

432*500*843

515*510*1085

515*510*1405

560*610*1380

1112*560*1232

1080*610*1380

1680*610*1380

External DimensionsmmW*D*H

522*595*1365

595*605*1620

595*605*1940

680*745*1870

1200*650*1895

1200*745*1870

1800*745*1870

Cargo shelf (layer)

3

3

3

3

3

3

3


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