How much does the stability test box for domestic drugs cost

NegotiableUpdate on 02/20

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

The drug stability test chamber is a specialized equipment that simulates the storage environment of drugs, evaluates the shelf life and stability of drugs. Its core function is to provide regulatory testing conditions for drug research and development, production, and quality testing by accurately controlling parameters such as temperature and humidity. 1、 The core functions and application scenarios of this device are mainly used to simulate different environmental conditions, test the stability of drugs during storage, and ensure the quality and safety of drugs. Simulation environment type: Long term stability test: Simulate the conventional storage conditions of drugs, usually at a temperature of 25 ℃; 2 ℃, relative humidity 60% 5%, with a testing period of more than 12 months. Accelerated stability test: Simulate storage conditions, typically at a temperature of 40 ℃; 2 ℃, relative humidity 75% 5%, rapid assessment of drug stability, with a typical trial period of 6 months. Intermediate condition test: Between long-term and accelerated tests, typically at a temperature of 30 ℃; 2 ℃, relative humidity 65% 5%, used to supplement the validation of drug stability. Core application scenario: Drug development stage: Determine the stability characteristics of the drug and provide data support for setting the expiration date of the drug. Drug production stage: Verify the reliability of production processes to ensure that mass-produced drugs meet stability requirements. Drug quality testing: used by regulatory agencies or enterprise quality inspection departments to randomly inspect drugs and verify whether they meet quality standards. 2、 The design of the drug stability test chamber for key technical features must strictly comply with the requirements of the Good Manufacturing Practice (GMP) and international ICH Q1A regulations. The core technical features are reflected in the following aspects: precise parameter control: temperature control range is usually from 0 ℃ to 6 ℃

Product Details

Product Features:

1. Using imported high-quality components to ensure long-term continuous operation and stable and reliable performance.

2. Touchscreen temperature and humidity controller, excellent human-machine interface.

3. Imported high-precision humidity sensor with small drift and no maintenance required.

4. The standard micro printer can print temperature and humidity curves and data in real time.

5. Standard SD card, capable of exporting electronic record data from the controller.

6. Equipped with RS485 interface as standard, it can monitor single or multiple instruments through computer networking.

7. Standard mobile SMS alarm, one SIM card can manage multiple devices.

The 8 main doors are equipped with key locks to prevent unrelated personnel from opening and affecting the test.

9. Imported fully enclosed heat-resistant compressor with low noise and long service life (one for backup and one for use).

10. Meet the requirements of FDA, ICH, and national pharmacopoeia for accelerated, long-term, intermediate, and high temperature and high humidity tests.

11. The circulating water supply system greatly delays the problem of bacterial growth in the water system.

12. Meet the low humidity tests for special drugs such as intravenous infusion at 40 ℃, 20% RH, and 25 ℃, 40% RH.

13. Provide IQ, OQ, and PQ validation data that comply with international standards.

14. Manufacturing Execution Standards (Technical Conditions): Refer to GB10586-2006.

Technical Specifications

model	Lhh- 150	Lhh- 250	Lhh- 400	Lhh- 500	Lhh- 800
Volume (L)	150	250	400	500	800
temperature range	10～65℃
temperature fluctuation	≤±0.5℃
temperature deviation	≤± 1 ℃ (uniformity ≤ 2 ℃)
humidity range	15～95%R.H
Humidity deviation	≤± 3% R.H (uniformity ≤ 5% R.H)
Humidification method	Electric steam humidifier (external humidification, more energy-efficient; avoids secondary pollution and is easier to maintain)
Working environment temperature	+5～40℃
inner material	Mirror 304 stainless steel
Shell material	Cold rolled steel plate spray coating
safety device	Power overload protection, independent studio overheating protection, compressor overload, overpressure protection, water blockage, water shortage protection
working power supply	AC220V±10% 50HZ
Installation power	1.2KW	1.4KW	2KW	2KW	2KW
Carrier board	2nd floor	3 levels	4th floor	4th floor	4th floor
Internal dimensions (mm)*	500X530X600	500X530X950	750X650X1030	800X1000X1000	1000X1000X1000
Dimensions (mm)*	990X690X1360	990X690X1700	1070X810X1820	1120X1160X1800	1320X1160X1800

Note: The dimensions are marked as depth X width X height

model	Lhh- 800 s （左右be dismissed from public office and expelled from the PartyDoor)	Lhh- 1000 s (Left and right double doors)	Lhh- 1500 s (Left and right double doors)	Lhh- 2000 s (Left and right double doors)
Volume (L)	800	1000	1500	2000
temperature range	0～65℃
temperature fluctuation	≤±0.5℃
temperature deviation	≤± 1 ℃ (uniformity ≤ 2 ℃)
humidity range	15～95%R.H
Humidity deviation	≤± 3% R.H (uniformity ≤ 5% R.H)
Humidification method	Electric steam humidifier (external humidification, more energy-efficient; avoids secondary pollution and is easier to maintain)
Working environment temperature	+5～40℃
inner material	304 mirror stainless steel
Shell material	Cold rolled steel plate spray coating
safety device	Power overload protection, independent studio overheating protection, compressor overload, overpressure protection, water blockage, water shortage protection
working power supply	AC220V±10% 50HZ
Installation power (W)	2000	2200	3000	3500
Carrier board	4th floor	4th floor	4th floor	4th floor
Internal dimensions (mm)	500X1300X1230	540X1400X1330	700X1610X1330	900X1670X1330
Dimensions (mm)	830X1460X1850	870X1560X1950	1030X1770X1950	1220X1830X1950

Note: The dimensions are marked as depth X width X height