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Pharmaceutical Stability Test Chamber

Pharmaceutical Stability Test Chamber

The Pharmaceutical Stability Test Chamber is suitable for the new drugs stability test and verification of drugs and new drugs in pharmaceutical enterprises and drug research institutes. It is designed and manufactured according to Chinese Pharmacopoeia Appendix XIX C Guiding Principles of drug stability test and GB/T10586-89. and scientifically simulate a long-term stable working temperature, humidity, and light environment required for drug failure evaluation, which is a piece of necessary equipment for pharmaceutical enterprises to pass GMP certification.

Enclosure Structure Of The Stability Test Chamber

video Of The Stability Chamber

Material structure: outer box material: high-quality cold-rolled steel plate CNC machine tool processing molding, shell surface for plastic spraying treatment, more bright and clean, beautiful

Temperature and humidity circulation system: specially air-conditioned long shaft fan motor with low noise, stainless steel multi-wing impeller with high and low-temperature resistance, to achieve vertical convection-diffusion circulation

The inner wall of the door is equipped with 8 ~ 10 20W fluorescent lamps for a lighting test

The internal studio is equipped with another piece of the tempered glass door to isolate the product from the lamp

The door has a large Angle of view insulation vacuum tempered glass, easy for users to inspect the sample test process

Adopt high-quality door seal and heat preservation material to make the whole machine more superior performance

Door handle: no reaction door handle, easier to operate

Casters: High quality fixed PU movable wheels are adopted at the bottom of the machine

Functional Features For Stability Chambers As Our Standard Set Up

Pharmaceutical Stability Test Chamber

Temperature and humidity controller

Original imported color touch screen controller, program control above 5 inches, with three-level authorization password, can store temperature and humidity values ​​for more than 5 years

Pharmaceutical Stability Test Chamber

Temperature Sensor

Imported VAISALA capacitive humidity sensor, DC detection, no maintenance

Pharmaceutical Stability Test Chamber

Refrigeration Compressors

Original imported fully enclosed compressor, long life, low noise

Pharmaceutical Stability Test Chamber

Data printing

Can print the model and serial number of the device, and print temperature, humidity and curve at the same time.

Pharmaceutical Stability Test Chamber

On-site alarm

On-site temperature and humidity deviation sound and light alarm, independent over-temperature alarm

Pharmaceutical Stability Test Chamber

Remote alarm

Remote SMS alarm (with power failure alarm) Multiple devices can share a mobile phone card

Pharmaceutical Stability Test Chamber

Over-temperature protection

Equipped with a dual insurance anti-dry protection system, and an independent over-temperature protection system can automatically cut off the power supply

Pharmaceutical Stability Test Chamber

Door lock

Equipped with a key to prevent unauthorized personnel from contacting drugs and affecting the test

Pharmaceutical Stability Test Chamber

Moveable: except walk-in types

4 casters, lockable

Pharmaceutical Stability Test Chamber

Visual: except walk-in types

Observe the sample through the inner glass door to minimize the change of test data

API(Active Pharmaceutical Ingredients)

Test name Test condition Time Note
Influence factor test 10~75℃
Light stability test Daylight standard ISO 010977 Tests on APIs on preparations with the inner and outer packaging removed.
Total illuminance not less than 1.2X106 Lux – hr Tests (if required): on formulations with the outer packaging removed.
Near ultraviolet energy, not less than 200w – hr/m2 Tests (if required): Tests on formulations in marketed packaging.
Spectral range: 320~400nm
(and the maximum emission energy in 350 ~ 3700nm)
Acceleration test 40°C±2°C/75%RH±5%RH 6months Impact on the quality of the raw drug (e.g. what may happen during transport)
Intermediate conditions: 30°C±2°C/65%RH±5%RH 12months
Refrigerated storage: 5°C ± 3°C (API) Accelerated
Test conditions 25°C ± 2°C/60%RH ± 5%RH
Long-term trials 25°C ± 2°C/60%RH ± 5%RH or
30°C±2°C/65%RH±5%RH

Formulation, Preparations In Drugs

Test name Test conditions Time
Non-permeable or semi-permeable easily packable formulations
Long-term trials 25°C±2°C/40%RH±5%RH     or 30°C±2°C /35%RH±5%RH  ●New formulations 12 months
●Generic formulations         6 months
Intermediate tests 30°C±2°C/65%RH±5%RH 6 months
Acceleration test 40°C±2°C/ no exceed(NMT)25%RH 6 months
Refrigerated formulations, to be refrigerated formulations such as the use of semi-permeable packaging, should also be carried out under the appropriate temperature conditions of the low-temperature test to assess its water loss
Long-term trials 5°C±3°C 12 months
Acceleration test 25°C±2°C/60%RH±5%RH 6 months
Refrigerated storage of reagents
Long-term trials  – 20°C±5°C 6 months

Specifications And Parameters For Standard Capacity Stability Chambers

Model NK-SD150 NK-SD250 NK-SD500 NK-SD1000 NK-SD2000
Working room W*H*D 500*600 *500mm 600*700*550mm 800*800 *800mm 1000*1000*1000mm 2050*755*1300mm
Temperature Range 10°C~65°C
Humidity Range 20~98% R.H
Fluctuation/Uniformity ±0.5°C/±2°C
Heating rate 1.0~3.0°C/min (average, no load)
Humidity control fluctuation ±2%RH
Supply voltage AC220V/AC380V ±10% 50±0.5Hz three-phase five-wire system
Note: Can be customized according to the size of customer requirements to meet customer needs

Size: D*W*H depth X width X height mm

Operating power is 1 set of refrigerant to do 25°C, 60% RH measured results,

Equipment use conditions: ambient temperature 5 ~ 35℃ ambient humidity: ≤ 85% RH

Pharmaceutical Stability Test Chamber

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Pharmaceutical Stability Test Chamber

Multi-Rooms Drug Stability Test Chamber

Multi-Rooms Stability Test Chamber means one chamber has different testing rooms, like stackable chambers. It may have 2 rooms or 3 rooms. Most used in the lab, with 4 casters easy to move around. It's got exactly the same function as standard pharmaceutical test chambers.

Specifications And Parameters For Standard Capacity Stability Chambers

Type 2 Rooms 2 Rooms 3 Rooms
Model NK-TSD150/NK-TGSD150 NK-TSD250/NK-TGSD250 NK-TGSD400
Volume 150L 250L 250L
Installed power 1800W 2000W 2000W
Operating power 550W 550W 550W
Inner Dimension 600*405*620mm 500*600*830mm Right 450*500*1000mm
Left 450*500*450mm
External Dimension 1470*810*1500nm 1370*1010*1700rnn 1280*840*19400nm
Note: TSD-no light TGSD-lighted
Pharmaceutical Stability Test Chamber

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Speak To A climate chamber Specialist

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Pharmaceutical Stability Test Chamber

Walk-In Pharmaceutical Stability Test Chamber

Walk-in drug stability test chamber is a scientific method to create a batch of drug failure assessment requires a long time to stabilize the temperature and humidity of the environmental space, suitable for pharmaceutical companies to accelerate the test and long-term test of drugs and new drugs, is the best choice for pharmaceutical companies to carry out large quantities of drug storage and stability test program, its characteristics are customized according to the actual environment on site size, compared to the general standard type drug stability test chamber, can maximize the use of laboratory space, in order to achieve the same test conditions of the large-capacity retention test requirements developed, the larger the volume can save a lot of procurement costs.

Specifications And Parameters For Standard Capacity Stability Chambers

Model NK****SD
Temperature Range 10~65°C as standard temp range
Temperature fluctuation ±0.5°C
Temperature Deviation ±1℃
Humidity range 30%~95%RH as the standard humid range
Humidity deviation ±3%RH
Power supply 380/220/50V/HZ, can be changed to your country standard power, like 230V, 125V, 120V, 110V
Inner Dimension Customized on-demand
External Dimension Customized on-demand, depends on the room size where the walking stability chamber will been placed
Triple data recording 1. Paper records with micro printer, print cycle frequency adjustable
2. Paperless recording, 64M cycle data storage inside the controller, export via built-in SD card including set value, measured value, real-time collection frequency adjustable, set collection frequency 1 minute Time can store 10 years of data
3. Real-time computer data recording
4. Using the Internet and Simas software can achieve remote commissioning and monitoring functions off-site
One PC can be connected to multiple devices of the same system at the same time, up to 30 instruments
Energy-saving and silent intelligence 1. Low energy consumption design, reduce the cost of use.
2. Silent design, ultra-low operating noise
3. Touch screen display, intuitive and precise, easier to operate
Safety protection 1. Low energy consumption design, reduce the cost of use.
2. Silent design, ultra-low operating noise
3. Touch screen display, intuitive and precise, easier to operate
Accessories Touch Screen Controller
Original imported PT100 temperature sensor
Imported low-power heat-resistant refrigeration compressor
Environmentally friendly fluorine-free refrigerant
External automatic circulation water supply system
Micro printer
Cell phone SMS alarm function
Pharmaceutical Stability Test Chamber

Contact Us For A Price

Speak To A climate chamber Specialist

get a quote

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NOKI INSTRUMENT is a professional manufacturer of environmental climate chambers and provides OEM services. Welcome to contact us through the following contact information:
Email address: [email protected],Whatsapp: 008618530078345!

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