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Drug stability test chamber
Time:2011.08.03  Hits:1 次   Source:ALP Technology

Special technical services of the case which passed druggery stability test by 3Q
 
Through a series activities such as: DQ (design confirmation), FAT (Manufacturers factory test), IQ (installation qualification), OQ (Operation confirmation), PQ (operating performance confirmation), the data and conclusions can prove that if the equipment can meet the requirements of production process, if equipment performance meet the requirements of design & products and GMP standard.
 
1.  Purpose of DQ: according to customer demand and production process, by compare with contract and drawing in order to review equipment performance, material, structure, accessories, control, instrument, etc, to confirm the rationality and reliability of products in design process.
 
2.  Purpose of FAT: through a series of experimental test by manufacture proves the quality and reliability of the equipment before delivery also prove the equipment can satisfy the basic requirements of design confirmation, products standard and international requirements of GMP.
 
3.  Purpose of IQ: by installation, commissioning and validation activities,a series of data were offered to validate if installation documents & conditions & outcome of drug stability testing case can comply with the design requirements, datum and document can meet the requirements of GMP management.
 
4.  Purpose of OQ: check instrumental and test report supplied by validate side at first, check and test equipment technology parameter, confirm the operation of equipment performance meet the design requirements, and related requirements in accordance with GMP requirements.
 
5.  Purpose of PO: by the qualification of installation and operational confirmation, test corresponding sample based on the specific craft of customer manufacturer, confirm the operation of equipment performance meet the design requirements, and related requirements in accordance with GMP requirements.
 
The new generations of drug stability test chamber, assemble year’s experience of design and production, and introduce into German technology, breach the defect of existing cast which can not endure long time and continuous operation. It adopting advanced technology of double compressor takes turns switch, and main imported parts performance is stable and reliable.
 
1.  Imported closed compressor, use R134a environmental protection refrigerants, low noise, high efficiency, long service life.
 
2.  Imported touch screen controller, large process control, a precise and reliable control, with R232 interface.
 
3.  Data record, online data acquisition, imported recorder with paper, two data recording mode selection.
 

 

Description

Drug stability test case

Integration stability test case

Item NO

YP-150SD

YP-150SDP

YP-150GSP

YP-250SD

YP-250SDP

YP-250GSP

YP-500SD

YP-500SDP

YP-500GSP

Inner size

600*405*620

680*605*730

700*800*900

Temperature range

065

no illumination065

illumination1065

Temperature control fluctuations

±0.5

Control windage

±2

Humidity control range

4095%RH

Humidity deviation

±3%RH

Illumination range

 

04500 lx

Illumination windage

 

±500LX

Regulating mode

Balance temperature and humidity regulation mode

Refrigeration system

Closed compressor independent control

Humidity transducer

Imported capacitive moisture sensorROTRONIC

Temperature transducer

Pt100 Platinum resistor

Controller

Imported programmable touch screen controller, can switch display between Chinese and English, specimen  RS232 interface

Recorder

Imported recorder with paperoptional

Data acquisition system

online data acquisition system can connect computers and paper recorder printing in two ways

Experimental unit

40  75%RH25 60%RH

Work environment temperature

535

Electrical source

AC  220V±10%  50HZ

Safety device

Compressor overheat, fan overheating, overheat, compressor over press, overload, water protections

Shelf (configuration)

2 pcs

 
 
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