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Preface
Thank you for purchasing a Drug Stability Test Chamber manufactured by Chongqing Yongsheng
Experiment Instrument Factory. After confirming the product model, you should carefully read the
instructions and get a good understanding of the contents before attempting to operate instrument.
The instruction manual was written for those who perform installation, operation and routine maintenance
for the drug test chamber. The instruction manual contains a description of the introduction to product,
installation and routine maintenance when operating the drug test chamber. You should therefore keep it
in a handy place to refer to when operating and handling the instrument. Be sure to observe all procedures
provided in the manual.
Note:
The performance and functions of the equipment will continue to improve and upgrade. The contents of
this manual are subject to change without notice.
The author of this manual has made efforts to ensure that the content is accurate and complete during the
production process. If you find any imperfections, please contact us.
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Content
1.OVERVIEW ....................................................................................................................................................................... 3
2.1.SPECIFICATIONS ................................................................................................................................................................ 3
4.STRUCTURE ...................................................................................................................................................................... 4
5.INSTALLATION .................................................................................................................................................................. 5
6.OPERATION ...................................................................................................................................................................... 6
6.2.POWET ON ........................................................................................................................................................................ 7
6.3.CONTROLLER .................................................................................................................................................................... 7
7.MAINTENANCE ............................................................................................................................................................... 17
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1.Overview
The SHH-SD-2T series drug stability test chamber is manufactured according to the relevant requirements of GB/T
In order to meet the 2015 edition Chinese Pharmacopoeia guidelines for the stability testing of raw materials and
preparations, it scientifically creates a long-term stable temperature and humidity environment space for the
evaluation of drug failure period, suitable for pharmaceutical companies to verify the stability of drugs.
Apart from the accelerated test, long-term test and high-humidity test specified in the 2015 edition of the Chinese
Pharmacopoeia's guidelines for the stability test of raw materials and preparations, the user may also set the test
conditions according to the requirements of the drug stability test of the unit. In addition, it meets certain drug
stability test conditions (such as ICH Q1A) as defined by ICH and FDA organizations.
2.Technical Parameters
2.1.Specifications
Model SHH-220SD-2T SHH-500SD-2T SHH-800SD-2T SHH-1000SD-2T SHH-2000SD-2T SHH-3000SD-2T
Temperature range (℃) 15 ~ 65
Temperature fluctuation (℃) ±0.5
Temperature deviation (℃) ±1
Humidity range (% RH) 15 ~ 95
Humidity deviation (% RH) ±3
Power supply (V/Hz) 220/50 220/50 220/50 220/50 220/50 220/50
Installed power (W) 1800 2300 3000 3000 4500 4500
Operating power (W) About 600 About 700 About 900 About 1100 About 1500 About 1700
Shelf (Set) 3 6 5 5 7 9
Internal dimension D×W×H (mm) 600×600×600 600×600×1300 800×850×1200 950×850×1200 1200×1100×1500 1200×1200×2000
External dimension D×W×H (mm) 1200×810×1250 1210×830×1950 1400×1080×1880 1550×1080×1870 1880×1330×2170 1540×1950×2350
Package dimension D×W×H (mm) 1290×878×1420 1290×920×2110 1495×1165×2045 1640×1165×2000 1900×1400×2300 1650×2020×2530
Net weight (kg) 210 300 380 410 630 730
4.Structure
rotate the handle, compress the seal, and close the glass door.
4.6 The system is equipped with an electric steam humidification system, as well as a water supply tank, a water
pump, a connecting pipe and related components.
4.7 Compressors: equipped with two sets of fully enclosed heat-resistant compressor units for low-power
operation to ensure continuous cooling and dehumidification for long life service; use environmentally
4.8 Temperature and humidity measurement sensor: the original German M series (M222 A level) Heraeus
temperature sensor and the United States HIH-4000 series of humidity sensors.
5.Installation
5.4 The system power supply adopts a single-phase (220±22V, 50±0.5Hz) three-wire system. When installing a
power outlet, the grounding wire must not be left unconnected to prevent electric shock.
5.5 Connect the water supply system:(See Figure 5.1 for details of water supply system)
a. One end is connected to the water inlet pipe and the other end is connected to the water pump outlet
b. The water outlet pipe and the overflow pipe are respectively connected, and the other ends are extended
into the water through the water tank cover.
c. Add appropriate amount of water into the water tank. The water level of the water tank should be kept
within the water mark lines and the water tank cover should be covered.
d. Check each water connection pipe to ensure that all connecting pipes are not folded and blocked.
e. Plug in the pump power supply, the pump is pumping normally, and the outlet pipe has water flowing out.
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6.Operation:
The setting value of the over-temperature protector should be 20 °C above the temperature test value of the
chamber, as shown in the figure below. The over-temperature protector is used as the safety protection device of
the test box. Please set it strictly according to the requirements. If the setting value is too high or too low, the
over-temperature protector will not work normally. The example is shown in Table 6.1 below.
Table 6.1
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protector is
40.0℃
recommended to be set at
6.2.Power on
Please confirm that the installation and preparation work of the chamber has been completed. Turn on the power
Table 6.2
6.3.Controller
6.3.1.Fixed value operation interface
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The device power is turned on, the system self-test is completed, and the fixed value operation interface is
displayed, as shown in Figure 6.1. The current interface is the state in which the device is running normally.
Fig.6.1
6.3.2.Temperature & Humidity setting
In the FIX OPERATION RUN interface, press area ① in Figure 6.1 to set temperature value. After inputting the
target set value, click ENTER to complete the temperature set value input. In the dialog box, BS is used to delete
each input value, CLEAR is used to delete all input values; ESC is to exit the setting input dialog box.
Fig.6.2
Humidity setting input
In the FIX OPERATION RUN interface, press area ① in Figure 6.1 to set humidity value. After inputting the
target set value, click ENTER to complete the humidity set value input. In the dialog box, BS is used to delete each
input value, CLEAR is used to delete all input values; ESC is to exit the setting input dialog box.
Fig.6.3
6.3.3.Status Indicator Bar
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The status indicator bar indicates the abnormal status during the operation of the test chamber. For the status and
When the difference between the measured temperature and the set value of
the test chamber is more than ±2.0 °C, the indicator will change from gray to
red, and the chamber will alarm and SMS alarm will be sent at the same
time. When the abnormal state is released, the indicator light automatically
When the difference between the measured humidity and the set value of the
test chamber is more than ±5% RH, the indicator will change from gray to
red, and the chamber will alarm and SMS alarm will be sent at the same
time. When the abnormal state is released, the indicator light automatically
When the chamber is running, the indicator light is red, indicating that the
running, the indicator turns into gray, which means the controller is out of
working.
When the chamber is running, the indicator light is red, indicating that the
stops running, the indicator turns into gray, which means the controller is out
of working.
cuts off all load power, and emits a sound and SMS alarm.
When the abnormal state is released, the indicator light automatically returns
When the water level of water level control box is lower than the float lower
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limit due to insufficient water in the water tank, failure of the pump, and
blockage of the inlet pipe, etc., the NO.W indicator changes from gray to
WATER ALARM, the chamber automatically cuts off the power of the
When the abnormal state is released, the indicator light automatically returns
When the chamber is blocked due to obstruction of the water outlet pipe and
other reasons, the water level control box’s water level is higher than the
water level float lower limit. FUL.W indicator light changes from gray to
ALARM, the chamber automatically cut off the power of the water pump,
When the abnormal state is released, the indicator light automatically returns
6.3.4.Button operation
Alm.off setting
When the chamber is abnormal, click the [Alm. off] button in position ⑧ of Figure 6.1. When the font changes
from gray to red, the sound alarm is closed. Turn on the button after power on the chamber and turn off the button
when the temperature and humidity are stable. Please be careful to turn this button on. Only when the button is off,
During the operation of the chamber, click the [Cooling 1] or [Cooling 2] button in position ⑧ in Figure 6.1.
When the font is red, the group is in the running state. When the font is gray, indicates that the group is in a
stopped state.
※Please refer to the cooling system’s setting requirements specified in Table 6.4 when the users do following test
conditions.
Table 6.4
Test The
Cooling1 Cooling 2 Note
condition refrigeration
When the unit is
40℃,75%R.H OFF ON N/A
Cooling1 strictly
is prohibited to
30℃,65%R.H ON OFF N/A confirmed start and stop
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to be frequently in
faulty, a short time,
When the local spring and summer ambient temperature shut down and the
is so high that the temperature cannot be lowered the interval
25℃,60%R.H ON OFF
to the set temperature, the users can simultaneously cooling 1 should be ≥5
turn on the Cooling 1 and Cooling 2 systems. and enable minutes.
the
cooling 2
Note :when the test conditions above 40℃,user should turn off
Above 40℃ OFF OFF
the cooling 1 and cooling 2 to avoid any damage to compressor.
When the temperature of the test chamber fluctuates greatly and it cannot be stabilized for a long time, in the fixed
value operation interface, click the [Temp-AT] button in position ⑧ in Figure 6.1, the button font turns red, then
the chamber starts the temperature calculation function. After the chamber automatically completes the temperature
automatic calculation, the button font is automatically restored to gray; during the calculation process, if the
When the humidity of the test chamber fluctuates greatly and it cannot be stabilized for a long time, in the fixed
value operation interface, click the [Humi-AT] button in position ⑧ in Figure 6.1, the button font turns red, then
the chamber starts the humidity calculation function. After the chamber automatically completes the humidity
automatic calculation, the button font is automatically restored to gray; during the calculation process, if the
chamber is stopped or canceled, the calculation result is invalid. The humidity calculation should be performed
Run/Stop settings
In the operation interface, click the [Stop] button in position 8 in Figure 6.1 to switch the working status of the
chamber.
When the operation interface position 8 shows [Stop], the heating and humidification of the chamber enters the PID
automatic control state, and the air circulation system, the heating system, the humidification system, the
After clicking [Stop], when position 8 shows [Run], the chamber control and load part will not work at this time,
After clicking [Run] again, the button changes to [Stop] and the device enters the PID automatic control state.
When the [Key Lock] button changes from gray to red, the function is turned on. In this setting interface, the
remaining parameters cannot be changed. In the on state, only the [Main] and [Next] buttons are operational in the
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operation interface.
Fig.6.4
6.3.6.Main password
Main password setting
In the operation interface, follow the [Main] - [Function & Fix] operation, as shown in Figure 6.4. In this interface,
set the [RESTRICT OF MAIN] to USE, then set the USER PASSWORD (0~9999), the function is turned on.
Please remember the password. If the password is lost, the meter needs to be returned to the factory for reset. In this
In the operation interface, when clicking the [Main] button, the user password setting dialog box pops up, enter the
correct password, and enter the [Main] operation. The user password setting dialog box is shown in Figure 6.5.
Fig.6.5
6.3.7.Data recording logging off and on
Data recording logging off
In the operation interface, click [Next] to enter the running PV curve interface, as shown in Figure 6.6. When the
[record] in the lower left corner is gray, it indicates that the PV data record is stopped. Click [Record] and select
"Yes". [Record] changes from gray to red and starts recording data.
In the operation interface, click [Next] to enter the running PV curve interface, as shown in Figure 6.6. When the
[record] in the lower left corner is red, it indicates that the PV data record is in operation. Click [Record] and select
"Yes". [Record] changes from red to gray and stops recording data.
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Fig.6.6
6.3.8.Data transmission and memory cleanup (electronic data backup management)
Data transmission
The data transmission must be performed while the data recording is stopped. Refer to 6.3.7 to see how to stop data
recording.
In the operation interface, according to the operation sequence of [Main] - [Graph & Rec.] - [Next], the instrument
Fig. 6.7
Insert the SD card into the controller’s card slot. Please clean the data files in the card before inserting.
The icon next to [Main] on the screen indicates that the SD card is not inserted or the SD card cannot be
recognized, user should re-insert the SD card or replace it. The icon indicates that the SD card has been
recognized and data transfer is valid when the transfer button becomes operational. Press [Trans] and select All
files to start data transmission. The data can be viewed and analyzed on the computer using the SIMS software
Memory clear
The internal memory of the controller is 64.0M, and the maximum number of PV files is 256. When the memory
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capacity is close to the upper limit, there will be an abnormal prompt at the top of the controller, the content is:
DANGERR! CHECK MEMORY SPACE. Confirm that the data transfer is successfully completed.Press
Fig.6.8
6.3.9.Time adjustment
Press [Main]→[Reserve Set] as shown in Fig.6.9. Please adjust the time in CURRENT TIME and don’t use
Note:
The time adjustment is performed when the recording is stopped, the printer is off, and the operation is stopped.
Fig.6.9
6.3.10.Screen calibration
Press [Main] → [Display Set], there is a green button module on the right side of the "Display Settings" interface.
Click and follow the prompts to complete the screen calibration. As shown in Figure 6.10.
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Fig.6.10
6.3.11.Printer parameter setting(纸质数据备份管理)
Press [Main] → [Function] & Fix] → [Next], as shown in Fig.6.11. In this setting interface, the TEMP PRINGT
Fig.6.11
The printing format is shown in Figure 6.12.
When METHOD SET is GRAPH, the printing format is the picture on the left, when METHOD SET IS TEXT, the
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Fig. 6.12
See Appendix 4 for the operation and maintenance of the printer.
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7.System Maintenance
As is known to all, drug stability test chamber is a kind of device for continuous operation day and night for a long
time. As the test sample is constantly sampled to put into box, actually, such device is always in the non-stop
operation state since being mounted, so, correct device maintenance is the key to ensure reliable operation. In order
to ensure the smooth completion of such long-term important drug expiry date test, hereby, we emphasize the
following points to hope that the reliable working performance of the products can be kept for a long time, please
a. Device should be placed in a good service environment, the temperature recommended by us is 5℃ to 35℃, for
the laboratory without such conditions, it needs to be equipped with proper air conditioning unit (air cooling) or
cooling tower (water cooling), and moreover, space air should keep a certain degree of spotless and sterility.
b. Device should be professionally managed by the specially-assigned person being trained: if condition is allowed,
unit should assign specially-assigned person to accept training study at supplier irregularly, so as to obtain
c. Be sure to regularly clean condenser within 3 to 6 months: just as we clean outdoor condenser via household air
conditioner, in order to ensure the reliable refrigeration and dehumidification effect of the device, be sure to
regularly overhaul condensate fan, and remove dirt and dust on the condenser, so as to ensure good ventilation and
d. Users must clean water route and humidifier in accordance with requirements: periodic replacement ensures a
certain degree of cleaning and sterility of the water quality in water tank, if water route is blocked or humidifier
scales formation, it is easy to cause humidifier dry burning, damaging humidifier, therefore, be sure to regularly
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Fig.7.1
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