1. Purpose
Establish and standardize standard operating procedures for drug stability test chambers,
2. area
It is suitable for the test of drug stability performance.
3. Responsibility
The central laboratory is responsible for implementation.
4. Content
4.1 Preparation before product use
The product should be used under the following normal use conditions
4.1.1 Ambient temperature: (5~35)℃;
4.1.2 Relative humidity: not more than 85%;
4.1.3 Atmospheric pressure: (86~106) kPa;
4.1.4 The altitude is not higher than 2000 meters;
4.1.5 Power supply: (220±22)V (50±1)Hz;
4.1.6 Indoors where corrosive gases exist and the surrounding area is well ventilated;
4.1.7 The distance between the equipment and surrounding objects or walls: front ≥ 900mm, left, right and top ≥ 300mm, rear ≥ 500mm
4.2 Operation steps
4.2.1 Elevate the water tank with a bracket and place it on the right side of the device. There is a submersible pump in the water tank. Insert the plastic pipe for the output of the submersible pump into the water refill socket on the right side of the device with a little force;
4.2.2 Insert the power plug of the submersible pump into the special power socket on the right side of the equipment;
4.2.3 When it is turned on for the first time, in order to ensure that the humidification water tank in the working room does not automatically enter water due to air blockage, please open the water inlet valve on the left, and then close the water discharge valve after the water flows out, and set the overflow valve on the right. Drain the water in a basin below the mouth or in a ditch.
4.2.4 Open the water tank cover and add pure water. (Control of water level: the lowest level should be submerged in the pump, and the highest level should not exceed the rubber ring at the connection pipe opening on the water tank).
4.2.5 After connecting to the power supply, turn on the power switch of the device, and the instrument should be in normal working condition.
4.2.6 Turn on the power for about half an hour, open the box door, and check the water level of the humidification evaporator water tank on the bottom of the studio. The humidification pipe should be immersed in water without overflowing, otherwise, the rear panel of the equipment should be opened to adjust the height of the water cup to solve the problem.
4.2.7 Adjustment of the height of the water cup: Open the rear sealing plate, loosen the screws that fix the water cup, and move the height of the water cup as a whole through the waist-shaped groove on the board. Overflow, adjust the position of the water glass to a higher position.
4.2.8 The water level of the water tank should be ensured, otherwise, the solution should be solved by adjusting the ground level or leveling the casters.
4.2.9 Set temperature and humidity as needed
4.2.10 After use, open the drain valve on the back of the device, drain the water in the humidification water tank and water cup in the working room, and dry the water in the working room. Regular cleaning of scale and other contaminants is a must! Otherwise, the use effect and lifespan will be affected.
4.3 Product maintenance and precautions
4.3.1 When the equipment is being transported, the inclination angle shall not be greater than 45 degrees to avoid damage to the refrigeration system.
4.3.2 After the equipment is transported and placed in place, it should be left for (1-2) days before starting up, so that the refrigeration system can work normally and prolong its life.
4.3.3 The device must be connected to a well-grounded power outlet!
4.3.4 Place the equipment in a balanced position. After the equipment is placed in place, add pure water to the water tank to a suitable water level, turn on the power switch of the equipment, and automatically add water to the water cup in the tank. After about half an hour, open the box door and observe the bottom surface of the studio. The level of the water tank should be parallel to the bottom plate and the evaporator should be submerged, and at the same time, it should not overflow into the working room. If it fails to meet the requirements, pad the box feet and open the back plate, and adjust the water level of the water cup to ensure that all the humidification evaporators are full. Immerse in water so that the temperature in the box is not directly heated during humidification.
4.3.5 When the temperature in the box is below the dew point, the humidity probe will easily accumulate water vapor after opening the box, making the humidity display 99.9%. At this time, it is necessary to heat the box and dry the humidity probe. It can be used only when the humidity display is below 99.8%.
4.3.6 During constant temperature and humidity operation, it should be ensured that there is sufficient water in the water tank, and the overflow tray has an overflow port marked on the rear of the equipment.
4.3.7 When the equipment runs at low temperature for a long time (when it is lower than the ambient temperature), it needs to run for about 2 hours at 40℃ every half a month to carry out "defrosting" treatment, and then put it into operation.