How does Beijing Peng Hongda Technology verify the temperature and humidity of the drug warehouse?

First of all, understand the purpose of verification? The purpose of temperature and humidity uniformity verification in warehouse is to ensure the quality, safety and stability of stored materials?

The warehouse shall ensure that the material storage environment is within the appropriate temperature and humidity range? Therefore, it should be proved that the temperature and humidity of the area where materials are stored are at least

Is the temperature distribution uniform? There is no obvious difference in temperature and humidity? And find the extreme points of temperature and humidity? As a long-term monitoring

Purpose. The layout of temperature and humidity verification should consider 1, warehouse area and area? The size of the area affects the layout.

What are the points? Only the area where materials are stacked needs temperature and humidity verification? 2. What is the environment around the warehouse? Near the outer wall

And doors, windows, workshops, etc. Easily affected by external temperature and humidity. 3. The three-dimensional layout of the warehouse and the stacking of goods? Cargo stacking height

Determines that verification should be distributed at different levels of space? And the stacking and stamping of goods affect the movement of airflow, thus affecting the uniform distribution of temperature and humidity.

Cloth? 4. Air conditioning supply and return outlets? When the air conditioner is turned on, the position near the air supply outlet and the air return outlet will be greatly affected. Open the air

Can the maximum and minimum temperature and humidity of the warehouse be different from those when the warehouse is not opened? So turn on the air conditioner to verify it. 5. Seasonal

Influence? Summer is the hottest season of the year? And the temperature is high? At this time, find the highest point of temperature and humidity. winter

Is this season the lowest temperature in a year? At this time, it is necessary to find out the lowest temperature and humidity. These two points must be used as long-term monitoring points? because

What if it does not exceed these two points? Then the temperature and humidity of the whole warehouse are within the specified range? So as to ensure the stable quality of stored products.

Qualitative.

Verification of temperature and humidity monitoring in drug warehouse

First, the necessity of warehouse temperature and humidity monitoring and verification

What are the external factors that affect the quality of drugs? Environmental sanitation, light, air, temperature, humidity, time, etc. It is controllable.

Metrics are related to storage devices, except time. At present, general drug warehouses can achieve better sanitary conditions and avoid direct sunlight.

Exposure conditions; And the influence of air on the quality of drugs? When the drug is approved by the production enterprise, the packaging has been

Examination and approval; Therefore, temperature and humidity are the main factors to be controlled in drug storage.

According to the empirical data that the chemical reaction speed is 2~4 times faster when the general temperature rises 10℃? Explain the influence of temperature on drug storage

Quality has a significant impact; At the same time, at present, some pharmaceutical manufacturers are still weak in moisture-proof measures for drugs? The drug is in a critical state.

It will get wet quickly under the condition of relative humidity; Therefore, the temperature and humidity of drug storage environment is the key factor affecting the quality of stored drugs at present.

Factors? Must be strictly controlled.

Due to the setting of the warehouse, the arrangement of temperature and humidity control equipment, the arrangement of warehouse shelves and the drug loading in the warehouse, etc.

There are great differences in temperature and humidity in different positions of the warehouse. According to the drug storage regulations, all drugs in the warehouse must be stored.

Conditions meet the prescribed principles? Therefore, it is necessary to verify the temperature and humidity of different positions in the warehouse under different conditions? Choose the right temperature and humidity.

Monitoring point.

Second, the verification method of warehouse temperature and humidity monitoring

Verification can be divided into pre-installation verification and post-installation verification of refrigeration equipment?

1, Verification before installation of refrigeration equipment? That is, the rational layout of refrigeration equipment? Generally based on empirical data? Room temperature storage interlayer every

200~300㎡ equipped with 4.5KW cold air unit? The installation density of the upper and lower floors should be appropriately increased or decreased by about 20%? The cold air unit is relatively,

Dislocation installation is the most effective? At the same time, it is more ideal to install ventilation equipment directly opposite the air cooler.

2. Verification of refrigeration equipment after installation? All established enterprises are equipped with a certain amount of refrigeration equipment? At present, this situation is better than

More; The main purpose of verification is to determine how to set the opening times of refrigeration equipment and set the temperature and humidity specifications under different climatic conditions.

Wai? Or whether it is necessary to add refrigeration equipment or auxiliary equipment (sometimes the refrigeration equipment has local temperature after being configured according to the specified density)

Large humidity deviation? At this time, adding auxiliary ventilation equipment can often have a good effect. Certification is generally divided into partial opening.

Verify and turn on Verify All?

The first step; Turn on the temperature and humidity control device partially (completely)? Stable for more than 30 minutes.

The second step; Calibration of test equipment (thermometer)? Prepare a corresponding number of qualified thermometers according to the monitoring points? let go

Proofreading in the same area with stable temperature and humidity; When the reading is stable (usually15min), record the temperature and humidity indicated by each thermometer?

Calculate the deviation value of other thermometers according to the indicated value of one thermometer? Record for use.

The third step; Detection point selection? Detection; According to the warehouse structure and temperature and humidity control equipment layout? Select a certain number of

Test representative test points?