Clean room purification workshop storage area
Clean room purification pharmaceutical cleanroom storage area
Each temperature-controlled storage area must be confirmed before use, and the degree of confirmation is determined by evaluation.
(1) Research on temperature distribution
A temperature distribution study is required for all spaces used to store and handle articles with specific temperature requirements.
①The purpose of temperature distribution research
Text label: clean room purification pharmaceutical cleanroom, purification pharmaceutical cleanroom storage area
Clean room purification workshop storage area
Each temperature-controlled storage area must be confirmed before use, and the degree of confirmation is determined by evaluation.
(1) Research on temperature distribution
A temperature distribution study is required for all spaces used to store and handle articles with specific temperature requirements.
①The purpose of temperature distribution research
a. Prove that the temperature environment of the temperature-controlled storage area meets the requirements through the study of temperature distribution, and confirm the safe storage area and the area that cannot be used for storage in the temperature-controlled storage area.
b. Find out the cold and hot spots in the temperature control area through the study of temperature distribution. Cold and hot spots need to be determined according to the season, as there can be significant differences in winter and summer.
c. If an automatic monitoring system needs to be installed in the temperature-controlled storage area, find a better place to place the conventional automatic monitoring temperature probe through the study of temperature distribution. If an automatic monitoring system has been installed in the temperature-controlled storage area, find a better location to relocate the automatic monitoring point through temperature distribution research.
d. Temperature distribution studies are also used to identify areas that require remedial action, for example, by altering existing airflow distribution to eliminate low and high hot spots, or retrofitting new air distribution equipment to reduce high-bay warehouses temperature stratification.
②Temperature distribution research strategy
a. The study of temperature distribution is generally divided into no-load and load.
b. The no-load temperature distribution study in the operation confirmation stage is generally carried out only once, regardless of seasonal factors.
c. If the storage area is affected by seasonal temperature fluctuations, it is necessary to conduct at least two load temperature distribution studies in each area to observe the impact of seasonal fluctuations. Cooler and warmer seasons can represent a worse situation. This confirms that the storage area can maintain a stable temperature throughout the year, and generally does not require a two-season study for the refrigerator and freezer rooms.
d. Time limits for temperature distribution studies Different countries have different requirements. In general, no-load temperature distribution studies are recorded for at least 24 consecutive hours. For temperature-controlled storage areas that do not fluctuate over time or seasonal air temperature (eg, refrigerated rooms and freezer rooms), the load temperature distribution study should be continuous for 24 to 72 hours or more.
Remarks: China's 'Product Operation Quality Management Specification' stipulates that after the parameters and use conditions of the warehouse meet the specified requirements and achieve stable operation, the effective continuous data collection time shall not be less than 48h.
e. If the temperature-controlled storage area is equipped with two cooling units, regardless of whether there is automatic switching, it is necessary to conduct a temperature distribution study on the operation of the two cooling units.
f. If the temperature distribution study process does not include door opening and power outage testing, door opening operations and possible outages are recorded during the study, so that all temperature fluctuations due to entry and exit of people or outages can be identified.
③Temperature distribution research points
Confirmation of temperature distribution points based on evaluation needs to consider:
a. Three-dimensional layout (from top to bottom, left to right, front to back);
b. Each fan outlet;
C. Each job entry and exit;
d. Wind direction angle of building structure;
e. The influence of shelves on airflow;
f. Storage area temperature control sensor location and temperature monitoring sensor location.
(2) Power-off test
Research the time that the temperature-controlled storage area maintains within the required temperature range after a power outage and the time it takes for the storage area to recover to the required temperature range after the power outage is restored. There are usually no established acceptance criteria, and the research results provide reference data for the handling of emergency storage items and emergency maintenance of the system. Zhongjing Global Purification can provide supporting services such as consultation, planning, design, construction, installation and transformation of purification workshops and clean rooms.
Power-off test strategies include two types: power-off until temperature exceeds standard and fixed power-off time.
①The temperature of the storage area is continuously recorded after the power is cut off until the temperature exceeds the standard.
When the temperature exceeds the required range, restore the power supply and determine the time to return to the acceptable temperature range.
②Fixed power-off time Predetermine a fixed power-off time,
If the power is off for 2 hours, regardless of whether the temperature of the storage area exceeds the required range, restore the power supply and determine the time required for the storage area to recover to an acceptable temperature range.
Because both test methods may cause excessive temperature, there may be risks when the storage area is filled with items, it is recommended to perform this test under no-load condition during operation confirmation.
(3) Door opening test
Study the time when the temperature exceeds the acceptable range after opening the door and the time it takes to return to the acceptable temperature range after closing the door; if there is only one door, study the longer opening time; if there are more than one door, consider the opening time and the opening sequence and whether more than one door will be opened at the same time.
Open door testing strategies include the following two:
①Keep the door open for a preset period of time, which will not cause the material temperature in the system to exceed the standard;
②Open the door until the temperature exceeds the acceptable range, and confirm the time when the temperature returns to the acceptable range after closing the door.
PHARMA needs to be able to reach social users in a way that complements what the brand is doing if they want to succeed at social commerce.
SUZHOU PHARMA MACHINERY CO.,LTD. assures you that you will be satisfied with its results and humbly request you to try this. We are hoping for a better business deal with you.
The trend toward using extraction machine CUSTOM SOLUTION SERVICES to ease extraction machine, once established, soon extended into such additional fields as extraction machine and extraction machine.
We should take a step back to review how PHARMA approach tracking, implementing, and communicating compliance-related changes and attempt to identify areas of improvement in their processes.
With the market analysts, exports from SUZHOU PHARMA MACHINERY CO.,LTD. facilities in China will surpass the forecast.