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Laminar flow weighing hood
1、 Basic Introduction to Laminar Flow Weighing Hood Weighing hood is a local cleaning device specifically designed for pharmaceutical, microbiological
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1、 Basic introduction of laminar flow weighing hood
Weighing hood is a local cleaning device specifically designed for pharmaceutical, microbiological research, and scientific experiments, providing vertical unidirectional airflow. Some clean air circulates in the work area, while others are discharged nearby. It generates negative pressure in the area and work area, preventing mutual pollution and ensuring a high cleanliness environment in the work area. By measuring and distributing dust and reagents in the equipment, the overflow and rise of dust and reagents can be suppressed, preventing them from being inhaled into the human body, preventing mutual pollution between dust and reagents, and preventing external environment and indoor workers.
2、 Usage of laminar flow weighing hood
Negative pressure metering room is a local purification device specifically used for pharmacies, microbiological research, scientific experiments, etc., and provides vertical unidirectional airflow. Some clean air circulates in the work area, while others are discharged to nearby areas for work. Generate negative pressure in the area to prevent mutual contamination, which is used to ensure a high cleanliness environment in the work area.
Does the GMP conversion of version 1.2010 require the use of laminar flow equipment in the weighing room?
Raw materials and auxiliary materials must be weighed using the 2010 GMP regulations in a specially designed weighing room or weighing room. The measuring room has a vertically downward laminar flow and an external negative pressure inside. Prevent the spread of dust and mutual pollution.
2. What is a cleanroom weighing room?
A clean weighing room, also known as a negative pressure weighing room used for weighing drugs in the pharmaceutical industry, forms a negative pressure vertical laminar flow to prevent harm to operators and weighing rooms during drug weighing. It can be an external area.
What are the components of a negative pressure measuring chamber?
The main components of the weighing room include: main filter, medium efficiency filter, high-efficiency filter, flow equalization membrane, fan, 304 stainless steel structural system, electrical system, automatic control system, pressure detection system, etc.
What is a negative pressure measuring cover?
Negative pressure weighing hood, also known as negative pressure weighing chamber, is an area air purifier specifically used for weighing raw materials and auxiliary materials in pharmaceutical factories. Provide a single vertical airflow, with some airflow circulating in the work area and the remaining airflow filtered by high-efficiency filters and discharged from the equipment, thereby making the inside of the equipment unfavorable to the outside. Generate pressure to prevent dust from spreading and mutual contamination. And protect the safety of our employees and the surrounding environment.
5. Is there negative pressure in the solid preparation workshop?
It must be negative pressure. According to the GMP 2010 version, the weighing of raw materials and auxiliary materials must be carried out in a specially designed weighing room or weighing chamber. There is a vertical downward airflow in the weighing room, and negative pressure must be applied internally to the outside to prevent dust from spreading. Cross contamination.
Is there a wind speed requirement for the weighing room in the solid preparation workshop?
The wind speed ranges from 0.36 to 0.54 m/s. According to GMP standards, the wind speed must be within this range. If the wind speed is too low or too high, it is impossible to remove dust.
Why is the weighing room in a solid dosage form factory under negative pressure?
Negative pressure is used to prevent the spread of dust and mutual pollution, and to protect the safety of workers and the surrounding environment. Therefore, the measuring room of the solid dosage form factory must be under negative pressure.
8. Is it possible to obtain the new GMP certification without purchasing a negative pressure measuring chamber?
I cannot pass. According to Article 52 of GMP in 2010, the weighing of raw materials and auxiliary materials must be carried out using designated weighing equipment.
How clean is the weighing room?
The 2010 version of GMP specifies that the weighing room must maintain consistent cleanliness with the production and feeding environment, and protective measures must be taken to prevent mutual contamination of the work area. Therefore, for sterile drugs, the cleanliness of the measuring room should reach Class A, and for non sterile drugs, it should reach Class C or B.
Is there a relationship between the air volume calculated in the negative pressure measurement chamber and the air volume at the air outlet?
The design air volume of the measurement room is directly proportional to the area of the air outlet. The larger the area, the greater the required air volume, but vice versa, the smaller it is.
11. Who provides the 3Q file to the negative pressure metering room?
The 3Q file is the IQ, PQ, and OQ file for the equipment required for the new GMP certification. These are the documents required for GMP validation. Files are usually created by pharmaceutical companies. Manufacturers can provide or guide the creation of a series of documents to customers of pharmaceutical companies.
What factors should be kept in mind when choosing a negative pressure measurement chamber?
When choosing a weighing room, it is necessary to consider the size of the weighing room, the number of operators, and the quantity of drugs being weighed.
How many other factors are there.
How do you handle the dust generated from weighing raw and auxiliary materials in the weighing room?
Due to the vertical unidirectional airflow in the weighing room, dust will fall off along with the airflow and eventually be attracted to the primary and medium efficiency filters at the bottom of the instrument.
Will the weighing room affect the airflow in the original room?
This is usually not the case. Due to the fact that 85% to 90% of the indoor airflow is internally circulated, the dependence on external airflow correction is minimal, and the impact on the external environment is basically minimal. If there is a slight impact, it can be resolved by fine-tuning the indoor air valve.
What if the weighing room vibrates too much and the verification fails?
The reason for excessive vibration may be due to unsecured equipment screws, unsecured fans, or the use of household fans. Usually, malicious manufacturers use household fans due to their low prices. The direct result is that the airflow of the equipment is too small, the surface smoothness is high, the vibration is large, and the service life of the motor is usually one year. We suggest that you use imported fans to avoid risks such as validation failures and subsequent maintenance.
Does the weighing room of a pharmaceutical factory need to be equipped with a local exhaust system?
The weighing room must be equipped with a local exhaust module. When the weighing chamber is in operation, the high-efficiency filter filters out 85% to 90% of the air and blows it vertically away, while also expelling 10% to 15% of the air from the local exhaust module. In this way, a relative negative pressure will be formed between the inside and outside of the weighing chamber, thereby preventing dust generated during the weighing process from contaminating the outside.
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