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Liquid preparation GMP workshop purification methods and shortcomings

Update:21 Jun 2019
Summary:

The quality of liquid preparations is related to people […]

The quality of liquid preparations is related to people's health and life. The production workshop must comply with GMP standards, to control pollution to a maximum extent, and to establish a strict and sterile production environment. Liquid preparation GMP workshop purification is one of the main means to ensure the successful implementation of GMP, which can eliminate all possible potential biological activity, dust and pyrogen pollution, and produce high quality and hygienic drug products. So, what are the purification methods for liquid preparation GMP workshops?
First, the physical purification method
Liquid preparation GMP workshop can be used for adsorption filtration - activated carbon purification. Activated carbon is a porous carbonaceous material with a highly developed pore structure. The porous structure of activated carbon provides a large surface area and is in full contact with gases (impurities), thereby imparting unique adsorption properties to activated carbon. It makes it very easy to achieve the purpose of absorbing and collecting impurities. Just like magnetic force, all molecules have mutual attraction.
Disadvantages: Ordinary activated carbon can not absorb all toxic gases, and the efficiency is low and easy to desorb.
Second, the electrostatic purification method
The liquid preparation GMP workshop can be cleaned by electrostatic method, which is the working principle of high-voltage electrostatic adsorption and dust removal. The cathode line in the electrostatic field generates corona discharge under the action of high-voltage static electricity, and a large amount of negative ions are generated in the corona layer, and the negative ions continuously move toward the anode under the action of the electrostatic field. When the dust in the air passes through the electric field, the dust is charged by the collision of the negative ions, and the dust after the charge is also subjected to the action of the electrostatic field, moving toward the anode (dust collecting pole), and releasing the electric charge after reaching the anode.
Disadvantages: It can remove fly ash (can't remove poisonous gas), its performance is lower and slower than mechanical type, and it is easy to produce ozone. This model is rated as the worst purifier by the US market.
Third, the chemical purification method
The liquid preparation GMP workshop can be purified by photocatalysis. The working principle is that when the air passes through the photocatalytic air purification device, the photocatalyst can not change itself under the illumination of light, but can promote the chemical reaction of harmful substances such as formaldehyde in the air. Benzene and the like are degraded under the action of photocatalysis to produce non-toxic and harmless substances, and the bacteria in the air of the GMP workshop are also removed by ultraviolet light, and the air is thus purified.
Disadvantages: Broad spectrum but low air flow rate, slower purification rate and certain radiation to the human body. In Europe and America, it is the GMP workshop purification method that has been eliminated.
Fourth, other purification methods
1. Washing method. Using the principle of siphoning and centrifugation, the purifying agent mixed with water is sucked into the suction pipe of the lower part of the coaxial centrifugal turbine of the motor base through the siphon principle, and is rotated at high speed by the alternating cover pole motor, and then the water purifying agent is mixed by the centrifugal principle. Sprayed in the bottle to form a water film, the dust and bacteria in the air are sucked into the water, and the purified air is blown into the room to quickly and effectively remove the toxins, dust, smoke and odor in the GMP workshop. , viruses, etc., and produce a lot of fresh oxygen.
2. Negative ion method. When the hydroxy anion is in contact with harmful gases floating in the air, it can reduce the active oxygen (oxygen radicals) generated by pollutants, nitrogen oxides, cigarettes, etc. from the atmosphere, and reduce the harmful effects of excessive active oxygen on the human body; The electric airborne dust settles without charge and the GMP workshop is purified.