Aerosol production purification workshop
Aerosol production purification pharmaceutical cleanroom
When preparing solution aerosols, attention should be paid to the influence of the mixing of propellant and co-solvent on solubility and stability, the size and surface tension of sprayed droplets, various additives such as antioxidants, preservatives , cosolvents, etc. on the irritating site of the drug; the preparation of suspension aerosols has...
Text label: aerosol production purification workshop, aerosol dust-free workshop, aerosol GMP workshop
Aerosol production purification workshop
When preparing solution aerosols, attention should be paid to the influence of the mixing of propellant and co-solvent on solubility and stability, the size and surface tension of sprayed droplets, various additives such as antioxidants, preservatives The irritant to the drug site, such as the latent solvent, etc.; the preparation of the suspension aerosol has certain difficulties, mainly including the increase of particle size, aggregation, agglomeration, blocking of the valve system, etc. When designing the formula of the powder, attention must be paid to improving the stability of the dispersion system; the moisture content should be extremely low, which should be below 0.03%, usually controlled below 0.005%, so as to avoid the coalescence of water particles; the inhaled particle size should be controlled below 5μm, not More than 10μm, and the maximum particle size of topical aerosols is generally controlled at 40-50μm; on the premise of not affecting physiological activity, select the derivative with the least solubility in the propellant; adjust the density of the propellant and suspended solids, try to Make the density of the two equal; add appropriate surfactants and other substances as suspending agents, wetting agents and dispersing agents for uniform and stable dispersion.
Aerosols should be prepared in a germ-proof environment. Various utensils, containers, etc. must be cleaned and sterilized by appropriate methods. During the whole operation process, attention should be paid to avoid microbial contamination. The process of preparing aerosols is as follows: containers, valves, etc. System processing and assembly→drug configuration and distribution→filling propellant→quality inspection→packaging→finished product. For container processing, take glass bottle slush molding as an example, first wash and dry the glass bottle, preheat it to 120-130 °C, and immerse it in the plastic mucus while it is still hot, so that a layer of plastic solution is evenly adhered below the neck of the bottle, and after inversion Dry at 150-170℃ for 15min for use; the requirement for plastic coating is to tightly wrap the glass bottle, with a smooth and beautiful appearance. Rubber products can be soaked in 75% ethanol for 24 hours to remove color and sterilize, and then dried for later use; plastic and nylon parts can be washed and immersed in 95% ethanol for later use; stainless steel springs are boiled in 1%-3% lye for 10-30min, Wash it several times with water, then two or three times with distilled water until it is free of greasy, soak it in 95% ethanol for later use, and finally assemble the above treated parts into a valve. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for aerosol production purification workshops and dust-free workshops.
Press-filling method: First, pour the prepared liquid medicine into the container at room temperature, then install the valve and fasten it tightly, and then press the quantitative propellant through the press-filling machine. It is best to pump the air in the container first. After the liquefied propellant is filtered by the sand bar, it enters the press machine. When the container is up, the filling needle extends into the valve stem, the valve of the press machine and the container are opened at the same time, and the liquefied propellant expands by itself and is pressed into the container; The pressure filling method has simple equipment, does not require low temperature operation, and consumes a lot of propellant, but the pressure changes greatly during use; the cold filling method is cooled to about -20 ° C by means of a cooling device, and the propellant is cooled to at least below the boiling point. 5 ℃, first pour the coolant into the container, then add the cooled propellant, immediately install and fasten the valve, the operation must be completed quickly, and the loss of the propellant has been reduced; the cold filling method is fast and has no effect on the valve , the pressure of the finished product is relatively stable, but it requires refrigeration equipment and low-temperature operation, and the propellant loses more; after the filling of the propellant is completed, a push button must be installed on the valve, and a protective cover must be added, so that the entire aerosol The preparation of the agent is complete.
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