Validation of eye drops equipment in purification plant
Validation of eye drops equipment in purification plant
The main equipment for purifying the eye drops in the workshop includes bottle washing machine and bottle washing system, filter device, filling device, etc. The bottle is generally cleaned by the water swirl method or the pressurized jet air washing method. After washing, the bottle needs to be extinguished. The bacteria can be used after drying; the verification contents of the bottle washing machine and the bottle washing system are mainly...
Text label: Design, construction and construction of purification plant, verification of eye drops equipment
Eye drops equipment verification in purification plant
The main equipment for purifying the eye drops in the pharmaceutical cleanroom includes bottle washing machine and bottle washing system, filter device, filling device, etc. The bottle is generally cleaned by the water swirl method or the pressurized jet air washing method. After washing, the bottle needs to be extinguished. After the bacteria are dried, it is ready for use; the verification content of the bottle washer and the bottle-washing system is mainly the cleanliness inspection of the bottle after cleaning, which involves bottle-washing water, compressed air, etc.; The dust particles in it should meet the cleanliness level of the production environment, and the drying box and heating medium should also meet the cleanliness level of the production environment; the compressed air should be supplied by an oil-free compressor. In the dehumidification treatment, the control of solid particles and biological particles should be consistent with the purification level of the production environment; the verification of the bottle is to first fill the distilled water to obtain a water sample, use the lamp inspection method to check the insoluble foreign matter, and use the sterile medium for sterility inspection.
The filtration of eye drops generally uses a vertical melting glass filter, a sand filter rod and a microporous membrane filter. The verification of the first two is mainly the pore size, which should meet the requirements of actual production needs. The verification of the latter is mainly from the Bubble point test and microbial challenge test, the bubble point test is used to check and ensure the quality of the microporous membrane; the filling method of eye drops is usually vacuum filling. The container should be tightly sealed. The equipment validation of eye drops includes pre-validation, installation validation, operation validation and performance validation. In pre-confirmation, it is necessary to review whether the equipment selection conforms to the current national regulations, whether the GMP requirements are implemented, and the production quality can be guaranteed; whether the purification function and cleaning function of the equipment are considered in the functional design, and whether the operation is safe, reliable, and easy to maintain; Whether advanced technologies such as lasers, microwaves, and infrared rays integrating mechanics, electricity, and instruments are used; whether it has online detection and monitoring functions; whether there are overload and protection measures for the abnormal conditions that may occur during the operation of the equipment; whether the equipment meets the requirements of the above , the interface requirements of the next production process; the design of the parts in contact with the drug should be flat, smooth, without grooves, edges and corners
, non-stick, no dust accumulation, easy to clean; the lubricating and sealing device is reasonably designed, safe, and will not cause pollution; there should be effective solutions to the noise, vibration, moisture dissipation, heat dissipation and other phenomena during equipment operation; equipment The raw materials, packaging materials, import and export of finished products and the design of the rejection port for waste and defective products should be clearly distinguished and not confused with each other; the appearance design of the equipment should be beautiful, concise, easy to operate, observe and repair. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification plants and purification workshops.
Observe the quality of the physical operation in the simulated production operation of the equipment or the physical production operation, verify the adaptability, continuity and reliability of the equipment function; check the quality of the finished product of the physical operation of the equipment, and verify the compliance of various performance parameters, such as Filling dose of eye drop filling machine, etc.; Check the reliability of equipment safety protection functions, such as automatic waste rejection, foreign body rejection, overpressure, overload alarm, jam stop, stop filling without bottle, etc.; observe the use of equipment cleaning function Check whether the equipment is easy and fast to clean, whether the cleaning is thorough, whether it affects other environments, and whether there is leakage; check the operation and maintenance of the equipment, check whether the operation of the equipment is convenient and flexible, whether it adapts to the natural movements of people, and whether the mechanism is easy to assemble and disassemble. , Whether the operation safety performance is good, and whether the emergency stop button and safety valve are sensitive.
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