Eye drop purification plant cleaning verification
Eye drop purification plant cleaning verification
The cleaning verification in the production process of the eye drops purification plant includes the cleaning of the bottle washer, liquid dispensing device, filter device, filling device, container resin processing and forming device, liquid feeding pipeline and other equipment. If the cleaning effect is not good, it will directly Affect the quality of the product, so cleaning verification is a...
Text label: eye drops purification plant, cleaning verification
Eye drops purification plant cleaning verification
The cleaning verification in the production process of the eye drops purification plant includes the cleaning of the bottle washer, liquid dispensing device, filter device, filling device, container resin processing and forming device, liquid feeding pipeline and other equipment. If the cleaning effect is not good, it will directly It affects the quality of the product, so the cleaning verification is the confirmation of the cleaning effect; the cleaning methods are divided into manual cleaning, automatic cleaning and semi-automatic cleaning. Manual cleaning is performed by the operator with scrubbing or high-pressure hose, and automatic cleaning is performed by automatic control. Scrub until dry cleaning, semi-automatic cleaning is a cleaning process that combines the above two methods. Cleaning points: the filling machine should be almost completely disassembled and cleaned; use drinking water to remove visible residues; use drinking water or purified water to wash invisible residues on the equipment according to certain procedures, and use detergent if necessary; use purified water to fix method and time to rinse the surface of the equipment to remove the dissolved low-concentration residues; decide whether to dry according to needs; check whether the cleaning meets the requirements; reassemble and store the disassembled device.
The properties of cleaning agents are different, and the cleaning methods used are also different. Common methods of cleaning equipment include online cleaning, off-line cleaning, manual scrubbing, pressure spraying, soaking, etc. For cleaners with strong alkalis, it is best to use Online cleaning can avoid direct contact between cleaning personnel and cleaning agents or other solutions; manual cleaning operators must use neutral or weak alkaline cleaning agents. For foam cleaning agents, the solution should be poured on the surface of the equipment to be cleaned. Manual cleaning; in order to protect the environment, a neutral, weakly acidic or weakly alkaline cleaning agent should be selected with low phosphorus content. If strong acid or strong alkali must be used for cleaning, it is necessary to collect the cleaning solution and adjust its pH with alkali or acid. It can be discharged only within the specified range. Part of the particles in the turbulent motion move perpendicular to the pipe wall, which is highly efficient for cleaning the dissolved solution of the pipe wall residue. Therefore, during the cleaning process, it is very important to maintain the turbulent operating form of the cleaning liquid. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification plants and clean workshops.
The formulation of the microbial contamination level should meet the requirements of production and quality control, such as absolutely sterile intraocular injection, the amount of bacteria should be ≤10/ml before sterile filtration, and general eye drops Before filtration, the bacterial load should be ≤100/ml; microorganisms in the air will contaminate the cleaned equipment through various ways. The longer the equipment is placed after cleaning, the more serious the pollution will be. If the equipment is put into production immediately after cleaning, the The level of microbial contamination is required to be low enough. For example, after the pipeline is cleaned, the microorganism is required to be ≤10CFU/100ml. The purification plant cleaning verification program should specify the equipment and cleaning methods to be verified; the cleaning procedures should be determined before the verification starts, and the cleaning procedures should be listed in the verification scheme to indicate that the cleaning procedures have been formulated; participate in the verification personnel list; determine the reference objects and limits Standard; explain the verification of sampling methods, tools, instruments and sampling and inspection methods; verification tests should be done at least 3 times to determine whether the limit standards are met; when the verification plan is approved and all preparations are completed, it can be implemented according to the plan.
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