Problem and Solution Solid Preparation Design
Problem and Solution Solid Preparation Design
November 28, 2022
1. Common Problems in Solid Preparation Design
(1)The design concept is backward, resting on its laurels, working behind closed doors, busy with blueprint manufacturing without design creation. The old drawing style of more than ten years ago is tinkering and patchwork, lacking breakthrough and forward-looking;
(2)Unreasonable partition, complicated design, repeated function. Multiple changing areas, multiple laundry areas, multiple container cleaning areas, multiple sanitary ware cleaning areas, multiple production auxiliary areas, and even multiple pre-stage crushing, granulation and drying processes;(3)One air-conditioning system, shared by all clean areas, is also a factor of cross-contamination;
(4)The design of explosion-proof areas is the biggest problem. The division of explosion-proof areas, the design of explosion-proof surfaces and explosion-venting surfaces is confusing, and cannot effectively ensure safety and minimize losses;
(5)Circular (or L-shaped) corridors, cross-contamination design, although there are partitions, cross-contamination cannot be effectively avoided, and even there is basically no partition concept. Personnel flow, laundry, utensil storage, sanitary ware washing and storage, crushing, granulation, drying, tableting, coating, capsule area, inner package area ring corridor design, the above all have no effective measures to prevent cross-contamination. Multiple formulations, varieties, and specifications cannot be produced at the same time, which is not conducive to the efficient operation of the workshop;
(6)Low degree of automation, outdated material transfer method, the pollution and cross-contamination cannot be effectively avoided, and online cleaning is not considered;
(7)The dust removal and dehumidification methods in the plant design are simple, and the design of buffer, isolation, and pressure difference protection is unreasonable, and pollution and cross-contamination cannot be effectively avoided;
2. Proposal and Requirements of Modular Design
(1)Reasonably partition, optimize functions, and simplify design;
(2)Ensure that multiple dosage forms and varieties can be produced simultaneously with minimal cross-contamination;(3)Advanced dust removal, dehumidification methods, buffer, isolation, pressure difference protection measures;
(4)Materials are airtightly transported to improve automation and production efficiency;
(5)Modular air-conditioning unit setting, flexible production arrangement;
(6)Reduce production costs, increase production batches, and ensure product quality;
3. Comprehensive Oral Solid Dosage Risk Points
(1)Measures to prevent contamination, cross-contamination, confusion and errors of materials and products;
(2)Airtight production;(3)Dust removal measures;
(4)Cleaning management of plant facilities and equipment;
(5)Drying method and storage time after cleaning;
(6)Prevent cross-contamination during material collection, distribution and storage;
(7)Prevent cross-contamination during sampling and weighing;
(8)The temporary storage process of intermediate products prevents cross-contamination;
(9)Environmental detection and monitoring;
(10)Personnel protection and discharge treatment of allergenic dust;
4. Risk Control
(1)The concept of zoning: the flow of people between zones, isolation, buffering, and pressure difference protection, reduce pollution and cross-contamination as much as possible;
(2)Modular zoning and independent air conditioning system, small and flexible configuration, technical mezzanine hanging air conditioning unit can be used;(3)Ensure that each process is relatively independent, and produce different varieties and specifications at the same time, which can reduce cross-contamination to an acceptable level;
(4)The top dust removal method is banned, and the top air supply and the bottom side return air are used to capture dust, and the airflow collects the pollution in the shortest distance as much as possible;
(5)Vacuum conveying and air conveying methods shall be adopted as much as possible, closed production methods shall be adopted as much as possible, and in-line automatic production methods shall be adopted as much as possible;
(6)The application of solid preparation on-line detection technology, such as near-infrared technology;
(7)Adopt advanced equipment equipped with self-dust removal function as much as possible;
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