Design and installation of clean workshop for pharmaceutical industry
Design and installation of clean workshop in pharmaceutical industry
The implementation of WIP manufacturing enterprises includes two aspects: software and hardware. Software is an advanced and reliable production process, strict management system, documents and quality control system; hardware is a qualified clean workshop, production environment and equipment, and hardware facilities are the basis for product production...
Text label: Design of clean pharmaceutical cleanroom for pharmaceutical industry, Design and installation of clean workshop
Design and installation of clean workshop for pharmaceutical industry
The implementation of WIP manufacturing enterprises includes two aspects: software and hardware. Software is an advanced and reliable production process, strict management system, documents and quality control system; hardware is a qualified clean workshop, production environment and equipment, and hardware facilities are the basic conditions for product production. The clean workshop facilities of product manufacturing enterprises mainly include: plant building entities (including doors and windows), roads, green lawns, and enclosure structures; production of clean workshop auxiliary public facilities, such as clean air conditioners and dust removal devices, lighting, fire sprinklers, etc. , sewer network, clean public works (such as purified water, water for injection, clean gas generation), etc. The rational design of the above clean workshops is directly related to the quality of the products.
In addition to strictly complying with the relevant regulations of GMP, the design of clean workshop facilities in the pharmaceutical industry must also comply with the relevant national policies, implement the current relevant standards and specifications, meet the requirements of practicality, safety and economy, save energy and protect environment. Under possible conditions, actively adopt advanced technology, which not only meets the needs of current production, but also considers future development; for existing building technology renovation projects, it is necessary to proceed from reality and make full use of existing resources.
As the basic hardware of product production, clean pharmaceutical cleanroom facilities are an important element of the quality system. Their location, design, construction, use and maintenance will have a significant impact on product quality. The reasonable layout of plant facilities, high-quality construction and necessary maintenance activities can provide reliable guarantees for the production and storage of products (such as clean environment, suitable temperature and humidity, etc.); it can minimize the risk of affecting product quality; At the same time, it can ensure the health and production safety of employees and provide the necessary protection for the environment. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of sterile rooms and clean workshops and other supporting services.
Product production enterprises must have a clean production environment, the ground, road and transportation of the factory area should not cause pollution to the production of products; the overall layout of production, administration, living and auxiliary areas should be reasonable and should not interfere with each other. The pharmaceutical cleanroom should be reasonably arranged according to the production process and the required air cleanliness level, and the operations in the same factory room and between adjacent ones should not interfere with each other. The flow of people and logistics should follow the direction of cleanliness level from low to high, and buffer transitions should be provided for different cleanliness levels.
Industrial clean workshops should have facilities to prevent the entry of insects and other animals; when designing and constructing workshops, the ease of cleaning should be considered. The inner surface of the clean room should be flat, smooth, without cracks, with tight joints, without particles falling off, and resistant to cleaning and disinfection. The junction of the wall and the ground should be curved or other measures should be taken to reduce dust accumulation and facilitate cleaning. The production area and storage area should have space suitable for the production scale to accommodate equipment and materials, facilitate production operations, store materials, intermediate products, products to be inspected and finished products, and minimize errors and cross-contamination. Various pipes, lamps, air vents and other public facilities in the clean area should be designed and installed to avoid parts that are not easy to clean; the pipes should be less bent, the lamps should be embedded, and the upper maintenance should be carried out.
The air outlet should be flat and the interface should be sealed; the clean area should be provided with sufficient lighting according to the requirements of production; the production department with special requirements for contrast can be set up with local lighting; Replacement; set up safe entrances and exits. Staff need to pass through a relatively long sanitary passage to enter the clean room. Therefore, a passage that is conducive to evacuation must be set up in the industrial clean workshop.
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