The layout design of the GMP workshop for medical devices should fully consider factors such as production process, equipment placement, and material flow to ensure the smoothness of the production process. The layout design should comply with GMP specifications, reasonably separate workshops with different cleanliness levels, and ensure that the direction of airflow and personnel flow between each area is reasonable. The floor should be made of wear-resistant, non-slip and easy-to-clean materials, such as epoxy self-leveling, PVC flooring, etc. The floor should be corrosion-resistant and able to withstand the chemicals and detergents in the production process, while the floor should have good anti-slip properties to ensure the safety of employees. The wall and ceiling should be treated with smooth, dust-free and mildew-resistant materials, such as color steel plates, ceramic tiles, etc. In areas with high cleanliness requirements, walls and ceilings should be integrated for decoration, leaving no dead corners and facilitating cleaning and disinfection. Lighting and ventilation: The workshop should have a good lighting and ventilation system to ensure that the illumination of the working area meets the production requirements, while maintaining air circulation to reduce the breeding of dust and microorganisms, the lighting equipment should have dustproof, anti-corrosion, shockproof and other properties, and the ventilation system should be cleaned and maintained regularly. Cleanliness control: For areas with cleanliness requirements, an air purification system should be set up to regularly monitor air cleanliness to ensure that it meets production requirements; The purification system should have high-efficiency filters that can remove dust and microorganisms; At the same time, personnel should be purified before entering the clean area to ensure that personnel do not carry pollution sources into the area.
Pipes and drainage systems should have good sealing and corrosion resistance to prevent pollution; The drainage system should be equipped with a device to prevent backflow of sewage to prevent the backflow of sewage, and the maintenance and cleaning of pipes and drainage systems should be carried out regularly. The electrical design of the workshop should comply with the relevant national standards and specifications to ensure the safety of electricity. At the same time, the workshop should be equipped with alarm system and fire extinguishing facilities to ensure that it can be dealt with in time in case of accidents. In addition, emergency exits should be set up in the workshop to ensure that employees can evacuate quickly in case of emergency. The workshop should be set up with clear identification and color code management, which is convenient for employees to identify and manage, and the content of the logo and color code should include equipment number, material name, operating procedures, etc., so that employees can quickly understand and master relevant information. At the same time, the design of the logo and color code should be concise and clear, easy to understand, and the quality assurance system workshop should establish a perfect quality assurance system to ensure product quality and safety. The quality assurance system should include raw material acceptance, production process control, finished product inspection and other links, and formulate corresponding standard operating procedures and quality standards. At the same time, the effectiveness of the quality assurance system should be regularly evaluated and improved. In order to ensure the normal operation of the workshop and the quality of the product, regular training and assessment should be carried out for employees. The training content should include operating procedures, quality standards, safety knowledge, etc., so that employees can be proficient in relevant skills and knowledge. The assessment should focus on the examination of practical operation and problem-solving ability to ensure that employees have practical operation ability. At the same time, the results of training and appraisal should be analyzed and fed back in order to further improve and enhance the skill level of employees. Guanhang Environmental Science and Technology can provide consulting, planning, design, construction, installation, transformation and other supporting services for medical equipment GMP workshops and dust-free workshops.