GMP standard cleanroom refers to a cleanroom that meets the requirements of Good Manufacturing Practice (GMP), which aims to ensure the hygiene and safety of pharmaceutical production and product quality.GMP standard cleanroom needs to follow strict hygiene and process requirements during the design and construction process to ensure the cleanliness of the production environment and to control the production of microorganisms, dust, pyrogens and other contaminants.
SICOLAB - GMP cleanroom engineering and construction services
Features of a GMP standard cleanroom include:
Reasonable layout and partitioning: According to the production process and equipment requirements, clean areas are reasonably partitioned, and functional areas such as operation rooms and storage rooms are set up. At the same time to ensure that the airflow between the regions is reasonable, to avoid cross-contamination.
High-quality building materials: Selection of good corrosion-resistant, dust-proof, antibacterial and other performance of the building materials, such as stainless steel, epoxy resin and so on. At the same time to ensure that all materials comply with relevant national standards.
High-efficiency filtration system: install high-efficiency filters, and strictly treat the new air outlet to avoid outdoor air pollution. Meanwhile, the filter should be replaced regularly to keep the effectiveness of the filtration system.
Environmental monitoring system: install temperature and humidity meter, differential pressure meter and other equipment, real-time monitoring of the indoor environment, and ensure that the data can be displayed in real time on the monitoring screen. At the same time to ensure that monitoring equipment in line with relevant national standards.
Ventilation system: According to the needs of the equipment and process in the workshop, set up a suitable ventilation system to ensure indoor air circulation, and avoid the accumulation of dust and microorganisms. At the same time, we should ensure that the noise control of the ventilation system complies with the relevant national standards.
Disinfection and sterilization measures: Adopt appropriate disinfection and sterilization measures, such as dry heat sterilization, moist heat sterilization, radiation sterilization, gas sterilization, etc., to eliminate microbial contamination in the production process. At the same time, regular environmental hygiene inspections and disinfection should be carried out.
Personnel management: develop a strict personnel management system, changing clothes, hand washing, disinfection and other operations for personnel entering the purification workshop to ensure that personnel do not become a source of contamination. At the same time, we should regularly conduct health and safety training and assessment of employees.
Production management: establish a perfect quality management system and operating procedures to ensure that the production process indicators in line with regulatory and standard requirements. At the same time, internal audits and management reviews should be conducted regularly to identify and improve problems in a timely manner.
In short, the GMP standard cleanroom is a highly clean production environment, designed to ensure the health and safety of pharmaceutical production and product quality. In the design and construction process need to follow strict norms and standards, the selection of appropriate materials and equipment, and strengthen environmental monitoring and control.