What standards must be met when constructing a GMP biopharmaceutical cleanroom?
In the biopharmaceutical industry, cleanrooms are important places for producing high-quality drugs. In order to ensure the quality and safety of products, the construction of cleanrooms must meet a series of strict standards. CELINE PHARMA will discuss in detail the standards that need to be met in the construction of GMP biopharmaceutical cleanrooms.
1. Air cleanliness standard
- A. Cleanliness level: According to the requirements of drug production, the cleanliness level of the cleanroom should meet the corresponding standards, such as ISO 7, ISO 8, etc. Different production areas should choose the appropriate cleanliness level according to the requirements of production process and product quality.
- B. Air filtration: In order to achieve the required cleanliness level, the cleanroom should be equipped with a high-efficiency air filter (HEPA) to ensure that pollutants such as dust and microorganisms in the air are effectively controlled.
2. Temperature and humidity control standards
- Temperature control: The temperature of the cleanroom should be kept within an appropriate range to meet the requirements of drug production and process. Temperature fluctuations should be controlled within a minimum range to ensure production stability and consistency of product quality.
- Humidity control: According to the needs of drug production and workshop operation, the humidity of the cleanroom should be controlled within a certain range. Too high or too low humidity may affect the quality and production efficiency of drugs.
3. Facility and layout standards
- Facility configuration: The cleanroom should be equipped with necessary facilities, such as lighting, ventilation, air conditioning, etc., to ensure that the environmental conditions in the workshop meet production requirements.
- Layout rationality: The layout of the workshop should be reasonably planned, and the functional areas should be clearly divided to avoid cross-contamination and confusion of people and logistics. The production area, auxiliary area and management area should be effectively isolated to ensure that there is no mutual influence between the areas.
4. Safety and environmental protection standards
- Safety facilities: The purification workshop should be equipped with necessary safety facilities, such as fire-fighting equipment, emergency eyewash equipment, shower facilities, etc., to deal with emergencies and ensure the safety of personnel.
- Environmental protection requirements: The construction and operation of the workshop should comply with environmental protection standards, ensure that the treatment and discharge of waste gas, wastewater and other wastes comply with relevant regulations and reduce the impact on the environment.
5. Other standards
- Electrical safety: The electrical equipment and lines in the purification workshop should comply with relevant electrical safety standards to ensure the safety of operators and the stability of production.
- Identification management: Obvious identification should be set for each area, equipment, pipeline, etc. in the workshop to facilitate identification by operators and managers. The identification should be clear, accurate and concise.
- Hygiene and cleaning: The hygiene and cleaning standards of the purification workshop are important measures to ensure the quality of drugs and the health of personnel. The workshop should be thoroughly cleaned and disinfected regularly to ensure that the environmental hygiene meets the standards.
- Verification and testing: The operation of the purification workshop should undergo strict verification and testing procedures to ensure that all indicators meet the preset standards. The results of verification and testing should be recorded and analyzed in a timely manner to continuously improve the performance and efficiency of the workshop.
- Personnel training: Operators and managers should receive professional training, be familiar with the operation and maintenance requirements of the cleanroom, and master the necessary operating skills and safety knowledge.
The construction of GMP biopharmaceutical cleanrooms needs to follow a series of strict standards to ensure that the production environment of drugs meets high quality requirements. These standards involve air cleanliness, temperature and humidity control, facilities and layout, safety and environmental protection. By following these standards, the performance of the cleanroom can be ensured to be stable, safe and reliable, thus providing strong support for the development of the biopharmaceutical industry.
CELINE PHARMA provides GMP biopharmaceutical cleanroom engineering construction services, covering cleanroom layout, hardware equipment, software configuration and laboratory management. In order to ensure the efficiency and safety of cleanliness, the infrastructure in various fields must be highly professional, stable and safe.