Design specifications for pharmaceutical clean plants
The design specifications for pharmaceutical clean plants are specifications formulated to ensure the cleanliness and sanitary conditions of the pharmaceutical production environment and aim to improve the quality and safety of pharmaceuticals.
The following are some common pharmaceutical clean plant design specification requirements:
Cleanliness level: According to the requirements of pharmaceutical production, clean plants should reach a certain cleanliness level, including the air cleanliness level specified by IS0 14644-1 and the cleanliness level specified by GMP. Specific requirements can be selected and set based on the pharmaceutical production process and product quality requirements.
Floor layout: The floor layout of the clean workshop should be reasonably planned to avoid cross-contamination of people and logistics. Usually, a partition layout is adopted to separate the production area, storage area, auxiliary area, etc., and set up corresponding entrances and exits and passages to ensure the orderly flow of personnel and materials.
Ventilation and air conditioning: Clean factories should have good ventilation and air conditioning systems to ensure indoor air circulation and stability of temperature and humidity. At the same time, high-efficiency filters should be used to filter the air entering the clean area to ensure that the air quality meets the requirements.
Lighting and power distribution: The lighting and power distribution system of the clean workshop should comply with relevant standards and specifications, and use efficient and energy-saving lighting fixtures and energy-saving electrical equipment. At the same time, corresponding lightning protection, grounding and other safety facilities should be installed.
Fire protection and safety: Clean factories should be equipped with corresponding fire protection and safety facilities, such as fire alarm systems, fire extinguishers, emergency evacuation channels, etc., to ensure the safety of the factory building.
Sanitary facilities: Clean factories should provide good sanitary facilities, including toilets, changing rooms, showers, etc., and appropriate detergents and disinfectants should be used to ensure hygienic conditions inside the factory.
Noise control: Noise control in clean factories should comply with relevant standards and specifications, and measures such as low-noise equipment and sound insulation materials should be used to reduce the noise level inside the factory. In short, the design specifications for pharmaceutical clean plants are very strict, and they need to be designed and constructed in accordance with relevant standards and specifications to ensure that the cleanliness and hygienic conditions of pharmaceutical production meet the requirements and to improve the quality and safety of pharmaceuticals.