Construction Standards for Medicinal Excipient Cleanrooms
2024.12.31
I. Introduction
In the pharmaceutical industry, the quality of medicinal excipients is of utmost importance for the safety and effectiveness of drugs. The environmental control during the production of medicinal excipients, especially the construction of cleanrooms, is a crucial aspect in ensuring product quality. Guangzhou Cleanroom Construction Co., Ltd., as a professional manufacturer of purification equipment, deeply understands the significance of the construction standards for medicinal excipient cleanrooms. The following will elaborate on these standards in detail.
II. Site - selection Requirements for Medicinal Excipient Cleanrooms
A. Environmental Factors
1. The cleanroom should be located far away from pollution sources, such as landfills and chemical plants. Atmospheric pollutants and microorganisms in the surrounding environment pose a potential threat to the production environment within the cleanroom. For example, in an industrial area, if there are many factories emitting exhaust gas nearby, it may increase the suspended particles in the air, thus affecting the purity of medicinal excipients.
2. It should be chosen in an area with good air quality and abundant greenery. Greenery can play a role in reducing dust and purifying the air, helping to create a relatively clean external environment for the cleanroom.
B. Geology and Terrain
1. The geological conditions of the selected site should be stable, avoiding earthquake - prone areas or regions prone to ground subsidence. Unstable geological conditions may cause cracks in the building structure of the cleanroom, damage its airtightness, and affect the purification effect.
2. The terrain should be flat, which is convenient for building construction and the installation and maintenance of purification equipment. If the terrain is undulating, it may bring difficulties to the design of the drainage system and air circulation system of the cleanroom.
III. Building Structure Standards for Cleanrooms
A. Walls and Floors
1. The walls should be made of materials with good air - tightness, such as color - coated steel plates. Color - coated steel plates have a smooth surface, are not prone to dust accumulation, and have good sealing performance, which can prevent external pollutants from entering the cleanroom.
2. The floor should be made of wear - resistant, corrosion - resistant, anti - static, and flat materials, such as epoxy self - leveling floors. The anti - static property can prevent static electricity from attracting dust and damaging production equipment, and the flat floor is convenient for cleaning and maintenance.
B. Doors and Windows
1. The doors and windows should be products with excellent air - tightness. The door usually adopts an air - tight door, which can fit tightly to the door frame when closed to prevent air leakage. If there are windows, double - or multi - layer insulating glass should be used, which can not only ensure lighting but also prevent heat transfer and the entry of pollutants.
2. The opening direction of the doors and windows should avoid disturbing the air flow organization in the cleanroom. For example, the door should open towards the side with higher pressure to ensure that a large amount of external polluted air is not introduced into the cleanroom when the door is opened.
IV. Air Purification System Standards for Cleanrooms
A. Air Supply and Exhaust
1. The cleanroom should be designed with a reasonable air supply and exhaust system according to the production process and cleanliness requirements. The air supply volume should ensure that the indoor air can be completely replaced within a specified time, generally calculated according to the cleanliness level and room volume. For example, for a medicinal excipient pulverization room with high cleanliness requirements, the air supply volume needs to meet a ventilation rate of more than [X] times per hour.
2. The exhaust system should be able to promptly discharge dust, odors, and harmful gases generated during the production process. For areas where volatile organic solvents are used, the exhaust system should also have explosion - proof functions.
B. Air Filtration
1. Air filtration is the core part of the air purification in the cleanroom. Generally, a combination of primary, medium - efficiency, and high - efficiency filters is used. The primary filter mainly filters large - particle dust, the medium - efficiency filter further filters medium - sized pollutants, and the high - efficiency filter is responsible for removing fine particles and microorganisms.
2. The selection of high - efficiency filters should be determined according to the cleanliness level of the cleanroom. For cleanrooms producing sterile medicinal excipients, H13 or H14 - grade high - efficiency filters are usually required, and their filtration efficiency for particles with a particle size of 0.3μm can reach 99.95% - 99.995%.
V. Temperature, Humidity, and Pressure Control Standards for Cleanrooms
A. Temperature and Humidity
1. The temperature in the medicinal excipient cleanroom is generally controlled between 18 - 26°C. Excessively high temperatures may cause some excipients to deteriorate. For example, some temperature - sensitive gel - like excipients may lose their original physical and chemical properties at high temperatures.
2. The humidity is usually controlled between 45% - 65%. Excessively high humidity is prone to the growth of microorganisms, while excessively low humidity may generate static electricity, affecting production operations and the quality of excipients.
B. Pressure
1. The cleanroom should maintain a certain positive pressure to prevent the intrusion of external polluted air. The pressure difference between rooms with different cleanliness levels is generally 5 - 10Pa. For example, between the excipient batching room (with a higher cleanliness level) and the corridor (with a lower cleanliness level), the pressure in the batching room should be higher than that in the corridor to ensure that the air in the corridor does not flow into the batching room.
VI. Lighting and Electrical Standards for Cleanrooms
A. Lighting
1. The lighting in the cleanroom should be uniform, bright, and glare - free. Generally, clean fluorescent lamps or LED lamps are used, and the illuminance should meet the needs of production operations. For fine - operation areas, such as the inspection platform for medicinal excipients, the illuminance should reach 300 - 500 lux to ensure that inspectors can accurately observe the appearance and quality of excipients.
2. The lamps should be of a sealed design to prevent dust from entering the lamp interior and to facilitate cleaning and maintenance.
B. Electrical
1. The electrical equipment in the cleanroom should have explosion - proof, dust - proof, and anti - static functions. All wires and cables should be laid in a concealed manner through pipes to avoid being exposed to the air, preventing dust accumulation and damage.
2. An emergency lighting system should be installed to ensure the safe evacuation of personnel and the emergency operation of important equipment in case of a sudden power outage. The emergency lighting time is generally not less than 30 minutes.
VII. Water Supply, Drainage, and Sanitary Facility Standards for Cleanrooms
A. Water Supply and Drainage
1. The water supply and drainage pipes in the cleanroom should be made of high - quality stainless steel or plastic pipes to prevent corrosion and leakage. The water supply pipes should be equipped with a filtering device to prevent impurities in the water from entering the cleanroom.
2. The drainage system should be designed with a reasonable water seal and trap to prevent odors and microorganisms from entering the cleanroom through the drainage pipes. For drainage with cleanliness requirements, such as equipment cleaning drainage, it should be treated to meet the corresponding water quality standards before being discharged.
B. Sanitary Facilities
1. If there are personnel operations in the cleanroom, sanitary facilities such as changing rooms, washbasins, and toilets that meet hygienic standards should be set up. The changing room should be divided into clean and non - clean areas. Before entering the cleanroom, personnel should change into clean work clothes in the changing room, and perform operations such as hand - washing and disinfection to prevent external pollutants from being brought into the cleanroom.
VIII. Conclusion
The construction of medicinal excipient cleanrooms is a systematic project that requires comprehensive consideration of various factors. With years of industry experience and professional technology, Guangzhou Cleanroom Construction Co., Ltd. can provide medicinal excipient manufacturers with high - standard cleanroom construction solutions and purification equipment, ensuring the cleanliness and safety of the production environment for medicinal excipients and safeguarding the quality of drugs.
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