I. Project background and needs
A large pharmaceutical group is a well-known biopharmaceutical, chemical agent manufacturers, its core production base is located in East China, with a number of 10,000, 100,000 grade GMP clean room, mainly for sterile preparations, biological products, research and development and production. The group's original workshop lighting system uses traditional clean lamps and lanterns, with the expansion of the production scale and industry compliance requirements, gradually exposed a number of pain points, seriously affecting production efficiency and compliance, the specific needs are as follows:
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Compliance Requirements: Strictly in line with the national standard "Technical Requirements for Cleanroom Lamps" (implemented on July 1, 2024), which was drafted and revised with the participation of CIIC-Tongming, and at the same time meets the lighting standards related to GMP certification and FDA testing to ensure that the lamps and lanterns have no accumulation of dust, no hygienic dead ends, low dust generation, and are suitable for the needs of environmental control and management of the cleanroom.
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Lighting performance requirements: workshop core operation area (preparation filling, drug testing) need high illuminance, high color rendering, illuminance uniformity ≥ 0.8, color rendering index Ra ≥ 90, to avoid production errors due to insufficient light, color rendering is not allowed; auxiliary areas need to take into account the energy saving and basic lighting, reduce energy costs.
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Environmental adaptation requirements: the workshop exists a small amount of volatile solvents, some areas need explosion-proof, three-proof performance, the lamps and lanterns need to have IP65 and above the level of protection, explosion-proof level to Ex e Ⅱ C T4 Gb, and at the same time have antibacterial, chemical corrosion resistance, can withstand alcohol, ozone disinfection, to avoid lamps and lanterns to pollute the production environment.
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Demand for convenient operation and maintenance: the original lamps and lanterns are frequently maintained and need to stop production to clean up when they are replaced, which affects the production progress, and the new lamps and lanterns are required to have a long service life, be easy to clean, and have a modular design, which can be realized without stopping the production for maintenance, and reduce the cost of operation and maintenance and the loss of stopping the production.
