Lighting requirements for pharmaceutical clean rooms/purification workshops

　　Abstract: With the rapid development of biomedical technology, a clean production environment is becoming more and more important, and the requirements for plant lighting are getting higher and higher. These requirements are partly reflected in the GMP specifications and industrial lighting standards, and more requirements are manifested in the requirements of the production process for the lighting environment. In general, these requirements include the functionality of lighting, the reliability of lamps, the coordination with buildings and HVAC, light quality, phobiological safety, and the applicability of lamps  special environments.

　　Keywords: pharmaceutical engineering, clean room, lighting

　　I. Introduction

　　In recent years, the biomedical industry has shown rapid growth worldwide, which provides more opportunities for human health and disease treatment, and also puts forward higher requirements for the lighting of the production environment. This article separately elaborates the requirements for space lighting, lighting fixtures and light sources from the aspects of clean environment, production technology, and material characteristics. It can provide guidance for the lighting design and construction of the pharmaceutical industry, and can also provide reference for product design and manufacturing for lighting manufacturers. .

　　Second, the requirements of a clean environment for lamps and lanterns

　　The manufacturing process of biomedicine needs  be completed in a clean room, and clean room technology is based on air filtration. Different levels of clean rooms require different airflow organization methods and different specifications of air filters, so they are doing clean room lighting design At the same time, it is necessary  consider the appearance and structure of the lamp  meet the requirements of the clean room.

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　　Figure 1. Typical clean room structure

　　1. The shape of the lamp must not accumulate dust. The design must follow the requirements of fluid mechanics. The shape of the lamp must be designed in a streamlined structure without any protrusions, depressions, gaps or gaps on the surface. This is also the intuitive difference between clean room lamps and general space lamps. .

　　Figure 2. Typical LED panel light for clean room

　　2. The structure of the luminaire cannot hinder the airflow. Therefore, the traditional luminaire is designed  be embedded, that is, the luminaire is installed in the ceiling of the clean room. However, there will be many problems in this way. Opening holes in the ceiling will not only cause high The construction cost also reduces the mechanical strength of the roof, and there are gaps between the lamps and the openings of the roof. When possible, the design of clean room lighting should avoid embedded structure, preferably thin panel structure, directly ceiling installation. Taking in account the impact on airflow, it is recommended that the thickness of the lamp should be controlled within 15mm, or the arc-shaped frame structure should be adopted.

　　3. The surface of the lamp should be smooth and uniform, and can not absorb dust, which can be met by anti-static treatment. For spaces that require biological cleanliness, the surface of the lamp must be able  prevent bacteria, and microorganisms cannot breed after falling on the surface of the lamp. For this reason, the surface of the lamp must be made of water-repellent materials, which cannot form a solution environment where microorganisms can survive.

　　Third, the requirements of the production process for lighting

　　The pharmaceutical production process is very complicated. The production workshop has many small-area operation rooms, as well as many dressing rooms, passages and transfer windows. These spaces are generally only a few square meters  tens of square meters, and sometimes even less than one square meter. Lighting design under the premise of power density limit.

　　1. Illumination is the basic requirement of the lighting environment, but for small spaces, the room index is very poor, and may be as small as 0.5. The lighting manual does not even have a reference value for the space utilization facr, and it is very difficult  design the lighting. We have made a lot of calculations for this, and compiled a space coefficient selection table, which can provide designers with reference.

　　2. The construction cost of clean rooms in biomedical facries is very high, which inevitably requires a high space utilization rate. At the same time, a large number of production equipment and instruments are installed in the workshop, which also affects the space layout of the lamps. The standard requirement for illuminance uniformity is 0.7 [1], the design needs  fully consider the installation position and light-emitting angle of the luminaire. In order  ensure a high uniformity of illuminance, it is necessary  combine the production process, choose professional light distribution lamps, and rationally arrange the installation positions of the lamps.

　　3. Cleanroom workers need  work for a long time under completely enclosed unnatural conditions, so the requirements for light quality are even higher. These requirements include the control of stroboscopic and glare and phobiological safety. For the consideration of power density, direct lighting is generally used, and the use of strong reflective surface materials in buildings should be avoided. Surface light sources should be used as much as possible in the light distribution of lamps and lanterns  reduce the application of point light sources and line light sources.

　　4. There are various chemical gases in the pharmaceutical production process, which imposes explosion-proof requirements on the production space. At present, products that can meet the requirements of cleanliness and explosion-proof standards at the same time.

　　Figure 3. SPT-CL1203-36Ex explosion-proof lamp for clean room

　　Fourth, the requirements of medicines and materials on the lighting spectrum

　　Some drugs or their raw materials have phochemical sensitivity and poor stability. They are prone  oxidation, decomposition, and discoloration when exposed  light, especially some chemotherapeutic drugs, which can undergo ring splitting, rearrangement, hydrolysis, polymerization, oxidation, and heterogeneity after dissolution. For complex reactions such as structure, light conditions can promote the progress of the above reactions [3]. Therefore, these drugs need  be protected from light during production, transportation and srage. In the production process, according  the requirements of the process conditions, it is necessary  provide sufficient lighting  facilitate the production operation, but also  prevent the effect of the medicine from being reduced by the light. In the selection of lighting equipment, high-energy light should be avoided, and long-wave low-energy light sources can generally be selected.

　　Table 2 Common light-sensitive drugs

　　Lighting engineers and pharmacists conducted a common research project. According  the phochemical properties of different drugs or their raw materials, light sources of different wavelengths were selected, and orthogonal experiments were performed  find out the most insensitive wavelengths of these drugs, and then follow these conditions Special lamps were made.

　　Figure 4. The dominant wavelength of the illumination source of calcitriol is 640nm

　　V. Conclusion

　　The pharmaceutical industry lighting must meet the general requirements of general lighting and has its own characteristics. Lighting designers should fully communicate with pharmaceutical scientists, pharmaceutical engineers, lamps and optical engineers, and select lighting products that meet the process requirements. At the same time, lighting designers should also cooperate with professional designers such as architecture, HVAC, electrical, etc.,  carry out lighting design under the condition of meeting clean room conditions and space requirements, and  provide a lighting environment that meets the requirements of pharmaceutical p