O Introduction

With the development of GMP clean technology at home and abroad in recent years, the requirements for the production environment of the pharmaceutical industry are becoming higher and higher, and the design of clean workshops is becoming more and more important. In order to implement the relevant national policies and the "Pharmaceutical Production Quality Management Standards" in the design of clean workshops in the pharmaceutical industry, to achieve advanced technology, economical application, safety and reliability, ensure quality, and meet the requirements of energy conservation and environmental protection, the state renewed in 2008 GB50457-2008 "Code for Design of Clean Workshops in the Pharmaceutical Industry" was released. The cleanliness of air in the clean workshop of the pharmaceutical industry is divided into one hundred, ten thousand, one hundred thousand and more than one hundred thousand (equivalent to three hundred thousand). The process is complicated and the environment is complex. The electrical design needs to closely cooperate with the process and heating. Through professional studies, the following is a brief discussion of the electrical lighting design in the clean workshop of the pharmaceutical industry.

1 Lighting design of clean workshop

1.1 Illuminance and illuminance uniformity

According to the study of visual function, it can be seen that the illuminance function when the contrast sensitivity changes, before reaching a certain contrast sensitivity value, it is very effective to increase the illuminance to improve the contrast sensitivity. The clean workshops of the pharmaceutical industry are closed workshops, and the interiors are mostly windowless rooms (areas). The International Lighting Commission (CIE) "Indoor Lighting Guide" stipulates that the minimum illumination of windowless workshops should not be less than 500 lx. According to the current power level in China, it should meet the basic requirements for lighting. When the minimum illumination is 150lx, it can basically meet the physical and psychological requirements of workers. In order to improve production efficiency, Article 14 of China's GMP (1998) stipulates that "the illumination of the main studio is declared to be 300 lx; ​​production sites with special requirements for the contrast degree can be provided with local lighting". As for auxiliary studios, corridors, air lock rooms, personnel purification and material purification rooms, considering the light and dark adaptation to the production workshop, the illuminance should not be lower than 150lx.

Illuminance uniformity refers to the ratio of the minimum illuminance on the specified surface to the average illuminance. When the illuminance ratio is appropriate, it can reduce fatigue and focus, so that there will not be a dark feeling when looking around the room. In the main working room of the medical clean room (area), the illuminance uniformity of lighting should not be less than 0.7, which is generally satisfied in engineering design.

1.2 Selection of light source

The clean workshops in the pharmaceutical industry have little natural ventilation. Generally, air supply and exhaust vents are provided in rooms and corridors in the purification area, and mechanical air supply and exhaust are performed through purified air conditioners. The increase in the number of air vents and the installation position limits the number of lamps and the installation position of the lamps. This requires that the number of lamps be minimized under the same illumination conditions. It is appropriate to use efficient light sources as the purification area (room)

light source. The luminous efficiency of high-efficiency fluorescent lamps is generally several times that of incandescent lamps, and the light source is a cold light source, which is not easy to heat. This not only meets the requirements for high efficiency of lamps and lanterns, but also reduces the energy consumption of air conditioners and meets the energy-saving requirements.

The pharmaceutical industry has less natural lighting. During working hours, the lamps generally need to be in working condition for a long time, which requires that the light source at work is closer to the natural light source. The spectral distribution of the light source of the fluorescent lamp is close to natural light, which can meet the requirements of the light source. At present, medical clean rooms (areas) with high contrast requirements generally use fluorescent lamps as light sources at home and abroad.

1.3 Selection of lamps

The function of the lamp is to protect the light source and to work in various environments, and to comply with appropriate safety standards.

Since there are certain requirements for air cleanliness in the clean workshop, the production of medicines needs to be disinfected and sterilized regularly. Therefore, the lamps in the clean room (area) should be lighting lamps that are simple in shape, not easy to accumulate dust, easy to clean, and easy to disinfect and sterilize. .

1.4 Installation of lamps

The environment of the clean factory room (area) is different from the ceiling. The installation of lighting fixtures will directly affect the clean room (area) from the pollution of the ceiling. The clean room (area) lamps generally have two installation methods: ceiling mounted surface installation and embedded ceiling concealed installation. Embedded ceiling installation will increase the opening area of ​​the ceiling, which not only makes it difficult to seal the opening of the roof during the construction process, but also the roof The upper opening seal is easy to be walked by the maintenance personnel to repair the equipment on the lifting item, causing the opening seal to rupture and form a communication with the clean room (area), causing pollution to the clean room (area). Although lighting fixtures are not the main source of dust in the clean room (area), if not installed properly, dust particles will penetrate into the clean room (area) through the gap between the lights. Moreover, it is embedded in the ceiling to install lamps, the investment is relatively large, and the luminous efficiency is relatively low. Practice has proved that in a non-unidirectional flow clean room, the choice of lighting fixtures will not reduce the air cleanliness level. In view of the above reasons, the lamps in the general clean area (room) should be mounted on the ceiling. If the installation of lamps and lanterns is restricted by the height of the layer and the special requirements of the process must be concealed, the size of the opening should be accurate, and it must be sealed to prevent dust particles from seeping into the clean room (area).

1.5 Selection of emergency lamps

Emergency lighting refers to lighting that is activated due to the failure of normal lighting power. Emergency lighting includes evacuation lighting, safety lighting and backup lighting.

If the lighting of the clean workshop of the pharmaceutical industry is interrupted due to power supply accidents, some pharmaceutical production will be scrapped, and some will cause fires, explosions, and poisoning accidents. It will bring danger and loss to personal safety and property. In the event of accidents and situations, standby lighting should be installed in the clean workshop of the pharmaceutical industry. The illuminance of the backup lighting should meet the required field

The minimum illumination of the operation of the location or location. The illuminance of the standby lighting should not be lower than the illuminance value of normal lighting on the main working surfaces of the fire control room, emergency generator room, power distribution room and telephone room.

The clean workshop in the pharmaceutical industry is a closed workshop, with many internal partitions, complicated indoor personnel flow routes, and roundabout entry and exit passages. To facilitate the evacuation of personnel in the event of an accident and to rescue and extinguish fires during a fire, the clean workshop should be equipped with emergency lighting for evacuation . Marking lights shall be installed at the corners of installation exits, emergency exits, evacuation exits and evacuation passages to facilitate the evacuation personnel to identify the direction of traffic and quickly evacuate the accident scene. Red emergency lights are set at the dedicated fire exits so that firefighters can enter the workshop in time to extinguish the fire.

Emergency lighting system generally recommends the use of lamps with battery energy storage. Each area is evenly distributed according to 25% to 30% of the total number of lamps. The shape of emergency lamps is the same as that of normal lamps. Usually, as a part of normal lighting, the battery is in a charged state. When there is a sudden power outage, it will automatically switch to the battery power supply state, and the lamps with energy storage inside will start working for the operator to do the aftercare before leaving. It is also possible to adopt a form in which some lamps and lanterns are additionally provided with dedicated lighting circuits and are powered by EPS or diesel generators, depending on the specific conditions of the project.

1.6 Selection and installation of lighting fixtures in hazardous clean areas with explosion-proof areas

The selection and installation of lighting appliances for medical clean rooms (areas) with explosion-proof requirements shall firstly comply with the relevant provisions of the current national standard GB50058 "Design Specifications for Electrical Apparatus for Explosive and Fire Hazardous Environments", and at the same time consider meeting the requirements for cleanliness.

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