Design and layout of
pre-filled syringe production line factory

factory workshop

Design and configuration of clean workshop for pre filling and sealing production line

With the rise of pre-filled syringes, the clean room design and layout of the pre-filled syringe production line have become crucial. The design of the clean room aims to eliminate air pollutants and control factors such as temperature, cleanliness, pressure, air velocity, noise vibration, lighting, and static electricity to meet specific requirements.

The design of the clean room needs to follow certain standards and specifications. Firstly, the site selection should have a reasonable layout, with a distance of more than 50 meters from traffic roads, and necessary fire access routes should be set up. The surrounding roads should use materials with good performance and low dust generation, and greenery should be implemented. Secondly, the layout and design of the process plan need to be coordinated. The clean room should retain necessary process equipment and meet the requirements of product process and air cleanliness level. The layout of fixed technical facilities should prioritize the requirements of the purification air conditioning system. The design of personnel purification and logistics purification should also be reasonable. The personnel changing area should be connected to ISO 5 or higher vertical unidirectional flow clean rooms, and the flow of personnel should be avoided, while material purification rooms and facilities should be set up. In addition, noise and micro-vibration control are also necessary. The noise level should comply with regulations, and factors such as building structure, ground construction, vibration isolation joint setting, and flexible connection between wall panels and ground and ceiling should be considered.

In the design of clean rooms for pre-filled syringe production lines, sterile isolation processes need to be considered. Personnel are the main source of microbial contamination in the production process of sterile products, so measures need to be taken to isolate personnel from sterile environments, limit contact between personnel and sterile items, and reduce the number of personnel operating in sterile environments. Traditional sterile processes mainly achieve isolation through PVC curtains and walls, providing and circulating clean air through HVAC systems to protect the laminar flow around the A-grade area and relying on limited pressure differentials to protect products. Another method is to use Restricted Access Barrier Systems (RABS), which provide more comprehensive environmental and personnel isolation, as well as glove operation.

Building and layout design are crucial for clean room design of pre-filled syringe production lines. The layout design needs to meet process requirements, accommodate equipment layouts, and facilitate the flow of personnel, materials, and waste. The design of clean room zoning should be determined based on key processes and component cleaning facilities, and common spatial classifications include A-grade, B-grade, C-grade, and D-grade areas. The design of storage and distribution systems needs to ensure the quality and supply requirements of pharmaceutical water based on peak water consumption statistics.

In the configuration of utility engineering facilities in clean rooms, process water is a critical part. Pharmaceutical water includes drinking water, purified water, water for injection, and sterilized water, which are prepared through appropriate unit operations or combination methods. Purified water is mainly prepared through pre-treatment systems and purification systems, where the pre-treatment system removes sources of membrane system contamination, and the purification system purifies the water produced by the pre-treatment system into purified water that meets pharmacopoeial requirements. Water for injection is prepared by distillation, and multi-effect distillation machines are commonly used equipment.

HVAC systems play an important role in the design of pre-filled syringe production line factories. They have a significant impact on the safety production, production efficiency, energy consumption, and product quality stability of pharmaceutical factories. The air conditioning system provides physical separation to prevent cross-contamination between products. Proper HVAC system design can achieve air purification, energy saving, and a safe environment. At the same time, automated control technology is also essential in clean rooms. Automated control systems can achieve automatic detection, data processing, analysis, judgment, and operation control, improving production efficiency, ensuring stable product quality, and saving energy.

The design and layout of pre-filled syringe production line factories are essential aspects that the pharmaceutical industry cannot ignore. Through rational clean room design, sterile isolation processes, building and layout design, configuration of utility engineering facilities, and automated control technology, a clean production environment can be achieved, ensuring stable product quality and production efficiency. The development of pre-filled syringes brings convenience and new opportunities to the pharmaceutical industry, and the design and layout of clean rooms are constantly evolving and improving to meet industry demands and trends.

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