What factors influence successful pharmaceutical plant planning and design?

With the rapid development of the biological industry and modern biotechnology, the separation and purification of functional proteins, and the pilot testing of new biotechnology drugs have become key technologies in modern biopharmaceutical engineering. The biotechnology industry is huge and complicated. The related industrial projects are very extensive. In terms of architecture, planning, construction, maintenance, and management are an important part of various different industrial projects in biotechnology.

In recent years, with the rapid increase in the difficulty of developing small-molecule drugs and the rapid growth of large-molecule drugs, recombinant proteins, vaccines, monoclonal antibodies, and new-generation treatments have become the key areas for the development and growth of the biomedical industry. The biotechnology industry is huge and complicated, and related industrial projects are very extensive. As far as architecture is concerned, planning, construction, maintenance, and management are an important part of various different industrial projects in biotechnology.

Biopharmaceutical plant clean space, in accordance with GMP regulations at home and abroad, human pharmaceutical plant clean space environment requirements are standardized, safety design concepts and methods, planning and design. Successful pharmaceutical plant planning and design includes good process design, process equipment that meets the requirements of ASME BPE 2012, public equipment, appropriate plant design, typographical layout of wall panels and cleanroom ceiling panels, moving line arrangements, space size planning, economical and Elements such as the design of an air-conditioning system that avoids pollution and a complete effective operation plan and execution records.

Biopharmaceutical plant design concept.

The design and construction of the plant should consider the equipment configuration and moving line, aseptic operation, quality control, quality assurance and regulations, biosafety, biological waste disposal, and enable the production of biological drugs to cooperate with the operation of the pharmaceutical factory. The design, construction, and verification of biopharmaceutical plants must meet GMP audit requirements:

1.The process equipment is based on the principles of advancedness, practicability, economy and reliability, and purchases advanced and efficient key process equipment to improve the production technology level of the enterprise.

2.The overall design of the plant area has a clear division, a reasonable layout, a smooth process flow, avoiding the intersection of logistics and people flow, and meeting the requirements of fire protection, planning, labor safety and health, and environmental protection.

3.Engineering design focuses on energy saving, environmental protection and fire protection measures. Environmental engineering implements the "three-simultaneity" principle of simultaneous design, construction, and commissioning of the main project. The project design should not only meet the needs of project implementation, but also leave room for the future development of the enterprise.

Engineering design of a biopharmaceutical plant.

The design process of a biopharmaceutical engineering project covers the basic procedures of engineering project design, process design, material balance, energy balance and thermal data estimation, process equipment design and material corrosion and corrosion prevention, workshop layout, pipeline design, pharmaceutical cleanliness Plant air-conditioning purification system design, non-technical design (including: architectural design, process water and its preparation, water supply and drainage, power supply, refrigeration, heating and ventilation, labor safety, environmental protection, engineering economy).

Biopharmaceutical engineering design is a comprehensive discipline combining a series of theories and practices using pharmaceutical theory, engineering design, and the actual biopharmaceutical companies to complete the planning and design, and to realize a series of theories and practices such as large-scale drug production and quality control. The object of biopharmaceutical engineering design research is to study how pharmaceutical projects organize, plan, and realize large-scale industrialized production of biopharmaceuticals, and eventually build a biopharmaceutical production enterprise with excellent quality, high scientific and technological content, high labor productivity, environmental protection standards, and safe operation.

After the successful development of new biological drugs in the laboratory, how to turn them into drugs that can be used clinically, how to turn the technology into productivity, how to turn the results into economic benefits, that is, how to carry out industrial scale production. The research content of biopharmaceutical engineering design can make the above assumptions become a reality, that is, the transformation from laboratory products to industrialized products is completed, and the research results of new drugs are transformed into plans for the construction of pharmaceutical companies and implemented.

Process design of biopharmaceutical plant.

The process of biopharmaceutical production is becoming more and more complicated. The variety of specifications of the raw materials used can easily cause human errors and cross-contamination of products. Therefore, the process layout of the clean plant is extremely important. In order to prevent confusion and cross-contamination between people and logistics, 4 basic requirements are put forward for the design code:

1.Set up import and export channels for personnel and materials respectively.

2.People and materials entering the clean production area should have their own purification rooms and facilities.

3. Only necessary process equipment and facilities should be set up in the production operation area.

4. The elevators that transport personnel and materials should be separated, and the elevators should not be located in clean areas. In addition, there are also response rules for the layout of clean rooms, the layout of production auxiliary rooms and the cleanliness level.

Whether the clean room of the pharmaceutical industry can meet the GMP requirements, personnel purification is a key part. Among the many sources of pollution, humans are the largest source of pollution. When people enter a clean area, if they do not perform purification or the purification effect is not good, they will bring in a large number of particles and microorganisms, which will seriously affect the cleanliness of the air in the clean area.

As the equipment itself and its installation quality are related to the cleanliness of the clean plant, the Design Code requires that clean rooms should be equipped with dust-proof and anti-microbial contamination equipment, and the structure, parts, internal and external surfaces, transmission components, and filtration of the equipment The materials, performance, accessories and installation of the device, etc. are clearly specified.

When the equipment is installed in rooms or cleanroom wall panels spanning different cleanliness levels, in addition to considering the fixation, a reliable sealing partition device should be used to ensure that different levels of cleanliness requirements are achieved. When using a conveyor belt for material transfer between different air cleanliness areas, in order to prevent cross-contamination, the conveyor belt should not pass through the partition, and should be transported in sections on both sides of the partition. In the non-sterile product production area, the material transfer between different air cleanliness areas must be transferred in sections unless the transfer device adopts continuous disinfection.

Things to consider when designing a biopharmaceutical plant include product needs and risk assessments; key process steps; product protection and avoidance of pollution; hazards / risks and personnel protection; environmental pollution control methods; aseptic product process categories; open production or confined Production; overall design of plant facilities; production area and HVAC system.

For building and layout, design standards should be considered; layout and logistics direction; room functions; building surface decoration and materials; conversion area; support area.

For mining ventilation and air-conditioning systems (HVAC), costs should be considered; sources of particulate pollution; key environmental parameters; risk assessment; facility layout and HVAC system requirements; coordination of processes and HVAC systems; monitoring systems; HVAC systems Confirmation; cleaning and maintenance of HVAC systems.

For electrical equipment, power distribution; lighting; hazardous environments; electrical pipelines; door interlocks; sockets and other equipment should be considered.

For control and instrumentation, key process environments should be considered; production process parameters; instrument list; electrical installation requirements.

The use of isolator technology should pay attention to system definition; equipment design; decontamination procedures (isolators); high-level disinfection (RABS and other barrier designs); environmental monitoring; leak detection (isolator); air system inspection.

If you want to learn more about the pharmaceutical industry, please contact us, wiskind.cleanroom@gmail,com.we will be happy to discuss the future development trend of the pharmaceutical industry with you.