What are the influencing factors involved in the planning and design of a successful pharmaceutical factory?(1)

Apr 09, 2021

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What are the influencing factors involved in the planning and design of a successful pharmaceutical factory?

With the rapid development of the biological industry and modern biotechnology, functional protein separation and purification, and pilot trials of new biotechnology drugs have become key technologies in modern biopharmaceutical engineering. The biotechnology industry is huge and complex, and related industry projects are very extensive. As far as architecture is concerned, planning, construction, maintenance, and management are an important part of various biotechnology industry projects.

In recent years, with the rapid increase in the difficulty of research and development of small molecule drugs and the rapid growth of large molecule drugs, recombinant proteins, vaccines, monoclonal antibodies and new-generation treatments have become key areas for the development and growth of the biomedical industry. It is estimated that by 2015, the global market for biopharmaceuticals will reach 239 billion US dollars. With the development of the biopharmaceutical market, single-use technology will also usher in a broader application prospect.

The biotechnology industry is huge and complex, and related industry projects are very extensive. As far as architecture is concerned, planning, construction, maintenance, and management are an important part of various biotechnology industry projects.

The clean space of biologics pharmaceutical factory, in accordance with domestic and foreign GMP regulations, human pharmaceutical factory clean space environmental requirements, safety design concepts and methods, planning and design. Successful pharmaceutical plant planning and design include good process design, process equipment that meets the requirements of ASME BPE 2012, public equipment, appropriate plant design, layout, flow line arrangement, space size planning, and economical and pollution-free air conditioning system design And complete validation operation plan and execution records and other elements.

Relevant regulations for biopharmaceutical plants

China’s new version of GMP was officially implemented on March 1, 2011. The new version of GMP is basically revised in accordance with the latest requirements of EU GMP and WHO GMP. In particular, higher requirements for plant facilities are put forward on the basis of the 98 version of GMP, such as plant facilities. The facilities are divided into production area, storage area, quality control area and auxiliary area respectively. Design and layout requirements are put forward. At the same time, it also requires pharmaceutical manufacturers to build or renovate factories, select equipment, and whether the design meets the requirements and GMP requirements. It is necessary to confirm, avoid blindness, and increase scientificity.

Faced with these new requirements and new trends, as a pharmaceutical manufacturer, in the design, construction and verification of new plant facilities or when renovating existing plant facilities, they must consider compliance with the new version of GMP. This is in the company’s understanding. It will be particularly important in the process of implementing the new version of GMP certification.

The design of the biopharmaceutical production plant must comply with the technical regulations of the relevant professions. Such as: clean plant design code GBJ73-84; "Drug Production Quality Management Code" (revised in 2010); ASME BPE 2012 biological process equipment, etc.

Biopharmaceutical plant design concept

The design and construction of the plant should consider equipment configuration and routing, aseptic operation, quality control, quality assurance and regulations, biological safety, biological waste treatment, 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 the requirements of GMP auditing:

·The process equipment is based on the principles of advancement, practicability, economy, and reliability, and the purchase of advanced and efficient key process equipment to improve the level of production technology of the enterprise ;

·The overall design of the plant area is clearly divided, the layout is reasonable, the process flow is smooth, avoiding the intersection of logistics and people, and meeting the requirements of fire protection, planning, labor safety and health, and environmental protection;

·The engineering design focuses on energy saving, environmental protection and fire protection measures. Environmental engineering implements the "three simultaneous" principles of simultaneous design, simultaneous construction and simultaneous production of the main project.

The project design must not only meet the needs of project implementation, but also leave room for the future development of the enterprise.

Engineering design of biopharmaceutical plant

The design process of biopharmaceutical engineering projects 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 anti-corrosion, workshop layout, piping design, pharmaceutical cleaning Plant air conditioning purification system design, non-process 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).