After all scientific and technological achievements in agriculture, forestry, animal husbandry, fishery, water conservancy, medicine and health, social welfare, energy, environmental protection, etc., have undergone preliminary technical appraisal or laboratory stage research and test success, they will go through many links and experience several scientific and technological achievements before going public. Only the steps of transforming into productivity can be sold on a large scale. Without these links, it is impossible to complete the marketization process. For example: after the outbreak of the new crown epidemic, our great motherland laid out five technical routes to develop new crown vaccines, including attenuated, inactivated, adenovirus vectors, recombinant proteins and nucleic acid vaccines. Six new coronavirus vaccines have entered the experimental stage one after another, including the mRNA messenger nucleic acid vaccine that has received much attention. As one of the effective preventive measures, people have high hopes for the research and development of the new crown vaccine. However, no matter how strong the technology is, it cannot be accomplished overnight. For the new crown vaccine, it takes small trials, pilot trials, process verification, on-site inspections and other important links from research and development to marketing before it can be launched to the group vaccination step.

The pilot plant is also short for the intermediate test. The success or failure of the industrialization of scientific and technological achievements mainly depends on the success or failure of the pilot test. After the pilot test, the success rate of industrialization can reach 80%; on the contrary, the success rate of industrialization is only 30%. As far as the medical field is concerned, all kinds of drugs and vaccines must undergo repeated verifications of phase I, phase II, and phase III in each link to obtain a marketing license. This important part of the pilot test needs to be completed in the pilot workshop. Industry insiders said: "Reasonable process layout can achieve advanced process and equipment, and create a good environment for workshop production, operation, equipment installation and maintenance, safety, health, and environmental protection." In addition to building various laboratories, CEIDI also The general contractor has prepared various pharmaceutical research and development projects, such as drug research, process development and pilot production workshops. Taking the construction content of a pharmaceutical pilot plant as an example, let's talk about the design and construction of the pharmaceutical pilot plant.

Reference standard for design of pharmaceutical pilot plant

The design of the pharmaceutical pilot production workshop must meet the requirements of the new version of GMP of the State Medical Supervision and Administration Bureau, and meet the requirements of the US FDA, European EDQM, and Japan PMDA. The regulatory basis is the new version of GMP and its appendices, the "Specifications for the Design of Clean Plants in the Pharmaceutical Industry" and National regulations on construction, fire protection, environmental protection, energy and other aspects. GMP requires the layout of the workshop to follow the following characteristics: reasonable layout, strict division of areas, prevention of cross-contamination, and convenient operation and production.

Design and planning of pharmaceutical pilot plant

The main functional areas of the project are: basic research and development area, immune laboratory, quality inspection laboratory, molecular laboratory and pilot production workshop, clean corridor, office area, and other areas. Several of the laboratory clean areas need to be designed in accordance with Class D requirements. The area of the clean area is 600 square meters, the flow of people and logistics are separated, and it is equipped with an access control system. For the production of non-sterile APIs, the temperature of the clean room is 18 °C ~ 26 °C, the relative humidity is 45% ~ 65%. The number of air changes is greater than 18 times/h, and the pressure between clean rooms of the same level The difference is not less than 5 Pa, the pressure difference between the clean area and the outdoor (shoe changing room, outer packaging room) should not be less than 12 Pa, and the open door adopts interlocking control.

Design of HVAC System in Pharmaceutical Pilot Workshop

The analysis here is only for the clean area. The HVAC system in the clean area is composed of a combined air-conditioning box, a surface cooler, a heater, a humidifier, an ozone generator, a fan system and a duct system. The system adopts a mixed form of fresh air and return air. After the clean air flow is distributed into each clean room by laminar flow, the contaminated fresh air (centrifugal room, drying room, packaging room, etc.) is directly discharged; the remaining return air is returned to the inlet of the air conditioning box for reuse , The air volume of the HVAC system is adjusted by frequency conversion, and the temperature and humidity are controlled by automatic adjustment.

Purified water system of pharmaceutical pilot plant

The particularity of pharmaceutical products determines its high requirements for water quality. The purified water in the purified water storage tank is processed by the delivery pump through online ultraviolet disinfection and ozone disinfection and filtration, and then sent to the purified water use point in the clean area workshop, etc., and finally passed through the cycle. The loop returns to the purified water storage tank. In the purified water system, the secondary reverse osmosis effluent, the total output of the storage tank, and the total return are all installed with an online conductivity meter. When the conductivity reaches the specified action index, the purified water returns to the primary reverse osmosis water storage tank.

CEIDI Xidi’s goal is to build a flexible, adaptable, full-featured, and investment-saving, multi-functional GMP-compliant pilot plant. A good pilot plant can improve product R&D capabilities, accelerate product industrialization, seize the market, and improve The core competitiveness of the enterprise. The construction experience of CEIDI Xidi is: the functional layout is set in accordance with the requirements of the process flow, according to the production volume and equipment, and the key clean area should be separated from the general functional area, and the high cleanliness section areas are close to the air conditioning purification. The system makes the pilot plant compact and saves investment. Clean engineering EPC (general contracting) companies will have greater advantages in designing and constructing such professional clean engineering.