Brief Discussion On Plant Layout Design Of Oral Solid Preparation Workshop

Good Manufacturing Practices (GMP) requires pharmaceutical, food and other enterprises to have advanced production equipment, scientific production process, strict testing system and perfect quality management system to ensure that the final product quality meets various requirements . The advantage of the layout of oral solid preparation workshops designed according to GMP standards is that it can effectively ensure the cleanliness of the production line. With the rapid development of the pharmaceutical industry, the continued construction of new clean workshops has also promoted the continuous update and improvement of the GMP standard tablet workshop, making the design of the GMP standard tablet workshop workshop layout a good development potential.

Part 1 Preface

The implementation of Good Manufacturing Practice (GMP) is one of the important means to ensure the quality of drugs. The 2019 version of the “Drug Administration Law of the People’s Republic of China”, which has been implemented since December 1, 2019, stipulates that GMP must be complied with in drug production activities. Standards, establish a qualified drug production quality management system, ensure that the entire process of drug production is in compliance with [2] legal and statutory requirements, and clarify GMP as the basic pharmaceutical company’s start-up conditions. At present, the pharmaceutical industry involves people’s lives and safety, which has always been a key area of national concern. The new version of the Drug Administration Law has further promoted the development of the pharmaceutical industry. The state requires all pharmaceutical manufacturing enterprises to meet GMP requirements. Based on this premise, the design of the oral solid preparation production workshop should be started from the source, and the oral solid preparation workshop should be designed according to the requirements of cost reduction, energy consumption reduction and efficiency maintenance to ensure compliance with the latest GMP management standards. Therefore, this paper puts forward some reasonable considerations based on the design ideas of the GMP workshop for oral solid preparations.

Part 2 Common Problems In Oral Solid Dosage Production Workshop

2.1 Shared Clean Area In The Previous Process

There are many oral solid dosage forms that are more common in our lives, such as tablets, granules, and capsules. During the production process, it mainly involves mixing, granulation, drying, and granulation. If enterprises want to improve the utilization efficiency of equipment and reduce the cost of equipment at the same time, they should set up multiple solid preparation production lines in the same clean area, which can reduce capital investment and improve economic benefits.

2.2 High Requirements For The Management Of Raw And Auxiliary Materials In The Production Workshop

When a variety of oral solid preparations are produced in the same production workshop, the raw and auxiliary materials and product components involved are various and different. If the production workshop wants to manage these raw and auxiliary materials well to meet the production requirements of different preparations, it needs to set up a variety of storage rooms, classify and manage the production materials, and set up special material management posts, equipped with technical personnel responsible for material management .

2.3 Multiple Processes Involve Dust Emission

The production workshop of oral solid preparations will generate dust during the production process, which brings certain difficulties to the quality control of drugs. Therefore, the production workshop is required to install dust removal and dust collection in the processes that easily generate a large amount of dust, such as crushing, sieving, drying, and general mixing. device. In order to improve the efficiency of dust treatment, the production workshop usually considers arranging the processes that generate dust in the same area.

Part 3 Design Ideas For Oral Solid Dosage Production Workshop Meeting GMP Requirements

3.1 Overall Layout Idea

When designing the GMP standard design for the oral solid preparation production workshop, it is necessary to focus on the product production process as much as possible, starting from the product production requirements and ambient air cleanliness, to provide convenience for the installation of production equipment, and to ensure that the equipment is easier to use and operate , to ensure that the designed workshop can meet the production needs.

3.2 Design Of Workshop Clean Area

(1) Reasonably arrange the flow of people and logistics in the workshop. When designing a production workshop for oral solid preparations, it is necessary to rationally arrange the flow of people and logistics in the workshop. In order to avoid cross-contamination, it is necessary to separate the clean rooms for personnel and materials, as well as for personnel and materials. In order to ensure that there will be no intersection between the flow of people and logistics, it can also make the logistics route shorter, the process route smoother, and the production efficiency further improved. If the design process is restricted by conditions, it is necessary to set up the flow of people and logistics in the same direction. It is necessary to ensure that the distance between the two is sufficient to ensure that the flow of people and logistics will not affect and hinder each other.

(2) Reasonably plan the flow of people. When designing a production workshop for oral solid preparations, reasonable planning of the flow of people can effectively reduce the risk of contamination caused by personnel taking oral solid preparations, and ensure that the passage of personnel becomes smooth and fast. In the process of planning the flow of people in the workshop, factors such as management personnel, production operators, equipment maintenance personnel and general personnel management should be paid attention to, because during the production of oral solid preparations, one of the most important pollutants in the clean room of the clean workshop It is the flow of people, so if you want the cleanliness of the workshop environment to comply with the latest revised GMP standard, the technical staff must clean the whole body in advance when they enter the production workshop.

After the staff are purified, the dust and microorganisms and other pollution sources carried on their bodies will be removed, so that it is possible to prevent pollution sources from entering the workshop, and at the same time prevent contamination of pharmaceutical preparations. Changing shoes, taking off coats and washing hands are important parts of the purification process. They are non-clean operations and should be completed in the same clean room in sequence. The next purification project should be arranged according to the actual situation. A clean room can be arranged separately, or it can be combined They are merged together.

(3) Scientific planning of logistics. In order to ensure a more scientific design of oral solid preparation production workshops, logistics should be standardized to ensure more reasonable drug production, processing, operation, and product quality testing. In the process of logistics planning, it should be ensured that it is practical and reasonable in combination with the scientific design of the production process to avoid cross-contamination, effectively reduce the possibility of material confusion, and improve the compatibility of related operations. In order to avoid cross-contamination between raw materials and finished products, the material inlet and the finished preparation outlet should be separated. The waste generated in the production process should have a special export, which should be separated from other entrances and exits to prevent multiple entrances and exits from being merged. Before the production materials are transported to the clean production area, in order to avoid bringing in pollution sources, they must also be cleaned to remove dust and pollutants carried on the materials, which can effectively avoid pollution accidents. The specific method is to first remove the outer packaging of the material in the clean room outside the clean area, and then enter the clean production area through the air lock room.

3.3 Packaging Area Design

(1) Sources of pollution in the pharmaceutical packaging process. During the packaging process of oral solid preparations, there are three types of pollution that come into contact with: foreign matter pollution, chemical pollution, and microbial pollution. Chinese pharmaceutical manufacturers have problems such as backward packaging equipment and technology, many varieties, many processes, and insufficient control of the work site. During the packaging process of medicines, the pollution sources carried by people, the pollution sources carried by logistics, and the pollution sources in the air may pose a threat to the quality and safety of medicines.

(2) Pollution prevention and control measures in the drug packaging process. The prevention and control of personnel pollution should be controlled from the aspects of personal hygiene, operation hygiene, and clean clothes hygiene. The prevention and control of packaging material pollution should be considered from three aspects: pre-production control, transmission control, and use control. In particular, the environmental design of packaging material storage must meet the requirements of temperature, humidity, and light. During the transfer of packaging materials to the packaging workshop, a special clean area should be designed, and special cleaning and sterilization facilities should be set up. In order to avoid pollution, buffer facilities should be set up in the passageway from the outsourcing area to the packaging workshop, and a chain door should be set up in this passageway. All materials entering the packaging workshop shall be stored in a special treatment room with strictly controlled environment. The air channel should be regularly or irregularly inspected, cleaned, sterilized, leak-tested or replaced by parts in accordance with the prescribed procedures; perform performance tests on power equipment such as fans; the air intake is equipped with an air filter, and the exhaust is designed with an anti-air backflow device .

Part 4 Conclusion

Since the implementation of the 2019 version of the “Drug Administration Law of the People’s Republic of China”, China has stopped the GMP certification work of drug manufacturers that have been in operation for 20 years, and implemented two certificates in one (drug production license and GMP certificate in one), the purpose is to improve Regulatory efficiency promotes the development of the entire pharmaceutical manufacturing industry in the direction of high standards and strict requirements. Drugs cannot be sterilized at the end of the production process like other items. Therefore, it is very important to have different purification level requirements for the production environment in the production of drugs. Strictly following the GMP standard factory design can meet the requirements of drug production for production. environmental requirements.