Design and Construction of Antibiotic Workshops
2024.11.12
In the field of pharmaceutical production, the design and construction of antibiotic workshops are of crucial importance and highly professional tasks. Guangzhou Kunling Purification Equipment Co., Ltd. has rich experience and professional technology in this area. Today, let's have an in-depth discussion on the key points of the design and construction of antibiotic workshops.
0
I. Preliminary Planning for Design
(A) Analysis of Process Requirements
The production processes of antibiotics are complex and diverse. At the beginning of the design, the production flow must be detailedly sorted out. From the receipt and storage of raw materials to the fermentation, extraction, and refining processes, etc., the layout of the workshop needs to be planned according to the production characteristics of different antibiotics. For example, the fermentation process of some antibiotics has strict requirements for temperature, humidity, and oxygen content. Therefore, the positions of the ventilation system and the temperature and humidity control equipment need to be reasonably arranged in the workshop layout. Meanwhile, the material transfer methods between different production stages, whether it is pipeline transportation, automated conveyor belts, or other means, should all be considered to ensure production efficiency and product quality.
(B) Compliance with Regulations and Standards
The pharmaceutical industry is strictly regulated by laws and regulations, and the design of antibiotic workshops is no exception. We need to comply with a series of relevant domestic and international standards such as GMP (Good Manufacturing Practice). These standards cover various aspects such as the cleanliness level of the workshop, the flow process of personnel and materials, and the selection and installation of equipment. For example, the division of clean areas must be clear, and effective isolation measures should be set up between different cleanliness level areas to prevent cross-contamination and ensure that the produced antibiotics meet the drug quality standards.
II. Workshop Layout Design
(A) Division of Functional Areas
A complete antibiotic workshop should include main functional areas such as the production area, auxiliary area, and quality control area. The production area is the core, and the positions of equipment such as fermenters, reactors, and centrifuges should be reasonably arranged according to the production process to ensure the smooth flow of materials and personnel. The auxiliary area, such as the air-conditioning machine room, power distribution room, and purified water preparation room, should be reasonably laid out to meet the energy and auxiliary facility requirements of production. The quality control area should be equipped with advanced testing equipment and laboratories to enable timely and accurate testing of intermediate and final products during the production process.
(B) Design of Personnel and Material Flows
To avoid cross-contamination, the flows of personnel and materials need to be designed separately. Personnel entering the workshop need to go through a series of procedures such as changing clothes and disinfection and enter their respective work areas through dedicated personnel passages. The entry of materials also requires independent passages and disinfection and purification procedures. For some highly active antibiotic raw materials, special protective measures should be set up to prevent harm to operators and the environment. For example, an airlock room can be set up to ensure that the clean environment inside the workshop is not affected by the outside when materials enter and exit.
III. Key Points during the Construction Process
(A) Construction of Building Structures
During the construction of building structures, attention should be paid to the sealing and stability of the workshop. The selection of materials for walls, floors, and ceilings should meet the cleanliness requirements and be able to withstand the erosion of chemicals during the cleaning and disinfection processes. The floor should be flat and smooth to facilitate cleaning and prevent dust accumulation. Meanwhile, according to the layout design of the workshop, installation holes and embedded parts for various equipment and pipelines should be reserved to ensure the smooth progress of subsequent construction.
(B) Installation of Purification Systems
The purification system is a crucial part of the antibiotic workshop. The installation of high-efficiency air filters (HEPA) should be carried out strictly in accordance with the specifications to ensure the filtering efficiency and the cleanliness of the air. The design and installation of ventilation ducts should consider the uniformity and stability of the air flow to avoid dead corners and vortices. In addition, air purification monitoring equipment should be equipped to monitor the air quality in the workshop in real time and ensure that all parameters meet the design requirements.
(C) Installation and Commissioning of Equipment
The installation and commissioning of antibiotic production equipment is an important link in the construction process. The installation of large equipment such as fermenters should ensure the levelness and perpendicularity, and the connecting pipes should be well sealed to prevent leakage. During the commissioning stage, the running parameters of the equipment should be tested in detail, such as the temperature control accuracy, stirring speed, and pressure, to ensure that the equipment can run stably and meet the production process requirements. Meanwhile, the linkage between the equipment and the purification system and the control system should be commissioned to ensure the smooth automated production process of the entire workshop.
IV. Quality Control and Acceptance
(A) Inspection of Construction Quality
During the construction process, a strict quality inspection system should be established. From the incoming inspection of building materials to the quality acceptance of each construction process, detailed records should be kept. For parts that do not meet the quality requirements, timely rectification should be carried out to ensure that the construction quality of the entire workshop reaches the design standard. For example, the flatness and sealing of the walls in the clean area should be regularly inspected, and the welding quality of the pipes should be nondestructively tested.
(B) System Verification and Acceptance
After the completion of construction, the entire antibiotic workshop should be subjected to system verification and acceptance. This includes aspects such as cleanliness verification, equipment performance verification, and production process verification. By simulating the production process, it is detected whether the workshop can stably produce antibiotic products that meet the quality standards. Only after passing the strict verification and acceptance procedures can the workshop be officially put into use, providing reliable guarantees for pharmaceutical production.
Guangzhou Kunling Purification Equipment Co., Ltd., relying on its professional team and advanced technology, has always adhered to high quality and high standards in the design and construction of antibiotic workshops, contributing to the development of the pharmaceutical industry. We will continue to work hard to create higher-quality, safer, and more efficient antibiotic production workshops for our clients.
Contact
Leave your information and we will contact you.