Biosafety Laboratory Construction History
I. Construction Management of Biosafety Laboratory
The construction of high-level biosafety laboratories in my country mainly involves the following competent departments: the National Development and Reform Commission and the Ministry of Science and Technology are responsible for project planning, project establishment and approval;
Text label: biological laboratory, biosafety laboratory, laboratory construction

Biosafety Laboratory Construction History


I. Construction Management of Biosafety Laboratory


The construction of high-level biosafety laboratories in my country mainly involves the following competent departments: the National Development and Reform Commission and the Ministry of Science and Technology are responsible for project planning, project approval and approval; the environmental protection department is responsible for the project EIA, the National Health Commission and the Ministry of Agriculture and Rural Affairs It is the competent business department, the Ministry of Housing and Urban-Rural Development that formulates construction and acceptance standards, and the China National Accreditation Service for Conformity Assessment is responsible for the certification and accreditation management of biosafety laboratories. In terms of activity qualification authorization and activity safety supervision, in September 2017, the State Council issued the 'Decision of the State Council on Cancelling and Approving Administrative Licensing Matters·2018)


my country's National Development and Reform Commission and the Ministry of Science and Technology jointly issued the 'High-level Biosafety Laboratory System Construction Plan (2016-2025)' (hereinafter referred to as the 'Plan') in November 2016. The importance of biosafety laboratory system construction planning, summarizing the construction achievements that have been achieved, and also summarizing the shortcomings of laboratory construction and management. The development goals for the construction of high-level biosafety laboratories in China in recent years are put forward: 'By 2025, a national system of high-level biosafety laboratories with reasonable layout and network operation will be formed. First, China's high-level biosafety laboratory system will be built. In accordance with the principles of regional distribution, complete functions and outstanding features, a construction layout of 5 to 7 fourth-level laboratories will be formed. On the basis of making full use of the existing third-level laboratories, a new batch of third-level laboratories (including mobile third-level laboratories) will be built. Laboratory), to achieve the goal of having at least one third-level laboratory in each province. With the fourth-level laboratory and the non-profit third-level laboratory as the main components, other non-public third-level laboratories and biosafety protection facilities are absorbed. A national high-level biosafety laboratory system has been established. Second, the management and operation and maintenance, technology development, standard formulation, evaluation and certification, and application guidance capabilities have been significantly improved. Third, the level of international scientific and technological cooperation has been significantly improved. 'The 'Plan' lists high-level experiments The specific key tasks of laboratory construction, including the construction planning of the fourth-level laboratory and the supervision and operation requirements of the third-level laboratory. On August 31, 2017, the former Ministry of Agriculture issued the 'Three-level Protection Standards for Biosafety of Veterinary Vaccine Production Enterprises' (Announcement No. 2573 of the Ministry of Agriculture of the People's Republic of China), and the biosafety protection conditions for veterinary vaccine production inspection should meet the requirements of veterinary vaccine production. The production workshops, animal rooms for inspection, quality inspection rooms, sewage treatment, live poison wastewater treatment facilities and protective measures that use the vaccine production enterprises' biosafety three-level protection requirements put forward the biosafety three-level protection requirements. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of microbiology laboratory, biosafety laboratory, clean laboratory and other supporting services.









Second, development status


my country's high-level biosafety laboratory has been constructed for more than ten years, from almost blank to today's beginning to take shape and system. As the most important hardware facility for biosafety, the construction of biosafety laboratories has achieved unprecedented development. As of July 2017, more than 70 biosafety laboratories have been accredited, including more than 50 high-level (level 3 and above) laboratories and more than 20 secondary laboratories. There are more than 50 accredited high-level biosafety laboratories, about 30 CDC systems, about 10 scientific research institutions or colleges, and some entry-exit inspection and quarantine systems. Geographically, the distribution is very uneven, distributed in 16 provinces and cities, most of which are concentrated in the eastern and southern regions, only 5 in the central provinces, 4 in the western provinces, and some provinces have not yet been built. Beijing has the highest concentration of 18; followed by Shanghai, Guangdong, Wuhan and other places, also more concentrated. As mentioned above, the number of tertiary laboratories registered in the United States in 2011 has reached 1,495. There is still a long way to go for laboratory construction and management in my country.


In general, at present, my country can fully rely on domestic technical strength in the engineering design and construction of high-level biosafety laboratories to achieve localization. Although there is a certain gap with developed countries in terms of details, the technical indicators have reached Requirements of various international and domestic standards. The current shortcoming is in some biosafety equipment, and the technical level and reliability of domestic products need to be further improved. For example, biological safety cabinets, independent ventilation cages (IVC) and animal feeding cages, etc., although they can be produced, but still need to further improve the quality; some large-scale equipment, such as large-scale sterilization equipment and animal carcass processing equipment that meet the needs of biosafety , sewage treatment equipment, etc., are still in the stage of trial production and research and development.
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Design and construction of cosmetic purification plant

According to the air quality requirements, the production workshop should be divided into clean area, quasi-clean area and general area according to the requirements of product process environment control; general area is the functional room or area without direct exposure of raw materials, inner packaging and semi-finished products ; The quasi-clean area is raw materials, internal...
Text label: Cosmetic purification plant, production workshop design, installation and construction

Design and construction of cosmetic purification plant


According to the air quality requirements, the production workshop should be divided into clean area, quasi-clean area and general area according to the requirements of product process environment control; general area is the functional room or area without direct exposure of raw materials, inner packaging and semi-finished products ; The quasi-cleaning area is the functional room or area where raw materials, inner packaging, etc. are exposed; the cleaning area is generally the functional room or area where the semi-finished product is exposed; The air quality in the container storage room should meet the 300,000-level cleanliness requirements; in view of the different air quality requirements in different cleanliness levels, the corresponding pressure difference should be maintained between the production areas of each level. The higher the cleanliness level, the higher the air pressure. For example, a certain positive pressure difference should be maintained between the clean area and the quasi-clean area, which is mainly to ensure that the air can always flow from the high-level clean area to the low-level clean area, otherwise it is likely to cause invisible cross-contamination; cosmetic purification plant production The control of temperature, humidity and relative humidity in the workshop should also meet the requirements of the product process. The company should formulate a pharmaceutical cleanroom environment monitoring plan and monitor it regularly so as to detect problems and take corrective measures in time; the waste gas and waste generated in the production process must also be effectively controlled and properly disposed of. , so that it will not pollute the product.


Enterprises should install lighting systems that meet various operating requirements according to different production operations, and provide enough lighting to facilitate employees' daily operations. Good lighting can effectively reduce quality risks caused by insufficient light, which is very important for nighttime production operations. It is particularly important; the mixed illuminance of the working surface of the production pharmaceutical cleanroom shall not be less than 220Ix, and the mixed illuminance of the working surface of the inspection site shall not be less than 450Ix; the lighting facilities of the enterprise shall also be able to prevent pollution from cracks and fragments, or take appropriate measures to protect the product. Pest pollution is also one of the common quality problems. Good control of the production environment can effectively reduce or even eliminate the possibility of pest pollution. Enterprises should establish written and effective rodent and pest control procedures and control plans, and production workshops should be equipped with effective rodent control procedures. Facilities where pests enter and gather, such as mosquito killers, mouse traps, and mouse-blocking boards, etc., and ensure that the on-site layout is reasonable; special personnel should be installed to clean, regularly inspect and monitor these facilities to ensure good working conditions; kill The installation position of the insect lamp should ensure that the light source does not directly face the door leading to the outdoors, so as to prevent the light from attracting insect pests. At the same time, food and other baits should not be placed in the indoor mousetrap to prevent the smell from attracting outdoor insects; Records should be kept of all cleaning, inspection and monitoring of pest facilities. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for cosmetic production workshops and purification plants.














The surface of the production equipment in direct contact with the product in the cosmetic purification plant should be flat, smooth, easy to clean, corrosion-resistant and easy to disinfect. The selected lubricant and cleaning agent shall not cause pollution to the product or container; the equipment that does not meet the requirements shall be In the long-term production process, it will react with the material, or be corroded by the material, causing the dissolved substances or the surface of the equipment to peel and fall off, causing pollution to the product. Therefore, all raw materials, equipment, pipes, tools and other materials that are in direct contact with the product should be Confirmed to ensure that no chemical contamination, microbiological contamination and physical contamination are introduced. Enterprises should arrange production equipment reasonably according to the production process requirements of cosmetic purification workshops and workshop layout requirements. Enterprises can install equipment in appropriate locations according to the size of the workshop, the flow of production processes, the direction and distance of material movement, etc. The workshop area ensures the normal operation of the equipment and meets the requirements of the production process; the placement of the equipment should avoid the impact of the movement of materials and equipment, and the movement of personnel on the quality, because the frequent movement of materials by personnel will cause material pollution, and the movement of personnel will also cause workshop particles. The increase in the number will affect the air quality of the pharmaceutical cleanroom, and the frequent movement of equipment will also affect the stability of the equipment.
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One of the important sources of pollution in the purification pharmaceutical cleanroom of cosmetics factories is the air environment. Therefore, the purification level of the workshop air should be controlled according to the requirements of the production process and product quality. In the cosmetics production environment, the air in the cosmetics filling workshop must be designed in accordance with GMP requirements. Design basis 1. 'Provisions on the Depth of Architectural Engineering Design Documents' (2008 Edition) 2. 'General Principles of Civil Building Design' GB50352-20053. 'Code for Fire Protection Design of High-rise Civil Buildings' GB50045-95 (2005 Edition) 4. 'National Civil Buildings' Technical Measures for Engineering Design - Architecture (2003 Edition) 5. 'Code for Design of Water Supply and Drainage in Buildings' GB50015-2003 (2009 Edition) 6. 'Code for Fire Protection in Architectural Design' GB50016-20067. 'Code for Design of Scientific Experiment Buildings' JGJ91-938 .'Code for Design of pharmaceutical cleanroom' GB50073-20139. 'Code for Construction and Acceptance of Architectural Decoration Engineering' JGJ73-9110. 'Standard for Quality Inspection and Evaluation of Construction Engineering' GBJ301-8811. 'Code for Construction and Acceptance of Clean Room' GB50591-201012. Party A Description of design task book and other normative construction plans 1. Functional division is conducive to the work of workshop personnel. The existing workshop is divided into 3 large functional areas. Located on the left and right lower sides of the corridor. The left workshop is: washing room, water treatment room, batching room, unpacking room, mixing room, filling room, bottle cleaning and disinfection room; the right pharmaceutical cleanroom is: washing room, batching room, unpacking room, mixing room, internal Packing room and finished product warehouse; the lower workshop is: outer packing room and finished product warehouse. The function of each room is displayed on the floor plan of each floor. 2. People and logistics personnel enter the clean room through the outside corridor, change shoes, change clothes, and enter the 100,000-level clean room after blowing in the air shower. Protective structure: The workshop is divided into upper and lower layers, the lower layer is the pharmaceutical cleanroom, and the ceiling height is 3.0m. The upper layer is the installation layer for pipes, lines and small equipment. This area has high requirements on the airtightness, thermal insulation and surface finish of the room. The enclosure materials are: a. The wall adopts high-grade steel keel and double-sided sandwich color steel plate (total thickness 50mm), and the inner surface of the masonry exterior wall is protected by high-grade steel keel and double-sided sandwich color steel plate. The height of the wall is the same as the upper surface of the ceiling, and the port is sealed flat. The rooms on the upper floor are interconnected for easy installation and construction. A large-area observation window is installed on the wall. Cosmetic workshop design b. The ceiling is made of high-quality steel keel and double-sided sandwich color steel plate. Under the ceiling is the pharma machinery, and above the ceiling is the installation layer of pipes and small pharma machinery. The suspenders are all 10mm diameter suspenders, and any suspenders with a length of more than 1.5m must be provided with reverse support. c. The ground adopts epoxy resin ground. d. The intersection angle between the wall and the ground adopts the same material as the ground to make a 5cm wide arc angle transition, and the intersection angle between the wall and the ceiling adopts the same homogenous arc angle transition as the wall. e. The door is a sandwich color steel plate door with observation window; the observation window on the wall is a single-layer tempered glass airtight type.
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Introduction

construction requires a meticulous approach, precision, and a deep understanding of the specific industry requirements. Whether it's for pharmaceuticals, electronics manufacturing, or food processing, cleanrooms are vital environments where contamination and particulate control are of utmost importance. In such highly regulated industries, the construction process must adhere to stringent standards and guidelines to ensure maximum efficiency and safety.

One of the most effective ways to simplify cleanroom construction is by opting for turn-key projects. Turn-key projects offer a comprehensive solution, handling everything from design and construction to validation and certification. This streamlined approach not only saves time but also eliminates the hassle of coordinating multiple contractors and vendors. In this article, we will delve into the various aspects of cleanroom construction simplified by turn-key projects.

The Importance of Construction

A cleanroom is a controlled environment designed to minimize the level of particles, pollutants, and other contaminants. Cleanrooms are utilized in various industries where product integrity, manufacturing processes, and human safety are critical. The importance of cleanroom construction lies in the need to maintain a highly controlled environment that adheres to strict standards, regulations, and guidelines.

construction goes beyond just creating a sterile space; it involves a holistic approach that takes into account the specific needs of the industry. Factors such as air filtration, temperature and humidity control, pressure differentials, and the choice of materials all play a crucial role in ensuring efficient functionality.

The Challenges of Construction

construction presents several challenges that necessitate careful planning and execution. Some of the common challenges include:

1. Compliance with Industry Standards and Regulations

Cleanrooms must comply with specific standards and regulations set by organizations such as ISO (International Organization for Standardization) and FDA (Food and Drug Administration). These standards dictate factors like air quality, particle counts, air change rates, and pressure differentials. Achieving compliance can be complex and time-consuming without proper expertise and experience.

2. Coordination of Multiple Contractors

Conventional construction projects often require coordination between multiple contractors and vendors, including architects, engineers, HVAC specialists, and electricians. Ensuring seamless communication and coordination among these different entities can be challenging, leading to delays and potential issues with the cleanroom's functionality.

3. Project Management and Timeline Adherence

construction projects have strict timelines, especially in industries where time-to-market is crucial. Failure to adhere to project timelines can have significant consequences, including delays in product development, testing, and manufacturing. Effective project management is crucial to ensure timely completion.

4. Validation and Certification

Once the cleanroom is constructed, it needs to go through a rigorous validation and certification process to ensure it meets the required standards. This process involves thorough testing and documentation to validate the cleanroom's performance and adherence to regulations.

How Turn-Key Projects Simplify Construction

Turn-key projects offer a comprehensive solution to overcome the challenges and complexities associated with cleanroom construction. This approach provides a single point of contact responsible for the entire construction process, from initial design to final certification. Here's how turn-key projects simplify cleanroom construction:

1. Streamlined Project Management

With turn-key projects, a dedicated project manager oversees the entire construction process, ensuring seamless communication and coordination among all stakeholders. This streamlined project management approach minimizes delays, allows for quick decision-making, and ensures the project stays on track.

The project manager effectively manages the timeline, budget, and resources, keeping all parties informed throughout the construction process. This centralized approach enables efficient problem-solving and reduces the chances of miscommunication or conflicting instructions.

2. Compliance with Standards and Regulations

Turn-key projects focus on compliance with industry standards and regulations right from the design phase. The project team comprises experts who are well-versed in the intricacies of cleanroom construction and are up-to-date with the latest standards and guidelines.

From air quality control to pressurization systems, every aspect is meticulously planned and executed to ensure compliance with the required regulations. This expertise ensures that the cleanroom meets the necessary standards without any compromises.

3. Efficient Resource Utilization

Turn-key projects optimize the utilization of resources, both in terms of budget and materials. By having a dedicated team in charge of procurement, the project manager can source the required materials and equipment at competitive prices. This eliminates the need for individual contractors to source their own materials, potentially leading to cost savings.

Furthermore, the project team ensures efficient utilization of available floor space, considering aspects such as workflow, pharma machinery placement, and personnel movement. This optimization maximizes the cleanroom's functionality while minimizing wasted space and unnecessary expenses.

4. Turn-Key Solutions from Start to Finish

Turn-key projects encompass the entire cleanroom construction process, starting from conceptualization and design to final validation and certification. The project team collaborates closely with the client to understand their specific requirements and develop a tailored solution.

The team takes care of architectural design, HVAC systems, electrical installations, cleanroom equipment, and furniture. This comprehensive approach ensures a cohesive and well-integrated pharma clean room, eliminating potential coordination issues between different contractors.

5. Faster Time to Market

By streamlining the construction process and leveraging expertise, turn-key projects significantly reduce the time required for cleanroom construction. The streamlined project management, proactive planning, and efficient resource utilization enable faster completion of the project.

This reduction in construction time ultimately translates into a faster time to market for products, critical in industries where staying ahead of the competition is vital. Quicker time to market allows companies to meet customer demands promptly, leading to increased customer satisfaction and market share.

Conclusion

construction is a complex undertaking, requiring adherence to strict standards and regulations while meeting industry-specific requirements. Turn-key projects simplify cleanroom construction by providing a comprehensive solution that handles every aspect, from design and construction to validation and certification.

With turn-key projects, project management becomes streamlined, ensuring efficient coordination and communication among all stakeholders. Compliance with industry standards and regulations is prioritized, and resources are optimized to maximize efficiency. Additionally, turn-key projects offer a faster time to market, enabling companies to meet customer demands promptly and gain a competitive edge.

Opting for a turn-key approach not only simplifies cleanroom construction but also minimizes risks, ensures compliance, and accelerates the overall project timeline. Whether it's a pharmaceutical cleanroom or a semiconductor manufacturing facility, considering a turn-key project can be the key to a successful and hassle-free cleanroom construction.

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