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Design and installation of clean pharma machinery system

The clean laboratory air supply has at least three stages of filtration, initial, medium and high efficiency, and the high-efficiency filter should be set at the end of the system. The air filter is the most important equipment in the air cleaning system. There are three types of filters. Class: primary filter, medium efficiency filter, high efficiency filter...
Text label: clean laboratory system, laboratory design and installation

Clean laboratory system design and installation


The clean laboratory air supply has at least three stages of filtration, initial, medium and high efficiency, and the high-efficiency filter should be set at the end of the system. The air filter is the most important equipment in the air cleaning system. There are three types of filters. Class: primary filter, medium-efficiency filter, high-efficiency filter or sub-high-efficiency filter; primary-efficiency filter is mainly to block settled dust particles and various foreign bodies with a particle size of more than 10 microns; medium-efficiency air filter first Filter out dust of 1-10 microns; high-efficiency filters are mainly used to capture particulate dust and various suspended solids below 0.5 μm, as the end filter of various filtration systems, using ultra-fine glass fiber as filter material, offset paper, The aluminum foil board and other materials are folded as a separator, sealed with a new type of polyurethane sealant, and made of galvanized sheet, stainless steel sheet, and aluminum alloy profile as the outer frame. The clean laboratory should have sufficient air supply for purification and air conditioning; the necessary pressure gradient, positive pressure gradient or negative pressure gradient should be maintained; there should be a reasonable airflow organization.


The laboratory must maintain a certain temperature and airflow, and the experimental area should maintain a negative pressure relative to the corridor and non-experimental area; in the design of the laboratory, not only the flow direction of the airflow, but also the flow rate, different cleanliness levels or different functions should be considered The pressure difference in the room is usually 5-10Pa, and the pressure difference between different functional rooms adjacent to the biosafety laboratory is usually 10-15Pa. The route of personnel and logistics should be fully considered to minimize the backflow and eddy current of indoor air to avoid pollution. If there are no special requirements, the temperature should be 18-26℃ and the relative humidity should be 45-65%; The static pressure difference between non-clean rooms should be greater than 10pa, the pressure difference between adjacent clean rooms with different cleanliness levels should be greater than 5pa, and the pressure difference between clean area and outdoor should be greater than 12pa; The measured air volume and the number of air changes should be greater than the respective design air volume or air change number, but should not exceed 20%, and the difference between the air volume of each indoor air outlet and the design air volume of each air outlet should not exceed ±15% of the design air volume; one-way flow The average wind speed measured in the clean room should be greater than the design wind speed, but should not exceed 15%; the illumination in the clean area without lighting is 200Ix-500Ix, and the auxiliary room, personnel purification and material purification room, airlock room, corridor, etc. should be 150Ix -300
Ix, GMP regulations are not less than 300Ix; the noise of non-unidirectional flow clean room should not be greater than 60dB(A) in the empty state of clean room, and the noise of unidirectional flow and mixed flow clean room should not be greater than 65dB(A) ; Generally, the self-cleaning time of a one-way flow clean room is better within 10 minutes, and the self-cleaning time of a non-one-way flow clean room should be no more than 30 minutes. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean laboratories and sterile laboratories.














In order to prevent the pressure difference from reversing in the clean laboratory, the blower can only be turned on after the exhaust air of the biosafety clean room is turned on, and the exhaust fan can only be turned off after the blower is stopped first. Air supply fans; independent air supply and exhaust systems should be used to prevent cross-infection of aerosols; negative pressure clean benches should be used for reagent preparation, specimen processing, and experimental devices in the parts that generate harmful gases; the setting of air-conditioning room directly affects the project cost and noise. Therefore, the layout of the computer room should be considered uniformly in the design stage of the plane plan. It is best to purify the air-conditioning computer room close to the clean room that requires air supply, and strive to keep the air duct line short, but it is also required to prevent noise and vibration. Separation from the clean room, both aspects should be considered.
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Cleanrooms are a critical component of many industries that require sterile and contamination-free environments. These environments are essential for various industries, such as pharmaceuticals, electronics, biotechnology, and scientific research. Cleanrooms require workers to don protective clothing, including cleanroom suits, to minimize contamination from people and their clothing. These suits can get hot, and it leads to the question, does it get hot in a cleanroom suit? In this article, we will explore the factors that contribute to the temperature in a cleanroom suit, how to manage heat in cleanroom suits, and the benefits of using a well-ventilated cleanroom suit.

What are Cleanroom Suits?

Cleanroom suits are specially designed clothing that serves to protect workers from contaminating the cleanroom environment. The suits are typically designed to be worn over regular clothing and consist of a jumpsuit, hood, gloves, and boot covers. The suits are made from non-shedding material and are able to keep contamination from the worker's body, such as skin flakes or hair, from entering and damaging the cleanroom.

What Causes Heat in Cleanroom Suits?

Cleanroom suits are made from materials designed to be non-shedding and provide a barrier between the worker and the cleanroom environment. The materials used in the suits are typically synthetic and do not allow air to escape or enter the suit. Therefore, the temperature inside the suit can become increasingly hot during long working hours.

The temperature in cleanroom suits can also be affected by external factors, such as the temperature and humidity level of the cleanroom itself. If the cleanroom requires a higher temperature, it may cause a rise in the temperature inside the suit, making it even more uncomfortable for the wearer.

How to Manage Heat in Cleanroom Suits

Heat in cleanroom suits can be managed by using well-ventilated suits or incorporating cooling technologies into the suits. Several strategies can be implemented to manage heat in cleanroom suits, and some of them include:

1. Using Well-Ventilated Cleanroom Suits: Well-ventilated cleanroom suits provide better air flow and cooling, reducing heat build-up inside the suit. Ventilated cleanroom suits are made from a breathable fabric that allows air to flow in and out, keeping the wearer cooler and more comfortable.

2. Incorporating Cooling Technologies: The use of cooling technologies, such as cooling vests or water-based cooling systems, can also be incorporated into the cleanroom suits. These technologies help to regulate the temperature inside the suit and keep workers comfortable during long working hours.

3. Wearing Lighter Weight Suits: Since cleanroom suits are designed to be non-shedding, thicker suits can trap more heat, making it uncomfortable for the wearer. Opting for lighter weight suits can help reduce heat build-up, resulting in a more comfortable work environment.

4. Taking Frequent Breaks: Cleanroom workers can take frequent breaks to leave the cleanroom environment and cool down, reducing the build-up of heat inside the suit.

5. Hydrating Frequently: Cleanroom workers can also hydrate frequently to help regulate their body temperature and reduce the risk of heat-related illnesses.

Benefits of Using a Well-Ventilated Cleanroom Suit

Using a well-ventilated cleanroom suit has several benefits, such as:

1. Improved Comfort: Well-ventilated cleanroom suits are designed to provide better air flow and cooling, reducing heat build-up inside the suit. This results in improved worker comfort, making their work environment more tolerable.

2. Increased Productivity: A comfortable work environment reduces distractions and discomfort, increasing worker productivity and efficiency.

3. Reduced Risk of Heat-Related Illnesses: Heat-related illnesses can be a significant concern for workers in hot environments. Using a well-ventilated cleanroom suit helps to regulate the temperature inside the suit, reducing the risk of heat-related illnesses.

4. Improved Safety: A more comfortable and cooler work environment can result in fewer distractions, ultimately improving the worker's focus, and reducing the risk of accidents.

Conclusion

Cleanroom workers need to be protected from contamination, and cleanroom suits are an essential component of that protection. The materials used in cleanroom suits can cause heat build-up, making it uncomfortable for workers. Strategies such as using well-ventilated suits or incorporating cooling technologies, can help manage this issue, resulting in improved worker comfort and productivity. Ultimately, cleanroom workers are critical components of many industries, and it is essential to provide them with a comfortable and safe work environment.

Introduction:

construction plays a crucial role in ensuring compliance in pharmacy operations. These specialized environments are essential for maintaining the sterility and safety of pharmaceutical products. Designing and constructing a pharmacy cleanroom requires careful consideration of various factors to meet regulatory requirements and ensure optimal functionality. This article explores key considerations for achieving compliance in pharmacy cleanroom construction, covering crucial aspects such as environmental controls, workflow optimization, personnel training, and ongoing monitoring.

The Role of Environmental Controls

Efficient environmental controls are vital in pharmacy cleanroom construction to maintain clean air quality, temperature, humidity, and pressure differentials. Cleanrooms must adhere to specific ISO standards, such as ISO 14644-1, which outlines particle count limits for various pharma clean room classifications. The classification of a pharmacy cleanroom depends on the type of compounding activities performed and the level of sterility required.

To achieve compliance, cleanroom construction should integrate a robust HVAC system designed to generate laminar airflow and minimize contamination risks. HEPA (High-Efficiency Particulate Air) filters should be strategically positioned to ensure maximum particle removal. The selection and placement of air vents, return ducts, and exhaust systems are critical for maintaining proper air circulation and minimizing the risk of cross-contamination.

Noise control is another important consideration in cleanroom design. Pharmacy cleanrooms often house sensitive equipment that can be negatively affected by excessive noise. Experts recommend incorporating soundproofing materials and configuring HVAC systems for quieter operation, promoting a conducive working environment for pharmacy personnel.

Optimizing Workflow Efficiency

Efficient workflow design is crucial for achieving compliance in pharmacy cleanrooms. Considerations should be given to the layout, design, and functionality of the workspace to enhance productivity and minimize the risk of errors. The following points should be addressed when optimizing workflow efficiency:

1. Segregation of Areas

Segregating different areas based on their cleanroom classification and purpose is vital to prevent contamination and cross-contamination. A well-designed pharmacy cleanroom should include separate spaces for receiving, storage, compounding, packaging, and waste disposal.

The receiving area is where incoming supplies and medications are inspected and sanitized before entering the cleanroom. It should be equipped with proper storage facilities, such as refrigerators and freezers, to maintain the integrity of temperature-sensitive products.

Compounding areas should be organized based on the type of compounding performed, such as non-hazardous sterile compounding (NHC) or hazardous sterile compounding (HSC). Adequate space should be allocated for essential pharma machinery, ensuring smooth workflow without unnecessary clutter.

Packaging areas require proper working surfaces for labeling, sealing, and packaging medications. Strict adherence to good manufacturing practices (GMP) is necessary to ensure accurate and safe packaging.

2. Ergonomic Considerations

Creating a pharmacy cleanroom environment that prioritizes ergonomics is vital for employee health and productivity. Repetitive tasks, prolonged standing, and poor posture can lead to musculoskeletal disorders among pharmacy personnel. Therefore, workstation height, adjustable seating, and adequate footrests should be considered during cleanroom construction.

Efficient handling and storage systems, such as automated vertical carousels or robotic retrieval systems, can minimize reaching, bending, and lifting, reducing the risk of injuries and improving workflow efficiency.

Personnel Training and Qualification

The success of a pharmacy cleanroom heavily relies on the competency and expertise of the personnel working within it. Comprehensive training and qualification programs should be implemented to ensure compliance with regulatory standards and best practices.

1. Training Programs

Training programs should cover a wide range of topics, including cleanroom behavior, aseptic techniques, hand hygiene, gowning procedures, hazardous material handling, and proper cleaning methods. Personnel must understand the importance of maintaining the cleanroom's integrity and actively work towards minimizing contamination risks.

Ongoing training should be provided to keep staff updated on the latest industry regulations, technological advancements, and best practices. Regular assessments and evaluations should be conducted to verify the knowledge and competency of pharmacy personnel.

2. Qualification and Certification

Pharmacy cleanroom personnel should meet specific qualification requirements, such as obtaining certification in sterile compounding and aseptic technique. This ensures the individuals possess the necessary knowledge and skills to perform their duties safely and effectively.

Certification programs offered by reputable organizations, such as the Pharmacy Compounding Accreditation Board (PCAB), provide a standardized framework for assessing an individual's competence in sterile compounding. personnel should undergo these certifications periodically to maintain their qualifications and stay updated on evolving industry practices.

Ongoing Monitoring and Maintenance

Once the pharmacy cleanroom construction is complete, ongoing monitoring and maintenance are crucial to ensure sustained compliance and optimal functionality.

1. Environmental Monitoring

Routine environmental monitoring involves assessing critical parameters, such as airborne particle counts, temperature, humidity, and pressure differentials. Automated monitoring systems can track these parameters continuously and provide real-time alerts if any deviations occur. Regular monitoring ensures early detection of potential issues and allows for prompt corrective actions to maintain compliance.

Calibration of monitoring equipment should be performed periodically to ensure accurate data collection. Additionally, documenting and maintaining records of monitoring results is essential for regulatory inspections and audits.

2. Preventive Maintenance

A comprehensive preventive maintenance program is essential to keep the cleanroom and associated equipment in optimal condition. Regular inspection, cleaning, and testing of equipment, such as laminar flow hoods and HEPA filters, are critical to ensure their proper functioning.

surfaces should be adequately cleaned and disinfected using appropriate agents and procedures to prevent microbial growth and maintain cleanliness standards.

Summary:

Achieving compliance in pharmacy cleanroom construction requires careful consideration of key factors, such as environmental controls, workflow optimization, personnel training, and ongoing monitoring. A well-designed cleanroom must adhere to strict standards, maintain efficient environmental controls, and optimize workflow efficiency to mitigate contamination risks and enhance productivity. Comprehensive training programs and qualifications for cleanroom personnel are crucial to ensure adherence to proper aseptic techniques. Ongoing monitoring and maintenance further contribute to sustained compliance and optimal functionality. By incorporating these considerations, pharmacy cleanrooms can provide a safe and sterile environment for compounding medications and contribute to overall patient safety.

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Introduction

Shipping containers have long been used as a convenient and cost-effective solution for transporting goods across the globe. However, their applications are not limited to just transportation. In recent years, there has been a growing trend of repurposing shipping containers into cleanrooms, which are controlled environments used for manufacturing and scientific research. This innovative approach offers a multitude of benefits, including flexibility, scalability, and portability. In this article, we will explore five innovative ways to utilize shipping container cleanrooms and how they can revolutionize various industries.

Creating On-site Facilities

Shipping Container Cleanrooms: A Game-Changer for On-site Lab Facilities

Operating an on-site laboratory can be a logistical challenge, especially in remote or hard-to-reach locations. Traditional construction methods can be time-consuming and expensive, making it impractical for many businesses. However, by utilizing shipping container cleanrooms, companies can overcome these limitations and set up fully functional laboratories in a fraction of the time and cost.

Shipping container cleanrooms are equipped with advanced air filtration systems, temperature control, and wall paneling with excellent insulation properties. These features create a controlled environment suitable for conducting various laboratory activities, such as chemical analysis, product testing, and research experiments. The flexibility of shipping container cleanrooms allows businesses to customize the interior layout according to their specific needs, ensuring optimal workflow and efficiency.

Moreover, shipping container cleanrooms provide the advantage of portability. They can be easily transported to different locations, making them an ideal solution for companies that need to establish temporary or mobile laboratories. Whether it is for environmental surveys, medical research in remote areas, or disaster response teams, shipping container cleanrooms offer a versatile and accessible option for on-site lab facilities.

Streamlining Pharmaceutical Manufacturing

Revolutionizing Pharmaceutical Manufacturing with Shipping Container Cleanrooms

The pharmaceutical industry requires stringent quality control measures to ensure the safety and efficacy of drugs. Traditional cleanrooms used in pharmaceutical manufacturing can be expensive to construct, maintain, and update. Here is where shipping container cleanrooms offer a game-changing solution.

By repurposing shipping containers into cleanrooms, pharmaceutical companies can significantly reduce costs and enhance operational efficiency. The modular design of shipping containers allows for quick assembly and easy integration into existing facilities or as standalone units. Companies can expand their manufacturing capacity by adding more cleanrooms when needed, without disruptive construction work.

Shipping container cleanrooms are equipped with advanced air handling units that provide effective particulate control and precise temperature and humidity regulation. These controlled environments not only ensure high product quality but also reduce the risk of contamination, allowing pharmaceutical companies to comply with the strict regulatory requirements. Furthermore, shipping container cleanrooms can be designed to meet Good Manufacturing Practice (GMP) guidelines, offering a controlled and compliant environment for pharmaceutical manufacturing.

Accelerating Aerospace Research and Development

Shipping Container Cleanrooms: A New Frontier for Aerospace R&D

Research and development in the aerospace industry demand controlled environments to simulate various conditions encountered during flights. Traditional cleanrooms built for aerospace R&D can be costly to maintain, limit flexibility, and may not be feasible for small-scale projects. Shipping container cleanrooms, on the other hand, provide an innovative solution that addresses these challenges.

Utilizing shipping containers as cleanrooms, aerospace companies can create controlled environments suitable for testing propulsion systems, electronics, and experimental materials. The modular design allows for easy installation of specialized pharma machinery, such as vibration tables or thermal chambers, to replicate extreme conditions. Additionally, shipping container cleanrooms provide adequate insulation to minimize sound and electromagnetic interference, ensuring accurate test results.

The portability of shipping container cleanrooms offers aerospace researchers the ability to conduct experiments in different locations, such as remote areas or temporary testing sites. This flexibility enables rapid prototyping, iterative design processes, and collaboration between different research teams. By leveraging shipping container cleanrooms, the aerospace industry can enhance its research capabilities and accelerate technological advancements at a reduced cost.

Enabling Efficient Data Center Construction

Transforming Data Center Construction with Shipping Container Cleanrooms

Data centers form the backbone of modern information technology infrastructure, demanding precise environmental conditions to safeguard costly pharma machinery. Traditional data center construction can be expensive, time-consuming, and inflexible in accommodating technology advancements. Shipping container cleanrooms offer an innovative approach to overcome these challenges.

By repurposing shipping containers into cleanrooms, data center operators can significantly reduce construction costs and time. The modular design allows for quick deployment and scalability as the demand for data processing and storage increases. Shipping container cleanrooms are equipped with effective thermal management systems that ensure optimal operating temperatures for electronic pharma machinery, minimizing energy consumption and cost.

Moreover, the flexibility of shipping container cleanrooms enables their integration into unconventional spaces, such as warehouses, unused parking lots, or rooftops. This adaptability enables data center operators to utilize existing infrastructure efficiently, reducing the need for large-scale construction projects. Shipping container cleanrooms also offer the advantage of mobility, allowing for relocation if needed. This feature is particularly useful for temporary data centers during special events or disaster recovery scenarios.

Enhancing Agricultural Research and Vertical Farming

Shipping Container Cleanrooms: Cultivating the Future of Agriculture

With the increasing demand for sustainable food production and limited arable land, agricultural research and innovation have become crucial. Shipping container cleanrooms present a unique opportunity to enhance agricultural research and enable vertical farming in urban areas.

By transforming shipping containers into cleanrooms, agricultural researchers can create controlled environments for studying plant growth, optimizing crop yield, and developing new agricultural techniques. The advanced air filtration systems in shipping container cleanrooms prevent the entry of pests and diseases, reducing the need for pesticides and herbicides. Additionally, the precise control over temperature, humidity, and lighting promotes efficient plant growth and allows for year-round cultivation.

The modular nature of shipping container cleanrooms enables vertical farming, where multiple cleanrooms can be stacked to maximize space utilization. Vertical farming offers a solution for growing crops in urban environments with limited land availability. It also provides the opportunity for localized food production, reducing transportation costs and the carbon footprint associated with long-distance food distribution.

Conclusion

Shipping container cleanrooms offer a highly versatile and innovative solution to various industries. From creating on-site laboratories to revolutionizing pharmaceutical manufacturing, accelerating aerospace research, enabling efficient data center construction, and enhancing agricultural research, the possibilities are vast. The modular and portable nature of shipping container cleanrooms provide businesses with the flexibility to adapt quickly to evolving needs and locations, while significantly reducing costs compared to traditional construction methods. As industries continue to seek efficient, cost-effective, and sustainable solutions, the utilization of shipping container cleanrooms is set to become increasingly prevalent, driving innovation and progress in multiple sectors.

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