What is the Bag In Bag Out – BIBO?
Cleanroom BIBO involves the use of airlocks, BIBO units, filters, HEPA filters, exhaust fans, and personal protective equipment (PPE). An airlock is a chamber that provides an intermediate area between the cleanroom and the external environment. It allows people and materials to enter or leave the cleanroom without contaminating it. BIBO units are special containers designed to hold contaminated materials such as gloves, garments, and tools. Filters and HEPA filters are used to remove contaminants from the air, while exhaust fans ensure that the air flows out of the cleanroom.
Advantages of Cleanroom BIBO
Cleanroom BIBO offers many benefits, including minimizing cross-contamination, reducing worker exposure to hazardous materials, preventing outside contamination, and ensuring compliance with regulatory requirements. By minimizing cross-contamination, it ensures the purity of the products being produced in the cleanroom. It also protects workers from exposure to hazardous materials and prevents outside contamination from entering the cleanroom, which could compromise the production process. Finally, Cleanroom BIBO ensures compliance with regulatory requirements, which is critical in industries where the production of sensitive materials is subject to strict regulations.
Cleanroom BIBO Standards
Cleanroom BIBO must comply with several standards to ensure the maintenance of a clean environment. These standards include standards for air cleanliness, air flow, and pressure differentials. Air cleanliness standards specify the maximum number of particles of a given size allowed per cubic meter of air. Air flow standards ensure that air flows from clean areas to less clean areas and prevent the accumulation of contaminants. Pressure differentials standards ensure that air flows from high-pressure areas to low-pressure areas, preventing the entry of contaminants from the outside environment.
Types of Cleanroom BIBO
Cleanroom BIBO comes in different types, including single bag BIBO, double bag BIBO, flexible bag BIBO, and rigid bag BIBO. Single bag BIBO involves placing contaminated materials in a single bag, which is then sealed and removed from the cleanroom. Double bag BIBO involves placing the contaminated bag in a second bag, which is then sealed and removed from the cleanroom. Flexible bag BIBO involves using a flexible bag, which is more suitable for handling irregularly shaped objects. Rigid bag BIBO involves using a rigid container, which is more suitable for handling sharp or heavy objects.
Maintenance and Certification of Cleanroom BIBO
To ensure the effectiveness of Cleanroom BIBO, it is essential to maintain and certify the equipment regularly. Cleaning and maintenance involve regular cleaning of the equipment, including filters, BIBO units, and exhaust fans. Certification and validation involve testing the equipment to ensure that it meets the required standards. Troubleshooting involves identifying and resolving any issues that arise during the operation of the equipment.
Bag In Bag Out – BIBO Technical Index
1. Filter Efficiency: The filtration rate for 0.3um particles is ≥99.97%.
2. Air Tightness: At a pressure of ±3500Pa, the amount of air leakage from the chamber per hour does not exceed 0.25% of the net volume of the chamber.
3. Pressure Endurance: Under continuous -2500Pa pressure for 60 minutes, there is no permanent structural deformation, and it meets the requirements of the exhaust device standard.
4. Leak Detection Method: Manual or automatic scanning leak detection.
5. Uniformity of Aerosol Distribution in Upstream Filter Detection: There are 9 evenly distributed measuring points on the cross-section directly adjacent to the upstream filter, and the aerosol concentration at any point does not deviate from the average by more than ±20%.
6. Filter Replacement Method: After in-situ gas sterilization of the interior of the chamber, the filter is replaced by being pressed on all four sides and using a bag-in-bag-out method, which is safe and convenient.
7. Corrosion Resistance: Made of 304 stainless steel, it is resistant to disinfectants, cleaning agents, acids, alkalis, and other chemical reagents.
Different Airflow Design For BIBO
Definition of BIBO Filter Section
The filter section refers to the number of filter units that the airflow passes through as it enters and exits the filter section, across the cross-sectional area of the inlet (e.g. 1, 2, 3 units). Up to 8 filter units can be assembled in a single filter section.
Bag In Bag Out - BIBO Unit Types
BIBO Material Selection and Key Parameters
When choosing BIBO equipment, it is important to consider the key parameters and functional requirements. The standard module has three airflow options: 1700m³/h, 3400m³/h, and 4250m³/h. These can be combined in various ways depending on the required airflow.
In terms of the material and construction of the equipment housing, it is recommended to use high-quality 304 stainless steel or cold-rolled sheet metal with a thickness of at least 2.0mm. All pressure-bearing joints and seams should be continuously welded with no air gaps, ensuring the equipment can withstand a pressure differential of up to ±2500pa.
Linear scanning – involves scanning the entire air outlet cross-section of the filter as a whole, and docking with an external scanning port. During the scanning process, the entire sampling head is in operation. This method is simple in structure, has a fast scanning time, and is efficient, so it is widely used in the market.
Row-by-row scanning – involves using four corresponding sampling heads for the entire air outlet cross-section of the filter, and docking with four external scanning ports during the scanning process. Only one of the sampling heads samples at a time, while the other three are not in operation. For example, if the 2nd sampling head samples, the 1st, 3rd, and 4th sampling heads do not operate, and so on to complete one set of scanning. This method has a complex process, longer scanning time, and high accuracy.
BIBO Inspection Items
- Pressure Capacity: The box body can withstand a pressure of -2500Pa for 60 minutes without cracking or permanent structural deformation. The device must also meet the requirements of the exhaust device standard (JG/T497-2016) for pressure capacity. BIBO does not deform under -2500Pa pressure. The structure can be adjusted according to the customer’s pressure capacity requirements.
- Air Tightness: The measured device must have a measured air tightness of not less than +3600Pa and -3600Pa pressure, and it should meet the evaluation technical specifications and exhaust device standards (the minute leakage rate of the pipeline-type exhaust high-efficiency filtration device should not exceed 0.1% of the net volume of the device at 1000Pa pressure) or the client’s requirements (the hourly leakage rate should not exceed 0.20% of the net volume). It must comply with the air tightness requirements of JG/T497-2016, and BIBO should still satisfy the 0.1%min-1 net volume of the device under -1000Pa pressure.
- Upstream Aerosol Uniformity: The measured device uses a high-efficiency filter for pre-filtration on the upstream and artificially creates dust from dust holes reserved upstream of the device. Nine test points are uniformly arranged on the upstream side of the device’s filter, and each test point is sampled sequentially. The deviation of the aerosol concentration test results of all nine measurement points from the arithmetic mean of each measurement point should not exceed ±20%, meeting the requirements of the exhaust device standard and laboratory specifications.
- Leak Detection Effectiveness: Using a stainless steel needle (0.7 (22G) gauge) that conforms to the requirements of GB/T18457-2015 “Stainless Steel Needle for Manufacturing Medical Devices” with a normal wall, three artificial leaks with an inner diameter of 0.390mm were manually created on the reference filter. The measured device should be able to identify the artificial leaks during the scanning leak detection process and accurately locate the leak position, meeting the requirements of the exhaust device standard.
- Disinfection Detection: Disinfectant is injected from the injection port, and there are eleven reserved locations in the box body, including the upper and lower corners, the center of the side wall of the box body, the center of the scanning mechanism, and the upper and lower sides behind the high-efficiency filter. The disinfection test uses thermo-tolerant and rod-like bacteria (ATCC 7953) spore tablets (5*10^3 CFU/tablet-5*10^6). One hydrogen peroxide disinfection machine (model: VHP VICTORY, serial number L0210017-01) is added to the hydrogen peroxide disinfectant (model PB006, batch number PE058M) to a depth of 35%. The high-efficiency filter unit disinfection port is connected, and a disinfection cycle is run (disinfection time is 3240 minutes, injection speed is 5g/min, the average concentration is 398.8ppm, and the air volume is 3500m^3/h). The test results of three runs are negative, meeting the requirements of the 2002 version of the “Disinfection Technical Specifications.”
- Biological safety sealed valve: Size: DN100-DN800; Square valves can be customized according to customer size; Material: Valve body (SUS304) / Sealing ring ([TFE/silicone]); Operation mode: Manual, electric, pneumatic; Surface treatment: Drawing, sandblasting; The air tightness test results show that the measured device meets the commissioning party’s requirements for leakage rate under no less than +3000Pa (not more than 0.2% of the net volume of the device). The specific test results are shown in the table (the measured value is 0.02%), which meets the ISO10648-2 standard. After 5000 switches, the leakage rate under 2500Pa still meets the requirement of 0.2%h-1 of the net volume.
- U-shaped sealing strip: Material: Silicone; Temperature range: -60-350 °C. It has the ability to resist oxidation, disinfectant corrosion, ozone, hydrogen peroxide, etc. The sealing strip has testing reports of CNAS and SGS qualifications.
- Safety bag: Size: L=2m (usually); the length can also be customized according to customer needs. Material: PVC/polymer; Temperature range: -40/115 °C. It has the ability to resist oxidation, disinfectant corrosion, ozone, hydrogen peroxide, etc.
Cleanroom Bag In Bag Out (BIBO) is an essential component of a cleanroom, ensuring the maintenance of a clean environment during the production of sensitive materials. Cleanroom BIBO involves the use of airlocks, BIBO units, filters, HEPA filters, exhaust fans, and PPE. The procedure involves four stages: preparation, entering the cleanroom, bagging out contaminated items, and exiting the cleanroom. Cleanroom BIBO offers many benefits, including minimizing cross-contamination, reducing worker exposure to hazardous materials, preventing outside contamination, and ensuring compliance with regulatory requirements. Cleanroom BIBO must comply with several standards, including standards for air cleanliness, air flow, and pressure differentials. Cleanroom BIBO comes in different types, including single bag BIBO, double bag BIBO, flexible bag BIBO, and rigid bag BIBO. To ensure the effectiveness of Cleanroom BIBO, it is essential to maintain and certify the equipment regularly.
Youth’s BIBO products have several advantages as a manufacturing company, including:
Building block design: The BIBO filter can adapt the design of a single filter or double filter system: a single filter is equipped with only one HEPA filter, and double is the HEPA filter with a primary filter. This design allows for customization and flexibility to meet the specific needs of different customers.
Safe replacement filter: The BIBO safe replacement filter box is specially designed to prevent the leakage of harmful particles during the process of replacing the filter material, which effectively prevents secondary air pollution. This ensures the safety of the replacement personnel and the surrounding environment.
Wide range of applications: Youth’s BIBO products can be used in a variety of settings, including medical care, pharmaceutical plants, microelectronics plants, the nuclear industry, and biochemical laboratories. This allows the company to serve a diverse range of customers.
High-quality materials: Youth’s BIBO products are made using high-quality materials, such as stainless steel and polyethylene, which are durable and resistant to corrosion. This ensures that the products have a long service life and can withstand the demands of various environments.
Expertise and experience: As a manufacturing company, Youth’s BIBO has expertise and experience in the field of air filtration and purification. This allows the company to provide high-quality products and excellent customer service.
What are the advantages of cleanroom BIBO systems?
Cleanroom BIBO systems provide improved safety by minimizing worker exposure to hazardous materials. They increase efficiency by allowing quick and easy filter replacement without disrupting production processes. These systems reduce the risk of contamination by securely containing trapped particles and preventing their release into the cleanroom environment.
Can cleanroom BIBO systems be customized for different cleanroom sizes?
Yes, cleanroom BIBO systems can be customized to accommodate various cleanroom sizes and specific requirements. They are designed to be adaptable to different cleanroom configurations.
How often should cleanroom filters be replaced using the BIBO procedure?
The frequency of filter replacement depends on several factors, including the cleanroom’s level of contamination and the specific industry requirements. Regular inspection and monitoring are necessary to determine the optimal replacement schedule.
Are cleanroom BIBO systems compliant with industry regulations?
Yes, cleanroom BIBO systems are designed to meet industry standards and regulatory requirements for contamination control. They undergo rigorous testing and certification to ensure their effectiveness and compliance.
Can cleanroom BIBO systems be retrofitted into existing cleanrooms?
Yes, cleanroom BIBO systems can be retrofitted into existing cleanrooms. However, it is essential to consult with experts or manufacturers to assess the feasibility and compatibility of the system with the specific cleanroom setup.
What are the key components of a cleanroom BIBO system?
The key components of a cleanroom BIBO system include the filter housing, the filter, and the bag-in or bag-out assembly. These components work together to facilitate safe and secure filter replacement.
Is training required to use a cleanroom BIBO system?
Yes, training is crucial for the proper use of a cleanroom BIBO system. Operators should receive training on the correct procedure, safety protocols, and maintenance practices to ensure effective and safe operation.
Are there any alternatives to cleanroom BIBO systems for filter replacement?
While cleanroom BIBO systems are highly effective, alternative methods for filter replacement, such as remote filter handling systems, may be suitable for certain cleanroom applications. The choice depends on specific requirements and feasibility assessments.
Can cleanroom BIBO systems be integrated with automation technologies?
Yes, cleanroom BIBO systems can be integrated with automation technologies to enhance efficiency and reduce human intervention. Automation can streamline the filter replacement process and minimize the risk of human error.
How can cleanroom BIBO systems contribute to cost savings?
Cleanroom BIBO systems contribute to cost savings by reducing production downtime during filter replacement, optimizing cleanroom efficiency, and preventing product contamination. These factors ultimately enhance productivity and minimize financial losses.
Are there any specific maintenance requirements for cleanroom BIBO systems?
Regular inspection, cleaning, and maintenance of cleanroom BIBO systems are essential. This includes filter inspections, seal checks, and cleaning of filter housings. Adhering to maintenance schedules helps ensure the system’s longevity and efficiency.
Can cleanroom BIBO systems be used for hazardous materials other than particles?
Cleanroom BIBO systems can be used for the removal of various hazardous materials, including chemical vapors and biological agents. However, specific considerations and adaptations may be required based on the nature of the contaminants.
Are there different sizes and types of bags used in cleanroom BIBO systems?
Yes, cleanroom BIBO systems utilize different sizes and types of bags to accommodate various filter sizes and types. The bags used in cleanroom BIBO systems are typically made of high-quality, puncture-resistant materials and have airtight seals to prevent any leakage or release of contaminants.
What are the key safety features of cleanroom BIBO systems?
Cleanroom BIBO systems are designed with several safety features to protect workers and prevent contamination. These features may include interlocking mechanisms on the double-door system, pressure differentials to maintain airflow direction, and alarms or indicators for monitoring system integrity.
Are cleanroom BIBO systems suitable for cleanrooms with stringent cleanliness requirements?
Yes, cleanroom BIBO systems are particularly suitable for cleanrooms with stringent cleanliness requirements. They are designed to ensure the highest level of contamination control, making them ideal for industries where even the smallest particles or contaminants can have significant impacts on product quality.
Can cleanroom BIBO systems be used in cleanrooms with explosive or flammable materials?
Cleanroom BIBO systems can be customized to meet the specific requirements of cleanrooms with explosive or flammable materials. Special precautions and additional safety measures may be implemented to ensure the safe handling and removal of filters in such environments.
How can I choose the right cleanroom BIBO system for my facility?
Selecting the right cleanroom bag in the bag-out system requires careful consideration of factors such as cleanroom size, contamination control requirements, industry regulations, and specific application needs. Consulting with cleanroom experts or system manufacturers can help determine the most suitable solution for your facility.