The Bag-In-Bag-Out (BIBO) Filter Box is an essential containment system designed to ensure safe filter replacement in hazardous environments — preventing operator exposure to toxic particles or biological contaminants.
Widely applied in pharmaceutical, chemical, and biosafety laboratories, the BIBO system complies with ISO 14644 and GMP standards, providing both safety and reliability in critical processes.
This article explains the working principle, key advantages, and main applications of BIBO filter boxes.
1. How Does a BIBO Filter Box Work?
The BIBO filter system operates on a closed-loop containment principle, preventing contamination during filter change-out. The process typically includes the following steps:
(1) Preparation Stage
Stop HVAC or exhaust airflow to prevent pressure fluctuations.
Personnel wear full PPE, including gloves, masks, and protective suits.
(2) Installing the Containment Bag
- A pre-sterilized flexible bag is securely attached to the filter housing’s docking ring.
- The hermetic sealing ensures zero leakage, verified by DOP/PAO integrity testing.
(3) Filter Replacement
HEPA/ULPA filter is carefully detached and enclosed inside the containment bag.
- No airborne release occurs — contaminants remain completely sealed within the bag.
(4) Sealing and Removal
- The bag is double-sealed (e.g., via zip ties or heat sealing) to secure hazardous materials.
- Waste disposal follows
EPA and WHO guidelines for biohazard or toxic materials.
(5) System Recommissioning
- A new filter is installed in the same housing.
- The system is revalidated through
airflow, integrity, and pressure testing to confirm safe operation.
2. Key Advantages of BIBO Systems
Feature | Benefit |
100% Containment | Prevents exposure to Class III–IV biohazards (e.g., fentanyl, anthrax, viral agents). |
Modular Integration | Compatible with HVAC systems, laminar flow units, glove boxes, and isolators. |
Regulatory Compliance | Meets FDA 21 CFR Part 11 , EU GMP Annex 1 , and ISO 14644 standards. |
Maintenance Efficiency | Enables quick, contamination-free filter changeover with minimal downtime. |
Enhanced Safety | Reduces operator exposure risk by up to 95% compared with open filter handling (NIOSH study). |
3. Top Applications of BIBO Filter Boxes
Used in tablet coating, vaccine production, and sterile filling areas.
Ensures containment of toxic powders and volatile compounds.
- Biosafety Level 3–4 Labs:
Provides critical protection against infectious and biological agents.
- Nuclear & Research Facilities:
Controls particulate contamination in radioactive or experimental setups.
4. Why Choose a BIBO System Over Traditional Filter Replacement?
Completely eliminates direct human contact with contaminated filters.
Reduces decontamination time by up to 70%, minimizing production downtime.
Enables safe disposal and recycling of hazardous filter media.
Maintains airtight performance and compliance with international safety standards.
5. Conclusion
The Bag-In-Bag-Out (BIBO) Filter Box is a critical solution for environments handling hazardous or bioactive materials.
By ensuring airtight containment, operator safety, and regulatory compliance, BIBO systems have become the standard choice for high-risk industries such as pharmaceuticals, biosafety, and advanced manufacturing.
Guangzhou Cleanroom Construction Co., Ltd. provides customized BIBO filter boxes and containment ventilation systems designed to meet ISO and GMP requirements.
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Contact us today to discuss your project and receive a tailored cleanroom containment solution.