Highly potent pharmaceutical compounds and active pharmaceutical ingredients (APIs), chemicals, and some biologic materials, sometimes hazardous, are handled in pharmaceutical manufacturing plants. In the process, fine dust and hazardous airborne particles can enter the air and become detrimental to human health if inhaled by workers. Certainly, this raises the need for pharmaceutical facilities to have an advanced air filtration and containment system.
The Bag-In Bag-Out (BIBO) filtration system is among the foremost safety systems used in pharmaceutical manufacturing plants. These fall under a group of modern critical air management solutions and are aimed at protecting workers through contamination prevention with consistent air quality.
What is Bag-In Bag-Out (BIBO) Filter Systems?
Bag in Bag out, or BIBO, is a filter system that enables safe handling of contaminated filters to be replaced without endangering personnel from hazardous particles. It is greatly used in pharmaceutical plants, cleanrooms, laboratories, and biotechnology facilities.
The system uses sealed bags attached to the filter housing, ensuring that when workers disconnect a used, contaminated filter, it remains enclosed within the bag, preventing any exposure to hazardous dust or particles. This methodology of replacing filters in a safe way has earned the BIBO system the title of Safe-Change System.
This is particularly important in relation to the pharmaceutical industry, where even minute quantities of airborne contamination can represent danger to both workers and products. You can explore EB Air Control’s bag-in bag-out housing for pharmaceutical-grade containment solutions.
Role of HEPA Filter Housing and ULPA Filtration
The most critical factor in ensuring the pharmaceutical air safety system is air filtration. Two major systems/defenses of filtration based on technology used are HEPA and ULPA.
HEPA Filtration
The component used with HEPA filtration units is the High-Efficiency Particulate Air filter, which is placed inside the system. These help in cleaning the environment by trapping very small particles that come forth from a variety of sources like pollution, dust, bacteria, aerosols, chemicals, etc., thus being ideal for providing cleanliness as far as the environment is supposed to be concerned. Furthermore, the quality and cleanliness of the air are important considerations when thinking about air filtration and whether it needs any contamination prevention.
ULPA Filtration
ULPA filtration delivers higher efficiency than HEPA filters, capturing extremely small particles and maintaining ultra-clean working environments by effectively decontaminating the air.
In many pharmaceutical industries, multi-filter stages are employed, which in most cases include the following:
- Prefilters
- HEPA filters
- ULPA filters
- Carbon filters
Working together, these work to purify the air to the fullest, which is also for the workers’ safety.
Benefits of Containment Housing
Indeed, the application of air filtration is the main and probably the most significant element in the system of pharmaceutical air safety. There are two major systems of filtration for defense, HEPA- and ULPA-based systems.
1. HEPA Filtration Units or Systems
The high-efficiency particulate air filter is placed inside the HEPA system. These filters aid in cleaning the environment by capturing very small particles that are produced from air pollution, dust, bacteria, aerosols, chemicals, etc. Thus, they are considered of high quality with respect to. cleanliness in air or desirability in cleanliness as per PLUS+; the air environment needs to be the restraining agent against contamination.
2. ULPA Filtration
ULPA filtration removes particulates more efficiently than HEPA filters, trapping even smaller particles and maintaining extremely low contaminant levels in ultra-clean environments.
A large number of different pharmaceutical industries incorporate a multi-filter stage, with various embodiments often including the following:
- Prefilters
- HEPA filters
- ULPA filters
- Carbon filters
These filters work together to make sure the air quality is as clean as can be—another safety factor for the employee.
PVC Change-Out Bags and Safe Filter Replacement
A key part of the BIBO system is the PVC change-out bags used in filter replacement. These changeout bags attach to the filter housing, thereby permitting service technicians to change out contaminant-laden filters safely without exposure.
Given below are the functions of PVC change-out bags.
- Serve to hold contaminated filters.
- Protect against exposure to dust and particles
- Facilitate safe disposal of the filters.
- Allow for the containment to be airtightly sealed during maintenance procedures.
They protect workers from dangerous substances. Without these bags, workers would be exposed to nothing but potential contaminants while changing out the filters.
Gas-Tight Isolation Dampers in Pharmaceutical HVAC Systems by EB Air Control.
Gas-tight isolation dampers are installed in pharmaceutical HVAC systems to isolate air sections for maintenance, an emergency, or filter replacement. Furthermore, these dampers prevent air leakage and help to maintain a containment zone within the facility.
The benefits of gas-tight isolation dampers shall include:
- Controlling accidental discharge of contaminated air
- Pressure control in the cleanroom
- Safe maintenance activities
- Protect workers from any exposure to ensure they are safe and secure
- Diminish controlled airflow and bring an end to the clogging by the duly installed system.
These dampers are absolutely necessary for pharmaceutical critical air management solutions. To understand more about how these work in containment environments, read our detailed guide on what is gas tight damper.
Why BIBO Systems Are Important in Pharmaceutical Manufacturing
Pharmaceutical facilities engage with substances that are harmful if inhaled, for example,
- Active pharmaceutical ingredients
- Antibiotics
- Hormones
- Chemical powders
- Cytotoxic drugs
- Biological materials
In the case of occupational exposure, serious concerns stand on the horizon. Particularly, such seemingly solid particles remain suspended in the slithering barriers of air, thus enabling them to navigate the air between two different points. On the other hand, Bag-in Bag-Out containment systems largely curtail such health risks because polluted filter bags are sealed off neatly without the subsequent human exposure during the process of filter change.
Toiling at containment systems has several fundamental purposes of personal benefit:
- Saves lives
- Prevents contamination
- Maintains cleanliness
- Takes care of safe filter exchange
- Comply with safety and regulatory requirements
- Help to keep airborne pollution within nominal levels
- Synchronizes an airflow system with containment level requirements.
These containment systems are best suited for exhaust systems, containment labs, cleanrooms, and air handling devices. For a broader look at how dampers support pharmaceutical environments, refer to our blog on dampers for pharmaceutical industry.
Critical Air Management Strategies
Modern pharmaceutical factories rely on critical air management solutions to protect clean air. The systems are outfitted with various air control and containment components that work in pairs.
This comprises the following:
- Bag-In Bag-Out (BIBO) systems
- HEPA Filter Housing
- ULPA Filtration
- Containment Housing
- Side-Access Filter Housing
- Safe-Change System
- PVC Change-Out Bags
- Gas-Tight Isolation Dampers
- Air Handling Units
- Venturi Air Valves
- Airflow Control Systems
- Cleanroom Ventilation Systems
Together, these systems enforce the personnel safety standards, provide product protection, and enforce proper air pollution control in pharmaceutical production buildings.
About EB Air Control Inc.
EB Air Control, the best manufacturer and supplier of HVAC products, Inc. provides custom-made HVAC equipment concerning the most refined air control, containment systems, and clean air management solutions. They deliver engineered airflow control systems for pharmaceutical, laboratory, cleanroom, and industrial applications. The row of products includes:
- Air control dampers
- Isolation dampers
- Bubble-tight dampers
- Venturi air valves
- Air-handling solutions
- Clean room airflow systems
- Containment and filtration systems
- Industrial heating, ventilation, and air conditioning control equipment
In pursuit of improving airflow control, containment safety, and energy optimization within pharmaceutical plants, coming up with experimental air-quality solutions would be necessary.
Pharmaceutical manufacturing facilities prioritize worker safety when handling chemical, biological, and hazardous powders. They use Bag-In-Bag-Out (BIBO) filter systems to protect workers by enabling the safe removal of contaminated filters without exposure.
When combined with HEPA filter housing, ULPA filtration, containment housing, side-access filter housing, PVC change-out bags, and gas-tight isolation Dampers, these systems provide a total clean air management solution that maintains purified air, protects workers, and ensures the safety and security of pharmaceutical production facilities.
In modern-day pharmaceutical infrastructures, BIBO systems not only imply a filtration device but are also necessary safety systems that ensure workers and products remain safe while trying to meet the requirements of a strict clean room.
