Negative Pressure System
Fabtech supplies the Negative Pressure System with the chamber maintained from -30 to -20 Pa (pascal, a small unit of pressure). A negative pressure isolator keeps the air inside its chamber at a lower pressure than the room, to prevent particles from escaping.
This one is the custom containment enclosure for a process step that none of our named isolators fits. It protects the operator and the room from the product.
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Fabtech offers Negative Pressure Systems for custom applications across OSD (tablets and capsules), injectable and QC (quality control) work, including inline process, non-sterile powder handling, R&D and aseptic processes. The chamber wall serves as the physical barrier.
The pressure is also a dynamic barrier: the direction of the air holds particles back. Together they protect the cleanroom from cross contamination and maintain cleanliness.
Ask for the chamber pressure, the leak test and the qualification documents in your enquiry.
On this page
Key fact Detail
- Chamber pressure
- Maintained from -30 to -20 Pa
- Control system
- PLC based
- Plant data system
- SCADA compatible
- Integration of process equipment
- 21 CFR compliant
- Validation
- Custom built validation protocol
Where the negative pressure system we supply is used
This system is for custom applications.
It is planned around your process and the equipment you use.
The chamber material, the filters and the number of glove ports are fixed for each project. They follow from your compound and your process.
Negative pressure keeps a product in. An aseptic process must also keep microbes out.
Where your process is aseptic, tell us, and the way the product is kept sterile is settled in the design.
Some process steps have an isolator of their own in our range. For weighing raw material, see the sampling and dispensing isolator.
For a tablet press, see the tablet compression isolator. For the granulation machines, see the granulation isolator.
How negative pressure contains the product
The room is at room pressure. The operator stands in the room and works through the chamber wall.
The chamber is a closed enclosure. Its pressure is maintained from -30 to -20 Pa, that is, below the pressure around it.
An exhaust fan draws air out and holds the chamber below room pressure.
A gap is any place where the wall is not perfectly sealed, such as a worn glove or a door seal. Air always moves from higher pressure to lower pressure.
So at any gap, air moves into the chamber. This inward flow works to prevent particles from escaping.
The exhaust carries the air out. In a negative pressure isolator, exhaust air normally leaves through filters that hold particles.
Control, records and validation
The system has a PLC-based control system.
A PLC (programmable logic controller) is an industrial computer that runs the equipment.
The system is compatible with Supervisory Control and Data Acquisition (SCADA). SCADA is the plant software that watches many machines from one screen and stores their data.
So the isolator can report to the same system as the rest of your plant.
Integration of process equipment is 21 CFR compliant. 21 CFR is Title 21 of the US Code of Federal Regulations.
Each system comes with a custom built validation protocol. A validation protocol is the written set of tests that proves the system does what its specification says.
Because every system is planned for one process, the protocol is written for that process too.
Negative pressure or positive pressure
The two pressures do opposite jobs.
A chamber below room pressure keeps a hazardous product in, to protect people. Positive pressure isolators push clean air outward, to protect a sterile product from the room.
Our guide to positive and negative pressure containment systems compares the two, and the negative pressure containment enclosures and solutions used in pharma.
A potent product harms people in very small amounts. For potent active ingredients, see the potent API processing isolator (PAPI) and the reactor charging isolator.
The full range is on our pharmaceutical isolators page.
What we need from you to plan the system
We start the plan from your compound.
Negative pressure equipment follows from it. Send us these four things:
- The compound and its exposure limit. The limit is called an OEL (occupational exposure limit). Your own occupational hygienist sets it. Our guide to OELs explains how.
- The process step. Tell us what the operator does inside the chamber, and how much material is handled in one batch.
- The equipment that goes inside or connects to the chamber. Send the make, the model and the size.
- How material goes in and comes out. Tell us the containers you use today.
Our guide to selecting a pharmaceutical containment system explains the nine decisions that follow from these answers.
FAQ
What is a negative pressure isolator?
It is a closed chamber kept at a lower air pressure than the room around it. If there is a small leak, air moves into the chamber. So a hazardous powder stays inside, and the operator works from outside through the chamber wall.
What pressure does a negative pressure isolator hold?
Fabtech supplies the Negative Pressure System with the chamber maintained from -30 to -20 Pa, that is, below the pressure around it. The pressure is a dynamic barrier, and the chamber wall is the physical barrier.
Where is negative pressure containment used?
Fabtech offers the system for OSD, injectable and QC work, including inline process, non-sterile powder handling, R&D and aseptic processes. It is used wherever a product must not reach the people around it.
Does negative pressure decide the containment level?
It is one part of containment. The level the isolator must reach comes from the OEL of your compound, and your own occupational hygienist sets that limit. The transfer method, the filters and the cleaning method are planned from the same limit.
Can the system connect to our plant control system?
Yes. The system has a PLC-based control system and is SCADA compatible. Integration of process equipment is 21 CFR compliant.
Tell us your process, your compound and the equipment that goes inside. We will plan the system
We reply within 24 hours.