Solution 06 / 07
Hazardous Drug Facility
Hazardous drugs reverse part of the usual cleanroom logic: the room must protect people from the product as well as the product from people. ALVEDA SOLUTIONS engineers the containment philosophy, pressure relationships and exhaust around the hazard assessment and the project basis.
The problem and its context
Receiving, storage, preparation, cleaning and waste all create exposure routes. Containment that only covers the preparation room leaves the rest of the chain exposed.
The right combination of primary containment, room pressure and airlock design depends on the hazard level, the quantities handled and whether the product must also be kept sterile.
Typical pressure points
- Combining negative pressure for containment with clean conditions for sterile products
- Containing every step of the chain, from receipt to waste
- Exhaust and filtration that do not move contamination into the building or outside
- Cleaning and decontamination routines that the room finishes can withstand
What the solution involves
- 01
Containment zoning for receipt, storage, preparation, cleaning and waste
- 02
Negative-pressure rooms and buffered airlocks defined by the hazard assessment
- 03
Primary engineering controls and their exhaust integrated with the HVAC design
- 04
Filtration and exhaust discharge arranged to protect people and surroundings
- 05
Finishes, details and spill provisions suited to decontamination
- 06
Qualification of containment rooms, airflow and exhaust systems
Engineering path
The service disciplines involved, in the order the project needs them. Each step links to the full service description.
- 01Hazardous drug facility engineeringThe containment philosophy derived from the hazard assessment.
- 02Containment zoning and handling routesSegregated routes for receipt, preparation, cleaning and waste.
- 03Negative pressure and airlock designPressure relationships and buffer rooms set by hazard and product risk.
- 04Containment HVAC and exhaustDedicated exhaust, filtration and discharge arrangements.
- 05Cleanroom envelope for containment roomsSealed envelope and finishes suited to decontamination.
- 06Utilities and drainage for hazardous areasServices, drainage and waste provisions planned around containment.
- 07Monitoring for containment areasMonitoring of pressure and conditions in the containment areas.
- 08GMP and containment design reviewDesign reviewed against the project basis and the client’s safety requirements.
- 09Containment qualificationQualification of rooms, airflow, pressure and exhaust.
Deliverables and design basis
Typical deliverables
- Containment concept and philosophy statement
- Zoning and handling route drawings
- Pressure and airlock diagrams for the agreed basis
- Containment HVAC and exhaust design
- Room data sheets with finishes and decontamination details
- Qualification plan for containment systems
Key design-basis considerations
- Hazard assessment and the list of hazardous drugs handled
- Quantities, dosage forms and handling steps
- Whether the product must also be protected as sterile
- The client’s occupational safety and environmental requirements
- The regulatory basis and standards applicable to the project
Classification, pressure relationships and containment are set by the project regulatory basis and the process risk.
How the regulatory design basis is setOccupational exposure limits and the hazard classification of each product are set by the client’s safety and quality functions. The engineering design is built on those inputs.
Next step
Planning this type of facility?
Share the product, the capacity and where the project stands. An engineer will reply with a proposed engineering path.
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