High Potency Facilities

In general High Potency Pharmaceutical production facilities require negative room pressure relative to adjacent areas of the building and HEPA filtration of all exhaust air.

Balancing of infiltration air flows and pressurization of adjacent room spaces are also important to ensure that potentially hazardous materials do not escape the production plant space. The HVAC design must also ensure that supply and exhaust grilles are positioned to minimize or eliminate employee exposure to process material during and after production cycles.

Several additional factors can dramatically affect the design of high potency pharmaceutical production facilities. These include:

• Exposure of intermediate or final products within the room environment.
• The types and characteristics of solvents used in the process
• Types of production equipment required by the process
• Level of cleanliness required to maintain purity

As a result of the above factors, one or more of the following considerations may enter into the plant design:

• Blast vent panels where flammable solvents are in use.
• HEPA filtration of incoming air in processes or areas where product is exposed to the environment.
• Airlocks where high levels of cleanliness or pressurization separation are needed.
• Dedicated changing rooms where personnel can robe and disrobe if special suiting is required.
• Cleaning rooms where totes can be cleaned prior to leaving.
• Utility rooms where vacuum pumps, circulating pumps, filters, heating and cooling equipment, solvent recovery and other process support equipment can be located.
• Material handling areas where feed materials and intermediate products can be stored and staged during production cycles.

Additional design considerations are:

• Contained drainage system
• Emergency showers and eye wash stations
• Sprinkler systems
• Lighting
• Fire evacuation routes

All of the above details must be carefully balanced in any plant design to provide a facility that meets all health and safety criteria and at the same time provides a user-friendly production facility that ensures optimum production