Salient Characteristics.pdf

Salient Characteristics Mobile Compounding Unit

IV Preparation Trailer Capabilities/Requirements:

1. The IV Preparation trailer shall meet all USP 797/USP 800 requirements and must be certified by an outside vendor, other than the manufacturer of the unit.

2. Exterior dimensions of the IV Preparation Trailer size shall be between 8’ and 12’ wide and 50’ and 57’ long.

3. There shall be pass throughs equipped with a HEPA filtration air purge between the workroom and the hazardous and non-hazardous buffer rooms.

4. Provided shelving, casework and work surfaces shall be 300 series stainless steel

5. Pharmacy staff will deactivate, decontaminate, and clean all areas where hazardous drugs are handled and disinfect all sterile compounding areas daily. The ceiling, interior walls and floors of the interior spaces and the pass throughs may be affected. These surfaces shall have minimal seams and crevices and be able to withstand appropriate deactivation, decontamination, disinfecting and cleaning agents.

6. Plumbing

a. A stainless-steel sink shall be available in each anteroom (2). Each station will also include an emergency eyewash and emergency shower or drench hose

b. The trailer shall have a utility tap to receive water from a provided source. This tap shall receive water from a garden hose type connection.

c. The trailer shall have a minimum 80 gallon on board freshwater tank

d. The trailer shall have a minimum 100 gallon on board grey water tank that will provide storage for batch dumping and will support gravity draining.

7. Power

a. The contractor shall provide a step-down transformer for the Government provided power

b. Contractor shall provide all necessary cabling to hook up the trailer and any necessary

ADA cable ramps.

8. Data

The trailer shall be equipped with a patch panel with connections to the workroom and buffer rooms.

9. Workroom Capabilities/Requirements

a. Filtration: ISO Class 8

Salient Characteristics Mobile Compounding Unit

b. Pressurization: Minimum 30 ACPH

c. Minimum size/space

d. Accommodate minimum 1 PC workstation/phone with min 2 (CAT5 min) data jacks and 2 power receptacles

e. Be centralized as to be able to access the anterooms for the hazardous and non-hazardous anterooms and IV preparation rooms.

10. Non-Hazardous and Hazardous Anteroom Capabilities/Requirements

a. Filtration: ISO Class 7

b. Pressurization: Positive pressure with minimum 30 ACPH

c. Minimum size/space: 4’ x 4’ x 7’ H (ceiling)

d. Contain casework for personal protective equipment (PPE) that must be donned by staff prior to entering the respective hazardous and non-hazardous IV preparation rooms

e. Contain a bench for staff to sit while donning/doffing PPE

11. Non-Hazardous IV Preparation/Buffer Room Capabilities/Requirements

b. Pressurization: Positive pressure with minimum 30 ACPH

c. Minimum size/space: 13’ x 8’ x 7’ H (ceiling)

d. The room shall have 2 laminar or vertical flow hoods with a minimum workspace dimension of 33” Wide x 22” Deep x 29” High for each cabinet. The hoods shall be ISO

Class 5 and be positive pressure.

e. Refrigerator: minimum 20 cubic foot capacity

f. Contain rolling shelving for working stock. Shelving shall have lockable casters and have a minimum of 4 shelves.

12. Hazardous IV Preparation/Buffer Room Capabilities/Requirements

b. Pressurization: Negative pressure with minimum 30 ACPH

c. Minimum size/space: 13’ x 8’ x 7’ H (ceiling)

d. The room shall have two Class 2 Biological Safety Cabinets with a minimum workspace dimension of 33” Wide x 22” Deep x 29” High for each cabinet. The hoods shall meet USP 800 requirements for the preparation of hazardous sterile IV preparations.

They shall be ISO Class 5 and be negative pressure.

e. Refrigerator: minimum 20 cubic foot capacity

f. Contain rolling shelving for working stock. Shelving shall have lockable casters and have a minimum of 4 shelves.