36C26118Q9198-005.pdf

SALIENT CHARACTERISTICS/PRICING SCHEDULE

“Brand Name or Equal”

EQUIPMENT REQUIREMENT: Manufacture: Odulair Model: HD2-NHD1 - USP 800 Mobile Trailer Facility.

Company is to design and build a 53' semi-trailer with one large ante room, one hazardous buffer room and one non-hazardous buffer room that meets USP 800 and USP 797 code compliance.

Drawings will be provided with the below salient characteristics. The Drawings/Semi-trailer will comply with the features listed below and the attached drawing:

Salient Characteristics USP 800 Hazardous Drug & USP 797 Non-Hazardous Drug Pharmaceutical Compounding Pharmacy Trailer

ROOMS & AREAS

• Ante Room ISO 7

• Sterile Hazardous Drug Buffer Room ISO 7

• Sterile Non-Hazardous Drug Buffer Room ISO 7

• Sterile Hazardous Drug Storage Area

• Self-Supporting Modular Design inclusive of walls, roof / ceiling, flooring, lighting, electrical & filtering equipment

• Modular clean room must fit within our trailer or within your designated space

• Modular Clean Room seismic integrity provisions where necessary

• Finishes - Non-porous and cleanable surfaces, ceilings, walls, and floors subject to wet cleaning

ANTE ROOM

• 2 Scrub sinks with eye wash station positioned at least 3’ from the Sterile HD Buffer Room door

• Clean Personal Protective Equipment (PPE) Storage Bin

• Soiled PPE Waste Bin

• Staff Changing Bench

• Environmental Services Closet

STERILE HAZARDOUS DRUG BUFFER ROOM Equipment

• 2 ISO 5 Class II Type B2 Biological Safety Cabinets (BSC) with 100% Outside Air Supply and Exhaust - 3ft each

• Interlocking HEPA filtered Pass-Thru Chamber from Ante Room

• Stainless Steel Workstation

• RFID Refrigerator for inventory control

• Soiled PPE Waste Bin

• Storage Cabinet for sterile hazardous drugs

STERILE NON-HAZARDOUS DRUG BUFFER ROOM Equipment

Attachment 1

• ISO 5 Horizontal Laminar Airflow Workbench ( LAFW) - 4ft

• Interlocking HEPA Filtered Pass-Thru Chamber from Ante Room

• Stainless Steel Workstation

• USP 797 Compliant Refrigerator

• Soiled PPE Waste Bin

• Non-Hazardous Drug Storage Cabinet

MECHANICAL ROOM

• Back-up Generator With Automatic Transfer Switch

• Water Storage Tanks (Fresh & Gray)

• Data Connection Package - Interior Video Intercom System

UTILITY REQUIREMENTS

• Electrical: 208V 3-Phase 200 Amps

• Water: 1" Potable Water Line

• Sewer: 4" Standard Sewer Line

WHEELCHAIR RAMP

• ADA Compliant

• Aluminum ramp with guardrails, landing, and stairs

• Width: 4'

• Installation on site

ENVIRONMENTAL CONTROLS

• All Facility & Engineering Controls Compliant with new USP 800 and USP 797

• Physically separated Ante Room and Sterile Hazardous Drug Buffer Room and Sterile Non Hazardous Drug Buffer

Room

• C-PEC Containment Primary Environmental Control: (BSC or LAFW) LControls) o ISO 5 Biological Safety Cabinet (BSC) located in the Sterile HD Buffer Room o ISO 5 LAFW located in Sterile Nonhazardous Buffer Room

• C-SEC Containment Secondary Environmental Controls (Room Controls) o ISO 7 Ante Room Environmental Controls:

• Positive pressure

• Minimum of 30 Air Exchanges Per Hour (ACPH) compliant with USP 800

• High Efficiency Particulate Air (HEPA) filtered supply air

• 24/7 Real-time Environmental Room Monitor providing:

❖ Temperature ❖ Humidity ❖ Differential pressure ❖ Airborne particle count o ISO 7 Sterile HD Buffer Room Environmental Controls:

• Negative pressure between 0.01” to 0.03” WC

• Minimum of 30 Air Exchanges Per Hour (ACPH) compliant with USP 800

• 100% Outside Supply Air (into room)

• High Efficiency Particulate Air (HEPA) filtered supply air

• Externally Vented 100% of Air Exhausted Directly Outside

• Zero recirculation of HD Buffer Room air

• 24/7 Real-time Environmental Room Monitor providing:

❖ Temperature ❖ Humidity ❖ Differential pressure ❖ Airborne particle count

• 24/7 Real-time Monitoring of RFID Refrigerator interior temperature to ensure drug safety o ISO 7 Sterile Non-HD Buffer Room Environmental Controls:

• Positive pressure

• Minimum of 30 Air Exchanges Per Hour (ACPH) compliant with USP 800

• High Efficiency Particulate Air (HEPA) filtered supply air

• 24/7 Real-time Environmental Room Monitor providing:

❖ Temperature ❖ Humidity ❖ Differential pressure ❖ Airborne particle count ❖ 24/7 Real-time Monitoring of RFID Refrigerator interior temperature to ensure drug safety

COMMISSIONING & CERTIFICATION

• Delivery

• Set-up

• On-site Test & Balance Certification

• Certification Supervision

• On-site Training