Attach A-Excel Sheet Salient Characteristics.xlsx
XLSX spreadsheet 39 KB Posted
- Attached to
- W023--USP 797/800 Mobile Pharmaceutical Trailer
- Solicitation number
- 36C26221Q0246
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Other files
| File | Type | Posted |
|---|---|---|
| Cover and Instructions 36C26221Q0246 -Trailer.docx | DOCX document | |
| Attachment B_SOW Salient Characteristics Doc.docx | DOCX document | |
| Attachment D past performance template.docx | DOCX document | |
| Engineering Plans.pdf | ||
| 36C26221Q0246.docx | DOCX document | |
| IT-SOP-07-013 Cable Installation Labeling and Testing version 2-add fiber _ IT closet requirement.pdf | ||
| Pharmacy Trailer Connections -Design.docx | DOCX document | |
| RFQ Trailer.pdf |
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1. Base CLIN Brand Name Brand Name Nomenclature Manufacturer Part Number if Applicable Salient Characteristics Category Salient Characteristic Description Requirement Equivalent Brand Equivalent Nomenclature Equivalent Part Number Equivalent Description Matching Salient Characteristics and/or location of information regarding equal capability Quantity Unit Price Extended Price
| 1 | Rooms & Areas | Unclassified area separating the main entrance from the anteroom | Preferred | $ - 0 | ||||
| 2 | Rooms & Areas | Anteroom | Required | $ - 0 | ||||
| 3 | Rooms & Areas | Sterile Hazardous Drug (HD) Buffer Room | Required | $ - 0 | ||||
| 4 | Rooms & Areas | Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Required | $ - 0 | ||||
| 5 | Rooms & Areas | Sterile Hazardous Drug Storage Area | Required | $ - 0 | ||||
| 6 | Rooms & Areas | Self-Supporting Modular Design inclusive of walls, roof, ceiling, flooring, lighting, electrical & filtering equipment | Required | $ - 0 | ||||
| 7 | Rooms & Areas | Modular clean room must fit in a 57' L x8'6"L W x 13'6" H DOT approved semi-trailer Modular Clean room seismic intergrity provisions where necessary | Preferred | $ - 0 | ||||
| 8 | Rooms & Areas | Finishes - Non-pourous and cleanable surfaces, ceilings, walls, and floors with minimal seams and crevices, able to withstand appropriate deactivation, decontamination, disinfecting and cleaning agents | Required | $ - 0 | ||||
| 9 | Equipment - Unclassified Area | Soiled PPE Waste Bin | Required | $ - 0 | ||||
| 10 | Equipment - Unclassified Area | Stainless steel workstation | Preferred | $ - 0 | ||||
| 11 | Equipment - Unclassified Area | One (1) data drop with 4 ports (RJ 45) | Required | $ - 0 | ||||
| 12 | Equipment - Unclassified Area | Two (2) 120V power outlest with 2 sockets each | Required | $ - 0 | ||||
| 13 | Equipment - Anterom | Scrub sink with eyewash station and anti-scald device positioned at least 1 meter from the sterile HD buffer room door | Required | $ - 0 | ||||
| 14 | Equipment - Anterom | Clean Personal Protective Equipment (PPE) Storage Bin | $ - 0 | |||||
| 15 | Equipment - Anterom | Soiled PPE Waste Bin | $ - 0 | |||||
| 16 | Equipment - Anterom | Staff Changing Bench | $ - 0 | |||||
| 17 | Equipment - Anterom | Environmental Services Cabinet | $ - 0 | |||||
| 18 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Anterom | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 19 | Equipment - Anterom | 3M™ Avagard™ Hands Free Wall Dispenser | $ - 0 | |||||
| 20 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) spaced 1 meter apart from each other with 100% Outside Air Supply and Exhaust | Required - Equivalent product acceptable | $ - 0 | |
| 21 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Interlocking HEPA filtered Pass-Thru Chamber from Anteroom | Required - Equivalent product acceptable | $ - 0 | ||||
| 22 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Stainless Steel Workstation | Required - Equivalent product acceptable | $ - 0 | ||||
| 23 | Thermo Scientific | Thermo Scientific Refrigerator model TSX3005GA | TSX3005GA | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Thermo Scientific Refrigerator model TSX3005GA or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 24 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Soiled PPE Waste Bin | Required - Equivalent product acceptable | $ - 0 | ||||
| 25 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Storage Cabinet for compounded sterile hazardous drugs | Required - Equivalent product acceptable | $ - 0 | ||||
| 26 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves | Required - Equivalent product acceptable | $ - 0 | ||||
| 27 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | One (1) data drop with 4 ports (RJ 45) | Required - Equivalent product acceptable | $ - 0 | ||||
| 28 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Three (3) 120V power outlets with two sockets each | Required - Equivalent product acceptable | $ - 0 | ||||
| 29 | Gai-Tronics | Clean Phone® Analog Telephone (Wall-Mount) - UL | 295-001W | Equipment - Sterile Hazardous Drug (HD) Buffer Room | A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W) | Preferred - Equivalent product acceptable | $ - 0 | |
| 30 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 31 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed) | Required - Equivalent product acceptable | $ - 0 | ||||
| 32 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) | $ - 0 | |||||
| 33 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Interlocking HEPA Filtered Pass-Thru Chamber from Anteroom or Unclassified Area | Required - Equivalent product acceptable | $ - 0 | ||||
| 34 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Stainless Steel Workstation | Required - Equivalent product acceptable | $ - 0 | ||||
| 35 | Thermo Scientific | Thermo Scientific Refrigerator model TSX3005GA | TSX3005GA | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Thermo Scientific Refrigerator model TSX3005GA or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 36 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Non-Hazardous Drug Storage Cabinet | Required - Equivalent product acceptable | $ - 0 | ||||
| 37 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves | Required - Equivalent product acceptable | $ - 0 | ||||
| 38 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | One (1) data drop with 4 ports (RJ 45) | Required - Equivalent product acceptable | $ - 0 | ||||
| 39 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Three (3) 120V power outlets with two sockets each | Required - Equivalent product acceptable | $ - 0 | ||||
| 40 | Gai-Tronics | Clean Phone® Analog Telephone (Wall-Mount) - UL | 295-001W | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W) | Preferred - Equivalent product acceptable | $ - 0 | |
| 41 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 42 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed) | $ - 0 | |||||
| 43 | Environmental Controls | All facility & engineering controls compliant with USP 797/800 standards. | Required | $ - 0 | ||||
| 44 | Environmental Controls | Trailer should be able to maintain appropriate internal temperature, humidity and pressure requirements while located in Long Beach, CA, which has a Mediterranean-type, coastal climate. Temperature extremes may range from 20°F – 112°F with a relative humidity up to 100%. | Required | $ - 0 | ||||
| 45 | Environmental Controls | The trailer must have fire alarm system that is completely independent and compliant with the NFPA requirement and has the capability to alert and automatically dial out when the fire alarm system is activated. | Required | $ - 0 | ||||
| 46 | Environmental Controls | Physically separated Anteroom and Sterile Hazardous Drug Buffer Room and Sterile Non-Hazardous Drug Buffer Room. | Required | $ - 0 | ||||
| 47 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Environmental Controls - Primary Engineering Controls | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile HD Buffer Room with 100% Outside Air Supply and Exhaust | Required | $ - 0 | |
| 48 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Environmental Controls - Primary Engineering Controls | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile Non-Hazardous Buffer Room | Required | $ - 0 | |
| 49 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Positive pressure with greater than or equal to 0.02-inch Water Column | Required | $ - 0 | ||||
| 50 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 51 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 52 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | High Efficiency Particulate Air (HEPA) filtered exhaust air | Required | $ - 0 | ||||
| 53 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 54 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 55 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 56 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Negative pressure between 0.01-inch Water Column to 0.03-inch Water Column | Required | $ - 0 | ||||
| 57 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 58 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 100% Outside Supply Air (into room) | Required | $ - 0 | ||||
| 59 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 60 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Zero recirculation of HD Buffer Room air | Required | $ - 0 | ||||
| 61 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Each compounding hood has a dedicated external exhaust that is HEPA-filtered directly to outsidem | Required | $ - 0 | ||||
| 62 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Buffer room has a dedicated and HEPA-filtered external exhaust that is 100% of air exhausted directly to outside | Required | $ - 0 | ||||
| 63 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 64 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 65 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 24/7 Real-time Monitoring Refrigerator interior temperature to ensure drug safety. The interior temperature for the refrigerator shall be between 2 degrees Celsius and 8 degrees Celsius. | Required | $ - 0 | ||||
| 66 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 67 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Positive pressure with greater than or equal to 0.02-inch Water Column | Required | $ - 0 | ||||
| 68 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 69 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | 100% Outside Supply Air (into room) | Required | $ - 0 | ||||
| 70 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 71 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Buffer room has High Efficiency Particulate Air (HEPA) filtered exhaust/return air | Required | $ - 0 | ||||
| 72 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Each compounding hood has built-in HEPA filter. | Required | $ - 0 | ||||
| 73 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 74 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 75 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | 24/7 Real-time Monitoring of refrigerator interior temperature to ensure drug safety. The interior temperature for the refrigerator shall be between 2 degrees Celsius and 8 degrees Celsius. | Required | $ - 0 | ||||
| 76 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 77 | Mechanical Room | Back-up Emergency Generator(s) with Automatic Transfer Switch | Required | $ - 0 | ||||
| 78 | Mechanical Room | On-board freshwater tank and an on-demand electric water pump to provide running water for a sink and eyewash | Required | $ - 0 | ||||
| 79 | Mechanical Room | Gray water holding tank | Required | $ - 0 | ||||
| 80 | Mechanical Room | The pharmacy cleanroom will arrive completely plumbed, ready for use via holding tanks | Required | $ - 0 | ||||
| 81 | Mechanical Room | HVAC system to utilize R410A refrigerant | Preferred | $ - 0 | ||||
| 82 | Mechanical Room | All cameras, card readers and data ports will be prewired with 400 ft of CAT6a cable. Excess cable will be bundled and exit the trailer on the front-right side of the trailer closest to the utility pedestal as shown on the site-prep design. | Required | $ - 0 | ||||
| 83 | Utility Requirements | Electrical: 208V 3-Phase 200 Amps | Required | $ - 0 | ||||
| 84 | Utility Requirements | Water: 3/4" Potable Water Line | Required | $ - 0 | ||||
| 85 | Utility Requirements | Sewer: 3" Standard Sewer Line | Required | $ - 0 | ||||
| 86 | Utility Requirements | Cables and conductors must be in conduits that are built for outside uses. All connections must be water proof and tightly sealed. | Required | $ - 0 | ||||
| 87 | Services - Installation | Installation and set-up of the Pharmacy Sterile Compounding Trailer, including connections for electrical, water, sewer and data. | Required | $ - 0 | ||||
| 88 | Services - Installation | The data cables shall be pulled through the utility pedestal conduit and connected to the appropriate switches in the IT closet in Building 164, Room 189. | Required | $ - 0 | ||||
| 89 | Services - Installation | The security camera and badge reader data cables shall be pulled through the utility pedestal conduit and connected to the appropriate switches in the security closet in Building 164, Room 137. | Required | $ - 0 | ||||
| 90 | Services - Installation | The vendor must perform on site utility connections. | Required | $ - 0 | ||||
| 91 | Services - Annual Maintenance | Full maintenance and repair services shall be required for a period of one (1) year after the Pharmacy Sterile Compounding Trailer is fully certified and in operation with two (2) additional option years. | Required | $ - 0 | ||||
| 92 | Services - Annual Maintenance | For emergency calls, contractor is required to respond on-site within 3 hours, and by the next business day for non-emergency calls. | Required | $ - 0 | ||||
| 93 | Services - Annual Maintenance | All repairs and maintenance services shall be performed after hours or during weekends so that the impact to the Medical Center operations is minimized. | Required | $ - 0 | ||||
| 94 | Services - Monthly | Change HVAC pre-filters. | Required | $ - 0 | ||||
| 95 | Services - Monthly | Exercise and test emergency generators in accordance with SCAQMD requirements and other federal and state requirements. | Required | $ - 0 | ||||
| 96 | Services - Monthly | Refuel generators and fuel tank as necessary. | Required | $ - 0 | ||||
| 97 | Services - Monthly | Add water treatment to grey water tank. Grey water tank shall be emptied on regular basis or when it is 80% full by the contractor. | Required | $ - 0 | ||||
| 98 | Services - Quarterly | Lubricate direct drive motors on exhaust fans | Required | $ - 0 | ||||
| 99 | Services - Quarterly | Check pressure on all tires of the pharmacy trailer and put in more air as necessary | Required | $ - 0 | ||||
| 100 | Services - Semi Annually | CETA certification in compliance with USP 797 and USP 800 | Required | $ - 0 | ||||
| 101 | Services - Semi Annually | Change HEPA filters in ceiling diffusers for both supply and exhaust and/or return | Required | $ - 0 | ||||
| 102 | Services - Semi Annually | Change filters in BSCs as needed | Required | $ - 0 | ||||
| 103 | Services - Semi Annually | Change HEPA filters in pass-thru windows | Required | $ - 0 | ||||
| 104 | Services - Semi Annually | Airborne particle count for all three rooms (anteroom, non-HD buffer room, and HD buffer room) | Required | $ - 0 | ||||
| 105 | Additonal Requirements | CETA Certification within 6 months or less is required as part of proof. | Required | $ - 0 | ||||
| 106 | Additonal Requirements | Guarantee that product will meet USP 797 and USP 800 standards, and VHA Directives 1108.06 and 1108.12. | Required | $ - 0 | ||||
| 107 | Additonal Requirements | Installation of aluminum access ramp and emergency exit stairs. Access ramp to pharmacy sterile compounding trailer must have a configurable orientation to meet installation site needs and must have an alternative stairs pathway to the main entry door of the pharmacy sterile compounding trailer. One (1) set of emergency exit stairs shall be provided in case of emergency. | Required | $ - 0 | ||||
| 108 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Additonal Requirements | Four (4) security cameras (Model AXIS Q3515-LVE Network Camera or similar) to be mounted on the external walls of the trailer at each corner, all capable of viewing the main entrance to the trailer or the emergency exit. As mentioned above, cameras to be wired with 400 ft of CAT6a cable. Upon installation, contractor to pull wires through the conduit provided at the site prep to the security closet in building 164. | Required - Equivalent product acceptable | $ - 0 | |
| 109 | Hirsch | ScrambleSmartProx | DS47L-SSP-TS | Additonal Requirements | Trailer main entrance to be secured via Hirsch ScrambleSmartProx Reader. Reader to be wired with 400 ft CAT6a cable. Upon installation, contractor to pull wire through the conduit provided at the site prep to the security closet in building 164. | Required - Equivalent product acceptable | $ - 0 | |
| 110 | Additonal Requirements | Contractor must be able to deliver and install pharmacy sterile compounding trailer within 6 months of awarding of contract. | Required | $ - 0 | ||||
| 111 | Additonal Requirements | The pharmacy sterile compounding trailer shall have back-up emergency power with Automatic Transfer Switch. The emergency generator(s) shall provide 100% coverage for the entire trailer and have the capacity to fully power the entire trailer for at least 72 continuous hours in case of normal power outage. | Required | $ - 0 | ||||
| 112 | Additonal Requirements | The trailer shall have fully functional, complete, and independent fire alarm compliant with NFPA 72 and NFPA 13 requirements respectively. | Required | $ - 0 | ||||
| 113 | Additonal Requirements | If required by South Coast Air Quality Management District (SCAQMD) and applicable federal, state and local regulations, obtain permit to construct and permit to operate from SCAQMD for emergency generators for the pharmacy sterile compounding trailer. | Required | $ - 0 | ||||
| Total | $ - 0 |
2. Option 1 CLIN Brand Name Brand Name Nomenclature Manufacturer Part Number if Applicable Salient Characteristics Category Salient Characteristic Description Requirement Equivalent Brand Equivalent Nomenclature Equivalent Part Number Equivalent Description Matching Salient Characteristics and/or location of information regarding equal capability Quantity Unit Price Extended Price
| 1 | Rooms & Areas | Unclassified area separating the main entrance from the anteroom | Preferred | $ - 0 | ||||
| 2 | Rooms & Areas | Anteroom | Required | $ - 0 | ||||
| 3 | Rooms & Areas | Sterile Hazardous Drug (HD) Buffer Room | Required | $ - 0 | ||||
| 4 | Rooms & Areas | Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Required | $ - 0 | ||||
| 5 | Rooms & Areas | Sterile Hazardous Drug Storage Area | Required | $ - 0 | ||||
| 6 | Rooms & Areas | Self-Supporting Modular Design inclusive of walls, roof, ceiling, flooring, lighting, electrical & filtering equipment | Required | $ - 0 | ||||
| 7 | Rooms & Areas | Modular clean room must fit in a 57' L x8'6"L W x 13'6" H DOT approved semi-trailer Modular Clean room seismic intergrity provisions where necessary | Preferred | $ - 0 | ||||
| 8 | Rooms & Areas | Finishes - Non-pourous and cleanable surfaces, ceilings, walls, and floors with minimal seams and crevices, able to withstand appropriate deactivation, decontamination, disinfecting and cleaning agents | Required | $ - 0 | ||||
| 9 | Equipment - Unclassified Area | Soiled PPE Waste Bin | Required | $ - 0 | ||||
| 10 | Equipment - Unclassified Area | Stainless steel workstation | Preferred | $ - 0 | ||||
| 11 | Equipment - Unclassified Area | One (1) data drop with 4 ports (RJ 45) | Required | $ - 0 | ||||
| 12 | Equipment - Unclassified Area | Two (2) 120V power outlest with 2 sockets each | Required | $ - 0 | ||||
| 13 | Equipment - Anterom | Scrub sink with eyewash station and anti-scald device positioned at least 1 meter from the sterile HD buffer room door | Required | $ - 0 | ||||
| 14 | Equipment - Anterom | Clean Personal Protective Equipment (PPE) Storage Bin | $ - 0 | |||||
| 15 | Equipment - Anterom | Soiled PPE Waste Bin | $ - 0 | |||||
| 16 | Equipment - Anterom | Staff Changing Bench | $ - 0 | |||||
| 17 | Equipment - Anterom | Environmental Services Cabinet | $ - 0 | |||||
| 18 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Anterom | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 19 | Equipment - Anterom | 3M™ Avagard™ Hands Free Wall Dispenser | $ - 0 | |||||
| 20 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) spaced 1 meter apart from each other with 100% Outside Air Supply and Exhaust | Required - Equivalent product acceptable | $ - 0 | |
| 21 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Interlocking HEPA filtered Pass-Thru Chamber from Anteroom | Required - Equivalent product acceptable | $ - 0 | ||||
| 22 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Stainless Steel Workstation | Required - Equivalent product acceptable | $ - 0 | ||||
| 23 | Thermo Scientific | Thermo Scientific Refrigerator model TSX3005GA | TSX3005GA | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Thermo Scientific Refrigerator model TSX3005GA or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 24 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Soiled PPE Waste Bin | Required - Equivalent product acceptable | $ - 0 | ||||
| 25 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Storage Cabinet for compounded sterile hazardous drugs | Required - Equivalent product acceptable | $ - 0 | ||||
| 26 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves | Required - Equivalent product acceptable | $ - 0 | ||||
| 27 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | One (1) data drop with 4 ports (RJ 45) | Required - Equivalent product acceptable | $ - 0 | ||||
| 28 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Three (3) 120V power outlets with two sockets each | Required - Equivalent product acceptable | $ - 0 | ||||
| 29 | Gai-Tronics | Clean Phone® Analog Telephone (Wall-Mount) - UL | 295-001W | Equipment - Sterile Hazardous Drug (HD) Buffer Room | A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W) | Preferred - Equivalent product acceptable | $ - 0 | |
| 30 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 31 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed) | Required - Equivalent product acceptable | $ - 0 | ||||
| 32 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) | $ - 0 | |||||
| 33 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Interlocking HEPA Filtered Pass-Thru Chamber from Anteroom or Unclassified Area | Required - Equivalent product acceptable | $ - 0 | ||||
| 34 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Stainless Steel Workstation | Required - Equivalent product acceptable | $ - 0 | ||||
| 35 | Thermo Scientific | Thermo Scientific Refrigerator model TSX3005GA | TSX3005GA | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Thermo Scientific Refrigerator model TSX3005GA or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 36 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Non-Hazardous Drug Storage Cabinet | Required - Equivalent product acceptable | $ - 0 | ||||
| 37 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves | Required - Equivalent product acceptable | $ - 0 | ||||
| 38 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | One (1) data drop with 4 ports (RJ 45) | Required - Equivalent product acceptable | $ - 0 | ||||
| 39 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Three (3) 120V power outlets with two sockets each | Required - Equivalent product acceptable | $ - 0 | ||||
| 40 | Gai-Tronics | Clean Phone® Analog Telephone (Wall-Mount) - UL | 295-001W | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W) | Preferred - Equivalent product acceptable | $ - 0 | |
| 41 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 42 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed) | $ - 0 | |||||
| 43 | Environmental Controls | All facility & engineering controls compliant with USP 797/800 standards. | Required | $ - 0 | ||||
| 44 | Environmental Controls | Trailer should be able to maintain appropriate internal temperature, humidity and pressure requirements while located in Long Beach, CA, which has a Mediterranean-type, coastal climate. Temperature extremes may range from 20°F – 112°F with a relative humidity up to 100%. | Required | $ - 0 | ||||
| 45 | Environmental Controls | The trailer must have fire alarm system that is completely independent and compliant with the NFPA requirement and has the capability to alert and automatically dial out when the fire alarm system is activated. | Required | $ - 0 | ||||
| 46 | Environmental Controls | Physically separated Anteroom and Sterile Hazardous Drug Buffer Room and Sterile Non-Hazardous Drug Buffer Room. | Required | $ - 0 | ||||
| 47 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Environmental Controls - Primary Engineering Controls | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile HD Buffer Room with 100% Outside Air Supply and Exhaust | Required | $ - 0 | |
| 48 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Environmental Controls - Primary Engineering Controls | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile Non-Hazardous Buffer Room | Required | $ - 0 | |
| 49 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Positive pressure with greater than or equal to 0.02-inch Water Column | Required | $ - 0 | ||||
| 50 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 51 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 52 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | High Efficiency Particulate Air (HEPA) filtered exhaust air | Required | $ - 0 | ||||
| 53 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 54 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 55 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 56 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Negative pressure between 0.01-inch Water Column to 0.03-inch Water Column | Required | $ - 0 | ||||
| 57 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 58 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 100% Outside Supply Air (into room) | Required | $ - 0 | ||||
| 59 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 60 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Zero recirculation of HD Buffer Room air | Required | $ - 0 | ||||
| 61 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Each compounding hood has a dedicated external exhaust that is HEPA-filtered directly to outsidem | Required | $ - 0 | ||||
| 62 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Buffer room has a dedicated and HEPA-filtered external exhaust that is 100% of air exhausted directly to outside | Required | $ - 0 | ||||
| 63 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 64 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 65 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 24/7 Real-time Monitoring Refrigerator interior temperature to ensure drug safety. The interior temperature for the refrigerator shall be between 2 degrees Celsius and 8 degrees Celsius. | Required | $ - 0 | ||||
| 66 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 67 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Positive pressure with greater than or equal to 0.02-inch Water Column | Required | $ - 0 | ||||
| 68 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 69 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | 100% Outside Supply Air (into room) | Required | $ - 0 | ||||
| 70 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 71 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Buffer room has High Efficiency Particulate Air (HEPA) filtered exhaust/return air | Required | $ - 0 | ||||
| 72 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Each compounding hood has built-in HEPA filter. | Required | $ - 0 | ||||
| 73 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 74 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 75 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | 24/7 Real-time Monitoring of refrigerator interior temperature to ensure drug safety. The interior temperature for the refrigerator shall be between 2 degrees Celsius and 8 degrees Celsius. | Required | $ - 0 | ||||
| 76 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile Non-HD Buffer Room | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 77 | Mechanical Room | Back-up Emergency Generator(s) with Automatic Transfer Switch | Required | $ - 0 | ||||
| 78 | Mechanical Room | On-board freshwater tank and an on-demand electric water pump to provide running water for a sink and eyewash | Required | $ - 0 | ||||
| 79 | Mechanical Room | Gray water holding tank | Required | $ - 0 | ||||
| 80 | Mechanical Room | The pharmacy cleanroom will arrive completely plumbed, ready for use via holding tanks | Required | $ - 0 | ||||
| 81 | Mechanical Room | HVAC system to utilize R410A refrigerant | Preferred | $ - 0 | ||||
| 82 | Mechanical Room | All cameras, card readers and data ports will be prewired with 400 ft of CAT6a cable. Excess cable will be bundled and exit the trailer on the front-right side of the trailer closest to the utility pedestal as shown on the site-prep design. | Required | $ - 0 | ||||
| 83 | Utility Requirements | Electrical: 208V 3-Phase 200 Amps | Required | $ - 0 | ||||
| 84 | Utility Requirements | Water: 3/4" Potable Water Line | Required | $ - 0 | ||||
| 85 | Utility Requirements | Sewer: 3" Standard Sewer Line | Required | $ - 0 | ||||
| 86 | Utility Requirements | Cables and conductors must be in conduits that are built for outside uses. All connections must be water proof and tightly sealed. | Required | $ - 0 | ||||
| 87 | Services - Installation | Installation and set-up of the Pharmacy Sterile Compounding Trailer, including connections for electrical, water, sewer and data. | Required | $ - 0 | ||||
| 88 | Services - Installation | The data cables shall be pulled through the utility pedestal conduit and connected to the appropriate switches in the IT closet in Building 164, Room 189. | Required | $ - 0 | ||||
| 89 | Services - Installation | The security camera and badge reader data cables shall be pulled through the utility pedestal conduit and connected to the appropriate switches in the security closet in Building 164, Room 137. | Required | $ - 0 | ||||
| 90 | Services - Installation | The vendor must perform on site utility connections. | Required | $ - 0 | ||||
| 91 | Services - Annual Maintenance | Full maintenance and repair services shall be required for a period of one (1) year after the Pharmacy Sterile Compounding Trailer is fully certified and in operation with two (2) additional option years. | Required | $ - 0 | ||||
| 92 | Services - Annual Maintenance | For emergency calls, contractor is required to respond on-site within 3 hours, and by the next business day for non-emergency calls. | Required | $ - 0 | ||||
| 93 | Services - Annual Maintenance | All repairs and maintenance services shall be performed after hours or during weekends so that the impact to the Medical Center operations is minimized. | Required | $ - 0 | ||||
| 94 | Services - Monthly | Change HVAC pre-filters. | Required | $ - 0 | ||||
| 95 | Services - Monthly | Exercise and test emergency generators in accordance with SCAQMD requirements and other federal and state requirements. | Required | $ - 0 | ||||
| 96 | Services - Monthly | Refuel generators and fuel tank as necessary. | Required | $ - 0 | ||||
| 97 | Services - Monthly | Add water treatment to grey water tank. Grey water tank shall be emptied on regular basis or when it is 80% full by the contractor. | Required | $ - 0 | ||||
| 98 | Services - Quarterly | Lubricate direct drive motors on exhaust fans | Required | $ - 0 | ||||
| 99 | Services - Quarterly | Check pressure on all tires of the pharmacy trailer and put in more air as necessary | Required | $ - 0 | ||||
| 100 | Services - Semi Annually | CETA certification in compliance with USP 797 and USP 800 | Required | $ - 0 | ||||
| 101 | Services - Semi Annually | Change HEPA filters in ceiling diffusers for both supply and exhaust and/or return | Required | $ - 0 | ||||
| 102 | Services - Semi Annually | Change filters in BSCs as needed | Required | $ - 0 | ||||
| 103 | Services - Semi Annually | Change HEPA filters in pass-thru windows | Required | $ - 0 | ||||
| 104 | Services - Semi Annually | Airborne particle count for all three rooms (anteroom, non-HD buffer room, and HD buffer room) | Required | $ - 0 | ||||
| 105 | Additonal Requirements | CETA Certification within 6 months or less is required as part of proof. | Required | $ - 0 | ||||
| 106 | Additonal Requirements | Guarantee that product will meet USP 797 and USP 800 standards, and VHA Directives 1108.06 and 1108.12. | Required | $ - 0 | ||||
| 107 | Additonal Requirements | Installation of aluminum access ramp and emergency exit stairs. Access ramp to pharmacy sterile compounding trailer must have a configurable orientation to meet installation site needs and must have an alternative stairs pathway to the main entry door of the pharmacy sterile compounding trailer. One (1) set of emergency exit stairs shall be provided in case of emergency. | Required | $ - 0 | ||||
| 108 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Additonal Requirements | Four (4) security cameras (Model AXIS Q3515-LVE Network Camera or similar) to be mounted on the external walls of the trailer at each corner, all capable of viewing the main entrance to the trailer or the emergency exit. As mentioned above, cameras to be wired with 400 ft of CAT6a cable. Upon installation, contractor to pull wires through the conduit provided at the site prep to the security closet in building 164. | Required - Equivalent product acceptable | $ - 0 | |
| 109 | Hirsch | ScrambleSmartProx | DS47L-SSP-TS | Additonal Requirements | Trailer main entrance to be secured via Hirsch ScrambleSmartProx Reader. Reader to be wired with 400 ft CAT6a cable. Upon installation, contractor to pull wire through the conduit provided at the site prep to the security closet in building 164. | Required - Equivalent product acceptable | $ - 0 | |
| 110 | Additonal Requirements | Contractor must be able to deliver and install pharmacy sterile compounding trailer within 6 months of awarding of contract. | Required | $ - 0 | ||||
| 111 | Additonal Requirements | The pharmacy sterile compounding trailer shall have back-up emergency power with Automatic Transfer Switch. The emergency generator(s) shall provide 100% coverage for the entire trailer and have the capacity to fully power the entire trailer for at least 72 continuous hours in case of normal power outage. | Required | $ - 0 | ||||
| 112 | Additonal Requirements | The trailer shall have fully functional, complete, and independent fire alarm compliant with NFPA 72 and NFPA 13 requirements respectively. | Required | $ - 0 | ||||
| 113 | Additonal Requirements | If required by South Coast Air Quality Management District (SCAQMD) and applicable federal, state and local regulations, obtain permit to construct and permit to operate from SCAQMD for emergency generators for the pharmacy sterile compounding trailer. | Required | $ - 0 | ||||
| Total | $ - 0 |
3. Option 2 CLIN Brand Name Brand Name Nomenclature Manufacturer Part Number if Applicable Salient Characteristics Category Salient Characteristic Description Requirement Equivalent Brand Equivalent Nomenclature Equivalent Part Number Equivalent Description Matching Salient Characteristics and/or location of information regarding equal capability Quantity Unit Price Extended Price
| 1 | Rooms & Areas | Unclassified area separating the main entrance from the anteroom | Preferred | $ - 0 | ||||
| 2 | Rooms & Areas | Anteroom | Required | $ - 0 | ||||
| 3 | Rooms & Areas | Sterile Hazardous Drug (HD) Buffer Room | Required | $ - 0 | ||||
| 4 | Rooms & Areas | Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Required | $ - 0 | ||||
| 5 | Rooms & Areas | Sterile Hazardous Drug Storage Area | Required | $ - 0 | ||||
| 6 | Rooms & Areas | Self-Supporting Modular Design inclusive of walls, roof, ceiling, flooring, lighting, electrical & filtering equipment | Required | $ - 0 | ||||
| 7 | Rooms & Areas | Modular clean room must fit in a 57' L x8'6"L W x 13'6" H DOT approved semi-trailer Modular Clean room seismic intergrity provisions where necessary | Preferred | $ - 0 | ||||
| 8 | Rooms & Areas | Finishes - Non-pourous and cleanable surfaces, ceilings, walls, and floors with minimal seams and crevices, able to withstand appropriate deactivation, decontamination, disinfecting and cleaning agents | Required | $ - 0 | ||||
| 9 | Equipment - Unclassified Area | Soiled PPE Waste Bin | Required | $ - 0 | ||||
| 10 | Equipment - Unclassified Area | Stainless steel workstation | Preferred | $ - 0 | ||||
| 11 | Equipment - Unclassified Area | One (1) data drop with 4 ports (RJ 45) | Required | $ - 0 | ||||
| 12 | Equipment - Unclassified Area | Two (2) 120V power outlest with 2 sockets each | Required | $ - 0 | ||||
| 13 | Equipment - Anterom | Scrub sink with eyewash station and anti-scald device positioned at least 1 meter from the sterile HD buffer room door | Required | $ - 0 | ||||
| 14 | Equipment - Anterom | Clean Personal Protective Equipment (PPE) Storage Bin | $ - 0 | |||||
| 15 | Equipment - Anterom | Soiled PPE Waste Bin | $ - 0 | |||||
| 16 | Equipment - Anterom | Staff Changing Bench | $ - 0 | |||||
| 17 | Equipment - Anterom | Environmental Services Cabinet | $ - 0 | |||||
| 18 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Anterom | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 19 | Equipment - Anterom | 3M™ Avagard™ Hands Free Wall Dispenser | $ - 0 | |||||
| 20 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) spaced 1 meter apart from each other with 100% Outside Air Supply and Exhaust | Required - Equivalent product acceptable | $ - 0 | |
| 21 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Interlocking HEPA filtered Pass-Thru Chamber from Anteroom | Required - Equivalent product acceptable | $ - 0 | ||||
| 22 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Stainless Steel Workstation | Required - Equivalent product acceptable | $ - 0 | ||||
| 23 | Thermo Scientific | Thermo Scientific Refrigerator model TSX3005GA | TSX3005GA | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Thermo Scientific Refrigerator model TSX3005GA or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 24 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Soiled PPE Waste Bin | Required - Equivalent product acceptable | $ - 0 | ||||
| 25 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Storage Cabinet for compounded sterile hazardous drugs | Required - Equivalent product acceptable | $ - 0 | ||||
| 26 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves | Required - Equivalent product acceptable | $ - 0 | ||||
| 27 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | One (1) data drop with 4 ports (RJ 45) | Required - Equivalent product acceptable | $ - 0 | ||||
| 28 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Three (3) 120V power outlets with two sockets each | Required - Equivalent product acceptable | $ - 0 | ||||
| 29 | Gai-Tronics | Clean Phone® Analog Telephone (Wall-Mount) - UL | 295-001W | Equipment - Sterile Hazardous Drug (HD) Buffer Room | A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W) | Preferred - Equivalent product acceptable | $ - 0 | |
| 30 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Sterile Hazardous Drug (HD) Buffer Room | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 31 | Equipment - Sterile Hazardous Drug (HD) Buffer Room | 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed) | Required - Equivalent product acceptable | $ - 0 | ||||
| 32 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) | $ - 0 | |||||
| 33 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Interlocking HEPA Filtered Pass-Thru Chamber from Anteroom or Unclassified Area | Required - Equivalent product acceptable | $ - 0 | ||||
| 34 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Stainless Steel Workstation | Required - Equivalent product acceptable | $ - 0 | ||||
| 35 | Thermo Scientific | Thermo Scientific Refrigerator model TSX3005GA | TSX3005GA | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Thermo Scientific Refrigerator model TSX3005GA or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 36 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Non-Hazardous Drug Storage Cabinet | Required - Equivalent product acceptable | $ - 0 | ||||
| 37 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves | Required - Equivalent product acceptable | $ - 0 | ||||
| 38 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | One (1) data drop with 4 ports (RJ 45) | Required - Equivalent product acceptable | $ - 0 | ||||
| 39 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Three (3) 120V power outlets with two sockets each | Required - Equivalent product acceptable | $ - 0 | ||||
| 40 | Gai-Tronics | Clean Phone® Analog Telephone (Wall-Mount) - UL | 295-001W | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W) | Preferred - Equivalent product acceptable | $ - 0 | |
| 41 | AXIS | AXIS M3045-V Network Camera | AXIS M3045-V Network Camera | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent | Required - Equivalent product acceptable | $ - 0 | |
| 42 | Equipment - Sterile Non-Hazardous Drug (Non-HD) Buffer Room | 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed) | $ - 0 | |||||
| 43 | Environmental Controls | All facility & engineering controls compliant with USP 797/800 standards. | Required | $ - 0 | ||||
| 44 | Environmental Controls | Trailer should be able to maintain appropriate internal temperature, humidity and pressure requirements while located in Long Beach, CA, which has a Mediterranean-type, coastal climate. Temperature extremes may range from 20°F – 112°F with a relative humidity up to 100%. | Required | $ - 0 | ||||
| 45 | Environmental Controls | The trailer must have fire alarm system that is completely independent and compliant with the NFPA requirement and has the capability to alert and automatically dial out when the fire alarm system is activated. | Required | $ - 0 | ||||
| 46 | Environmental Controls | Physically separated Anteroom and Sterile Hazardous Drug Buffer Room and Sterile Non-Hazardous Drug Buffer Room. | Required | $ - 0 | ||||
| 47 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Environmental Controls - Primary Engineering Controls | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile HD Buffer Room with 100% Outside Air Supply and Exhaust | Required | $ - 0 | |
| 48 | Baker | SterilGard e3 Class II Type A2 Biological Safety Cabinet - 4' | SG404 | Environmental Controls - Primary Engineering Controls | Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile Non-Hazardous Buffer Room | Required | $ - 0 | |
| 49 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Positive pressure with greater than or equal to 0.02-inch Water Column | Required | $ - 0 | ||||
| 50 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 51 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 52 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | High Efficiency Particulate Air (HEPA) filtered exhaust air | Required | $ - 0 | ||||
| 53 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius | Required | $ - 0 | ||||
| 54 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | Humidity level shall be between 30% and 60% | Required | $ - 0 | ||||
| 55 | Environmental Controls - Secondary Engineering Controls - ISO 7 Anteroom | 24/7 Real-time Environmental Room Monitor providing: Room temperature, Humidity,Differential pressure | Required | $ - 0 | ||||
| 56 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Negative pressure between 0.01-inch Water Column to 0.03-inch Water Column | Required | $ - 0 | ||||
| 57 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual | Required | $ - 0 | ||||
| 58 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | 100% Outside Supply Air (into room) | Required | $ - 0 | ||||
| 59 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | High Efficiency Particulate Air (HEPA) filtered supply air | Required | $ - 0 | ||||
| 60 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Zero recirculation of HD Buffer Room air | Required | $ - 0 | ||||
| 61 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Each compounding hood has a dedicated external exhaust that is HEPA-filtered directly to outsidem | Required | $ - 0 | ||||
| 62 | Environmental Controls - Secondary Engineering Controls - ISO 7 Sterile HD Buffer Room | Buffer room has a dedicated and HEPA-filtered external exhaust that is 100% of air exhausted directly to outside | Required | $ - 0 |
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