16-223-SOL-00121.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/bids are being requested and a written solicitation will not be issued.

The solicitation number is 16-223-SOL-00121. This solicitation is issued as a Request for Quotation (RFQ). This is a firm fixed price requirement. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-89, 08-15-2016. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing. This notice is for Full and Open Competition.

DHHS FDA Office of Acquisitions and Grants Services is requesting quotes for two 4 Glove Rigid Isolator, one 3-Glove Transfer Isolator, one Water Filtration System and a four year preventive maintenance plan for each Isolators.

Requirements and Characteristics:

4-Glove Rigid Isolators with attached hatch

· The isolator must be able to be separated for installation as needed to fit into a service elevator 54 in (W) x 102 in (L), then turn 90 degrees and pass through a double door way, 78 in (W) x 95 in (H), travel through a laboratory space and make a 90 degree turn and pass between laboratory benches which are 5 feet apart then turn 90 degrees and pass through a laboratory door which is 6 feet wide into its installation location. If separation/disassembly is required the contract shall include reassembly of the isolator at the final installation location.

· Outfitted with the characteristics listed below to include the following integrated equipment procured and installed by the contractor: a Millipore Symbio sterility test pump, active viable air sampling instrument and non-viable particulate monitoring instrument.

· Factory acceptance testing

· Installation of the isolators at Pacific Regional Laboratory Southwest

· Generation of installation and operational qualification documents

· Execution of installation and operational qualification at Pacific Regional Laboratory Southwest

· Generation of cycle development documents

· Execution of cycle development at Pacific Regional Laboratory Southwest

· A service agreement for preventative maintenance with one year included and an option of up to four additional years

· Capable of being used to perform sterility testing in accordance with the USP pharmacopeia. The unit shall provide an aseptic environment for sterility testing and other aseptic manipulations within the chamber.

· Equipped with HEPA filters and as appropriate pre-filters which provide air to the isolator chamber which meets ISO 5 requirements.

· Equipped with fittings to allow for periodic leak testing to be performed on the HEPA filters.

· Equipped with positive pressure and turbulent air flow.

· Construction consists of appropriate grades of stainless steel. The inner corners of the main chamber being rounded to allow for good cleaning.

· Equipped with a hinged front tempered safety glass window to allow for access to the chamber for loading of supplies and test samples.

· Equipped with 4 glove ports outfitted with CSM (chlorosulphonated polyethylene or by the former brand name Hypalon®) sleeves or equivalent and compatible gloves.

· Function of the isolator and associated decontamination unit shall be controlled with an installed PLC system with an operator interface touch panel.

· The PLC system shall display system status, alarms, phases of the decontamination cycle and be FDA 21CFR Part 11 compliant.

· The PLC system must be able to store and produce alarm reports. Recipes and other appropriate system reports are printed or delivered by other means (USB portable drive).

· Equipped with a decontamination unit capable of producing and then delivering vaporized hydrogen peroxide, ionized hydrogen peroxide or equivalent into the main chamber and the transfer chamber to reduce the microbial load of chamber surfaces by a 6 log reduction of spores.

· The unit should include an integrated pressure decay test.

· The following minimum decontamination cycle parameters should be included and monitored during a cycle:

· Temperature

· Relative humidity

· H2O2 injection duration and rate

· H2O2 concentration

· Equipped with an attached transfer hatch which allows for independent decontamination of both chambers.

· Transfer hatch shall be constructed of 316L stainless steel with a hinged front tempered safety glass window to allow for access to the chamber.

· Between the transfer hatch and the main chamber of the isolator there must be a leak tight door which can be opened from the main isolator chamber.

· Transfer hatch should be outfitted with racking.

· Equipped with an 190 DPTE XS alpha flange on the floor of the main chamber

· Equipped with a 350 DPTE XS alpha flange on the right side of the main chamber.

· Equipped with a concave circular drain dish with a pass-through for filtrate on the floor of the main chamber.

· The main chamber shall be equipped with shelving racks, hanging bars and hooks for the hanging bars.

· Equipped with an integrated low level H2O2 monitoring device mounted on the exterior of the isolator to monitor room H2O2 levels.

· Both the main chamber and the attached transfer chamber shall be equipped with a low level H2O2 vapor concentration monitoring device.

· Equipped with an integrated glove testing system.

· Equipped with 4 glove extenders

· Equipped with an integrated active viable air monitoring instrument which can be activated via the isolator’s PLC/HMI or in an equivalent manner.

· Equipped with an integrated active non-viable particulate monitoring instrument which can be activated via the isolator’s PLC/HMI or in an equivalent manner.

· Equipped with a catalytic converter that receives the chamber exhaust and removes H2O2 to a level of 1ppm prior to exhausting the air into the surrounding room.

· Equipped with an integrated Millipore Steritest Symbio pump with foot switch.

· Equipped with a service plate on the right side of the main chamber which allows for the pass through of cables and tubing.

· Equipped with a second HEPA filter on chamber exhaust to allow for the testing of potent products within the isolator.

· Equipped with a trolley to remove waste from the isolator via the 190 DPTE X alpha flange.

· Equipped with casters to allow for movement and transport from the loading dock to the permanent location on the second floor, wing 3 of the laboratory in room 2309.

· Must have a factory acceptance test completed at the manufacturing site which shall include documentation review, P & ID check, electrical component checks, dimension checks, check of sensor calibration certificates, software version verification, input and output checks, leak test, air change rate per hour and air flow mapping.

· Must have validation documentation created to include installation qualification and operational qualification tests which shall include the following:

· Installation qualification:

· Documentation review

· P&ID verification

· Utility connections verified

· Electrical installation verification

· Mechanical installation (ventilation system)

· Calibration checks and functional testing of measuring equipment to include pressure sensors, temperature sensors

· Filter leak testing

· Operational qualification:

· Pressure differential verification

· Air change rate per hour

· Particle Counts to meet ISO 5 standards

· Alarm verification

· Verification of various functional modes

· Verification of vaporized hydrogen peroxide injection calibration

· Must have execution of the installation and operational qualification performed onsite at Pacification Regional Laboratory Southwest after installation.

· Must have cycle development documentation created to include the following:

· Air distribution study

· Temperature distribution and Chemical indicator testing

· Definition of worst case load pattern

· Biodecontamination using biological indicators

· Determination of aeration time

· Must have execution of the cycle development for a worst case load and an empty chamber load performed onsite at Pacific Regional Laboratory Southwest after the installation and operational qualification activities.

· Cycle development verification should include the following:

· Up to 5 runs for the loaded transfer hatch cycle to optimize the decontamination cycle using biological indicators.

· Three runs for the loaded transfer hatch cycle verification using biological indicators.

· Three runs for the empty chamber cycle verification using biological indicators.

· Must include installation of the isolator and on-site training provided to 3-4 analysts which must include hands-on instruction.

· The contractor shall provide a minimum of a one year manufacturing warranty for all manufactured equipment, parts and operational services for the sterility testing isolator, sterility test pump, glove integrity tester, viable monitoring instrument and non-viable particulate monitoring instrument. The warranty shall be included with the new equipment and not separately priced. The warranty shall not be combined with the preventative maintenance support services.

· The contractor shall provide a full support for the installed equipment, including regular/periodic service visits to maintain the system, including retesting and re-qualification to optimum performance. The contractor shall provide on-site response within a week after the Government notifies the contractor that services are needed.

· The contractor shall recommend and make available a full schedule of spare parts. The contractor shall identify the spare parts that will be made available as part of the final documentation for the Isolator.

3-GLOVE TRANSFER ISOLATOR SPECIFICATIONS

· Outfitted with the characteristics listed below to include the following integrated equipment procured and installed by the contractor: an active viable air sampling instrument and non-viable particulate monitoring instrument.

· Factory acceptance testing

· Installation of the isolator at Pacific Regional Laboratory Southwest

· Generation of installation and operational qualification documents

· Execution of installation and operational qualification at Pacific Regional Laboratory Southwest

· Generation of cycle development documents

· Execution of cycle development at Pacific Regional Laboratory Southwest

· Shipping costs

· A service agreement for preventative maintenance with one year included and an option of up to four additional years

· Capable of being used in conjunction with a sterility testing isolator. The unit shall provide an aseptic environment appropriate for sterility testing and other aseptic manipulations within the chamber.

· Equipped with HEPA filters and as appropriate pre-filters which provide air to the isolator chamber which meets ISO 5 requirements.

· Equipped with fittings to allow for periodic leak testing to be performed on the HEPA filters.

· Equipped with positive pressure and turbulent air flow.

· The isolator shall be equipped with an uninterruptable power supply to maintain power to the isolator during the process of moving the isolator and transferring the decontaminated chamber articles to the workstation isolator.

· Equipped with a flexible transparent canopy. Construction of the canopy shall consist of clear PVC (polyvinyl chloride) at least 0.3mm thick with ultrasonic welded construction, reinforced corners, zippers to allow for removal of the canopy, three glove ports outfitted with CSM (chlorosulphonated polyethylene or by the former brand name Hypalon®) sleeves or equivalent and compatible gloves.

· Construction of the work surface inside the isolator shall consist of 316L stainless steel.

· Construction of the upper and lower support structure shall consist of a tubular welded frame.

· Function of the isolator and associated decontamination unit shall be controlled with an installed PLC system with an operator interface touch panel.

· The PLC system shall display system status, alarms, phases of the decontamination cycle and be FDA 21CFR Part 11 compliant.

· The PLC system must be able to store and produce alarm reports. Recipes and other appropriate system reports are printed or delivered by other means (USB portable drive).

· Equipped with a decontamination unit capable of producing and then delivering vaporized hydrogen peroxide, ionized hydrogen peroxide or equivalent into the main chamber to reduce the microbial load of chamber surfaces by a 6 log reduction of spores.

· The unit should include an integrated pressure decay test.

· The following minimum decontamination cycle parameters should be included and monitored during a cycle:

· Temperature

· Relative humidity

· H2O2 injection duration and rate

· H2O2 concentration

· Equipped with a concave circular drain dish with a pass-through for filtrate on the stainless steel work surface of the isolator.

· The isolator chamber shall be equipped with shelving racks, hanging bars and hooks for the hanging bars and a transfer bridge to facilitate movement of articles from this chamber to a workstation isolator.

· The isolator shall be equipped with a 350 DPTE XS Beta flange to allow for the aseptic connection and disconnection to a workstation isolator without breaching the integrity of either isolator. The system shall allow for the transfer of material and articles between this transfer isolator and the workstation isolator.

· The isolator canopy shall be equipped on one end with a 316L stainless steel, 22 inch inner diameter ring, attachment mechanism and end cap which allows for access to the isolator main chamber for set-up and maintenance and when reassembled provides a leak tight seal.

· The isolator canopy shall be equipped with a service plate that allows the pass through of fluids, vacuum and power cords.

· Equipped with an integrated low level H2O2 monitoring device mounted on the exterior of the isolator to monitor room H2O2 levels.

· The main chamber shall be equipped with a low level H2O2 vapor concentration monitoring device.

· Equipped with 3 glove extenders.

· Equipped with an integrated glove testing system.

· Equipped with an integrated active viable air monitoring instrument which can be activated via the isolator’s PLC/HMI or in an equivalent manner.

· Equipped with an integrated active non-viable particulate monitoring instrument which can be activated via the isolator’s PLC/HMI or in an equivalent manner.

· Equipped with a catalytic converter that receives the chamber exhaust and removes H2O2 to a level of 1ppm prior to exhausting the air into the surrounding room.

· Prepared for the installation of a Millipore Symbio pump on the stainless steel worksurface. Preparation includes a hole with plug that would allow for the installation of a steritest pump at a future date. Procurement and installation of the pump is not included in this contract.

· Equipped with casters to allow for movement and transport from the loading dock to the permanent location on the second floor, wing 3 of the laboratory in room 2309 and movement within room 2309 to dock and undock to a workstation isolator.

· The isolator must be able to be disassembled for installation, if needed, to fit into a service elevator 54 in (W) x 102 in (L), then turn 90 degrees and pass through a double door way, 78 in (W) x 95 in (H), travel through a laboratory space and make a 90 degree turn and pass between laboratory benches which are 5 feet apart then turn 90 degrees and pass through a laboratory door which is 6 feet wide into room 2309. If disassembly is required the contract shall include reassembly of the isolator at the final installation location.

· Must have a factory acceptance test completed at the manufacturing site which shall include documentation review, P & ID check, electrical component checks, dimension checks, check of sensor calibration certificates, software version verification, input and output checks, leak test, air change rate per hour and air flow mapping.

· Must have validation documentation created to include installation qualification and operational qualification tests which shall include the following:

· Installation qualification:

· Documentation review

· P&ID verification

· Utility connections verified

· Electrical installation verification

· Mechanical installation (ventilation system)

· Calibration checks and functional testing of measuring equipment to include pressure sensors, temperature sensors

· Filter leak testing

· Operational qualification:

· Pressure differential verification

· Air change rate per hour

· Particle Counts to meet ISO 5 standards

· Alarm verification

· Verification of various functional modes

· Verification of vaporized hydrogen peroxide injection calibration

· Must have execution of the installation and operational qualification performed onsite at Pacification Regional Laboratory Southwest after installation.

· Must have cycle development documentation created to include the following:

· Air distribution study

· Temperature distribution and Chemical indicator testing

· Definition of worst case load pattern

· Bio decontamination using biological indicators

· Determination of aeration time

· Must have execution of the cycle development for a worst case load performed onsite at Pacific Regional Laboratory Southwest after the installation and operational qualification activities.

· Cycle development verification should include the following:

· Up to 5 runs for the loaded chamber to optimize the decontamination cycle using biological indicators.

· Three runs for the loaded chamber for cycle verification using biological indicators.

· Must include installation of the isolator and on-site training provided to 3-4 analysts which must include hands-on instruction.

· The contractor shall provide a minimum of a one year manufacturing warranty for all manufactured equipment, parts and operational services for the sterility testing isolator, sterility test pump, glove integrity tester, viable monitoring instrument and non-viable particulate monitoring instrument. The warranty shall be included with the new equipment and not separately priced. The warranty shall not be combined with the preventative maintenance support services.

· The contractor shall provide a full support for the installed equipment, including regular/periodic service visits to maintain the system, including retesting and re-qualification to optimum performance. The contractor shall provide on-site response within a week after the Government notifies the contractor that services are needed.

· The contractor shall recommend and make available a full schedule of spare parts. The contractor shall identify the spare parts that will be made available as part of the final documentation for the Isolator.

Ultrapure Water Filtration Specifications:

· System must deliver ultrapure 18.2MΩ cm water and is equipped with the following: UV purification, ultrafiltration, volumetric dispensing, total organic carbon monitor, feed water monitoring. Unit foot print should not exceed 30Hx24Wx20D in inches.

Preventive Maintenance Services will include:

· The contractor shall include one annual preventative maintenance visit for base year and four option years for preventive maintenance service.

· Accommodation, Expenses, Hotel and Travel Time

· Shipment of Testing Equipment and Supply Rentals

· Preventive Maintenance:

a. Visual Inspection / Check of All Seals, Gaskets and Filters

b. Check of Pressure Hold Integrity of the System

c. Instrument Accuracy Verification

d. Filter Integrity Verification

e. Check of Equipment Functionality – Controls and Mechanical

f. Changing of Dräger VHP High and Low Sensors (VHP Sensors Supplied by Others) An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration.

The government is not responsible for locating or securing any information, which is not identified in the submission. To ensure sufficient information is available, vendors must furnish as part of their proposal all descriptive material (such as cuts, illustration, drawings, or other information) necessary for the government to determine whether the product meets their requirements.

Contract type: Commercial Item-Firm Fixed Price. Simplified procurement procedures will be utilized.

FOB Point of Delivery for Service or Supplies:

FDA/PRL-SW

19701 Fairchild

Irvine, CA 92612-2506

The period of performance: Delivery is required 30 days after receipt of order.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None

The provision at FAR 52.212-2 Evaluation – Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows:

(i) Technical capability of the item offered to meet the Government requirement

(ii) Price.

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product meets the technical requirements. If the vendor proposes to modify a product so as to make it conform to the requirement of this solicitation the vendor shall include a clear description of such proposed modifications and clearly mark any descriptive materials to show modifications. The government reserves the right to make an award without discussions.

The provision at FAR 52.212-3. Offeror Representations and Certifications – Commercial Items applies to this acquisition. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications – Commercial Items with their offers.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following addenda have been attached to the clause. None.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders – Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-1.52.225-13, 52.232-33 and 52.232-34 Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov.

SAM Requirements – An Offeror must be registered on System for Award Management (SAM) before an award can be made to the Offeror. If the Offeror is not registered in SAM, the Offeror must go to the SAM website at http://www.sam.gov.

The Defense Priorities and Allocations System and assigned rating are not applicable to this solicitation notice.

Applicable Numbered Note(s) None.

Offers are due in person, by mail, e-mail or fax on or before September 13, 2016 by 3:00 p.m. (Eastern Time, at Food and Drug Administration, U.S. Customhouse, 200 Chestnut Street, Philadelphia, PA 19106, Attn: Janice Heard. ph (215)717-3093, fax (215)597-4390, email: Janice.Heard@fda.hhs.gov.