This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The NAICS Code for this procurement is 334516 - Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard for NAICS 334516 is 500 employees. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates FDA to award a contract. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this Sources Sought Notice. Any response received will not be used as a proposal.

The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. ONLY SMALL BUSINESSES NEED TO RESPOND TO THIS SOURCES SOUGHT NOTICE.

No official solicitation currently exists in connection to this Sources Sought Notice. If in the future an official solicitation is released, there is no guarantee that sources responding to this Sources Sought Notice will be included on the source list.

The Food and Drug Administration (FDA) is interested in procuring one (1) Sterility Test Isolator to perform small number or batches of sterility testing (3-6 tests per day) relevant to pharmaceutical products produced under aseptic conditions. The equipment is needed to protect the sterile product/sample from the overall testing process and the additional external factors that may influence the testing outcomes and/or work products.

INSTRUMENT SPECIFICATIONS AND TECHNICAL REQUIREMENTS

• The unit shall be able to achieve a minimum of log 6 reduction in spore forming micro-organisms.

• The Isolator must have conducted a validation study to using live bacteria (biological indictor) to show the effectiveness of the decontamination process.

• The Isolator shall meet the requirements of ISO 14644-7:2004.

• Shall have an EU GMP Grade A environment throughout the chamber.

• The Sterility Test Isolator shall be capable of protecting product from the process generated and externally generated factors that would compromise quality of test processes and results.

• The Sterility Test Isolator shall be suitable for performing both Direct Inoculation and Filter Membrane sterility tests. The Isolator shall have the flexibility to be bio-decontaminated by an ionized Hydrogen Peroxide generator or a Bioquell L2 HPV generator type of bio-decontamination systems or a comparable method/process that will achieve the same bio-decontamination while reducing facilities modification.

• Must fit in an approximate space of L 59 in X W 47 in X H 89.

• Must fit into a service elevator, 54 in (W) x 102 in (L), then through a double door way, 78 in (W) x 95 in (H), around a 90 degree corner, travel a short hall, then turn another 90 degrees through two laboratory door ways; an outer door-way (2205A), 43 in (W) x 95 in (H) and an inner door-way (room 2206), 42 in (W) x 95 in (H).

• Must have 3 gloves made of TOSOH TS-430 grade or similar fitted into the Gull Wing Door type front visor as ports.

• Must have interior space to accommodate Millipore 6 place manifold.

• Must have connection to an ionized Hydrogen Peroxide for decontamination system.

• Must include hydrogen peroxide decontamination unit as a system with tested bio-contamination cycle development or a comparable system to achieve the 6-fold reduction in spore-forming microorganisms.

• Must have wheels.

• Must have a Pressure monitor.

• Must have stainless steel construction with height adjustment.

• Must have a Gull Wing Door type front visor that hinges outwards and upwards.

• Must have power receptacle typical for test isolator construction.

• Must have a Glove tester.

• Must have a sterility test pump.

• Must have post assembly verification for performance qualification.

• Air Classification: ISO Class 5 (EUGMP Grade A) all chambers

• Airflow Pattern: Single Pass Turbulent airflow to all chambers

• Number of Air Changes:

150 air changes/hr minimum all chambers normal operation
240 air changes/hr main chamber during aeration
400 air changes/hr transfer chamber during aeration

• Operating Pressure: Main Chamber +50Pa Transfer Hatch +35Pa

• Lighting Levels: 700lux within main chamber only

• Noise Levels: Less than 70dBA

• Temperature: Uncontrolled (Monitoring only)

• Humidity: Uncontrolled (Monitoring only)

• Inlet Filtration: ULPA U15 grade filter having an efficiency of 99.9998% the test method used being a full face photometer leak test in accordance with PD6609, using a DOP test aerosol generated with a thermal generator. (Filter Efficiency 99.9995% in accordance with EN1822)

• Exhaust Filtration: HEPA H14 grade filter having an efficiency of 99.997% the test method used being a full face photometer leak test in accordance with PD6609, using a DOP test aerosol generated with a thermal generator. (Filter Efficiency 99.995% in accordance with EN1822)

• Pre-Filter: Inlet Filters are protected on the upstream side with a H10 pre filters.Bio-decontamination: A minimum of log 6 reduction in spore forming micro-organisms validated using G. Stearothermophilus biological indicators.

SPECIAL REQUIREMENTS
Training
• One training session for 6-8 FDA Analysts
• On-site technical consultation event as follow-up to training session

Remote technical support
Web access 24-hours a day or via phone during company's business hours

Warranty
The contractor shall provide a minimum of a one year manufacturing warranty for all manufactured equipment, parts, and operational services for the sterility test isolator, sterility test pump, and glove integrity tester. The warranty shall be included with the new equipment and not separately priced. The warranty shall include one preventative maintenance visit within the first year after equipment acceptance by the Government.

Preventative Maintenance and Support Services
The contractor shall provide 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. These services shall be provided at a minimum one year and not to exceed four years.

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. All PLC controlled containment systems must include an indicator to advise the equipment requires a service.

PLACE OF PERFORMANCE
19701 Fairchild
Irvine, CA 92612

Interested small businesses capable of performing this requirement should respond to this Sources Sought Notice with a Capability Statement no later than July 11, 2013. Responses are limited to a maximum of ten (10) pages (font size 10 or larger), inclusive of any descriptive literature, brochures, tear sheets, marketing materials, etc. detailing the items/equipments the respondent is regularly engaged in manufacturing, servicing, and/or selling. Capability Statements must be emailed directly to Nicole Stevenson at [email protected] by the due date. All information provided will become property of the Food and Drug Administration (FDA) and will not be returned.

Responses to this Sources Sought Notice shall demonstrate that the respondent is regularly engaged in the manufacturing and/or the sale of same or substantially similar items. The target audience for this Notice is small business manufacturers or small businesses capable of supplying U.S.-manufactured products of another small business manufacturer or producer. At a minimum, the response shall include the following:

Business Information:
1. DUNS Number
2. Company Name
3. Company Address
4. Company Point of Contact, phone number and email address
5. Type of company under NAICS Code, as validated via the System for Award Management (SAM). Contractors must be registered in SAM accessed via the Internet at https://www.sam.gov/portal/public/SAM/.
6. Point of Contact, phone number and email address of at least three (3) individuals who can verify the demonstrated capabilities identified in the response.
7. Your GSA Schedule Number(s) and Special Item Numbers (SINs) that are appropriate for this requirement. All items and services must be on GSA Schedules and all applicable GSA Schedule Number(s) and SINs need to be identified.

Detailed Information on Items/Equipment/Services the Respondent Can Supply:
Descriptive literature, brochures, tear sheets, marketing materials, etc. detailing the items/equipments the respondent is regularly engaged in manufacturing, servicing, and/or selling.

Past Performance Information
Past Performance information for the manufacture and/or sale o same or substantially similar items/equipment to include:
1. Date of Sale
2. Description (should also include drawings and photos)
3. Dollar Value
4. Client Name and Mailing Address
5. Client Point of Contact Name, Mailing Address, Phone Number, Email Address
6. Name of Manufacturer of Items/Equipment if not the Respondent

Bid Protests Not Available