Attachment B - Brand Name JOFOC.pdf

SOLE SOURCE JUSTIFICATION FOR SIMPLIFIED ACQUISITIONS

FAR Part 13.106-1

1. Identification of the agency and the contracting activity:

In accordance with Federal Acquisition Regulation (FAR) 13.106-1 and 41 U.S.C. 1901, the Office of Acquisition Management proposes to award a purchase order one unit of laboratory Steri-cult CO2 Incubator model 3311 by manufacturer “Thermo Scientific” to support risk group 3 biological agents’ cell culture working in Biological Safety Level

(BSL) 3 , USAMD-AFRIMS. The total estimated cost is approximately cost is

• Steri-cult CO2 Incubator model 3311, exterior dimension, 88.9x 109.2x 100.1 centimeters, interior volume 11.4 cu.ft (322.8 liters) with 1 year-warranty.

2. The nature and/or description of the action being approved.

Firm-Fixed-Price (FFP) purchase order for procurement of Thermo Scientific Steri-cult CO2 Incubator model 3311. The existing Forma Steri-Cult CO₂ incubator unit has exceeded its intended operational lifespan, having been in use for over 10 years. Even it remains function, but is aware that a catastrophic failure in an older unit would necessitate immediate replacement.

The CO2 incubator has been played a crucial role in supporting research to be essential equipment for growing and maintaining cell cultures under controlled environmental conditions. The BSL 3 laboratory at USAMD-AFRIMS works with BSL3 pathogens.

The research endeavors that have been facilitated by this incubator unit include:

• Isolation and propagation of Severe acute respiratory syndrome coronavirus 2

(SARS-CoV-2): This CO2 incubator has been instrumental in providing the controlled environment necessary for studying and cultivating the SARS-CoV-2 virus, aiding in the understanding of its behavior and characteristics.

• "CHIKVSOUTH: The chikungunya disease burden, transmission, and persistence in southern Thailand: The incubator has been utilized in investigations related to the prevalence, transmission dynamics, and long-term persistence of chikungunya disease in the southern regions of Thailand.

• "Chikungunya Epidemiology and Household Transmission in Surat Thani province”: This research initiative has benefited from the CO2 incubator's controlled conditions, enabling the study of chikungunya disease epidemiology and its transmission within households specifically in the Surat Thani province.

Using an old CO2 incubator when working with BSL 3 pathogens can pose risks to disease e.

containment and workplace safety. The BSL 3 pathogens have a higher risk of spreading if they are not properly contained. If the incubator does not provide adequate containment, there is a risk that airborne pathogens could be released into the laboratory environment, potentially leading to infections.

3. A description of the supplies or services required to meet the Department’s needs.

To ensure the reliable CO2 incubator that is compatible with our nature of BSL3 pathogens research studies and building, the Thermo Scientific Steri-cult CO2 Incubator model 3311 is a piece of laboratory equipment provided us used for high-volume culturing with a high level of contamination control. The Steri-Cult CO2 incubator model 3311 include:

• Ultimate protection for high-value cultures: Steri-Cult incubators are designed to provide the highest level of protection for valuable cultures. Steri-Cult features a validatable in-chamber HEPA air filtration system which continuously removes particulates and maintains cultures in chamber like cleanroom Class 100 air quality conditions.

• Microprocessor Controls: Steri-Cult incubators microprocessor controls allow for precise temperature, humidity, and CO2 levels. These features contribute to the reliability and efficiency of the incubator.

• The high-capacity chamber is designed to provide maximum culturing space for high-throughput applications. Interior capacity: The Steri-Cult CO2 incubator is available in

11.4 cu.ft (323L) capacity and is suitable for the AFRIMS’ BSL3 laboratory space.

• Automated Sterilization Cycle: The automated sterilization cycle with 140°C high temperature sterilization which reliably eliminates contamination from all internal surfaces, and with a unique design eliminating standing water from within the Steri-

Cult, there is no opportunity for waterborne contaminants to threaten the research studies.

4. An identification of the statutory authority permitting other than full and open competition:

This acquisition is conducted under the authority of 41 U.S.C. 3304, as implemented through FAR 13 and substantiated by the following regulatory authority: FAR 13.106-

1(b)(1) Brand Nam

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the action require use of the authority cited.

Acquisition of the a laboratory Steri-cult CO2 Incubator model 3311 will ensure that

AFRIMS' BSL3 research studies will continue to optimally use resources which will be of best use of Government funds. To mitigate risk of the accidental release or spread of

BSL3 pathogens, it's essential to use CO2 incubators that are specifically designed to prevent accidental release could have serious consequences for both laboratory personnel and the environment.

• Contamination Control: The incubator features polished 304 stainless steel interior surfaces that are easy to clean, reducing the risk of unwanted microbiological growth and contamination.

• Validatable in-chamber HEPA air filtration system: The Steri-Cult CO2 incubators are designed to provide the highest level of protection for your valuable cultures, including the Class 5 HEPA filtration system, ensures a clean and controlled environment for optimal cell growth and viability.

• Automated Sterilization Cycle: The Steri-Cult CO2 incubator model

3311includes an automated sterilization cycle that eliminates biological contaminants without harming cultured cells. The sterilization cycle of the Steri-

Cult CO2 Incubator consists of three phases: heat 140°C high temperature, sterilizing (hold for a specific duration, typically 14 hours or less), and cool down to its normal operating temperature.

Advanced microprocessor components: The Steri-Cult CO2 incubator maintains controlled environmental conditions such as temperature, humidity, and CO2 concentration. These conditions are crucial for the growth and maintenance of cells in culture. A stable environment helps ensure accurate and reproducible results, to significantly elevate the productivity of RG3 virus isolation assays and related projects involving Chikungunya virus and SARS-CoV-2 virus studies in BSL3 laboratory. The specific requirements for a laboratory's working conditions can indeed vary widely depending on the nature of the research being conducted. Most conditions are often used for cell culture work, particularly for mammalian cell lines is:

• Temperature 37°C,

• Relative humidity 80-90%, and

• Carbon dioxide (CO2) concentration 5%

By accommodating the incubation of more than 50 flasks and 25 plates per week, this addition brings about numerous benefits that will expedite and enhance the research efforts.

Water Jacketed Options: The model offers water jacketed incubators provide excellent temperature stability, even during power outages.

Monitoring and Alarms: These incubators are equipped with sophisticated monitoring systems that constantly track environmental conditions, CO2 levels, RH, and power failure. Alarms are set to alert personnel in case of deviations from safe parameters.

https://www.thelabworldgroup.com/product/thermo-steri-cult-incubator/ https://www.thelabworldgroup.com/product/thermo-steri-cult-incubator/

Capacity: The Chamber has a capacity of 323 liters, which should be sufficient for experimental demands and AFRIMS BSL3 laboratory space.

If switching to a different brand, laboratory personnel may confront with:

• Analyze and select another brand that is suitable for the lab's needs. Consider features such as temperature and humidity control, chamber capacity, ease of maintenance, and alert systems for troubleshooting to ensure a smooth and safe transition for the lab's operations and experiments.

• Careful planning is necessary for the switch. Determine the date for removing the old equipment, installing the new one, the method of transitioning the equipment, and testing the new equipment to ensure it operates correctly.

• If the new equipment has different usage procedures from the old one, lab personnel should receive training on how to operate it, adjust temperature and humidity settings, perform checks, and troubleshoot issues.

• Once the new equipment is installed, lab personnel should test it to ensure it functions correctly. Verify temperature and humidity settings to ensure they match the required conditions.

• If the new equipment has complex features or usage procedures, additional training sessions may be necessary to ensure that lab personnel understand its operation and troubleshooting methods.

• Lab personnel should be informed about the maintenance requirements of the new equipment to ensure its efficient and prolonged operation.

Per above mentioned, it appears that the Steri-cult CO2 Incubator model 3311 aligns well with the specific requirements of USAMD-AFRIMS laboratories, especially within a BSL 3 laboratory environment. It offers the necessary features to support cell culture research while maintaining the required cleanliness and contamination control standards. This information could be used to justify the continued use of this model within the USAMD-AFRIMS laboratories and to communicate its benefits to relevant stakeholders.

6. A description of the efforts made to ensure that offers are solicited from as many potential sources as is practicable, include whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

A notice was not and will not be posted on SAM. The exception at DOSAR 652.202-70 applies

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable

The Contracting Officer determines that the anticipated cost will be fair and reasonable based on the IGCE and market research conducted by the requesting office and by comparison to previous orders for similar items. Offers will be solicited from all vendors capable of meeting the brand name requirement.

8. A description of the market research conducted (per FAR Part 10) and the results or a statement of the reason market research was not conducted.

After conducting a comprehensive market survey, we have identified CO2 incubators with similar automated sterilization specifications available. However, their chamber capacities don't align with our projected workload. We found an automated sterilization

CO2 incubator with a chamber capacity of 323 liters that aligns well with our projected workload. The desired automated sterilization specifications is the Steri- cult CO2

Incubator model 3311 as below comparison.

Comparisons on specification of CO2 incubators with similar automated sterilization system

Technical specifications

CelCulture ®

ESCO

CO2 Incubator ICO240

Memmert

Galaxy® 170 R/S

New Brunswick

Steri-Cul

CO2 incubator model 3311

Temperature Control

Range, °C

18 to 32°C 18 °C to 50 °C 10 °C to 50 °C 10 °C to 50 °C

CO2 Control Range, % CO2

0 to 19.5 0 to 20 0 to 20 0 to 20

Humidity Range 85-90 40 - 97 85-95 Ambient to 95

Contamination

Control Methods

180˚C high heat sterilization cycle

None High Temperature

Disinfection 120˚C

(optional)

140°C overnight (14 hours)

Interior Volume 240 L (8.5 ft³) 241 L (8.5 ft³) 165 L (5.82 ft³) 322.8 L (11.4 ft³)

External Dimensions

(W x D x H)

750 x 770 x 906 mm

(29.5” x 30.3” x 35.6”)

759 x 1180 x 691 mm

(29.9” x 46.5” x 27.2”)

708 x 845 x 701 mm

(27.9” x 33.3” x 27.6”)

686 x 1092 x 1002 mm

(27” x 43” x 39.4”).

Meet our requirement

9. Any other facts supporting the use of other than full and open competition such as:

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

None.

11. A statement of any actions the agency will take to remove or overcome any future barriers to competition before any subsequent acquisition for the supplies or services required. Include a statement that this J&A for other than full and open competition will be published on FedBizOpps in accordance with FAR Section 6.305 within 14 days of award (or within 30 days if the J&A is for unusual and compelling urgency.)

None.

CERTIFICATIONS

TECHNICAL AND REQUIREMENTS CERTIFICATION

I certify that this justification is accurate and contains complete data necessary to support the recommendation for other than full and open competition.

SIGNATURE:

17 Aug 23 CPT Zachary Albright Date

Chief, Lab Ops.

USAMD-AFRIMS

CONTRACTING OFFICER CERTIFICATION

I certify that this submission is accurate to the best of my knowledge, and that it contains complete information necessary to enable other officials to make an informed recommendation for approval or disapproval.

SIGNATURE:

Michelle R. Braunstein

Contracting Officer

Date

A/OPE/AQM/IP/RPSO

APPROVALS

SIGNATURE:

Kenneth G. Mamba

Branch Chief

A/OPE/AQM/IP/RPSO

Date

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