23-004142 Sources Sought.pdf

SAM.gov

SOURCES SOUGHT NOTICE

1. Solicitation Number: 75N95023Q00320SSN

2. Title: Formulation Laboratory Equipment

3. Classification Code: 66 – Instruments and Laboratory Equipment

4. NAICS Code: 423830 - Industrial Machinery and Equipment Merchant

Wholesalers

5. Description:

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

For equipment/supply requirements, responses must include: (1) the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture), as well as (2) the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer

Rule).

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the

Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background:

The National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health, aims to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the Division of Preclinical

Innovation (DPI), Therapeutic Development Branch (TDB), is to partner with researchers to generate preclinical data and clinical-grade material for use in

Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand new formulation laboratory dedicated to preclinical research will be opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized Instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs.

The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials.

Purpose and Objectives: The purpose of this acquisition is to acquire the following Brand Name or Equal formulation laboratory equipment that meet all salient characteristics.

1) Alphie 3 Mixer-Blender or Equal

i) 30003-000001 - Alphie 3 Mixer-Blender

(1) - 2.5-Liter capacity

(2) - 1-phase x 100-120V x 60 Hz

(3) - Motor 0.33 hp (0.25 kW)

(4) - Cage Speed Between 10 – 80 rpm max. (40 rpm shaft)

(5) - Continuously variable.

(6) - Container can be fastened with rubber clamping rings by using tensioning crown.

(7) - 1x Set Clamping rings (Straps) and 1x Crown included.

(8) - Container size diameter 115mm x 275mm long.

(9) - Machine Weight Approximate. 75kg.

ii) 30003-000200-1 - 200 ml 316L Stainless Steel Container for Alphie (Not electropolished)

iii) 30003-000500-1 - 500ml 316L Container

iv) 30003-001000-1 - 1.0-liter 316L Stainless Steel Bottle

2) Retsch AS200 Digital Sieve Shaker or Equal

i) 2660-000007 - AS200 Digital Sieve Shaker

(1) - Vertical Motion with 2 Dimensional Effect

(2) - Powerful Electro-Magnet, 110 Volt, 60Hz

(3) - Adjustable Oscillation Height, 0-3mm

(4) - Adjustable Timer, 0-60 minutes

(5) - Holds 8 Full Height, or 16 Half Height Sieves

(6) - Up-gradable for Wet Sieving Operation

(7) - Up-Gradable for Vibrating Ball

ii) 2660-326621 - Clamping Device "Comfort"

iii) 2660-000400 - 400 MESH SIEVE

(1) - 8" Diameter x 2" Height

(2) - Stainless Steel

(3) - For Vibrating Laboratory Sieving Machine

iv) 2660-000200 - 200 MESH SIEVE

(1) - 8" Diameter x 2" Height

(2) - Stainless Steel

(3) - For Vibrating Laboratory Sieving Machine

v) 2660-000100 - 100 MESH SIEVE

(1) - 8" Diameter x 2" Height

(2) - Stainless Steel

(3) - For Vibrating Laboratory Sieving Machine

vi) 2660-000600 - Bottom Collecting Pan

vii) 2660-000653 - Sieve Cover

viii) 2660-033505 - Cubes of Polyurethane 20x20x20mm

ix) 2660-033360 - Brushes, 3 Pieces

3) Retsch UR1 110V Cleaning Sonicator or Equal

i) 2658-910001 - Retsch UR1 110V Cleaning Sonicator

(1) 110V

(2) 60Hz

(3) 5.7 Liter

(4) 24.5cm Dia. X 13.00cm

ii) 2658-070249 - Stainless Steel Lid for UR1

iii) 2658-450001 - Stainless Steel Basket for UR1

iv) 2658-200001 - Detergent TICKPUR RW 77, 1 Liter

4) Model 00 JET O Mizer Mill 630 SS or Equal

i) 1807-000002 - Model 00 JET O Mizer Mill 630 SS

(1) - Two piece, easy clean body & cover, hardened type 630 stainless steel

(2) - sanitary integral feed hopper with venturi inlet

(3) - sanitary pusher nozzle assembly

(4) - mll finish, #4 Pharmaceutical polish

(5) - quick-disconnect filter bag adapter, type 316 SS

(6) - system tray with piping, gauges and valves, type 304SS

(7) - vibratory feeder wit V-style feeder trough and variable speed control

(8) - 3-2"x9" Dacron Product collection filter bags

(9) - Air requirements: 5 SCFM of compressed air or bottled gas @100psi

(10) - electrical requirements: 115V, 60Hz, 1 Phase

ii) 1806-000050 - HIGH YIELD PRODUCT COLLECTOR

(1) - Housing constructed in type 316 stainless steel

(2) - Quick disconnect inlet and out connections

(3) - One (1) Dacron filter sleeve

(4) - Quick brake apart construction

(5) - Pulse regulator

(6) - Adjustable support stand

5) SK-300S2 Kakuhunter Centrifugal Planetary Mixer or Equal

i) 201-000001 - SK-300S2 Kakuhunter Centrifugal Planetary Mixer

(1) -Voltage 1 x 115

(2) -Single container

(3) -Power Cord

ii) 201-001002 - STANDARD CONTAINER 002 CUPS

(1) - For SK-300S2

(2) - For SK-300SV2

(3) - For SK-300TVS2

(4) - Polypropylene lid, HDPE body. White

(5) - Part No. CA-(1); Code 002

(6) - MOQ 4 cups

(7) - 300ml

iii) 210-000150x - PLASTIC CUP Disposable Liner

(1) - SR-300/350 Modules Kakuhunter Centrifugal Planetary Mixer

(2) - 150ml

(3) - Disposable

(4) - Thick heavy wall MOQ 50

Delivery Date: Within 180 days after receipt of order

6. Capability statement /information sought: Respondents must provide clear and convincing documentation of their capability of providing the equipment specified in this notice.

The respondent must also provide their UEI number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

One (1) copy of the response is required and must be in Microsoft Word or Adobe

PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must be in an outline format that addresses each of the elements of the service requirement and in the capability statement /information sought paragraphs stated herein.

The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.

The response must be submitted to Sarah Adan, at e-mail address sarah.adan@nih.gov , and Valerie Whipple, at e-mail address valerie.whipple@nih.gov, with the subject line 75N95023Q00320SSN.

The response must be received on or before May 25, 2023, 12:00 pm, Eastern Time.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The

Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the

Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

mailto:sarah.adan@nih.gov mailto:valerie.whipple@nih.gov