Attachment 1 - Purchase Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: This requisition is to purchase Brand Name or

Equal Alphie 3 Mixer-Blender, AS200 Digital Sieve Shaker, UR1 110V Cleaning

Sonicator, Model 00 JET O Mizer Mill 630 SS, and SK-300S2 Kakuhunter Centrifugal

Planetary Mixer with accessories and services for the Formulation Laboratory within the

Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation

(DPI) at NCATS.

2. Background Information and Objective: 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.

1. A 3-D powder mixer is an essential piece of equipment in a formulation lab because it provides the necessary mixing capabilities to achieve homogeneity in powder mixtures. The mixing of powders is critical in many industries, including pharmaceuticals, food and beverage, and chemical manufacturing. The main advantage of a 3-D powder mixer is its ability to blend materials thoroughly by using multiple axes of rotation. This type of mixer provides high levels of homogeneity, which is necessary when creating uniform mixtures of different powders. A homogenous mixture ensures consistent product quality, avoids segregation, and improves the overall efficiency of the manufacturing process. Furthermore, a 3-D powder mixer can also reduce the risk of contamination, as the materials are mixed in a closed environment, preventing outside contaminants from entering the mixture.

This is especially important in pharmaceuticals, where any contamination can have serious consequences.

2. A digital sieve shaker is an essential piece of equipment in a formulation lab because it provides a highly accurate and consistent way to measure particle size distribution in powdered materials. Particle size is a critical factor in many industries, including pharmaceuticals, food and beverage, and chemical manufacturing, and it can impact the quality, performance, and safety of the final product. The use of a digital sieve shaker allows for precise control over the sieving process, ensuring that particles are separated accurately and consistently. This is important because variations in particle size can affect the properties of the final product, such as solubility, stability, flowability, and compressibility. A digital sieve shaker can also save time and increase efficiency in a formulation lab. It can automate the sieving process, reducing the need for manual labor and allowing technicians to focus on other tasks.

Additionally, a digital sieve shaker can generate detailed reports that provide important data on particle size distribution, which can be used to optimize formulations and improve product quality.

3. A jet milling machine is an essential piece of equipment in a formulation lab because it provides a way to reduce the particle size of materials to a fine powder. Particle size reduction is important in many industries, including pharmaceuticals, food and beverage, and chemical manufacturing. Smaller particle sizes can lead to improved product performance, such as increased solubility and bioavailability. The main advantage of a jet milling machine is its ability to produce fine particles with a narrow size distribution. The process involves high-speed jets of compressed air or inert gas that cause the particles to collide and break apart into smaller particles. This method of particle size reduction is preferred over other methods, such as ball milling or crushing, because it does not generate heat, which can degrade the material. A jet milling machine can also be used to create controlled particle shapes and surface characteristics. This is important in pharmaceuticals, where the physical properties of a drug can impact its efficacy and safety. Furthermore, a jet milling machine can save time and increase efficiency in a formulation lab. It can automate the milling process, reducing the need for manual labor and allowing technicians to focus on other tasks. Additionally, a jet milling machine can produce large quantities of material in a short amount of time, which is important in manufacturing applications.

4. A centrifugal planetary mixer is an important piece of equipment in a formulation lab because it provides a way to mix materials with high levels of homogeneity, which is essential for creating consistent and high-quality products. The mixer uses a unique mixing mechanism that combines centrifugal and planetary forces, resulting in a highly efficient and effective mixing process. The main advantage of a centrifugal planetary mixer is its ability to handle a wide range of viscosities and materials, including powders, liquids, and semi-solids. The mixer is capable of mixing materials with high levels of homogeneity, which is important for ensuring consistent product quality and avoiding segregation. A centrifugal planetary mixer is also beneficial because it can mix materials without introducing a lot of air into the mixture. This is important for applications such as pharmaceuticals, where air bubbles can negatively impact the efficacy and stability of a product. Furthermore, a centrifugal planetary mixer can save time and increase efficiency in a formulation lab. It can automate the mixing process, reducing the need for manual labor and allowing technicians to focus on other tasks. Additionally, the mixer is capable of producing large batches of material in a short amount of time, which is important in manufacturing applications.

3. Generic Name of Product:

1. 3-D Powder Mixer Blender

2. Digital Sieve Shaker

3. Cleaning Sonicator

4. Jet Miller

5. Centrifugal Planetary Mixer

4. Salient characteristics The unique features of the Alphie 3 Mixer-Blender, AS200

Digital Sieve Shaker, UR1 110V Cleaning Sonicator, Model 00 JET O Mizer Mill 630 SS, and SK-300S2 Kakuhunter Centrifugal Planetary Mixer are:

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

5. Quantity:

1. Alphie 3-D Powder Mixer Blender: One (1) each

2. AS200Digital Sieve Shaker: One (1) each

3. UR1Cleaning Sonicator: One (1) each

4. JET O Mizer Jet Miller: One (1) each

5. SK-300S2Centrifugal Planetary Mixer: One (1) for 5)/i); Four (4) for 5)/ii); Fifty

(50) for 5)/iii)

6. Delivery Date: Six months after Receipt of Order

7. Delivery Address: 9808 Medical Center Drive. Bldg. E Room 205, Rockville, MD 20850

8. Period of Performance: At least one (1) year factory warranty

9. Option(s): None