36C24E20Q0180.docx

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* = Required Field Contract Opportunity Sources Sought Notice ABQ 501-20-3-0157-0510 Capsule Weight Inspection Machine

(VA-20-00059770)

15212-5319 36C24E20Q0180 07-03-2020 16:00

EASTERN TIME, NEW YORK, USA

N 339112 US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319

ALBUQUERQUE VA

The VA Albuquerque, VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CSP CRPCC) manufactures capsules for use in drug trials. CSP CRPCC requires a BRAND NAME or EQUAL to Key International IW-60 Capsule Weight Inspection Machine. Each Drug and Placebo capsule manufactured at CSP CRPCC will be individually weighed by the machine to ensure high quality capsules that each meet the weight specification for drug trial patients while automating the process. This is not a solicitation announcement.

CAPSULE WEIGHT INSPECTION MACHINE SALIENT CHARACTERISTICS (Brand name or equal to Key International IW-60 Capsule Weight Inspection Machine):

A. Required Features

1. Operator Touch Screen (HMI).

2. Alarm function for product level shortage and errors such as doors, motor, and weight.

3. Hopper to hold up to 100,000 capsules with a capsule level sensor.

4. Compressed Air PSI (pounds per square inch) must be at least 80 PSI.

5. Vacuum or conveyor uploading system.

6. Removable change parts for different capsule sizes without using specialty tools.

7. Spare parts kit for user level preventative maintenance

8. Change parts for capsule sizes 00, 0, 1, 2, 3, 4, DBAA

9. Capsule Weight Range 8 mg to 1,500 mg

10. Maximum output required by hour is 60,000 capsules

11. Reject Pattern must be 2-way (pass and faulty)

12. Accuracy requirement for each capsule must be a minimum of +/- 2mg B. Physical Dimensions and weight:

1. Dimensions. Maximum with +/- 3 inches:

Width 914mm (3 ft) Depth 914mm (3 ft) Height 1,829mm (6 ft)

2. Weight must be less than 750 pounds (340kg)

3. Machine must be mobile to move from equipment storage to different production areas with lockable casters.

C. Electrical Requirements:

1. Voltage 208-220 volts, 3 phase, 60Hz D. Operating Temperature:

1. Between 18°C (64.4°F) and 30°C (86°F).

E. Additional Items:

1. Must meet cGMP and 21 CFR Part 11 Requirements

2. Must include Installation and Training.

3. Must include a validation package including IQ/OQ validation documentation

4. Must have a warranty of not less than 1 year

5. Lead time must not exceed 6 months Crating and freight

This is a Sources Sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (large business, small business, 8(a), SDVOSB, etc.), relative to NAICS code 339112). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. Based on responses to this synopsis, the Government may issue an RFQ. This notice is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Friday, July 3, 2020, 4:00PM, EST. Interest/capability statements may be sent to Elaine DiBucci at elaine.dibucci@va.gov and should include company name, address, point of contact, business size, and product information. No telephone responses will be accepted. This notice is to assist the Government in determining sources only. A solicitation is not currently available. If a solicitation is issued, all interested parties must respond to that solicitation announcement separately from the responses to this announcement