36C26225Q1051 0001.docx

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Hestia Sim Hestia.Sim@va.gov

PLACE OF PERFORMANCE

VA Cooperative Studies Program

Clinical Research Pharmacy Coordinating Center

2401 Centre Avenue SE

Albuquerque, NM 87106

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Amendment 0001 against RFQ/Solicitation 36C26225Q1051 is issued

i. To post the revised salient characteristics. Refer to below, highlighted for changes.

ii. To extend the offer due date through 7/7/2025 10am Pacific Local Time.

All other terms and conditions remain unchanged.

Bottle Tablet Counter must have following salient characteristics:

Bottle Tablet Counter must have following salient characteristics:

· Tablet counting approaching 100% accuracy as documented by qualifications of development machines and counters previously sold. Data must be provided with the offer for evaluation.

· Must take less than 3 minutes to tear down the bottle filler and less than 3 minutes to reassemble the bottle filler.

· Must be insensitive to dust; the counter does not have to be shut down to clean off the sensor when ‘dust’ on product (primarily from tablets) covers the sensor.

· Must be able to count tablets and capsules, soft gels (liquid filled soft gelatin capsules), oily, shiny, translucent, or reflective products.

· Product changeover must not require tools.

· Tablet and capsules counting mechanism (camera counting system) must not touch the product to minimize cleaning.

· Must have wireless connectivity to allow remote connection to the machine to provide service and troubleshooting support if needed. Must have an ability to control remotely for support if needed.

· Filler equipment that extends over the conveyor belt and into the operator area is not acceptable due to limited space at the facility.

· Must be able to separate the camera vision system from the feeding track.

· Must provide a minimum of five (5) year parts warranty.

· Must be vision-based system; the system uses cameras, lighting, sensors, and imaging processing software to automatically inspect tablets and capsules for defects and deviations from pre-set (recipe driven) criteria and to accurately and quickly count the number of tablets/capsules being filled into each bottle.

· Must process up to 60 bottles per minute for 100 count bottles, and 15 bottles per minute for 1000 count bottles.

· Must have a minimum of 30L hopper capacity.

· Must be able to process following dimension bottles: 40mm – 200mm height, 30mm – 120mm diameter, round and oval shaped bottles.

· Must be able to process tablet and/or capsule of 3mm – 30mm in length, 2mm – 20 mm in diameter/width.

· Equipment’s input voltage must be 230 VAC 50 / 60HZ, single phase, 1000W.

· Compressed Air: Air intake system 6mm, dry air compressor, 6 bar – VA currently has an in-house compressed air system. Equipment exceeding this amount of compressed air is not acceptable, as it would require an additional purchase to meet the increased demand.

· Product contact parts must be 316L stainless steel or FDA approved product contact material.

· Parts must be corrosion resistant.

· Must provide a minimum of one year warranty on equipment and a minimum of five warranty on parts without extra charge

· Software upgrades over life of the bottle filler must be included in the purchase price.

· Must be Wi-Fi compatible (remote connectivity)

· Overall dimension must not exceed footprint of 45” X 22” X 76.5”.

· Must fit through a door with a height of 76.5”, width of 6’

· Total equipment must not exceed 2,300 lbs.

· Must not exceed 70 decibel rating when running 7mm round tablets to prevent noise pollution at the facility.

· Must have a defective product verification system which recognizes defective product and broken pieces as small as 0.5mm. The counter shall stop counting when it detects a defective product and shall reject the bottle.

· Must have a defective product verification; if the system believes the count is incorrect or there is a defective or incorrect products in the bottle, the equipment must push the bottle off the line at the reject station.

· Must include an integrated, automated gating/indexing system that facilitates continuous bottle flow and counting.

· Must have sensors for bottle orientation (upside down), bottle in filling position, reject station, outfeed.

· Must have Touch-panel/screen, PC-based HMI with intuitive graphic interface

· Must have adjustable height

· The contractor must install equipment at the Pharmacy Coordinating Center (PCC).

· Must detect foreign color.

· Must have Color detection + 10% color difference per color for tablets or capsules being run for its accuracy.

· Must be capable of at least three (3) tablet/capsule precounts (precounts product to ensure continuous, uninterrupted operation of the filling line).

· Must be able to count tablets and capsules.

· Must count an infinite number of tablets per bottle.

· There must be no blind spots in the counting area.

· Must have a vision and algorithm-based counting.

· Must be Federal and Drug Administration (FDA) Good Manufacturing Practice (GMP) and 21 CFR Part 11 compliant.

· Must include an automated product recipe setup specifically designed for drug products, in order to minimize manual configuration and reduce overall setup time. Measurements shall be taken using camera and product (calibrations or similar) holding tool for input in the product recipe.

· Must be able to process Unlimited Recipe programs for products.

· Vendor must provide on-site training a minimum twice for a year.

· Must provide Factory Acceptance Testing (FAT) at the contractor/manufacture site and provide a video link for PCC personnel to observe the testing.

· Installation Qualification (IQ) and Operational Qualification (OQ) must be conducted by contractor at the PCC facility and observed by at least one PCC staff member

· IQ/OQ documents must be provided in English no less than one month prior to conducting IQ/OQ verifications.

· Must provide English Language Operations and Maintenance Manuals.

· Must provide English Language Equipment schematics.

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Amendment to a Previous Combined Solicitation