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This document contains questions and answers regarding a solicitation for an automated vial filling and labeling system. The solicitation is seeking a benchtop laboratory scale system with a capacity of approximately 200 vials per hour. It must include a touch screen human-machine interface and have the ability to automatically fill, cap, and label cryovials. Acceptable technologies for filling include peristaltic pumps or two high accuracy pumps. The system and onsite installation, qualification, and four years of post-warranty maintenance are being solicited from the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services as solicitation number 75F40123Q117784.

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75F40123Q117784 Q&A

QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of quotes/proposals and their corresponding answers.

Question 1: Pg 4 of 40, Item # 20. The footprint, the size given is too small for a production system. The size given of: 42 inches long by 29.7 inches wide by 45.2 inches tall is too small for this type of system

Response: The vial filler and labeler is of laboratory scale to be placed on a bench.

Question 2: Pg 3 of 40, Item # 4. The fill volumes of 0.05ml to 2.0ml is in the range of what a system like this would do. The problem is the request for a peristaltic pump. A peristaltic pump will not be accurate enough. For fill volumes such as these you would need two high accuracy pumps.

Response: Both technologies are acceptable.

Question 3: Pg 3 of 40, Item # 5. The cryo tubes are unscrewed, filled, capped and labeled. For production system like this, the tubes and caps always come separately. We work with medium and large producers and none of them have ever bought a tube filler or cryo tube filler that uncaps pre-caped tubes.

The industry standard is tubes and caps separately so they can be automatically sorted, fed and used in the system efficiently.

Response: The tubes and caps can come separately. However we are looking for a smaller, benchtop laboratory scale system.

Question 4: Pg 4 of 40, Item # 17. It says “HTI GUI”. I think it should say HMI? HMI means 'Human Machine Interface'. All of our systems come with HMI and a touch screen for operator interface with the system directly at that spot. GUI is more typical is the facility has a SCADA computer system for interfacing a computer and/or laptop with the filling system. SCADA means 'Supervisory Control and Data Acquisition system. Most (if not all) manufacturers like us do not supply the SCADA systems as it is something that needs to be installed and maintained by a company that specializes in that.

Response: It was supposed to be “HMI”. GUI is a requirement. SCADA is not a requirement.

Additionally: the requirement should have included the capacity we are looking for: “The capacity shall be ~ 200 vials per hour.”

(End of Q&A)

File details come from the government source that posted it. Updated .