Ask yourself this: what is the annualized labor cost to do this manually? Most literature feeders (vacuum or friction styles) will cost less than one full-time person for one year. This means a payback of less than one year.

If this ongoing production requires literature, it’s pretty easy to justify automatic feeding. This will also improve quality because you can add automatic sensing to verify the placement. Several companies offer either friction feeders or vacuum feeders that can do this. My company offers both.

Thanks to Joerg Liedtke from Laetus GmbH for helping to respond to questions 1 and 2.

1. Trying to understand future requirements for Serialization on vial label
and outer carton for an IV product….?

A: Currently the smallest unit to be serialized is the “unit of sale.” Typically a single vial is not sold, so in your case, serialization would likely need to occur for the carton.

2. When will serialization be required by FDA (Federal) and/or by the state of California?

A: Basically the FDA is currently just starting to define an SNI, see more information at this link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm#_Toc254967078

The California State Board of Pharmacy enrolled a E-Pedigree law that will become effective in 2015.
Please find detailed information here:

http://www.pharmacy.ca.gov/about/e_pedigree.shtml

3. How can this be automated?

A combination of product handling, printing, vision, and IT is required for a complete solution. Firms such as Laetus can provide much of the solution while MGS Machine can provide product handling of the carton as seen here:

http://www.mgsmachine.com/prodvideo.php?id=25&vidid=video1

Yes, my company, MGS Machine, does make such a machine. I must admit, to be fair, there are other firms that do as well. Most firms that produce cartoners for the personal care market will meet your basic  requirements as outlined.

Automatic feeding is an area that may help you distinguish the better firms from the rest. I suggest that you compile your specifications (perhaps in a URS format), determine your selection criteria, and ask for some budgetary proposals. One other key decision filter is to search for firms that have experience with this particular application.

This answer is provided by Marty Kleinhardt from IMS: Integrity Machine Services. The sealing material for this application depends on the container properties. The sealant provider we would most highly recommend would be Oracle Packaging (Phyllis Pardue-Hines 336/777-5860 phyllishines@oraclepkg.com) for the heat seal foil.

We build the machinery to punch the flat lid from the roll stock that also seals it to the container.

There are a lot of variables in your situation, which raises a number of questions. What is the root cause of the empty bottles? Why are the preventive measures on the line (vision and checkweigher) not working effectively? What are the contents of the bottle (solid dose, liquid, powder) and what is the weight of the content relative to the bottle? Is this line validated? If so, this should not be happening.

I’d be glad to talk to you directly about this if you wish. I can be reached at 763/425-8808.

This answer is courtesy of Kregg Albrecht at Nosco:

My first suggestion would be to procure a blister board that is coated in a pattern. At Nosco, we can coat a heat seal blister adhesive in virtually any pattern so that the area not needing to be sealed would be void of any adhesive. If a flood-coated board is required, I would suggest modifying the tooling so that the area in question would not be subject to any heat and pressure during the sealing process. In regard to printing some sort of barrier on the adhesive, this may be possible. In the world of pressure-sensitive adhesives, this is called “deadening” the adhesive. I am not aware of this technique being used in blister applications, because it would be a challenge given the aggressive bonding associated with heat seal adhesives, but it may be worth a shot. I would recommend testing a heat-resistant UV curable varnish.

Key quality issues to inspect in wallet folding are:

· Adherence of adhesive such that the blister is well contained and can’t be easily accessed (creating a CR format)?
· Is a blister present in the wallet?
· Is literature present in the wallet? (optional)

A manual or semiautomatic walleting operation will likely require manual inspection. Automated walleting can have much of the inspection built into the packaging equipment. There can be phases before getting to 100% automation: seal the card with manual station, fold manually (add automatic folding later), place literature (add automatic later), and seal the card closed (add automatic later). All of these steps can be done fully automatically….depends on your justification. We help clients figure this out all the time. Contact me to walk through your scenario.

Response provided by Ben Brower of Pharmaworks:

Two channels sounds like you want to drop to different tablets into a blister? If so, most all dedicated feeders can do this. Contact Pharmaworks (Ben Brower) if more specifics are needed.

Response provided by Peter Buczynsky of Pharmaworks:

It depends on the type of feeding system being used. Here are some specifics:

Brush Box:
· Cavity shape and orientation are extremely important.
· Maintain the appropriate level of product in the box.
· Use correct agitation speeds.
Dedicated feeder:
· Feeding tubes often get plugged, causing empty cavities. This is the responsibility of the feeder OEM to design these tubes optimally to avoid product shingling.
· Maintain appropriate level.

We handle secondary packaging and product handling of vials and syringes.  Assuming the device is prefilled, its critical that the product handling is gentle and positive. For example, vials or syringes might be driven through a timing screw, then tipped into a bucket on a cartoner infeed. Guide rails can limit the ‘fall’ of the vial into the bucket, but there is a point at which the vial isn’t contained positively.

Robotics provide the best, current solution. A high-speed robot can positively pick and place the vials gently. The cost of robotics has fallen in recent years; however, this solution still may be slightly greater than traditional product-handling methods. Frequently, the cost/value of a pharmaceutical or biologic held in a vial is quite high. When considering the cost of a robot, once factoring in the reduction in scrapped product caused by traditional product handling, robotics is often the clear choice.

Ken Himes at Filamatic offers further input on the cost issue:  “There appears to be no standard industry data on this subject, but this comparison might help:

- traditional glass vial injectible system = cost of “1X”
- a glass syringe system = cost of “2X”
- a plastic syringe system = cost of “2.5X”

Himes adds that “the prefilled syringe market is growing 10-15% per year for the foreseeable future. Vial usage appears to be flat.”