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.”

We  frequently see 16- to 18-point board (0.016 to 0.018 in. thick). Using 14- or may be even 12-point board shouldn’t affect most equipment much. The areas most vulnerable to using thin board are:

(1) Magazine and wallet pick: Decreased thickness increases porosity of the material and can affect vacuum pick. The wallet blanks tend to be long. Extra mechanisms may need to be introduced to bring the face of the wallet to the pick point without dragging its ends. Floppy wallet stock may affect the accuracy of code recognition due to potential variability of code location relatively to the scanner (camera).

(2) Plowing and folding: Thinner material will have tendency to be dragged back in folding plows and powered folding fixtures. It may require extra mechanisms for wallet squaring. The thinner stock is easier to imprint upon, create creases, etc. The blister inside the wallet may protrude through the thinner board after compression and make the finished product look less attractive.  A glue wallet might show witness marks from the adhesive more easily.

This response is courtesy of Martin Beriswill from Doyen Medipharm:

The determination of what pressure to test packages at is a calculation that provides you with the pressure parameters based on material and package size.  The pressure test is used to simulate the packages in high altitude conditions, either mountain area or and/or planes.  The pressure is used to confirm the materials and especially the seal strengths are sufficient to maintain the seal integrity and therefore the package sterility. Check with the supplier of the pressure testing equipment.  I would think they would have the calculation and could also provide them with more specific details.  Or contact me and I’ll try some other resources.

This response is courtesy of Martin Beriswill from Doyen Medipharm:

Check with your material supplier. Often suppliers have sealing data on their materials.  The data they have is usually from intermittent lab equipment they use during their development of the materials, so they can confirm performance to the material end user.  If you’re using an intermittent sealing process, the supplier information may be relevant. But if the supplier uses intermittent test equipment and you are using continuous motion sealing equipment, the supplier parameters will not correlate.

Gabor Szakacs at SureTorque helps us on this one. In Gabor’s opinion, the release torque evaluation can be performed in-house without reperforming the same testing on-site. Just use the same standards and test equipment at both places. If the container/cap changes, the evaluation should be repeated. If the capper/induction sealer changes, the evaluation should not be performed again.

Factors that affect this decision are: (1) glue versus heat sealed wallet, (2) the pricing of your contract relative to the labor required, and (3) the length of the contract. First, a glue wallet is typically produced with automated machinery but heat seal can be done semiautomatically. If a glue wallet is required, so likely will be an automated solution regardless of line speed. Pricing, labor cost, and length of contract are all related. A simple assumption of $40K annualized cost per line operator with a two shift operation is $80K annualized per operator position, which is potentially reduced by automating. With only reducing the line by a handful of operators, via automation, your payback can be as little as one year. This also goes to the length of the contract. If you can get at least an 18-month or two-year contract (or longer), then its likely that you will benefit from automating your line. Also, once the job is finished, you’ll own the asset and can sell time on it for new projects. Feel free to contact me directly with your particular scenario.

There are a number of variables that make a definitive answer difficult. For a complete response, we need more information on process flow and your equipment and capacities. However, here is a qualified response.

First, identify the blister(s) after introduction into the cartoner (just prior to loading). Then, print an identification on the carton based upon the blister/blisters (we frequently use a 2-D bar code on the end flap of the carton). Finally, load the cartons into the case, read, and identify all bar codes (print and apply a label that is applied to the case that contains the carton identifications). The application will dictate what is printed (the identifier for each carton or a “License Plate” tag for the case).