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Likewise dental sutures vary from medical sutures. To keep them all straight and to facilitate selection within the operating room industry-standard color codes were developed. Packaging-wise this meant varying labels for the packages.
The packaging process varies too. "The FDA has required all medical device manufacturers to validate not only equipment but the process for making that particular package" explains DiMercurio. Absorbable and nonabsorbable sutures each require a separate validation with separate heat-seal requirements. These variables translate into one thing for Cottrell: the need for quick changeover.
"The Klockner form/fill/seal blister thermoformer allows us to produce state-of-the-art packaging for our new medical and dental sutures" says DiMercurio. "The Compacker-2 gave us the flexibility to change over quickly. We select from the microprocessor control the desired product set-up which resets heat parameters and we're ready to go within twenty minutes or so." The machine is controlled by an Allen-Bradley (Milwaukee WI) SLC 500 microprocessor operated through a touch-screen that allows simplified control of all packaging parameters. "Once you establish the validated parameters for the package they can be programmed into the microprocessor so that no package will vary outside of those parameters" says DiMercurio. "If for some reason the parameters aren't met the equipment shuts down and notifies the operator."
Peelable blisters
The peelable blister package begins with a roll of 10-mil thick PVC sheet from American Mirrex (New Castle DE). It's fed through the CP-2 for blister forming two-up. Depth of draw is .040" according to DiMercurio. The tray measures 1 3/8" x 4" x 1/8".
After cavities have been thermoformed sutures which have been previously hand-wound onto carrier cards are manually placed into the PVC thermoform. If absorbable sutures are being packaged the blisters proceed to a metering station which consists of an Ivek (North Springfield VT) Digispense(TM) 8 meter. A total of 1.25 mL of alcohol-fill solution is pumped into the tray.
High-quality labels
Meanwhile mounted above the forming stations a printing station handles lidding. "In the medical profession your label is very important" says DiMercurio. Cottrell's lidding is preprinted with only industry color codes. A 13-mil adhesive-coated Tyvek from Oliver Products (Grand Rapids MI) is used for nonabsorbable sutures. For the absorbable version Cottrell uses a 4-mil lamination of polyester on the outside and heat-seal coated foil on the inside. It's supplied by Tolas (Feasterville PA). All text including logos nomenclature and other essential information including an illustration of the suture is printed flexographically on an Adolph Gottscho (Union NJ) Model 806-4 printer. As forming and filling take place below the lidstock first goes through a printing station then air drying before meeting the blister trays at the sealing station.
Here lids and trays are heat-sealed together. The CP-2 can reach speeds from 60 to 90 packages/min with absorbable sutures running at the low end so that the alcohol doesn't spill during sealing.
From there they pass through a cool-down station and index for die-cutting two-up. The sealed blisters then wait for final inspection by one or two people. Blisters are then manually inserted into the secondary packaging a pouch made of clear polyester on top and white Tyvek on bottom. These are sent to Cottrell by its sister company which makes them. Materials for them are supplied by Cur*Med (Oshkosh WI).
Once thermoforms are inside their pouches they are manually heat-sealed.
Electron beam sterilization is next and finally cartoning into groups of 12 for distribution to medical offices.
The ProMed line of sutures has been on the market since early 1995 and customer acceptance has been excellent says DiMercurio. "We are reaching many new customers who want new products--and the CP-2 fits right into that picture for future production."
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