Sanofi-Aventis is the world's third-largest pharmaceutical company, with facilities in more than 100 countries. Its plant in St. Louis is strictly a packaging operation that runs products brought in from other Sanofi operations as well as from third parties. The newest line, installed in 2004, produces physicians' samples packaged in blister-packs. During PD's visit, the line was running blister-packs containing two 6.25-mg tablets of Sanofi's new extended-release AmbienCR®.
The operation starts with a Model UPS4-MT intermittent-motion blister-manufacturing machine from Uhlmann Packaging Systems (www.uhlmann-usa.com). "We have other Uhlmann equipment here in the plant, and we're very satisfied with it," says engineering group supervisor David Powell. "We consider Uhlmann to be the Cadillac of blister machines, and we wouldn't consider anyone else."
The machine was running a roll of clear, 10-mil Pentapharm® polyvinyl chloride mono film from Klöckner Pentaplast (www.kpfilms.com) for these tablets. This is a single-layer film, but other products run on this line use film that includes a layer of Aclar® fluoropolymer film from Honeywell Specialty Materials (www.honeywell.com) laminated to the PVC. Ineos Films Inc. (www.ineosfilms.com) also supplies film for the blisters.
Film enters the machine and travels through a preheating station and then to a forming station, where compressed air with a plug assist forms 12 blisters per index, while the machine has paused between cycles. After the blisters are formed, the film moves to the tablet-feeding section, where a GFSII feeder from Gemel Precision Tool Co., Inc. (www.Gemel.com) moves up and down to fill 12 blister-packs with two tablets during each cycle. Tablets are conveyed from a floor hopper beside the Uhlmann machine up to a smaller hopper on top of the feeder. From there, a vibrating pan delivers the tablets into a bowl on the GFSII feeder that moves up and down and fills 24 individual plastic tubes that carry the tablets to the blisters. The feeder has two plates that reciprocate during the feeding cycle. Both plates incorporate o-rings that capture the tablets, while transfers are taking place. These o-rings, which minimize product damage, are a key feature of the Gemel feeders. During each cycle, the top plate opens, and the line of tablets in each tube drops the length of one tablet to the o-rings on the top plate, after which the top plate closes across the tube, and the o-rings hold up the remaining tablets. The bottom plate then reciprocates, and the tablets drop down plastic chutes into the cavities in the blisters on the conveyor below. This vertical gating technique with the o-rings minimizes cleaning time and provides easy and gentle product release.
The web then travels beneath an Uhlmann VisioTec Visiochrom inspection system, which checks the blisters for position, presence, chips, shape and color fidelity. Results are displayed on the machine's touch-screen monitor, which records statistics for each blister and documents all parameters and measurement results for validation. When the system detects a bad package, it signals the programmable logic controller, which logs the blister into a shift register. This tracks that specific blister to a reject station located beneath the die-cut station, where it is ejected.
After leaving the inspection system, the blisters pass through a lidstock-sealing station. The lidstock is a roll of foil/poly/paper-laminated film, which is printed with the Ambien logo and colors on the foil top side, and contains instructions for opening the blister as well as dosage instructions on the paper bottom side. Suppliers of lidstock include Alcoa (www.alcoa.com), Alcan Packaging Pharma Center (www.alcanpackaging.com), and Hueck Foils (www.hueckfoils.net).
The lidding material enters from the rear of the machine and travels through a Model B12 flexo printer from Adolph Gottscho, Inc. (www.gottscho.com) that prints a lot code and expiration date on the paper side. The material is then pulled up above the machine and passes through a reversing shoulder that rotates the material 90 deg so that it is parallel to the forming material passing below. The lidding material then travels down to be sealed onto the formed web. A print-registration system looks for a black rectangular mark on the lidding material in order to ensure that it lines up correctly with the formed web.
A single-stroke index immediately after the lid-sealing station pulls the material through the machine at 12 blisters/index. Next is a compensation loop that brings the material to the multistroke section of the machine, where the stations operate four times faster than the forming and sealing stations. The web of sealed blisters travels through a station that perforates the blisters so that a user can peel away the lidding material to access the product. The web of blisters then enters a multistroke index, which advances one blister row per index. This is followed by a punch station, where the three blisters in that row are cut out of the web. The waste web is shredded, after which it discharges into a large plastic bag.
A lowerator device uses vacuum to hold the individual blister-packs and place them onto a cross conveyor as they are punched out of the web. At this point, blisters that have been selected to be rejected by the Visiochrom inspection system or other defect sensors are removed. As a further check, a reject-verification system confirms the presence or absence of the blisters passing on the conveyor after the reject station, to make sure the packages that were supposed to be rejected were actually removed. If it detects a package that is not supposed to be present, it shuts down the blister machine and sounds an alarm.
A model Neslab HY300 chiller from Thermo Electron Corp. (www.thermo.com/tc) chills the water that is pumped through the blister machine to cool the blisters after they have been formed and after the top film has been applied and sealed.
The blisters travel single-file up the conveyor from the Uhlmann machine to a Model SC6 Cartopac cartoner from IWKA PacSystems, Inc. (www.iwkapacsystems.com). The blisters drop into a vertical magazine from which an oscillating feeder places them into lugs on a conveyor passing below. Following this, a feeder from RonTech AG (www.rontech.ch), which IWKA PacSystems supplied, picks inserts from an inclined magazine and places them on top of the blisters in the lugs. Sensors installed downstream from the insert placer check for missing blisters and/or inserts, while a bar-code scanner checks to ensure that the correct insert has been placed.
Next the blisters and inserts travel to the carton-insertion section of the machine. End-load cartons are delivered in a magazine and are picked up by suction cups on three arms on a rotating pickup system that prebreaks and preopens the cartons as they are placed on the conveyor. An embossing wheel stamps lot code and expiration date on a major flap of each carton as it passes on the conveyor. Arms push the blisters and inserts into the cartons, after which the ends are tucked into place. The machine control keeps track of cartons that should be rejected because of an error, and a reject verification scanner checks exiting cartons and shuts down the machine if any discrepancy is detected. Another bar-code scanner checks each carton to ensure the correct carton has been loaded on the machine.
The cartons then travel over a Model 1500 checkweigher from Boekels USA/IAI (ww.boekels.com). Next, they are manually placed into trays that travel past an Excel ink-jet printer from Videojet Technologies, Inc. (www.videojet.com), which applies the lot code and expiration date.
The trays enter a Model SE-10C bottom-loading case packer from Sabel Eng. Corp. (www.sabelengr.com). A servo-driven collation module stacks the incoming product in four layers of four trays each and transfers the load to the elevator platform. Vacuum cups pull a flat case from the case magazine, and open and place it over the elevator platform, which rises to place the load inside the case. The bottom inner flaps are folded as the filled case is pushed free of the elevator platform, after which the remaining flaps are folded, and the top and bottom of the case are sealed with tape using tape-heads from 3M (www.3m.com). Sabel's Model SE-10C is very compact and can be changed over in less than 10 min without using tools.
The case is then conveyed through a labeler from Quadrel Labeling Systems (www.quadrel.com) with an M8485se print head from Sato America, Inc. (www.satoamerica.com). Each label is printed with two sets of product descriptions and bar codes, and the labels are applied around one corner of the case so the information is visible from two directions. The cases travel over a Micromatic checkweigher from Mettler-Toledo Hi-Speed Inc. (www.hispeedcheckweigher.com) for fill verification, after which they are manually palletized.
More information is available:Adolph Gottscho, Inc., 908/688-2400. www.gottscho.com.Alcan Packaging Pharma Center, 502/647-2308. www.alcanpackaging.com.Alcoa, 804/281-2262. www.alcoa.com.BoekelsUSA/IAI, 201/651-0500. www.boekels.com.Gemel Precision Tool Co., Inc., 215/355-2174. www.gemel.com.Honeywell Specialty Materials, 908/730-6048. www.honeywell.com/aclar.Hueck Foils, 732/974-4100. www.hueckfoils.net.Ineos Films Inc., 302/838-4000. www.ineosfilms.com.IWKA PacSystems, Inc., 973/227-5575. www.iwkapacsystems.com.Klöckner Pentaplast of America, Inc., 540/832-3600. www.kpfilms.com.Mettler-Toledo Hi-Speed, Inc., 607/257-6000. www.hispeedcheckweigher.com.Quadrel Labelng Systems, 440/602-4700. www.quadm.l.com.RonTech AG, 0041-0-81-257-01. www.rontech.ch.Sabel Engineering Corp., 707/938-4771. www.sabelengr.com.Sato America, Inc., 704/644-1650. www.satoamerica.com.Thermo Electron Corp., 800/258-0830. www.thermo.com/tc.3M, 800/722-5463. www.3m.com.Uhlmann Packaging Systems, 973/541-6271. www.uhlmann-usa.com.Videojet Technologies, Inc., 630/860-7300. www.videojet.com.