PD_Packaging Digest

Packaging Digest, April 2013

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38 BEST PRACTICES // APRIL 2013 www.PackagingDigest.com Pharma bottling line adds flexibility With the addition of a high-speed tablet filling line—along with a "brite stock" model—Praxis Packaging Solutions is expanding and IMPROVING ITS CONTRACT CAPABILITIES. David Vaczek, Contributing Writer Praxis Packaging Solutions is adding the final touches to its first primary fill equipment line for providing vertically integrated packaging services for over-the-counter (OTC) and prescription pharmaceutical customers. Designed to work flexibly with Praxis's secondary packaging capability, the high-speed tablet filling line supports compliant, efficient filling and packaging of a multitude of stock-keeping units (SKUs), as well as high-volume projects. For housing the line, the contract packager added on 45,000 sq ft to its already 130,000 sq ft of cGMP space at its Grand Rapids, MI, facility. "We have had a great deal of interest from our current customer base to expand to the next step in contract packaging—primary tablet filling—and new potential clients have expressed interest in this expansion," says Scott Hanmer, vp of sales, Praxis Packaging. "With these new capabilities, we can confidently sit down with a variety of customers to meet their needs." Te line is designed for straight-through production or for supporting the "brite stock" model, which is typically used in food canning operations. High-volume jobs run in one pass from bulk product to labeled finished goods. Changeparts Praxis' primary fill line features a Fowler Products retourque station (Model CA-8 360). magenta cyan yellow black are available for a array of bottle sizes. Alternately, primary filling and secondary labeling may be occurring simultaneously on different products. Te inventoried brite stock is packed off as needed in response to fluctuating demand across SKUs with different retail labels or for different countries. "We have engineered the line to be able to do filling and a different label simultaneously, and still maintain segregation and control from a quality and compliance standpoint," says Scott Wells, project lead consultant, PharmaAgility Consulting Group. Contracted by Praxis for the project, PharmaAgility drew on its network of consultants with expertise in quality, compliance, engineering, and operations, who also helped with training and recruiting, Hanmer says. Simultaneous filling and labeling PharmaAgility sourced the line from a big pharma company, reengineering it to Praxis's requirements. Filling on the primary side of the line can be independent of the secondary operations. "It is an innovative design that gives Praxis the most flexibility to offer to their client base. Tey can be filling on one side of the line, and labeling a different product on the other side of the line, and still be fully compliant," Wells adds. In the packaging-to-demand scenario, Praxis can respond more quickly to demand variations from seasonal OTCs or new product launches. "It gives our customers many more options in our traditional core competency of secondary packaging," Hanmer says. PharmaAgility's line revamp includes serialization capabilities that expand Praxis's ability to help manufacturers meet pending serialization requirements. Te line features a Weiler highspeed labeler with integrated Videojet printer and e-pedigree-capable Systech Sentri vision system. "Praxis will be able to offer a contract solution to companies facing the large investment hurdle of implementing serialization. We have tied in the different vendors in a holistic solution, to make it as cost neutral as possible through process improvement and waste reduction," Wells says. According to Wells, this has been the most rapid implementation his company has been a part of. Praxis made decisions quickly. Equipment was specified and purchased at the end of August 2012 and delivered Sept. 11. Qualification started immediately after the commissioning was complete. Te line was in a product-validation-ready state by December. Because this is the first time Praxis was handling open product in its facility, PharmaAgility put quality systems in place so it sits on a solid foundation of quality. "With FDA and European Medicines Agency (EMA) compliance, Praxis can ensure to authorities and its clients it is producing conforming product," Wells says. Te primary line features an Omega Design unscrambler, and an Aylward Model 725DL counter-filler. Te filler counts the fill by sensing the breaks in a beam that is present over the primary fill chute for each fill unit. Bottles are inspected as they are indexed 25 at a time, with underfilled or overfilled bottles auto-rejected; passed bottles are then further inspected at an OCS checkweigher. Te capping station was upgraded with a KapsAll Packaging Systems GC-8 capper supporting both screw and snap caps used in pharma applications. Bottles then move to an Enercon induction sealer, and on to a Fowler Products retourquer (Model CA-8 360). A CEIA metal detector is available. Coding for control Te primary line through the retourque station is separated from downstream secondary operations by a cGMP-compliant wall for accountability and control. In straight-through production, filled bottles pass through a transitive separation wall to the Weiler labeler (Model PRL-1500L-S10) for label application and variable printing with a Videojet thermal print system. Multiple cameras check for label content, placement, orientation and quality. Bottles destined for brite stock are coded for identification after the retourquer with a portable Videojet UV printer, before conveyance off the line to storage. Te UV code is checked when the bottles are brought back for secondary labeling to ensure the right product is getting the right product label. Te warehoused-stocked unlabeled bottles are pulled into the labeling operation based on customer ES222272_PD1304_038.pgs 03.28.2013 23:02 UBM

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