By David Vaczek, Pharmaceutical & Medical Packaging News, Published: January 8th, 2013
Integrated with Praxis’s secondary packaging base, the line flexibly accommodates high and low volume requirements. Praxis Packaging Solutions is adding the final touches to its first primary fill equipment line for providing vertically integrated packaging services for OTC and pharmaceutical customers.
Designed to work flexibly with Praxis’s secondary capability, the high-speed tablet filling line supports compliant, efficient filling and packaging of a multitude of 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, Vice President of Sales, Praxis Packaging.
“With these new capabilities, we can confidently sit down with a wide variety of customers to meet their needs,” Hanmer adds.
The line is designed for straight through production or for supporting a “brite stock” model. High volume jobs run in one pass from bulk product to labeled finished goods. Change parts are available for a wide array of bottle sizes.
Alternately, primary filling and secondary labeling may be occurring simultaneously on different products. The inventoried brite stock is packed off as needed in response to fluctuating demand across SKUs with different retail labels or 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, PharmAgility Consulting Group, Stuart, FL.
Contracted by Praxis for the project, PharmAgility 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
PharmAgility 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. They 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.
PharmAgility’s line revamp includes serialization capabilities that expand Praxis’s ability to help manufacturers meet pending serialization requirements. The line features a Weiler high-speed 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.
“This has been the most rapid implementation we have been a part of. Praxis made decisions quickly. Equipment was specified and purchased at the end of August and delivered September 11. Qualification will start following the completion of commissioning.
We will be in a product-validation-ready state in December. This is the first time they are handling open product in their facility. We are putting the 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 their clients they are producing conforming product,” Wells says.
The primary line features an Omega Design unscrambler, and an Aylward Model 725DL counter-filler. The 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.
The capping station was upgraded with a Kaps-All 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). An CEIA metal detector is available.
CODING FOR CONTROL
The primary fill line through the retourque station is separated from downstream secondary operations by a cGMP-comliant 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 retourqer with a portable Videojet UV printer, before conveyance off the line to storage. The UV code is checked when bottles are brought back for secondary labeling to ensure the right product is getting the right product label.
The warehoused-stocked unlabeled bottles are pulled into the labeling operation based on customer demand. The process provides a quicker turnaround time with orders filled more closely to the order date.
“We can issue the brite stock to any of a number of our secondary packaging lines located in our 100,000 sq ft adjacent space for labeling, inserts, stretch cards, and cartoning.
The labeling of the brite stock is married up with the secondary pack equipment. The flexibility that PharmAgility group has engineered into the line for us is spectacular,” Hanmer says.
“Traditional lines in batch production mode producing multiple SKUs each in a different trade dress present “unrewarded complexity” – the additional changeovers take away time, add cost, and reduce your efficiency as you increase the amount of variation put into the system,” Wells says.
A growing trend in the pharma space, the brite stock model can be more efficient when multiple products and packouts create multiple changeovers and downtime.
Upstream primary line performance is not impacted by downstream labeling starts and stops for label changes, increasing equipment uptime. Primary and secondary lines can run more efficiently, as the primary filling process can typically be run faster than the downstream labeling process, Wells says.
PharmAgility redesigned a line that was centrally controlled to one where component stations are individually controlled, mostly using Allen Bradley Panel View Plus HMIs. The primary line equipment is synchronizable to enable an efficient product flow through the entire line for different speeds and pack out configurations. Variable speed drivers on each machine are sequenced – generally to the rage of the filler – to avoid overloading or starving equipment stations.
Quality and control solutions include automated and manual in-process checks, and a product control and segregation system for cGMP-compliant accountability and control. “We wanted this to be a world class quality system for meeting FDA requirements and customers’ expectations,” Wells says.
Will the new set up offer the capacity required as more customers come looking for more services under one roof?
“We can easily expand. The facility is outfitted to be able to accept multiple lines when the need arises. If demand comes in that exceeds the capability of the one filler, it is engineered to be scalable; we are prepared to accept a second or third line,” Hanmer says.