Total Corrugate Recycled: 1,421,175 lbs

By recycling paper in 2012, Praxis saved:

12,080 trees

4,794,130 gallons of water

56,137 gallons of oil

2,345 cubic yards of landfill space

Kept 42,635 lbs of air pollution effluents out of the air

4,372,971 Kwh of energy

$28,424 of landfill space

*The amount of paper material reycled through Shred-it yielded an additional 241 trees saved.

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.

LINE TUNING

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.

Based in Allegan, MI, Perrigo has been partnered locally with Praxis for over 20 years. The strength of their supplier relationship has allowed for unified development of SOP’s, training procedures, and most importantly, quality systems that support each company’s fundamental business objectives.

Praxis also received this award in 2009 and 2010.

Photo: (Left to Right)

Scott Hanmer, VP of Sales (Praxis), Steve Davis (Perrigo), Anne Armstrong, VP of Quality (Praxis)

Grand Rapids, MI, December 05, 2012 – Praxis Packaging Solutions is pleased to announce today the addition of Michael Bourdo as Director of Operations. Bourdo brings over twenty years of progressive management experience, including manufacturing management and corporate planning, to the Senior Management Team.

Some of Bourdo’s more recent experience includes various roles within food manufacturing facilities such as Vice President of Supply Chain for Fresh Food Concepts, Plant Manager for Bay Valley Foods, and prior to joining Praxis, some project work as the Interim Director of Operations for Future Food Brands.

In each of these roles, Bourdo made significant improvements to overall operations, facility infrastructure, line functionality, product quality, and safety resulting in substantial cost savings and reduction of customer complaints.

“We look forward to the contributions Mike will be making as Praxis continues to grow and expand,” stated Shannon VanNoy, Human Resources Manager.

Bourdo holds a BS in Biological Sciences from Michigan Technological University.

Grand Rapids, MI, November 6, 2012 – Praxis Packaging Solutions announced today the expansion of its Columbus location by adding 6,400 square feet to it’s already 30,000 square feet of cGMP operational space.

The Columbus facility is currently registered with the U.S. Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Environmental Protection Agency (EPA) in addition to being GMP certified with the European Medicines Agency (EMA).

The additional space will allow Praxis to grow its number of flexible production cells at this location.

The only thing faster than Praxis’ new high-speed tablet line is the company’s expansion into vertically integrated pharma packaging

Diversified contract packager Praxis Packaging Solutions bumped-out its headquarters site in Grand Rapids, MI, in recent months to make room for a growing business. A major piece of that growth will come from a new high-speed tablet filling and packaging line that deepens the company’s commitment to over-the-counter and prescription drug packaging.

The new line is “part of an ongoing effort to improve upon our existing portfolio of capabilities and service offerings,” Scott Hanmer, vice president of sales, told Contract Packaging during a late-October facility tour.

Key pieces of equipment include an unscrambler from Omega Design (www.omegadesign.com), counter-filler from Aylward (www.aylward-usa.com), checkweigher from OCS (www.ocs-cw.com), capper from Kaps-all Packaging Systems (www.kapsall.com), re-torquer from Fowler Products (www.fowlerproducts.com), induction sealer from Enercon Industries (www.enerconind.com), and high-speed labeler from Weiler Labeling Systems (www.weilerls.com).

In addition to stressing greater vertical integration with existing services from upstream consulting to secondary packaging and beyond, the line has baked-in flexibility, which Hanmer said has been “engineered into the process, from the equipment and line layout to the material handling and process flow.”

That flexibility includes the capacity to handle 200-300 containers per minute of varying shapes and sizes from roughly 40 cc to 300 cc. Other examples include the availability of snap- or screw-on caps; the ability to run simultaneous filling and labeling or the agility to pack and store to bright-stock, or label and package simultaneously as needed in order to meet customer requirements.

Praxis’ mangement agility has been equally impressive in partnering, sourcing and fast-tracking the project. In August, the company contracted with the PharmAgility Consulting Group, Stuart, FL, to assess the feasibility, planning, and installation of primary filling equipment and a supporting current Good Manufacturing Practices (cGMP) primary fill quality system. The high-speed line was sourced from a global Big Pharma brand; redesigned and placed in September, and powered-up on October 10. Validation was underway within days.

The line will meet U.S. Food and Drug Administration as well as European Medicines Agency standards. Additionally, the line includes thermal printing from Videojet Technologies (www.videojet.com) and will be fitted with additional vision, coding, and information technology upgrades for compliance with global  unit-level serialization as well as the California e-pedigree law set to go into effect in 2015.

The company already uses manufacturing execution and vision systems from Systech (www.systech-tips.com), and plans call for the addition of the developer’s serialization modules.

A commitment to expanding with primary pharmaceutical packaging and “overwhelmingly positive response” from customers led to rapid project implementation, Scott Wells, Managing Director for PharmAgility, says. “Getting the facility expanded and the line qualified is one priority, the other critical priority is developing the primary fill cGMP quality system – ensuring Praxis is also world class in terms of their quality and compliance,” he adds.

The line will meet U.S. Food and Drug Administration as well as European Medicines Agency standards, and will also comply with U.S. and global unit-level serialization requirements, from coding and vision technology to serialization software from Systech (www.systech-tips.com), whose manufacturing execution system is already in use in the plant.

“Ensuring Praxis is ideally positioned now for future requirements such as ePedigree and product serialization will be an advantage for current and future customers,” said Scott Dunckley, operation lead for PharmAgility.

In addition to the new line, Praxis in summer added 45,000 square feet to its headquarters site, bringing total operations in Grand Rapids to 175,000 square feet. The company also operates a roughly 30,000 square-foot facility in Columbus, OH.

In related news, the Columbus facility last summer earned a GMP Certificate of Compliance from the European Medicines Agency (EMA) for secondary packaging of non-sterile drug products.

Besides its pharmaceutical work, the company serves various food, beverage, CPG and promotional customers with services spanning design and consulting, primary and secondary packaging; repack kitting and assembly; warehousing, inventory management and distribution.

Grand Rapids, MI, October 11, 2012 – Praxis Packaging Solutions announced today the expansion of its Grand Rapids location by adding 45,000 square feet of cGMP operational space. The extra space will be used in conjunction with the current 130,000 square feet at 7650 Caterpillar Court.

“Over the past few years, we have seen considerable opportunity for growth,” said Scott Hanmer, Vice President of Sales. As a result, the Praxis management team has been working diligently to improve upon our existing portfolio of capabilities and service offerings.”

“As efforts to support current and new business remain at the forefront, Praxis holds fast to its core strengths and fundamental business objectives. Most importantly, our ability to offer high level quality standards valued by our customers and key vendors,” Hanmer assures.

Praxis operates a second 30,000 square foot facility in Columbus, OH.

1. Cleveland Chapter Institute of Packaging Professionals Annual Golf Outing

Friday, August 24, 2012

10:30am Shotgun Start

Astorhurst Country Club, Walton Hills, OH

2. Cincinnati Chapter Institute of Packaging Professionals Annual Golf Outing

Friday, September 14, 2012

9:00am Shotgun Start

Beckett Ridge Country Club, West Chester, OH

3. West Michigan Institute of Packaging Professionals

Thursday, September 27, 2012

1:00pm Shotgun Start

Quail Ridge Golf Club, Ada, MI

Praxis Packaging Solutions Now Certified EMA GMP Secondary Packaging Site

2012 Praxis 4th of July party!