Malnove News keeps you up to date and informed on what's going on in the Packaging and Packaging Solutions industry.
Stay up to date with "What's New" at Malnove by selecting any one of the drop down selections below. We love to share our experiences and bring them to you in the most concise and formal way possible. Our news section not only keeps you up to date on what going on at Malnove, but also what's coming up in the near future. We hope you enjoy some of our most recent Press Releases as much as we like to bring them to you.
Malnove Inc. Purchases its First Heidelberg Press with Speedmaster XL 145 VLF
January 29, 2018 (Press Release)
Malnove, a leading producer of folding cartons, recently joined the Heidelberg family by investing in its first Speedmaster XL 145-7+L very large format press. The new press is fully equipped with a long list of options and innovations including the latest “Push-to-Stop” technology, which can provide autonomous job changeover without operator intervention— dramatically reducing make-ready time and increasing uptime and productivity.
The Very Large Format Press with Proven Performance
Malnove purchased the Speedmaster XL 145, to be installed in the Utah facility, to better service its customers on the West Coast. With the company’s increasing growth, Malnove began the search for a new large format press to handle the additional volume.
“After extensive research and reviewing each manufacturer carefully, we felt that the Heidelberg XL 145 had a competitive advantage with reduced make-ready time and speed to production,” said Eric Malnove, Executive Vice President of Malnove Inc. “Heidelberg’s Speedmaster XL 145 has the most modern, large format platform available with the technology our company needs to be competitive.”
Malnove’s XL 145 investment includes options such as Inpress Control 2 inline spectrophotometer that achieves both color and register on the fly, inspection of each printed sheet (assuring quality products are delivered to Malnove’s customers), as well as fully integrated UV technology.
“With the new XL 145, the UV capabilities will expand our market and meet our customers’ growing demands for high quality products,” said Dale Houck, President of Malnove Inc.
The Deciding Factor - People
Even with all the unique features the XL 145 offers, Malnove invested in their first Heidelberg for one particular reason: the people.
“All printing presses can print, that’s what they do. After running competitive equipment for years, we felt Heidelberg truly wanted to partner with us. Preventative maintenance, predictive monitoring, and solid service after the sale was also key,” said Houck.
“I think the tipping point for us was after hearing from other companies who have already chosen Heidelberg’s large format presses - the technology, service, and support they are experiencing; the choice was an easy one,” said Malnove.
Heidelberg has the largest service coverage in the industry and offers a wide range of technical, financial and performance services to ensure that customers are getting the most from their equipment. The wide network means that close-by technicians are readily available to help customers in need.
With features such as Heidelberg’s “Predictive Monitoring,” customers will be informed about a problem before it actually becomes an issue. This leads to less downtime and increased productivity for print shops. And with the new Heidelberg Assistant, customers can track service calls and have a complete overview of the service and maintenance status of their print shop, as well as other features such as online ordering of service and consumables.
About Malnove Packaging
Founded in 1948 in Omaha, Nebraska, Malnove manufactures and supplies packaging products and systems for customers in North America. The company develops specialized systems to form, fill, and seal cartons in plants; it installs packaging systems, including product handling, cartoning, case packing, palletizing, and line controls. Malnove serves consumer product goods companies and retailers. It operates folding carton converting facilities in Jacksonville, Florida, Omaha, Nebraska, and Clearfield, Utah.
US folding carton manufacturer Malnove to install KBA Rapida 145 seven-color 57-Inch sheetfed press at its Nebraska facility
DALLAS, TX, June 4, 2013 (Press Release)
KBA North America is pleased to announce that Malnove, the largest independent folding carton manufacturer in North America, has chosen to equip its Omaha, Nebraska facility with a new KBA Rapida 145, 57-inch seven-color sheetfed press equipped with a host of impressive automation features including the KBA SIS Sensoricsidelay-free Infeed, board version, DensiTronic Professional Closed Loop Spectrophotometry, Auto Register, LogoTronic Professional, CleanTronicSynchro, and a high-speed package for a maximum speed of 17,000 sph. The 57-inch press also features a new tower coater concept, extended delivery, and overall preparation for UV applications.
"KBA continues to introduce new technology and innovations that allow our company to thrive and prosper," says president Paul Malnove. "Our strategy is to embrace new high-speed presses to answer the demands of our customers. We have formed an important alliance with KBA and installed our first large-format KBA Rapida 142 in the U.S. in our Omaha plant in 1997. For more than 15 years, our common press platforms across all of our facilities have provided our customers with the benefit of being able to produce any carton, for any customer, in any plant with the same quality and pictorial results."Malnove's new KBA Rapida 145 features new automation seen for the first time at Drupa. These include the KBA SIS Sensoricsidelay-free Infeed,theCleanTronicSynchro system (two washing beams) for simultaneous washing of ink rollers, blankets and impression cylinders parallel to plate changing, and additional parallel makeready processes that contribute to significantly higher net production output compared to the predecessor series and presses from other manufacturers. Convenient operation is guaranteed at the new ErgoTronic console with wall screen, picture-in-picture function.
"As the established market leader in large format presses, KBA chose Drupa 2012 as a fitting occasion to redefine and elevate the benchmarks for offset printing in large format," says Mark Hischar, president and CEO of KBA North America. "We're proud that our Rapida 145 was the largest sheetfed offset press on display at Drupa. Its unique features make the Rapida 145 more efficient and enhance productivity for commercial and packaging printers worldwide. We are proud of our partnership with Malnove and being able to supply them with the most technologically-advanced presses in the market." Founded in 1948, Malnove designs and converts high-quality folding carton packaging at its three plants located in Omaha, Nebraska; Jacksonville, Florida; and Clearfield, Utah. Malnove is committed to delivering sustainable value through its commitment to its three tenets - intelligent packaging design, continuous process improvement, and speed-to-market.
KBA North America is located in Dallas, Texas and a member of the KBA Group. Established almost 200 years ago in Wuerzburg, Germany, Koenig & Bauer AG (KBA) is the oldest and second largest press manufacturer worldwide. KBA's banner, 'People & Print', reflects its dual focus as a leading innovator for print entrepreneurs. The group's product range is the broadest in the industry; its portfolio includes commercial and newspaper web presses, sheetfed offset presses in all format classes, inkjet systems and presses, special presses for banknotes, securities, metal-decorating, smart cards and discs.
Malnove Announces Stackrite™ III with Concentric Screening
Two Chefs on a Roll www.twochefsonaroll.com/home.html recently selected Malnove's new Stackrite ™ III for their "Trader Joe's Chocolate Celebration Cake". Malnove's Stackrite ™ III technology was originally developed to deliver significant corner post compression strength in a paperboard-based packaging solution. The technology was adapted to meet very specific customer needs in this application. The unique Stackrite ™ III corners were used to protect and retain the cake in the carton, including the "Rich Buttercream Frosting".
Malnove's Omaha Plant printed the carton using the latest high definition "Concentric" Screening technology from Artwork Systems'. "Concentric Screening is a revolutionary halftone dot technology that divides the conventional round dot into thin concentric rings. These rings limit ink film thickness on the offset plate, thereby providing greater stability on press and increased color saturation. Printers are able to increase—even double—screen rulings without experiencing the traditional problems of mottle, dot gain, and variability typically associated with high screen rulings".
Malnove's Packaging Systems Group recently designed a fully automated Stackrite ™ III fully cartoning system which will be completed within the next 60 days. Installation of this technology will allow Two Chefs on a Roll to productively form, fill and seal this package in their Carson, California plant.
firstname.lastname@example.org, Vice President of Marketing and Business Development
Foil water 'bottle' quenches a thirst for flavor Design Trends, Packaging Digest
Dolling up dull, bottled water, a new flavor enhancer, Water Sensations(R) in six fruity flavors, has made its debut in a mini, foil-based pouch shaped like a water bottle. The inspiration of Nina Riley, founder and CEO of Water Sensations, Inc., Southport, CT, the single-serve flavor enhancer is designed to make it easier for consumers to get their recommended eight to 10 glasses of water per day and provide a healthier beverage option for kids.
Water Sensations—in Peach, Orange, Strawberry/Kiwi, Grape, Mixed Berry and Lemon—is a clear, naturally flavored liquid, sweetened with sucralose that is sugar-, caffeine- and preservative-free. Each serving is formulated to flavor a standard, 16.9- oz bottle or large glass of water, with no stirring or shaking required. Notable is the product's patent-pending packaging, also a vision of Riley's, which consists of a unique, foil-based pouch shaped like a water bottle called the Liquipack(TM), supplied by CLP Packaging Solutions, Inc. (www.clp-packaging.com). Explains Riley, "I always felt that since this product is made for bottled water, a lot of brand equity would result from a bottle-shaped package." Designed first and foremost for convenience, the pack has a tearable top with a diameter that fits comfortably into the opening of a standard-size water bottle to eliminate mess while pouring. Preeminently portable, Liqui-Packs were made for packing in a briefcase, a purse, a lunchbox or a gym bag.
Water Sensations is sold in a flip-top carton from Malnove, Inc. (www.malnove.com) that Riley says "really communicates something clean, new and different." Each carton holds 16 Liqui-Packs for an average retail cost of $3.99—a great value when compared to flavored bottled water products, which Riley says can cost $3.99 for a six-pack. Since May, the product has been available in retail stores in the Northeast and Mid Atlantic regions, as well as on the company's website, www.watersensations.com Target begins its launch of Water Sensations this month.
Malnove Commissions Three KBA Sheetfed Presses Converting Magazine
Malnove commissions three KBA sheetfed presses Malnove, Inc., the largest independent folding-carton manufacturer in North America, will buy three Rapida 142 sheetfed-offset presses from KBA North America in a deal worth $13.8 million. The 56-in., 7-color presses each have an anilox coater and delivery extension. The first press will be installed in Malnove's Omaha, NE, plant this winter. "Signing this contract with KBA extends our business relationship with them even further," says president Paul Malnove. "We installed the first large-format Rapida 142 in the US in our Omaha plant in 1997, and since then we have produced over 200 million impressions." Founded in 1948, Malnove converts high-quality packaging at its three plants located in Omaha, Jacksonville (FL), and Clearfield (UT). The Nebraska facility offers sheetfed and gravure printing up to seven colors and flexo printing up to six colors, with backside coaters. The Florida facility, the newest folding-carton plant in the US, has seven-color sheetfed capability and six-color flexo capability. The Utah facility features sheetfed printing up to seven colors.
New continuous-motion cartoner improves output Jack Mans,
Plant Operations Editor, Packaging Digest
CPR International packages a line of seasonings in 5- and 10-g pouches for Goya Foods, Inc., the largest Hispanic food company in the U.S. Goya Foods, Inc., was founded in 1936 in New York by Spanish immigrants Prudencio and Carolina Unanue, who began importing authentic Spanish products such as olives, olive oil and sardines, and selling them to New York's growing Hispanic population. More than 65 years later, Goya has become America's premiere purveyor of rice, beans, seasonings, nectars and authentic Latin specialties. Goya products are distributed from coast to coast and beyond, to customers from all backgrounds who seek great-tasting, quality food products.
CPR installed the first new high-speed line for the seasonings in '93, and has installed four more lines over the past seven years to meet customer demand. Last year, it doubled the speed of the Cloud LLC filler on the initial line, added some pouch handling equipment after the filler and replaced an intermittent-motion Klöckner Bartelt cartoner with a new servo-driven continuous-motion Klöckner Bartelt cartoner to keep up with the filler. "We have Klöckner equipment, and we have a great relationship with them, so they were the first company we called when we decided to upgrade production here in Miami," says CPR general manager Frank Unanue.
Cartoner features six servo drives
This line runs cartons containing eight and 12 pouches at speeds of 1,100 and 1,300 pouches/min, respectively. The new Klöckner Bartelt cartoner has six Indramat servo drives (now part of Bosch Rexroth, which acquired Indramat a year ago): the main carton feed, the infeed bucket conveyor and barrel loader assembly, two on the minor flap closers (one on each side), and two on the carton flight chains (each side). "These servos replace more than half of the mechanical parts from mechanical cartoners and have a position accuracy of 32,000 to one, so they provide exceptional reliability and precision," says Klöckner Bartelt regional sales manager David Houmes.The continuous bandoleer of pouches from a horizontal Cloud pouch machine is cut into pairs, with a perforation between the two pouches in each pair by the Cloud knife. Pairs of pouches are formed into stacks directly in the cartoner buckets passing continuously beneath. In this operation, the first pouch hits the front of the bucket, while the last pouch hits the end of the bucket. The buckets then pass beneath a rotating conditioning wheel that presses the pouches to more evenly distribute the product to yield a consistent stack for cartoning. Prior to loading, vacuum cups on rotating arms pick individual cartons out of the carton magazine, open the cartons, and place them in the carton flight conveyor. A servo-driven flap closer tucks the minor flaps on the non-load side, after which barrel-loader pusher-arms insert the pouches into the open end of the moving carton. The cartons are then conveyed past the minor flap closer on the load side, after which the major flaps are finally closed and sealed by a Nordson Model 3400V hot-melt unit.
Rotary powder filler runs up to 1,300 pouches/min
To start the packaging operation, pouches are formed and filled by a rotary poucher from Cloud LLC. The unit is equipped with a PK Series automatic web splicer from Keene Technology, Inc. Two rolls of film are mounted vertically on this splicing unwind unit, one above the other. The unwinding roll passes through a 6-ft-highstorage festoon, where it makes several vertical passes over rollers, before it travels to the pouch machine. Prior to a splice, the top idler rollers in the festoon move upward to create more storage.
When a splice is performed, the festoon idler rollers are lowered so that the stored film allows the pouch machine to keep running. During this time, the trailing edge of the expiring roll is automatically taped to the leading edge of the new roll. As the film is dispensed from the splicer, the rollers rise to restore the film reserve. After leaving the splicer, the film passes through an alignment inspection and alignment system from Fife Corp. Mounted on the infeed of the pouch machine, this system moves a series of rollers slightly to shift the film to maintain alignment. The film for the pouches, a lamination of clay-coated paper/low-density polypropylene/foil/low-density polyethylene, is supplied by several companies, one of which is Prime Graphics, Inc.
From the alignment rollers, the film travels over a plow that folds it at the bottom. The web then travels past a horizontal rotary-sealing drum that has vertical sealing bars that create the vertical seals. As the film leaves this drum, it passes through a bottom-sealing section. This bottom seal is not actually required, but it results in a nicer-looking pouch.
CPR runs several different powdered seasonings on the line, including Sazon Goya, salad, and ham. The seasoning is mixed in another room, and is delivered to the filling room in a large bin. It is then transported by an inclined screw conveyor from Flexicon Corp. to the overhead hopper of the auger filler unit, which was supplied by Klöckner Bartelt. The Cloud filler wheel consists of a large revolving drum that carries the open-top pouches past two parallel, dual-discharging, servo-driven auger fillers. On the filler wheel, pouches are blown wide open with an air knife. The filler plate is tipped slightly toward the filling section, so that the funnels are lower at this point and penetrate slightly into the pouches during filling.The outer edge of the top of the filler plate consists of 48 chambers separated by knife-edge partitions. Each chamber has a funnel bottom that actually delivers the powder into the open pouch waiting beneath. Both the filler wheel and the augers run continuously, and the volume dispensed into each pouch is adjusted by changing the speed of the augers relative to the speed of the pouch machine. A suction tube removes any powder that builds up on the partitions to help optimize accuracy.
The continuous web of pouches leaving the filler passes between two horizontal rollers that seal the tops, and then goes over a wheel that deposits it into a long Cloud Cumulus conveyor that provides an accumulating section in case of downstream operating problems. The bandoleer of pouches then moves over a series of flighted wheels that change the direction of the web 90 degrees before it enters the pouch cutoff machine.
On its way into the Cloud Remote Knife, the pouches are conditioned for flatness. The web also passes an inspection station where a probe checks for empty pouches, and an electric eye watches for the tape that spliced the rolls together. If either of these is detected, those pouches, along with adjacent pouches, will be rejected after they are separated.
In the knife, the bandoleer passes over the major hub that carries it past an adjacent cutting wheel. This wheel actually has alternating cutting and perforating blades that cut the web into tandem pouches (two-pouch segments connected by a perforated section of film). To maintain control, the separated pairs are gripped by the suction cups on the major hub, and these cups deliver the pairs to suction cups on the transfer wheel.This wheel creates stacks of pouches in the buckets of the Klöckner Bartelt cartoner as described previously.
Packer loads cartons on tray, applies lid
As the cartons leave the cartoner, a code containing line number, shift and date is applied by a Xymark laser printer from Linx Technologies, Inc. (formerly GSI Lumonics). The cartons then pass over a Checkmate 2 checkweigher from Hi-Speed Checkweigher. In addition to monitoring cartons with an accuracy of ±1 g, the checkweigher incorporates a closed-loop feedback option that adjusts the speed of the augers on the filler to deliver the proper weight of powder into the pouches. At CPR, the checkweigher collects weight data continuously, from up to 150 cartons, and continuously corrects the filler settings to optimize the process.
After checkweighing, the cartons travel around a conveyor loop, and nine cartons at a time are pushed onto the conveyor feeding the tray packer, which, along with a top placement unit, was supplied by Schneider Packaging Equipment. This machine loads the cartons onto a tray, and then applies a lid to the tray.
As cartons enter the machine, three of them are stood on-edge at a time and are pushed into loading lanes. When eight lanes containing 24 cartons have been assembled, the cartons are pushed onto the tray blank, which has the flaps on the far end already formed. The flaps on the loading end are formed and glued after the cartons are loaded.
The sides of the tray are sloped toward the front, so when the top is removed in the store, consumers can see the cartons. The tray is then turned 90 degrees, and pushed into the next section, where it is pushed up into the flat lid, dispensed from a magazine. The sides of the top are pushed down around the tray, and are glued by a Nordson Corp. Model 2304 hot-melt unit. As the tray discharges, tape is applied to secure the lid.
Vial making maintains healthy pace Lauren R. Hartman, Senior Editor, Packaging Digest
Being an innovator has its ups and downs. At the Orlando, FL, operation of fast growing Nephron Pharmaceuticals Corp., the ups are in full swing. The company's ever-expanding respiratory therapy solutions production plant in Orlando is now packaging single, unit-of-use, sterile, low-density polyethylene vials containing 0.5- percent sterile albuterol sulfate inhalation solution. The Nephron product is the first drug in a unit-of-use container to be approved by the U.S. Food and Drug Administration.
Extrusion/blow-molded in a modified process using transparent LDPE that allows viewing of the liquid content in a shatter-resistant yet easy-to-twist-open container, the 1/2-mL unit-of-use vial of non preserved albuterol sulfate inhalation solution should let consumers breathe a bit easier. The pre measured vial is individually packaged in a foil-laminated pouch. Until now, the product was available only in larger quantities in multi-dose bottles containing 10, 20 or 30 mL that had to be measured using a calibrated dropper. Nephron's innovative new vial package containing the 0.5-percent, 0.5-mL pre measured medication allows patients to open a single, sterile, disposable container that eliminates the measuring dropper and provides a specific quantity of the drug every time.
Nephron has produced the drug since '97 in other package formats. However, the unit-of-use vial package, ready to mix with other oral inhalation drugs, saline or other diluents, for dispersion from a nebulizer, is a breakthrough that took about four years to earn the FDA's approval. The 0.5-percent version of the drug in this container completed validation in July, and has been available in the clear LDPE single 0.5-mL vial since August 1.
Steve Simmons, Nephron's president, told PD during a recent plant visit that the unit-of-use vial pack represents a significant advance in innovative packaging for such a drug product. "This is a whole new [version of the] product, one we've been working on with the Food and Drug Administration for a number of years. It's the first sterile drug product for oral inhalation packaged in this manner."To accommodate demand for the new product and unit-of-use vial package, Nephron is in the midst of installing new packaging equipment, which, when installation is complete, will total an equipment investment of $3 million. The equipment improves upon similar vial lines installed in the plant during the last six years. Already in place is a group of vertical f/f/s single-vial pouching machines from Japan's Tokyo Automatic Machinery Works (TAM), provided exclusively in the Americas by Duma Package Machinery, that packages the vials individually but generates the pouches in continuous, perforated strips of 10 pouches per strip.
One million vials/week
Running the vials on a 24/7 basis, with a shutdown for maintenance and cleanup every five days, the ever-expanding 72,000-sq-ft Orlando plant began its first production-level runs of the unit-of-use vial packs in July on a 12-cavity aseptic blow/fill/seal system at a rate of 12 interconnected, flexible vials per "card," four cycles/min, or 48 vials/min.
In addition to bringing in the new pouching machines, the plant, as of press time, was about to ramp up capacity on the vial with the installation of a 40-cavity vial-molding system along with vial card-trimming and finishing equipment from Weiler Eng. (formerly Automatic Liquid Packaging, which supplied the 12-cavity ALP blow/fill/seal system). Also to be added is a Nikka Densok high-voltage leak-detection system and new conveyors from Westlund Eng. The upgrades will come in handy, as Nephron expects to boost production volumes to an astounding 1 million vials every five days. "We can't seem to keep our warehouses full," Simmons says. "We're marketing and selling more product all the time. In order to meet full demand for production quantities for this particular vial, we needed to have a larger-capacity blow/fill/seal system." Replacing the 12-cavity unit is Weiler's customized and modified Model 640 40-cavity Asep-Teche aseptic extrusion/blow/fill/seal system modified to accommodate Nephron's needs that produces, fills and seals the vials in multiples of 40 per cycle, or two sets of 20 vials. A vial set produced on the 40-cavity machine will include five interconnected vials per "card," four cards to a set, which will be molded at speeds of 160 vials/min. Once the 640 is running, the existing 12-cavity machine will remain at the plant for pilot projects.
"Right now, the line is sort of like a mosaic of pieces we're putting together," Simmons says. "The 40-cavity equipment and the machines that will trim and feed the vials to the pouchers aren't here yet, but should arrive in a few weeks. They will allow us to go from producing about 80,000 units a day to 200,000 units a day." After being sent through the Duma/TAM vf/f/s machines, the continuous, perforated strips of 10 pouches are loaded in groups of three strips into 30-count SBS tucktop/automatic-bottom folding cartons and shipped to hospitals, drug wholesalers and pharmacies nationwide.
The unit-of-use vial line makes the fourth vial-packaging line in place at the plant. Two other lines are currently being upgraded with improved packaging equipment, Simmons tells PD. "One challenge we've experienced with this new vial and pouch format was how to get a single vial into a single pouch without human intervention," he says. "We have to have a pouch that protects the solution against light and air and meets all of the regulations, but we typically pack multiple vials into pouches, not single vials." Last year, Duma installed a single-head pouch machine for Nephron to test on a trial basis and in October '00, Nephron purchased the Model 301 single tube production-volume machine and one of the two Model 771 twin-tube machines. A few months later, the company added the second twin-tube system to complete its test-batch runs of the new product.
Straight forward machine design
The vial-pouching machines bring speed, simplicity and stability to the operation. "They are compact, can keep up with our volumes, and for the price, they were the right machines for the job," says Simmons. "Wayne Barr from Wei-Pak suggested the Duma machines," he says, adding that Barr found other equipment solutions for Nephron and was instrumental in its equipment selections for the entire unit-of-use vial line.
The TAM TWR 771 and TWR 301 strip-pouching machines are capable of packaging vials at speeds of 240 and 120/min, respectively, which will mesh with Nephron's vial blow/fill/seal speeds, which will soon average 160 vials/min. Duma integrated a Markem SmartDate2C thermal-transfer coder inside each pouching machine to imprint lot numbers and expiration dates on the pouch stock so that they appear on the pouch's front panel. A sensor in the forming tube on each machine ensures that an individual vial goes into every pouch made. Each print impression in the pouch stock is also encoded and scanned in the pouching machines to verify that the pouch material for the run is the correct one for the product being pouched. Accurate and stable feeding of the pouch stock and pouch sealing are carried out by the servo controls of the vf/f/s systems, which feature easy-to-operate touchscreen control panels and MMI and LCD displays for input of commands. The machines' vacuum "U" control chambers maintain even pouch film tension and edge alignment as the chambers eliminate the need for tension rollers. The controls also allow Nephron to run assorted film thicknesses without wrinkling.
Nephron appreciates the straightforward design and performance of the vf/f/s pouching machines, which didn't require extensive training to operate. The machines' film conveyors have few rollers, so film tracks easily, and overflows are eliminated. Pouch stock is controlled by a servo motor that allows precise setting of quantity and speed, achieving constant web feed and print registration. Film splicing can be done in-register, and roll changes can be done on-the-fly, a nice benefit, according to Nephron. Other bonuses include large, clear doors and an easy-access maintenance door that pivots out of the way to provide ample visibility to the interior components of the machine.
Able to output pouches ranging from 2.5 to about 7.8 in. W and 1.9 to 11.81 in. L, the machines in Nephron's case afford fin-sealed pouches measuring 6 in. L x 2.25 in. W to hold the single vials of 0.5-mL, 0.5-percent albuterol sulfate inhalation solution. Flexicon provides the two-color-printed foil/nylon/LDPE pouch stock, which is supplied on 430-mm-dia (16.9-in.) rolls.
Ahead of pouching, upstream production of the vials themselves is equally noteworthy and will become more so when the Asep-Tech 40-cavity modified blow/fill/seal vial machine arrives. The sets of vials are produced, filled and sealed in a sterile, operator-less environment in one of several clean rooms Nephron has separated from the rest of the packaging functions. The 12-cavity vial machine running during PD's visit was a short walk from the main packaging and vial-production area. The system extrudes raw pellets of medical grade 20-6064 virgin LDPE resin from DuPont before it molds, fills and seals the teardrop-shaped vials, their twist-off seals, bottom tabs and other interconnected plastic material. Never touched by human hands, the solution is pumped to the filler from 316L stainless-steel jacketed tanks. Traveling through a previously sterilized path, the non sterile fluid first hits dual sterilization filters upon processing, sterilizing it prior to filling. During PD's visit, the aseptically filled and sealed cards of 12 vials exited the HE PA filtered clean room by conveyor and were deflashed by hand. Next, they were further separated into individual vials and sent through a leak-detector built in-house. Loaded by hand into gaylords, the vials were transferred to the pouching machines on the main packaging floor.
Also at the time, a Class 10,000 clean room was being readied for the modified 40- cavity Asep-Tech 640 aseptic blow/fill/seal equipment which, when in place, will generate vial sets in the same five steps as does the 12-cavity machine, except, instead of 12 vials at a time, eight sets, or 40 vials will be produced at a time. Both the 12-cavity and 40-cavity systems operate thusly: The LDPE resin is extruded into parison heads, eight of which are being equipped on the 40-cavity machine. As the mold closes, the parison is cut. The bottom of each parison is pinched closed, and the top is held in place. The mold then conveys to a forming/filling nozzle within the machine, as the blow/fill nozzle lowers to the parison until it aligns with the neck of the mold.
According to Simmons, Nehpron's machines have been modified to ensure validation by use of a vacuum to draw the wall of the vial out, instead of the usual way, in which sterile, filtered, compressed air is blown into the parison and expands it against the wall of the integrally cooled mold cavity. Afterwards, the sterile product is metered into the vial through the nozzle, which then retracts. Separate sealing molds then close to form the vial tops and to hermetically seal the containers. The mold splits the vial sets into two, 20-vial sets. When the mold opens, the molded, filled and sealed vial sets emerge and exit the clean room, upright, on a patented bird's foot conveyor to the first of two automatic trimming systems. The first microprocessor-controlled system deflashes the sets into separate cards, incorporating five interconnected vials. When the additional equipment arrives, the cards will then be oriented horizontally and fed into the new Model HDI-1S nondestructive electronic leak/pinhole-detection system from Nikka Densok. The HDI system checks the twist-off seals and necks of just-made vials using a high frequency, high-voltage spark test that detects secondary contamination of the product. Especially designed to work with blow/fill/seal containers, the inspection unit ensures that the vials are sealed by identifying small pinholes, cracks and other seal imperfections or leakage. Any rejects will be pushed off of the main conveyor into a rejection bucket for further evaluation, while "good" cards will progress to the second of the Weiler-built stations, a conveyorized stripper system that will separate the cards into single vials. For the time being, the vials are individually hand-fed onto belts leading to the hopper of each of the TAM vf/f/s strip-pouching machines. Simmons indicates that the manual vial-feeding process leading to each of the pouching machine infeeds will be replaced by a five-lane "wheel spoke" conveyor system that will appear like a hand with five fingers, elevating the vials in single file.
The pouching systems operate in intermittent motion as the foil-based rollstock, which contains enough material to produce about 2,600 pouches, unwinds through a set of rollers that tension the material as it nears the forming shoulder. Each pouch has a bar code, read by a scanner that verifies that the pouch material for the run is the correct one for the product being pouched. Just before pouch forming begins, the web of material is encoded by the SmartDate2C with the lot number, expiration date and machine number.
Next, the web passes a sensor positioned in the forming tube that ensures a vial has dropped into the pouch before it will finish sealing. The servo-controlled machine also automatically measures out the length of each pouch to perforate it and cuts a strip of 10 pouches. The vials meanwhile drop through the hopper chute in the pouch-forming section as the web encloses the forming tube and collar, and a vertical fin seal is made, the vacuum chamber maintaining film tension and alignment all the while.
The top seal is then made on the leading bag, and a bottom seal is made to the trailing bag. A tear-nick applicator built into the seal bar makes a small, easy-open notch in the top seal before a combination perforating/cutting knife makes a perforation between individual pouches and a full cut between strips of 10 pouches. The filled, sealed vial packs emerge from the machine in continuous strips onto an incline conveyor, are inspected and are then taken to a nearby packoff area.
Manual cartoning...for now
There, operators inspect the pouches, accordion-fold the continuous strips of 10 pouches and load them by threes into the 30-count SBS folding cartons from Malnove, insert product literature, and then case-pack 10 of the cartons into a master shipping case. Cartons are inspected for proper pouch count, contents and pertinent information and are hand-stamped with lot code and expiration date. Cartoning and casing will continue to be performed manually for the near future, Simmons says, but the cartons will soon be automatically checkweighed For now, operators weigh the filled, sealed cartons on calibrated scales. "We plan to add checkweighing soon, but the cartoning and case packing functions aren't likely to be automated for a while, because we have to figure out a way to automatically handle the strip-packs of 10 pouches once they come out of the bagging machines."The prognosis looks good for Nephron's new product and packaging operation in Orlando, which is about to increase in size by 50 percent, as another portion of the building is being acquired for production, Simmons says with enthusiasm. "We expect to install six more production lines within a year, and Nephron will be introducing additional products in bar-coded single-vial pouches. One is a patented, two-chamber vial for segregated, sterile solutions. Another is a cost-saving diagnostic product for hospital use. As hospitals increase their use of bar-coded products to cut costs, we see this as only the beginning of unit-of-use packaging." For users of pulmonary drug products, that could be a healthy breath of fresh air.