Hi-Tech Pharmacal Co., Inc. is a specialty pharmaceutical company that develops, manufactures and markets branded and generic prescription and over-the-counter products for the general healthcare industry. Founded in 1982, Hi-Tech offers more than 100 products. The company specializes in difficult-to-manufacture liquid and semi-solid dosage forms and manufactures a range of sterile ophthalmic, otic and inhalation products.

Hi-Tech's manufacturing facility in Amityville, NY, has 14 packaging lines that include 11 liquid-filling lines, two aseptic-packaging lines and a tube-filling line. Examples of standardization include seven Kalish Filltronic in-line fillers from IMA Nova Packaging Systems (www.imanova.com), seven cappers from Kaps-All Packaging Systems (www.kapsall.com), six labelers from D.L.-Tech, Inc. (www.dl-tech.net) and six vision-inspection systems from DVT Corp. (www.dvtsensors.com).

For another look at filling and capping liquid pharmaceutical products, this time at contract packer Celeste Industries, go to www.packagingdigest.com/ info/celesteindustries/

A liquid line that was running cough syrup during PD's visit is typical of Hi-Tech's operations. The line runs a variety of products in bottle sizes ranging from 4 to 32 oz at speeds up to 100 bottles/min. A worker manually places bottles on the conveyor, which delivers them to a 12-head Kalish Filltronic in-line filler from Nova Packaging. In the bottom-up filling process, an indexing finger stops the bottles when 12 are in place beneath the nozzles, which descend into the bottles, discharge and retract, and the next group of 12 bottles is admitted. An interesting feature is that the nozzles descend into the bottles by means of a programmable drive system. This allows you to predetermine the distance of the dive and includes a safety that inhibits any downward force or release of product, should a bottle somehow be out of place and the nozzles misses the opening and hits the bottle. Therefore, there is no damage; the nozzle just stops until it is retracted at the end of the fill cycle.

The nozzles are equipped with positive shutoff plungers that open as the nozzles lift up in the bottles and then close at the end of the fill cycle. A dedicated sanitary gear pump, driven by its own motor, serves each nozzle. Each gear pump is equipped with an encoder that counts pulses as the gear moves, providing excellent fill accuracy. For each container size and product, the control system can be set to a specific pulse count that delivers the correct volume of product and stops the pump when that number has been reached.

The fillers at Hi-Tech were equipped with PLCs from Omron Electronics LLC (www.omron.com) or Allen-Bradley PLCs from Rockwell Automation (www.rockwell.com). The latest models are equipped with Omron Sysmac CJ1 series programmable-logic controllers and a CTC touchscreen human-machine interface (HMI) from the CTC Div. of Parker Hannifin Corp. (www.ctcusa.com). The systems allow the operator to display fill count, have pump-status indicators and provide total fill and current status for each nozzle, and they retain hundreds of different product/bottle combinations in memory that can be recalled by the operator.

"This Kalish Filltronic filler is the most versatile liquid filler on the market," says maintenance manager John Williams. "I can change the fill volume from a half ounce to a gallon electronically without doing anything mechanical like changing pumps."

Filled bottles are conveyed to a Model A6 capper from Kaps-All Packaging Systems, which incorporates six revolving spindles—three on each side of the conveyor—that tighten the caps on the bottles. The first pair starts the cap, the second continues the torquing, and the third finishes it. The capper is equipped with an overhead rotary feeder that orients the caps open-side-down and delivers them down a track to the capping head. Bottles pick the caps from the track discharge as they enter the torquing section of the machine. A key feature of the machine is its very simple design. No changeparts are required for a wide range of cap sizes and container sizes and shapes. Changes are accomplished with simple, patented knob adjustments, and head-height changes for container sizes from vials to gallons are accomplished by an automatic motorized system.

The capper features a remote-controlled clutch system. Pneumatically operated torque-limiting clutches allow the operator to adjust the application torque of the caps as they are applied to the containers. They can be adjusted while the machine is in operation, eliminating lost time and the need to adjust each clutch individually. Calibrated dials assure the operator of repeatable torque setting for each capping application without the need of torque wrenches and separate tools.

The capper incorporates an electronic torque monitor that measures the application torque of the caps while they are being applied to the container and signals the operator if the torque is out of spec. The torque is displayed on a liquid-crystal display screen, and a built-in computer with a standard statistical analysis package allows an operator to display the test results.

"As with the filler, this capper is very versatile. It can be changed electronically for a wide range of bottle sizes without requiring any mechanical changes," says Williams. "Kaps-All cappers are user-friendly and easy to service and repair. And the company is right up the road, so they give us excellent service."

A Kalish neck bander that applies a tamper-evident, printed band over the cap and down onto the neck of the bottle is installed after the capper. This neck bander is no longer manufactured, but IMA Nova Packaging supplies service and spare parts. Bottles then pass though a shrink tunnel from OAL Associates, Inc. (www.oal-inc.com) that shrinks the tamper-evident band onto the cap and bottle. These bands were not applied to the cough syrup bottle being run during PD's visit.

Next, the bottles are conveyed to a dual-head pressure-sensitive labeler from D.L.-Tech, Inc. Bottles are diverted onto the labeler conveyor, which has labeling stations mounted on both sides. Depending on the bottle being run, this labeler will apply a single spot label, two spot labels to opposite sides of the bottle, a wraparound label or a multipage insert label. In this operation, each roll of labels is mounted horizontally and is pulled to the labeling wedge where the label is stripped from the web and applied to the bottle. As the web of labels enters the labeler, it passes an Allen hot-foil printer from Thermo Electron Corp. (www.thermo.com) that applies a lot code and a date to each label.

Bottles entering the labeler pass through a metering station in which fingers space them properly for label application. The bottles then enter a section with an overhead belt that holds them firmly in place as the label is applied. After the label has been applied, the bottle travels past a freewheeling sponge that wipes the label firmly onto the bottle. Bottles are hand-packed into shippers, which are sent through a top-and-bottom taper. The shippers are then conveyed past a DL-Tech print-and-apply labeler that incorporates a Model M8485Se thermal-transfer printer from Sato America, Inc. (www.satoamerica.com). In this operation, the web of blank labels is pulled past the printer, which prints the product name, the date and the product code, along with associated bar codes. The label is stripped from the backing web and is applied to the shipper as it passes on the conveyor. The shippers are then hand-palletized.

Hi-Tech uses a vision-inspection system from DVT Corp. to check the lot code and date on the bottle and case labels, as well as bar codes and product names on the case labels. A DVT Legend 540 camera is installed after each labeler, and a match string corresponding to the product being run is entered into both cameras through an HMI. The cameras compare each label with the match string and stop the line if an error is detected. Data and images are uploaded to the plant Ethernet, and Williams can view this on a PC in his office and can make changes to the inspection parameters as needed. "The DVT system is user-friendly and easy to program, and they provide excellent support," says Williams. "Another big advantage is that their software is free."

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