Tablet, capsule inspection provides the right RxTablet, capsule inspection provides the right Rx
January 29, 2014
West-ward Pharmaceutical Corp., a generic prescription drug manufacturer based in Eatontown, NJ, has been in an ambitious expansion mode over the past few years. To be successful, the company's packaging lines must perform at high accuracies, with consistency and reliability. To provide 100-percent inspection and to ensure quality and precision for hundreds of perscription tablets and capsules, West-ward uses a range of Lock Inspection Systems (www.lockinspection.com), metal detectors and checkweighers from its tablet-manufacturing operation through to final case packing. These include the MET 30+ pharmaceutical metal detector, the WeighChek CK 2500 checkweigher and the WeighChek CK50 case weigher.
West-ward produces about 100 medications in approximately 300 stockkeeping units, including two over-the-counter (OTC) products, as well as assorted cardiovascular drugs, muscle relaxants and antibiotics available by prescription, in various quantities, package configurations and formulations for distribution to major wholesalers across the country and to governmental facilities. The drugs are packed on four lines that run anywhere from 60 bottles of 100-count tablets/min to 150 bottles/min, depending on the product, the tablet or capsule size and filling equipment and the package configuration. The products include tablets and capsules in opaque white high-density polyethylene rounds from several sources in sizes from 60 cc to 1,250 cc.
An increase in demand for its products prompted West-ward to expand its Eatontown plant by 86,000 sq ft last year and another 130,000 sq ft this year, for a current total of 250,000 sq ft. This was done to provide sufficient room for further growth. The packaging team wanted rugged equipment as well as sensitive, economical and accurate systems that could ensure that the products comply with customer needs and with changing U.S. Food and Drug Administration requirements. In its search for equipment to improve these and maintain its strict product quality standards, the company found the WeighChek and the MET 30+ most suitable for its tablet/capsule production lines.
West-ward installed a whopping 19 of the detection systems and outfitted four of its packaging lines with the Weighcheck CK 2500 checkweighers, so far adding one WeighChek CK50 shipping-case weigher at its packoff location. Explains Martin Sheer, director of manufacturing, West-ward selected Lock for its technological expertise and for its ability to custom-build systems to suit each application.
Positioned at the outfeed stations of its tablet presses and capsule-manufacturing machinery, the MET 30+ metal detectors play a critical role in the upstream medication production at the plant, Sheer says. “The reason we installed the metal detectors in our manufacturing area was to eliminate the remote possibility of any metal contamination in the raw materials from contaminating a tablet or a capsule.”
The equipment comes standard with dual serial communication ports that are ready to use whenever West-ward needs them.
A customer of Lock's for 20 years, West-ward looked to Lock once again for more equipment that could provide it with a keen level of sensitivity, stability and ease of use. “We were also looking for detection/inspection equipment that was reasonably priced, and wanted it from a supplier that's responsive to our needs,” Sheer tells PD. “We've looked elsewhere in the past, but we switched to Lock. Their equipment meets these needs and is easy for us to set up. ”
Points out Mark D'Onofrio, vp of Lock Inspection Systems, “West-ward has a range of our equipment, spanning from their tablet/capsule-manufacturing area all the way through to final packaging. They require a high level of sensitivity in their equipment so, of course, we provided everything we could to meet their needs.”
The 1-mHz system is designed to detect and reject metal particles at rated speeds up to 30,000 tablets/min. It can find ferrous metals as small as 0.25 mm, nonferrous metals down to 0.5-mm and stainless steel to 0.5 mm in size. Able to withstand aggressive cleanings and washdown conditions, the MET 30+ system automatically stores up to 100 product setups, retaining 300 metal-detection events in memory. The detection system also provides 100-percent inspection of the products. While West-ward opted for a standard membrane keypad with a two-line display, a touchscreen interface is also available.
Sheer says the metal detectors are more accurate than what the West-ward plant experienced previously, finding contaminants as minute as 0.3 mm. Provided through Lock's equipment representative, Tom McNelis at Kirmatco, Inc. (732/513-5221) and installed by Lock's factory representatives, the equipment features quick rejection of unacceptable containers and product.
The polished-stainless-steel MET 30+ detectors each came with a speedy, dual-acting Rotenoid rejection gate designed for efficient rejection of potentially contaminated tablets and capsules. The gate's lift-flap mechanism allows it to flip up and divert tablets downward should there be any contaminated tablets.
Designed to seek out nearly any kind of metal, the MET 30+ detectors each have an adjustable stand that allows it to be rotated 180 deg for universal installation on most tablet presses and employ Lock's exclusive ADC software, which allows West-ward to meet both its own quality-control standards and those of its customers. The software permits all data, product signals and detection parameters to be viewed graphically by networking to a PC or laptop. Lock states that the software takes transmitted and received signals from the metal detector and translates the data into a graphical format, providing operational and maintenance staff with an on-screen diagnostic tool.
The checkweighers are accurate to ±1 g. Validation documentation is provided with all of the systems. “We use inspection systems in a number of ways,” says Sheer, director of manufacturing at West-ward Pharmaceuticals. “The metal detectors are in our manufacturing area. Every tablet and capsule is sent through those machines. We use the checkweighers in our packaging department to check the fill accuracies on our bottling lines and use the case weigher to alert operators if any bottles of controlled drugs are missing inside the shipping cases.”
Sheer says the checkweighers are also quite accurate. “We see weighing accuracies to about two grams. And we intend to install three additional case weighers, which are portable and can be moved from line to line.”
Eliminating the need for sample testing off-line, the WeighChek 2500 bottle checkweighers offer a high rate of weighing accuracy, five-zone weighing for under and overweighments and intermediate weight zones that track the accuracies of past weight zones. Provided with either membrane keypads and touchscreen operator interfaces (West-ward uses both types), the systems automatically calibrate and set up bottle weighments, which are kept in memory to expedite product changeovers.
With a rugged construction of 100-percent stainless steel and preset memory storage for 100 setups of West-ward's case sizes, the CK50 has an easy-to-understand touchscreen user interface. Its large weighing platform handles a variety of case sizes.
Capable of packaging any of the products, the lines run five days a week for about two hours each day. Says Sheer, “We conduct a twenty-five-percent inspection.”
The tablets and capsules arrive at the plant packed in bulk totes and are transferred to the packaging/staging area. “We set the equipment according to preset tolerances as per our packaging standard for each product,” says Sheer. We 'challenge' the checkweighers prior to each run. This is in addition to our routine validation of the entire system.”
After the drugs are inspected for metal by the MET 30+ systems, they fall into plastic buckets. The buckets, like the bottles, bottle labels and other packaging components, are then checked first by the plant's Quality Assurance department for the proper specifications and quality and are transferred to the bottling area where a packaging run begins after QA personnel check component counts.
The bottles are unscrambled on Pace (www.pacepkg.com) bottle unscramblers with cleanout systems and next convey via Paratran III parallel container transfer units from Travtec Packaging Eng. (www. travtec.uk.com) to be bottled using 15- and 42-in. slat fillers from Integrated Packaging Systems (www.ipsnj.com), some of which were installed concurrently with the inspection equipment. Next, the filled bottles pass through the CK 2500 checkweighers, where they're 100-percent-inspected for accurate weights. Each bottle is weighed dynamically (on the fly), and out of tolerance bottles are automatically rejected from the line. Cotton is inserted into the bottles by Lakso cottoners from IMA Nova (www.imanova.com) and the bottles quickly convey to capping systems from suppliers including KapsAll (www.kapsall.com) and Kompass (www.thekompass.it), the latter of which are sold by Integrated Packaging.With caps (from various suppliers) in place, the bottles are induction-sealed and the caps are re-torqued on KapsAll equipment before they're labeled on Quadrel (www.quadrel.com) labelers. The sealed, labeled containers then receive outsert labels via MGS (www.mgsmachine.com outserters and are case-packed by hand in counts of 12 or 24 bottles into the shipping cases. For another weight verification and quality-control measure, the cases are then weighed on the Weighchek CK50, which signals if a case is missing a bottle or bottles.
With this new inspection machinery, West-ward has improved its metal detection and checkweighing procedures and is able to better demonstrate and verify the quality of its drug products. “We expect a three-year return on this equipment investment,” sums up a pleased Sheer, who adds,“but more importantly, we look at the equipment as an upgrade to our quality. The checkweighers and metal detectors are needed by any responsible company to assure that the best possible products reach customers and consumers.”
More information is available:
Lock Inspection Systems, 800/227-5539. www.lockinspection.com.
IMA Nova, 800/851-1518, www.imanova.com.
Integrated Packaging Systems, Inc., 973/263-5200. www.ipsnj.com.
KapsAll, 631/727-0300. www.kapsall.com.
Kirmatco, Inc., 732/513-5221.
Kompass, s.r.l., 39 037 669 4894. www.thekompass.it
MGS Machine Corp., 763/425-8808. www.mgsmachine.com.
Pace Packaging Corp., 973/227-1040. www.pacepkg.com.
Quadrel Labeling Systems, 800/321-8509. www.quadrel.com.
Travtec Packaging Eng., 44 (0) 1942 677664. www.travtec.uk.com.
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