Noven upgrades its automated proofreading…

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AutoProofPro ImagingSuite DotScan BarCode System
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Miami-based Noven Pharmaceuticals’ uses automated proofreading with Braille measurement and reading.
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In the modern pharmaceutical landscape, organizations must navigate a global patchwork of regulations and standards in order get their product to market.

Noven Pharmaceuticals, Inc. out of Miami tackles this challenge every day.  A subsidiary of Hisamitsu in Tokyo, Japan, Noven manufactures and packages products to the American and European markets that includes prescription-only products, including those for women’s health (menopausal products), for attention deficit disorders, and for pain management. These products are sold to pharmacies, while other products are marketed and sold under a partnership.

European requirements for Braille and medication guides printed in all the European Union languages create quite the compliance challenge. The difficulty is compounded by the need to deliver products in a timely fashion, while at the same time retaining a high degree of confidence in the accuracy of printed information on product leaflets, foils, cartons, and labels. In addition, Noven is reportedly one of the few companies doing business in the U.S. that ships products with Braille on the packaging.

Braille is printed on packages for products shipped only to European countries, where it is a regulatory requirement for doing business there. In order to ensure that visually impaired individuals can read the embossed Braille dots, Noven’s Quality Control Department must be sure the points are sufficiently defined and that the content is correct.

Technological solutions

Although digital proofreading technology has been around for decades, recent advancements have improved the capability of such systems beyond simple comparison of A to B, to encompass all the attributes of packaging and other printed components of pharmaceutical products. To meet the growing regulatory challenge of international business in the 21st century, Noven chose Complete Inspection Systems Inc, (CIS), to provide a new digital proofreading system.

The CIS equipment was installed, validated, and released for use in August 2013. The equipment installed included an AutoProof Pro with Image Compare software, Braille Verification System, and the Integra 9510 Barcode Verification System to both read and indicate that the barcode has been printed to ANSI standards. Only one system was installed—three components and two scanners, a wide-sheet scanner, and a flatbed scanner.

The CIS instrumentation replaced “a very old and obsolete camera-based system for text verification that was able to scan only small sections of the sample being inspected at a time. This was a very cumbersome and time-consuming task since some of our products are films,” says Ivette Larralde-Valdes, Senior QC Compliance Specialist at Noven. “During inspection, an approximately 1-foot by 2-foot film samples are cut to be inspected for text. The camera system only allowed a section of 4 inches by 4 inches to be inspected at a time. During an inspection, 30 frames or more had to be taken in order to complete a text verification inspection of a film.”

With the CIS equipment, only one scan (taken with a wide-sheet scanner) is made of the sample film and inspection is done with the image compare system. A master sample is also scanned, or used from the library, in the same manner and both images are compared at once. With one inspection, there’s one scanning, and quick results.

Noven considered three vendors for the new system, and the items that were evaluated were for compliance to 21 CFR part 11, technical support, and price.

“CIS was able to meet all these requirements with the most competitive price,” indicates Larralde-Valdes. “The proximity of CIS headquarters to Noven’s facility in Florida was also an advantage when considering this vendor. Noven felt that the instruments that CIS provided would be able to meet our standards of operation better that the instruments provided by the other vendors. The Braille system provided by the other vendor was a ‘dot touch-type’ variety, which we did not feel was as reliable as the high-resolution, multiple-based camera Braille system provided by CIS. CIS’s Braille system, with dot height measuring and dot spacing measuring system, we believe, is superior to other systems in the market.”

According to CIS, the system is reported to be the first of its kind in the U.S. to inspect Braille height and configuration for readability by the visually impaired, in addition to the usual tasks of barcode and content verification. Armando Diaz, Noven’s Quality Inspector and the primary user of the system, says, “it really helped drive home why this point is important.”

Time-sensitive environment

Given the reality of rushed production schedules and compressed timelines, efficiency, quality control departments are more important than ever.

Noven’s use of CIS’s AutoProof Pro Imaging Suite brings the process of print inspection into the main corporate IT framework. The system is directly connected to the corporate network, both on the front end in the task of retrieving archived approved digital artwork, and on the back end in storing records of document inspection and maintaining the audit trail and user access control that is part of the 21 CFR Part 11-compliant system.

“We used to keep an archive of master documents in filing cabinets” says Fior Rondon, Supervisor of the Incoming Inspection and Sampling area of the Noven quality control department. “Using our digital inspection machine involved sifting through drawers of thousands of printed master documents, AutoProof Pro allows us to keep those files digitally.”

IT is also pleased. “The records of the quality control team can now be archived and backed up as part of our regular data maintenance process,” Rondon says.

Validation

For any system to be put into production in a pharmaceutical environment it must first be validated. For a device that is going to be relied upon for guaranteeing print accuracy in a foreign language this is particularly important as the inspectors will have nothing in their real-life experience to compare the error against.

The system must provide a definitive answer to the user as to whether the information matches or not.

“We have a very exacting standard for validation,” says Janet Gonzalez, Noven’s Senior Manager, System Administration and Quality Project Management. “We spent nearly three weeks validating this system and we have a very high level of confidence in the product.”

Product flexibility and benefits

Noven uses the CIS systems mainly for transdermal products, but also for solid-dose products. Transdermal products are packaged in-house in Miami on several packing lines, where they’re produced and packaged from raw material to final product.

Noven’s Janet Gonzalez says the company, “has benefited by the purchase of the CIS instruments by being able to expand its inspection of products, product types, and by complying with regulations as established by our regulators.

“We’ve also benefited by increasing the volume of samples inspected per day, since the CIS [equipment] is able to perform this task much faster than our previous equipment.”

Specifically, the previous inspection time was one hour whereas the CIS AutoProof Pro system inspection time (per sample) is 20 minutes.

The CIS equipment does not affect the packaging line or process since Braille is not checked at the packaging stage but rather at the initial inspection of the incoming product before it reaches the production line. CIS equipment allows Noven to meet MRHA regulatory requirements for overseas shipments.

“Our future plans may include expansion of our proofreading and product inspection to the artwork department, with the review of the master artwork as received from the vendor,” indicated Gonzalez. “We would like to begin with the review of the text, barcoding, Braille verification, and translation at the early stages of the process in order to minimize and prevent printing error.”

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Worlds Most Advanced 2D Barcode and Next Generation Secure Hologram.

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CIS has become the exclusive developer, for HD Barcode LLC, of a new encrypted barcode – called HD Barcode™ –- which can hold 175 times more data than traditional 2D barcodes, such as DataMatrix and QR. Whereas the traditional codes are limited to about 4 kilobytes of data, the HD Barcode can encode up to 703 kilobytes. This means it can easily contain comprehensive information, including product specs, information for product use in multiple languages, full-color images and HTML and Zip files.

Click here to read article…  featured in Reconnaissance Tax Stamp News™.

Smart Packaging For Smart Brands

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PkgDesignhttp://www.packagedesignmag.com/content/show-preview-smart-packaging-for-smart-brands

 

Packaging is getting smarter. New active packaging systems, also referred to as intelligent or smart packaging, are making life easier for the consumer by helping to ensure the quality, safety and freshness of everyday products. Most commonly found in the food, beverage and pharmaceutical industries, these active packaging solutions are designed to prolong shelf life, monitor freshness, track and trace a particular product’s journey or provide a seal of authentication.

According to a study from Research and Markets, a global market research resource based in Dublin, Ireland, the global active and smart packaging technology market for food and beverages will grow from $15.79 million in 2010 to $23.47 million in 2015. Smart packaging technologies are becoming increasingly important as shoppers look for value in what they purchase—getting the most for their dollar with the confidence that what they are putting in their basket is the real deal.

A variety of active packaging solutions help conquer challenges like freshness and counterfeiting, and some of the latest technologies on the market will be showcased at Pack Expo Las Vegas 2013, Sept. 23-25 at the Las Vegas Convention Center.

The real deal
Knowing if a product is authentic can be worrisome for consumers, and providing that confidence can be challenging for manufacturers who don’t want their brand misrepresented by counterfeiting. Complete Inspection Systems, Inc. (Booth No. 5000), a provider of digital print inspection and cutting-edge tracking and authentication technologies, plans to exhibit a new product in its portfolio, HD Barcode.

While it’s similar to a QR code, which has become synonymous with product tracking, identification and marketing, the HD Barcode from Complete Inspection systems is what president Gary Parish calls “a QR code on steroids.”

“QR codes can have about 4kB of data. The HD Barcode can handle 703kB. So it’s like jumping a quantum leap forward,” says Parish.

This multi-use barcode holds more secure data, and can be configured so it will not scan properly if copied. The codes can be scanned with a smartphone or PC scanner to reveal detailed product information without the need of the Internet. The barcodes, explains Parish, include alpha/numeric codes that must match in the authentication system and can be used on a wide range of items, such as a driver’s license for identification, or on packaging for authentication and multi-
lingual instructions. A HD barcode can also be customized with full color images or in different shapes to complement specific packaging traits. It can even be printed to be visible only with infrared or ultraviolet light.

This type of product, says Parish, is increasingly important in the pharmaceutical industry because of the prevalence of counterfeit drugs. And because the HD Barcode can store so much data, it can provide information including location of label printing, revision numbers and distribution regions making the journey of the drugs traceable. This also could be used for fresh produce.

Holographic packaging solutions, like those offered by Sonoco (Booth No. 714) also provide a seal of authentication to stymie counterfeiters, according to Tom McClaughry, CPP, creative services manager for Alloyd Design Works, a Sonoco company. Sonoco works with a supplier that provides proprietary, customizable holographic laminate.

McClaughry says the company is targeting high-end products, like mobile phones or custom, high volume, applications to protect against counterfeiting.

“We are anticipating some customers might want a custom pattern or some other visual icon that is more difficult to reproduce within the pack,” says McClaughry. “The holographic laminate is heat sealed onto an entire package, for example a blister card, and is highly visible, more so than other holographic packaging on the market. It takes ambient light and refracts it, so as you are walking by, depending on the angle of refraction, you get an eye-catching effect.”

Oxygen detection
Intelligent or smart packaging also includes technologies such as oxygen absorbers, oxygen scavengers and instruments that trace oxygen levels within a package to ensure freshness and quality for food and beverage items.

OxySense Inc. (Booth No. 5752), a producer of noninvasive oxygen measurement systems and permeation testing, is set for a Pack Expo Las Vegas introduction of its new low-cost printable sensor, which will allow producers of modified atmosphere bulk packages and packers of high-value products to include a real-time oxygen sensor in every package.

OxySense says the new verification system, VerOx, will allow 100% verification of good packaging and seals at the point of manufacture and the point of use, eliminating most issues related to package and seal failures. The technology will give the food and pharmaceutical industries a way to confirm package integrity at the point of receipt.

“This is a marketplace where there is a lot of concern about oxygen, not only on the food side, but more in the high-value item area and the medical and pharmaceutical areas,” says Peter Gerard, the former president and CEO of OxySense who’s now a consultant to the company. VerOx, which will be sold under the company’s OxyDot (O2xyDot) brand, is based on similar fluorescence decay and oxygen measurement technology. He adds that a sensor, a fluorescent dot the size of a pencil eraser, absorbs oxygen and emits light that is measured to calculate the level of oxygen.

“The sensor will measure the oxygen of the adjacent area no matter what form it is,” notes Gerard. “So if you had the sensor in the air then it will measure the air. If you put it in wine, it will measure the dissolved oxygen in the wine.”

Freshness first
Sealed Air (Booth No. 1141), known for its Cryovacfood packaging solutions, has extended its product range with Freshness Plus Pouches which incorporate oxygen-scavenging solutions in a rollstock format for vertical pouch packaging (VPP). Freshness Plus for VPP is an active-barrier oxygen scavenging film that removes oxygen that migrates from the inside or outside of the packaging to ensure no flex cracks so oxygen cannot degrade the product.

This active packaging technology is engineered to extend shelf life, maximize flavor and product color while reducing odors and is ideal for items including tomatoes, avocados, fruit pulps and fruit purees.

“The technology behind Freshness Plus for VPP increases the capacity for many foodservice operations to add menu items that incorporate oxygen-sensitive products central to recent food trends, such as the increased use of guacamole as a condiment and the addition of tropical fruit smoothie flavors,” says John Gaston, director of marketing for fluid packaging at Sealed Air Food & Beverage.

Multisorb Technologies (Booth No. 5684) offers a range of oxygen absorbers in a variety of formats for food and beverages. The company’s packet systems, card systems and stand-alone products are designed to extend shelf life and preserve freshness, flavor and color. The company says it also offers sustainability advantages with its products, citing a reduction of packaged product loss such as shrinkage, loss of potency and spoilage and improving supply chain management by extending shelf life.

Moisture plays as important a role in packaged food freshness as oxygen. Wisepac Active Packaging Components (Booth No. 5312) is recognized as the first non-European company to earn certification by the German Institute for Standardization (DIN) for its desiccant packaging. The company’s Wisesorb desiccant products provide moisture-proof solutions for packaging in a wide range of industries including food and pharmaceutical. The company, which produces and sells an estimated 8,000 tons of desiccant products yearly, offers desiccant bags, small package desiccants, container dedicated desiccants, continuous strip desiccants, small cylindrical desiccants, desiccant tablets, humidity indicator cards and liquid absorbent.

Track and Trace
Radio frequency identification (RFID) tags and chips are also considered smart labels because they are used to track and trace packages and bulk products throughout the distribution chain. This can play an important role in product recalls, quality control and the authentication of sensitive or high value products.

Zebra Technologies (Booth No. 5745) offers a variety of passive and active RFID solutions, as well as mobile printers and coders based on the needs of its customer. According to the company, RFID needs are trending towards an increase in item-level tagging rather than box or carton tagging, allowing retailers a deeper understanding of data such as inventory levels.

“Retailers are after item level serialization, assigning unique serial numbers to every item for more detailed tracking information,” says Marty Johnson, product marketing manager. “RFID can also create an ‘ePedigree’. That ePedigree concept could be used to help ensure the safety of food or pharmaceuticals.”

For example, food items could be tracked and traced all the way to the field they originated from and when that crop was picked.

Another company that offers RFID technology solutions is WS Packaging Group, Inc. (Booth  No. 3414). Its specialty product, RFID & inTag features an intelligent tag that can be used for unique applications and can be applied to pallets, cases or individual products to help companies combat challenges such as counterfeiting.

We can expect to see continued advancements in smart packaging solutions expand creative options for package designers and brand owners.

For more information, visit  http://www.packagedesignmag.com/content/show-preview-smart-packaging-for-smart-brands

HD Barcode™ for Instant Product Authentication

PRESS RELEASE: Complete Inspection Systems, Inc.

HD Barcode™ for Instant Product Authentication- No Internet Connection Required!

Complete Inspection Systems Inc. introduces the HD Barcode™- a revolutionary 2D barcode for absolute product authentication – without requiring Internet or database look-ups.

Traditional 2D barcodes, such as DataMatrix and QR codes, are limited in data capacity and require an Internet connection or time-consuming database look-ups. HD Barcode™ has none of these shortcomings; a single code can hold 175 times more data than a traditional 2D barcode and may contain text, images, HTML, as well as, other files types. HD Barcode™ uses a proprietary reading application that allows an authorized user to scan and read these comprehensive product details at any location. No Internet or database look-ups required.

Manufacturers can include track and trace information, product specifications, e-pedigree data, plant location, manufacture date, distribution region(s), package, carton or label identifiers, user data, full color images, and marketing incentives. Easily imprint on a wide variety of materials including, component parts, cartons, labels, blister packs, inserts and containers. The HD Barcode™ offers many custom formatting options to aesthetically complement packaging, such as embossed brand logos or images directly on top of the HD Barcode™ and the ability to create square, rectangular, or micro codes.

All this information is contained within the HD Barcode™ allowing manufacturers to positively identify their products, protect their brand name, reveal product diversion, prevent unauthorized duplication and quickly identify counterfeit products using an all-in-one barcode solution. Each HD Barcode™ includes a unique manufacturer identification code and only authorized users have the ability to scan and read encrypted data using either a Smartphone or PC based application.

For additional security, the HD Barcode™ code generator program remains independent from reading applications preventing unauthorized reproduction of codes. HD Barcode™ technology prohibits coping and will display a failed message if the barcode has been compromised. Reading applications can be configured to require registration with an expiration date and password. Multiple covert codes (such as random code numbers or patterns, signatures, UV or IR codes) can be embedded within the HD barcode™ or placed with other printed material during the normal printing process. The location and contents of these separate covert codes are revealed when the HD Barcode™ is scanned. This two-step authentication process between the HD Barcode™ and the covert code makes it almost impossible for a counterfeiter to identify or change the contents of the HD Barcode™, while giving the manufacturer flexibility to change covert code placement or contents. The HD Barcode™ and the separate covert codes may be easily added during the normal printing process.

Applications for Android and Apple’s iOS are provided allowing authorized users to conclusively verify products within seconds, all while mobile and requiring no Internet or database connectivity.

Contact: Gary Parish

President, Complete Inspection Systems, Inc.

Email

PH: +1 (321) 952-2490

Fax: +1 (321) 952-2475

Exporter of the Year for Safety and Security

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Press Release: ThinkGlobal, Inc.

Think Global, publisher for the Department of Commerce, held a special ceremony at Capitol Hill in Washington, DC naming Complete Inspection Systems, Inc. winner of the Exporter of the Year Award in Safety and Security.  “We were honored not only to have received this prestigious award, but also for the support of local representative for Brevard County, Congressman Posey, who took time out of his busy schedule to attend the ceremony,” said Gary Parish, President of Complete Inspection Systems, Inc.

All Exporter of the Year award winners also will be profiled in the May/June 2013 issue of Commercial News USA.

“Our software and solutions help save lives in the pharmaceutical, medical device and packaging industries by identifying print errors and component mix-ups,” says Gary L. Parish, President of Complete Inspection Systems. “Since a significant amount of manufacturers operate in other countries, using automated inspection helps provide safe imports back to the USA and is the key to our growth. Obtaining international recognition will lead to additional opportunities, which is very exciting as we are currently announcing our newest most advanced 2D barcode in the world, the HD Barcode. This advanced proprietary barcode can encrypt up to 703 kilobytes of data, embed full color photo images, and is easily be read using any Smartphone.”

Criteria on which winners were selected include the total number of documented export transactions, the total percentage increase in sales, exports as a percentage of total sales, the company’s commitment to exporting, the company’s commitment to customer service, and the company’s innovation and originality in marketing products or services. To be eligible for the award, a company must currently be exporting from the United States.

“Complete Inspection Systems is indicative of how proactive American companies are growing by exporting,” said Gregory Sandler, president of ThinkGlobal. “This year’s winners reflect the diversity of American exporters, 97 percent of whom are small-medium sized enterprises. Exporting is a critical part of the U.S. economy, accounting for 12.5 percent of the nation’s GDP. In fact, 70 percent of the world’s purchasing power is located outside of the United States.”

About ThinkGlobal

ThinkGlobal Inc. is a print and online publishing company that manages the USA Export Expo and produces Commercial News USA, the official export promotion magazine of the U.S. Department of Commerce. ThinkGlobal also is a corporate marketing partner with the U.S. Commercial Service, part of the International Trade Administration within the Commerce Department. www.thinkglobal.com

Information about the Exporter of the Year awards, including profiles of all the winning companies, is available online at  “Exporter of the Year”

Contact: Gary Parish

President, Complete Inspection Systems, Inc.

Email

PH: +1 (321) 952-2490

Fax: +1 (321) 952-2475

 

Track, Trace, Authenticate «

Company Insight: World Pharmaceutical Frontiers

Supply chain security-
Complete Inspection Systems, Inc. develops and supplies automated inspection and proofreading technology, CEO Gary Parish briefs World Pharmaceutical Frontiers on the group’s HD Barcode™, and how it can engender absolute product identification and brand protection without adding significant cost to the manufacturing process.

View article here: http://viewer.zmags.com/publication/69c433e6#/69c433e6/80

Contact: Gary Parish
President, Complete Inspection Systems, Inc.
Email
PH: +1 (321) 952-2490
Fax: +1 (321) 952-2475

Pack Expo 2013 Tradeshow

Pack Expo 2013 in Las Vegas – Visit Us in Booth C-5000!

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Complete Inspection Systems, Inc. will be presenting our automated proofing and inspection systems at this years PackExpo 2013 in Las Vegas.

With an expanded focus on processing and integrated processing-packaging systems, PACK EXPO International 2013 is the one and only place to find total solutions. No other show in the industry can match its size, its scope or its impact on so many vertical markets.

Interphex 2013

Interphex 2013 In New York – Visit Us in Booth 2132!

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INTERPHEX is the leading annual pharmaceutical and biopharmaceutical trade show. Key decision makers find the networking opportunities, products, services and information they need to ensure quality and maximize efficiency, agility, and flexibility that solve manufacturing and supply chain problems. INTERPHEX is where intelligence and passion intersect with the full spectrum of industry products and services to create new insights and innovation.

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