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

Checking the Fine Print – Bayer HealthCare Partners With CIS

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As FDA tightens controls over the accuracy of labeling content, drug makers continue to respond with more-thorough means of checking all packaging components. Still, consumers and the legal system demand more 100% accountability for even the most minute of errors. Something as minor as a missed hyphen can turn a 1/2 tablet dosage into a 1.2 tablet dosage, a potentially dangerous oversight. To avoid such mistakes, current GMPs require 200% human inspection. However, even with this 200% inspection policy, labeling mistakes and omissions remain the largest reason for recalls.

Moving beyond human inspection, Bayer HealthCare (Morristown, NJ) has taken the lead by automating the proofreading process for its printed materials. The firm has partnered with Complete Inspection Systems, Inc. (CIS; Indialantic, FL). Complete Inspection Systems, Inc. has created a new proofreading system designed to cover a full range of visual inspection tasks. Its flagship product, AutoProof Pro, is designed to locate any labeling problems from first draft through the final production process. AutoProof Pro is a suite of tightly integrated tools that work together to ensure the accuracy of day-to-day quality-assurance tasks. The software is designed to run on standard office computers and peripherals, so the system can be shared between publishing, printing, and production services.

Labeling control manager Terry Cullen, along with system operators Karen Kunkle and Linda Lynch, who handle graphics and materials for a number of Bayer plants, championed Bayer’s proofreading project. Bayer decided to incorporate AutoProof Pro into its label control department to act as the quality control tool throughout the entire process. Bayer’s user requirement specifications included ensuring that operators could automatically inspect and compare text at each step of the process.

For instance, after the original printed regulatory material is created and submitted to FDA, it is often revised. After FDA approval, it is then sent to the graphics department so that artwork can be created for the product. The regulatory document is then compared against the insert, label, or carton. Such proofing can be very difficult, as the formatting, character size, style, and number of words per row may not even match. Multiple languages, graphs, charts, and images are also often used, further increasing the chances of proofreading errors.

To assist Bayer with these tasks, Complete Inspection Systems, Inc. two reading and inspection modules. The first, called the PDF Text Extractor, gives Bayer the ability to convert almost any electronic file to a PDF format. The user can then select or zone an area and compare it with 100% accuracy to other documents in almost any language supported by Unicode standards. The operator saves the extracted text for use with the AutoProof Pro Text Compare Module.

The operator can then take the finished insert, convert it to a PDF, read it, and save it as a text file as well. The operator can then go to the AutoProof Pro main menu, select the Text Compare icon, and load the regulatory document and the finished insert. The Text Compare function locates each character and aligns it as closely as possible to the other document. Any characters found on one document but not on the other are highlighted. In less than 5 seconds, AutoProof Pro highlights any differences in the two files.

Using AutoProof Pro, Bayer can automatically proofread material from the earliest stages of production to the final product. AutoProof Pro validates documents even if they have been reformatted, exported to other applications, or even authored on different operating systems. To inspect printed materials, AutoProof Pro uses advanced visual comparison techniques tuned to pick up even the smallest errors. Printed materials can be scanned using a variety of devices, ranging from desktop scanners to 50-in. sheet feeders. AutoProof Pro compares sample documents with the original approved master, looking for any changes in the written copy, document formatting, graphics, and bar coding, as well as imperfections created by mechanical printing problems. For complete end-to-end product validation, AutoProof Pro can be used to compare packaging components removed directly from production to validate them against a master.

AutoProof Pro was also designed to meet 21 CFR Part 11 standards.

QuantumCompare Document Inspection for Packaging and Inserts

Complete Inspection Systems, Inc., has announced its advanced new document comparison system. QuantumCompare sets a new standard in digital document comparison; for the first time, two electronic documents can be inspected for content and style differences, regardless of their appearance, layout, authoring, distillation engine or number of pages. Differences are highlighted in the body of the original document, in the precise context in which they are found. Using unique new technology, QuantumCompare analyzes the unique Unicode value of each character, rather than its shape or appearance, making it the most advanced text comparison software on the market today.

QuantumCompare is a user friendly document comparison system for any digital documents in which accuracy is absolutely critical: product information, packaging, manuals, labels and booklets. It is Unicode-based and can read and distill PDF files for comparison from a number of common formats. It is capable of finding differences in font type, font style, text color and can compare other text attributes like bolding and italicization.  To begin a comparison, the user loads the master and sample documents into the system, and selects the regions to be compared (or selects nothing, in order to compare the entire document). Next, the operator executes the comparison – the computer will compile the words present in the two files and compare their underlying data values, as well as the attribute tags such as font, bolding, italics, color and size. The system will then report back the results to the operator. In the example here, among other errors, the word “linearly” was left out of the sample – the system reports the change as a deleted word. A word present in the master file was left out of the sample and hence the word is deleted. The change is highlighted in the document in the original context and the difference is listed in the Difference Navigator along with the type of difference.

Detected errors are identified, aligned and color-coded the Difference Navigator pane. Errors are reported in the same order as they appear within the document, allowing the operator to read and revise sequentially. Use Quantum Compare to check your documents after each revision to verify that only intentional changes were made. What was changed? What is the precise nature of the change? Quantum Compare will give details about how and where the change occurred, and can generate a detailed report of discrepancies.

MultiCheck all Inclusive Vision Inspection Solution

Complete Inspection Systems, Inc., an automated vision systems manufacturer, has launched its newest quality assurance and inspection system, Multicheck.

MultiCheck  is an all inclusive image inspection solution, with the ability to verify 100% of the copy and graphics on labels, cartons, and other materials by performing image comparisons, text comparisons, reading and verifying the barcodes as well as performing Optical Character Recognition (OCR) on documents and applications with variable information such as clinical trial labels.

The MultiCheck  system is designed for those users whose needs exceed the basic requirements of inspection and designed specifically to proofread labels, inserts and cartons with variable information, as is often the case in clinical trials.  MultiCheck  also has a database component, so that the master documents can be cataloged, with their inspection types and zones already set.

The MultiCheck system consists of a computer and an imaging workstation with a 12 megapixel camera, and a powerful software suite. The system can capture a high-resolution, shadow-free image of any object up to 17 x 23 inches in diameter, under uniform lighting conditions. The camera has built in zoom and macro features so that all objects can be clearly captured.


HD Barcode Secure Identification of Product or Person

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Complete Inspection Systems, Inc. has introduced the world’s most advanced 2D barcode for absolute identification without Internet lookup.

The HD Barcode is a revolution in data density, holding up to 703kB of secure, encrypted information that can be customized with unique private versions of the HD Barcode. Additional security features include a code generator program that is kept separate from the readers ensuring that the barcode can never be reproduced.

As a second security measure, the code can contain data about other covert features and their locations within the identification card. This information can be easily moved as required and only the company has access to that information.

Complete Inspection Systems, Inc. also provides Android or iOS Smartphone apps that can read the HD Barcode and provide conclusive data in the form of images and secure information that would reveal diversion or detect copying of the identification card.


Q-Spec™ End of Line Inspection for Inserts, Cartons and Kit Components

Complete Inspection Systems, Inc. is proud to introduce the newest Vision/Barcode based inspection system Q-Spec™.

Q-Spec™ is a kit verification system designed to inspect and verify all of your labeled components, including inserts, cartons, or other kit components during your final packaging assembly. The system can be custom configured to match your kit against your work order or database.  No barcode, no problem, we can use HD camera based technology to read and match your product code utilizing Optical Character Recognition (OCR) or Optical Character Verification (OCV) technology. Q-Spec™ can be configured to read both the work order and component to eliminate errors by typing in the data. Q-Spec™ provides an accurate and detailed report of any differences found by part number or the expected kits shipped. The system can be configured to require correct flow of the packaging of each kit as well as adding extra or defective components or labels not used. Optional features, such as seal inspection of pouches, product count, or verifying barcodes meet ANSI standards may be added.

Q-Spec™ allows the user to only inspect a random sample of the kits or products being assembled and packaged.


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