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Machine Vision Continues to Have Opportunities in Pharmaceuticals
by Nello Zuech, Contributing Editor - AIA Posted 04/20/2004
It was evident at the recent Interphex Trade Show at the Javits Center in New York City that there are still drivers encouraging the adoption of machine vision in the pharmaceutical industry: product and packaging counterfeiting, unit dose packaging, document integrity, bar code integrity as well as the general quality concerns associated with product and packaging observed over the years.
Complete Inspection Systems promoted a system targeted at counterfeiting associated with packages and labels. It seems the graphics can be printed with embedded symbols, which are not evident to the eye. For example, logos containing intricate, precisely separated geometric patterns or shaded backgrounds, and covert graphics invisible to the naked eye can be printed. Only when viewed with a filter or certain lenticular lens design do these symbols become apparent. Graphics printed with line width in the micron range make copying or reproduction difficult.
Lenticular graphics are made up of two components: a lenticular screen (or lens), and a flat printed image. The grooves and ridges of the lens are actually lenticules, which focus a person’s sight on different parts of the underlying picture. The printed picture is actually made up of multiple pictures, which are printed in alternating lines. A narrow band of each image is printed sequentially with narrow bands of each additional image. For example, if three images are combined, the composite print will include a narrow band of image #1, followed by a narrow band of image #2, then followed by a narrow band of image #3. That pattern of printing is continued (1,2,3,1,2,3,1,2,3) for the entire composite print. Viewed in this state, the image is fuzzy. However, viewed under the lens pattern of the lenticular screen, a different view of the image is received from different angles. Specific codes can be embedded in one of the layers.
The lenticular effect within the specific layer is viewed in reverse, and changes focus in only one dimension. The lenticule takes a thin, vertical slice of the total image area that it spans and magnifies it in such a way that, from the proper viewing distance and angle, the thin slice appears to fill the entire lens surface. As a result, the viewer can see only one slice per lenticule at any time containing the anti-counterfeiting code, regardless of viewing angle. This image can be transmitted back to a manufacturer anywhere in the world via a cell phone or over the Internet and they can then determine if indeed the product or the package is a counterfeit.
One major application associated with unit dose packaging is reading the RSS/Composite symbology (Reduced Space Symbology with a 2D component) code. Such codes can include the national drug code, expiration date and lot number. Cognex was one company at the recent Interphex Show demonstrating their In-Sight smart camera-based reader. The readers also support ISO/IEC-15416 quality metrics and can return quality scores useful in generating print quality assessment of the RSS code. Not all pharmaceutical companies have yet to commit to RSS, however, as some are favoring Data Matrix 2D symbology since they can contain even more information.
Regardless of which code is chosen, the quality of the printing is extremely important. There are certain industry standard ANSI/ISO/IEC (ISO/IEC 15416) criteria for quality with various grades given corresponding to meeting criteria standards established. A grade of C or better is required to assure readability and overall reliability throughout the supply chain as well as for any internal tracking. Bar code print verification was being demonstrated by Label Vision Systems at the Show. While they have traditionally offered online systems they recently introduced an offline system (Integra 9500) using an area camera to capture even a 1D code based on 256 lines rather than the typically used 10 – 16. Print quality is based on grading all nine of the standard’s parameters (edge determination, minimum reflectance, minimum edge contrast, symbol contrast, modulation, defects/spots/voids, quiet zone, decode, decodability) plus added features of determining blemishes, opacity and human readable validation. The system automatically displays problem areas for quick resolution of printing concerns. System uses a 1280 x 1024 camera thus permitting analysis based on every 0.003’‘ of the bar code height, in the case of 1D codes. The same unit can also assess the print quality of 2D codes.
Traceability is another growing issue in pharmaceuticals both of product and packaging. On the packaging side, SysTech International was promoting their ability to read serialized numbers on labels and packages offering the ability for supply chain tracking of the package.
This was in addition to promoting their comprehensive line of machine vision systems targeted at packaging lines: blister pack inspection, lot/date/component code reading/verification, presence/absence, product tracking based on 2D symbol reading, print quality inspection and detection of UV, IR codes and anti-counterfeiting holographic labels. These vision sensing systems along with other sensors and bar code readers integrate into their TIPS Advisor, which collects the information in real time from all sensor modalities on a given packaging line and stores it in a history database. Insights can be derived immediately on packaging line concerns that can be corrected before serious downtime is experienced yielding gains in packaging line productivity by reducing downtime.
Several companies suggested they were offering the next generation proof reading products. The AVIA system from Mnemonics incorporates very precise registration algorithms yielding fewer false rejects following the image subtraction of the text being inspected when compared to the standard stored in memory. They suggest they eliminate distortions caused by paper stretch and bleed-through. Pixels that might otherwise be highlighted due to such image misregistration issues are eliminated and only those pixels associated with real changes in the scene are brought to the attention of the operator. System functions as a supply chain productivity tool and can be used on production documents, printing plates and pre-press documents comparing them to a master document (electronic or printed). Ultimate discrimination of concern in text, graphics, chemical formulae, charts and pictures is dictated by user specified size and intensity changes. System ranks and tabulates flaws and provides an Internet (HTML) compatible document reviewed by a person who recommends corrective action.
Global Vision and Complete Inspection Systems (CIS) also exhibited proof reading systems. The Global Vision system includes an Image Management System, which utilizes Oracle or SQl server for archiving masters, samples and inspection reports. CIS suggests they offer a family of related products. Their AutoProof Pro Docu-Match performs the document proof reading. AutoProof Pro Docu-Scan OCR provides software tools for actual OCR, ICR, OMR, OCR-A, OCR-B, E-13 (MICR) and bar code recognition capability. System supports standard dictionaries and optional 1,000,000 word medical and legal dictionaries in almost any language. An output file provides information on the text differences from the master file including punctuation marks, missing words, added words, paragraph changes, misspelled words, etc. AutoProof Pro-CT is designed specifically for clinical trials for automatically feeding pin or roll fed labels to verify both standard and variable text.
AutoProof Pro Docu-Manage is their document management system handling multi-user interaction of document creation, modification, management and retrieval. AutoProof Pro Encrypt permits documents to be encrypted with the standard 128-bit RSA public and private key encryption adopted by Verisign and Thwarte digital providers to assure authenticity of origin and enable the use of digital signatures.
The traditional suppliers of other application-specific machine vision systems were at the show. Eisai exhibited their full line of vial/ampoule, filled and unfilled, liquid and freeze dried inspection systems. Not at the show but coming to the States this summer is their LIM system to check for particulate in liquids before the freezing operation. Two versions will be offered – one to handle 200 units per minute and the second to handle 300 units per minute. Also in their booth was their partner M.W. Technologies, a company with manual and semi-automatic ampoule/vial visual inspection stations.
Brevetti, out of Italy, was back at the show this year exhibiting in their distributor’s booth – Victor International Marketing. Suggest that by adopting the most recent vision board technology they are now able to perform more rigorous inspection, as well as do more inspections at higher speeds. Next generation products are likely to embed smart camera technology.
A new competitor in the vial/ampoule inspection market was ATS Automation. Their Linear Inspection System was developed specifically for high-speed inspection of translucent plastic ampoules and ampoule cards. System checks for the typical faults: molding deformities (voids, pits, holes), broken tabs and twist tops, separated ampoules including split cards, wall discoloration, foreign particle inclusions, liquid fill levels, particulates in liquid and OCR or other coding recognition at rates up to 500 per minute. They suggest that with minor modifications platform can be configured to handle lyophilized product, emulsions & suspensions, solutions, as well as common primary packages, including vials, glass ampoules, and pre-filled syringes and cartridges.
Seidenader was also at the show with their competitive line of vial/ampoule inspection systems as well as systems targeted at solid dosage inspection: tablets, caplets, capsules, etc. The Proditec solid dosage inspection system line out of France was on exhibit at the Bohle booth. While AC Compacting was not exhibiting any solid dosage inspection systems this year, it was suggested that over the summer they would be distributing the Ikegami system out of Japan.
American SensorX displayed a number of applications that they have addressed for the pharmaceutical and medical device markets: catheter inspection: needle tip inspection, sheath Inspection, lot number expiration date, barcode decoding; vial inspection: vial inspection: brick Inspection with and without plastic wrap, chip detection; ampoule inspection: seal shape, presence of split line, impurities, scratches and abrasions on the glass, stains on the glass; glass bottle inspection: inspection of glass pre or post wash, inspection of lip, neck shoulder, body and base of bottle, glass molding defects, detection of air bubble in glass; capsule inspection: capsule gel, crushed, broken, empty cavities, counting, bottle under-fill; tablet inspection: broken, color inspection, shape analysis; blister inspection: integrity, alpha-numeric, lot number and expiration date; label inspection: alpha-numeric, lot number and expiration date, barcode reading. In addition they were demonstrating their chemical capsule integrity analyzer (chemical composition, moisture content, hardness, active ingredient) based on their SpectRx NIR technology.
Other application-specific machine vision systems included online full print inspection system by Label Vision Systems. Calia Technology demonstrated a machine vision-based slat counter developed by the Fraunhofer Institute that they are commercializing in North America. An x-ray-based machine vision system targeted at packaging applications could be seen at the Filtec booth (they are the Stateside distributor of the Dylog product line out of Italy) and were also promoting their own x-ray-based fill height detector. Also promoting an x-ray-based fill height detector was Themo Electron. Safeline was another company promoting their soft x-ray inspection system for filled package content inspection.
Accu-Sort was there with their bar code reading capability including their machine vision-based bar coders and structured light-based carton sizing system for distribution and warehouse management. A couple of companies were offering particle sizing systems based on machine vision processing of particle images: Ankersmid Particle Size and Shape Division of MCC, Micromeritics, and Canty, Inc.
Various production machinery equipment suppliers were exhibiting value adding machine vision systems: Uhlmann’s blister pack line included a Visiotec blister pack inspection system. NJM had an Optel Vision date and lot code reader on their labeler. They suggested they also offer Acuity products for the application. Domino Amjet demonstrated their printer with a Cognex system. Control Micros Systems exhibited a vision system checking their laser driller.
At the Cognex booth they had an interesting demonstration of being able to perform date/lot code verification on curved surfaces with the characters appearing at varying depths, varying spaces and perspectives. System could also handle ink jet printing of varying dot densities. System handles print associated with properties of ink jet printers from different manufacturers based on library of essentially ‘‘font’‘-specific to manufacturer.
Other general-purpose machine vision systems found at the show included DVT in various distributor/integrator booths (Applied Control Engineering, FP Development, Maverick Technologies). SV Research’s general-purpose technology could be found in the Seidenader booth, with whom they are affiliated. A specific implementation promoted was their SV CodeTracker, which allows inspection and reading of code on pharmaceutical containers immediately after the filling/closing process while a second module inspects the containers in rotation to verify code and match it with the label to be applied.
Optel Vision exhibited their latest packaging line inspection systems: label laser inspector, code inspector, blister pack inspector and bar code station all functions integrated into a single processor unit. Banner was at the show exhibiting their complete line of sensors including their PresencePlus Pro. It was demonstrated inspecting blister packs in a backlighted application. In the Romaco booth one could still find the Laetus technology performing OCR/OCV and bar code reading. At the Faber Technology booth one could see the ipd NetSight II.
A newcomer to the Show this year was Ross Inspection Systems, an integrator of machine vision systems, many of which have been for various applications in the pharmaceutical and medical device industries. Applications they have addressed include closure/stopper inspection, glass vial inspection to assure free of cracks, chips, bubbles, air lines, large chords and tool marks anywhere, print inspection on syringes and oral dosing devices, molded baby bottle nipple inspection, etc.
Another integrator at the show was Global Controls/Canavision, out of Canada. Their pharmaceutical applications include blister pack inspection, label date/lot code verification and bar code validation, color-based inspections and carton inspection.
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