20 years of inspection

Packagers improve quality assurance, productivity with automated inspection.

In life science packaging, quality is the first priority, outweighing even economic considerations. For ensuring defect-free product is delivered to the market, companies have invested heavily in automated inspection technology.

Packagers have extensively deployed camera vision inspection, checkweighing, metal detection, and other solutions across primary and secondary packaging lines, and often at redundant levels. Using automated proofreading software, packagers are enabled to quickly look for differences among text files, artwork files, and printed components.

In automating inspection over the past 20 years, companies have reduced human inspection processes that are limited in scope and inherently prone to error. As safety requirements globally placed rising demands on controlling for and documenting quality, 100% inspection via technology has become standard practice.

Companies were driven by FDA regulations and government mandates as well as by their own internal quality assurance initiatives. FDA’s bar code rule of 2004 requiring unit-dose bar coding of blisters created a need for full web scanability at production speeds. As pharma manufacturers plan for serialization—and seek to pack more information into small 1-D and 2-D bar codes—advanced inspection systems for bar code verification and grading became essential.

20 years of Inspection Milestones.

Manufacturers and contract packagers deployed vision systems to confirm the presence and placement of package components, measure dimensions, inspect label print quality and content, detect raised stoppers, find defects and particulates in vial and syringe filling, ensure blister fill accuracy, confirm package colors, and verify bar code readability, among many applications.

“Companies realize that they can save a lot of money and possibly prevent a costly recall by adding any type of inspection process to a line. It is not worth risking an entire shipment being sent back due to one bad package,” observed Tom McLean, general manager, Mettler-Toledo CI-Vision in 2011.

“You are guaranteed that no rejects will get through. Large pharma companies understand this drastic improvement in inspection so for most revalidating processes in order to put in an automated inspection system isn’t an issue,” McClean added.

The technology has progressively become more powerful, faster, and simpler to set up and use. Image sensors and camera vision systems are offered in “smart camera’ formats with on-board image processing where menu-driven tool set supports flexible deployment.

As technology that ensures defect free product in supplied materials and in finished product provided to patients, automated inspection is today a strategic component of pharma packaging practice.

“There are many opportunities in the typical packaging process to create defects so we want to ensure a robust and multi-leveled inspection at every operation. While this approach is very capital intensive, the benefits for our clients as well as the ultimate patient are immeasurable,”says Justin Schroeder, senior director, marketing and development services, Packaging Coordinators Inc.

“As a general rule, any time we are filling a product or applying a code we are doing automated online inspection,” Schroeder adds.

Boosting productivity

Machine vision has improved production processes and enabled enterprise-level analysis.

Cognex is among vendors offering PC software for centralized monitoring and control of the multiple dozens of devices on a typical factory floor.

Information on product or package failures identified by an inspection device can be sent via Ethernet to a PLC to effect an immediate adjustment, or to a server via FTP to a database or ERP system, as Carl Gerst, ID program manager for Cognex Corp. described in 2003.

“You can implement a feedback loop to feed data further up the line to control the process. For instance, if you pick up changes in print, you can add toner to the printer before it runs out,” Gerst said.

“Creating tools that are self-diagnostic, self-training, and self-tuning will transform machine vision from being a mandated and sometimes grudgingly accepted technology to a sought-after tool that improves packaging line productivity and efficiency,” Mike Soborski, director of inspection solutions, Systech International predicted in 2006.

As advanced inspection technology helps ensure reliable quality and increases productivity, labor-intensive and tedious manual inspection is reduced or eliminated.

“Camera inspection has helped tremendously in increasing the output on bottle filling lines. The camera detects to less than a 2 mm difference the height of the cap on the bottle. Now we are not stopping the line to check for loose caps. In-line manual inspection is an albatross from the past,” said John Bitner in 2011, then director of packaging development, Watson Pharmaceuticals.

For a customer packaging injectable and lyophilized drug products, Genesis Machinery Products in 2006 implemented a vial inspection system for detecting raised vial stoppers. Two Cognex In-Sight 5400 vision sensors perform full circumference inspection of stoppered vials prior to capping and sealing. Cognex software tools analyze the images captured by sensors against pre-trained reference images. The In-Sight vision sensor sends pass fail information to the capping machine’s PLC to trigger a rejection in case of failed product. The system replaced photo light technology that was dependent on correct alignment of the photo eye by the operator during product changeovers and that would sometimes reject good product because of normal variations in vial height.

Barr Labs in 2009 sought blister fill accuracy with 100% inspection of punched blisters as a final step before cartoning with a vision system developed by Pharmaworks. Top and bottom cameras inspect blisters at 275 per minute with reject and reject verification without stopping the machine.

Pfizer in 2009 would adopt x-ray inspection after the company found that neither a vision system nor checkweigher were catching broken tablets and the occasional crushed or folded blister packs inside OTC blister packages. After packs are lidded, cut, stacked, and put into final packaging, they are run through a Mettler-Toledo Safeline PowerChek x-ray inspection system. The system verifies product and package integrity through blister packs stacked four deep, while checking for multiple contaminants, at 300 packs per minute. Used to inspect over a dozen OTC products, the system continuously analyzes product variations, automatically adjusting to achieve optimum sensitivity, and—Pfizer would report—virtually eliminate false rejects.

Actavis Inc. focused on quality improvement on bottle filling lines with the 2010 deployment of the Inspect wt (web technology) camera inspection solution from Laetus. The OCR/OCV print inspection function replaced manual verification of the presence and integrity of variable printed data; a grid integrity tool checks presence of applied labels, inserts, and outserts. Actavis planned to build out the Ethernet-based, centrally-PC controlled Inspect wt solution with the addition of cameras for case pack bottle counts and presence of color and embossed lettering on dosage cups on the bottles.

B. Braun deployed smart cameras and the Impact suite of inspection tools from PPT Vision for inspection and tracking on medical device packaging lines in Penang, Malaysia. On ampules of liquid medication, cameras with their own processors and operating systems verify bar codes are readable and printed to ISO print quality standard; OCR ensures that labels match product numbers and day and lot codes marked on the ampules. On needle production lines, the company inspected 60 different needle types, for length, diameter, twist, and bevel angle.

QPSI in 2010 upgraded inspection on primary and secondary pack lines across five plants with the iVu Image Sensor System from Banner Engineering and Cognex DataMan image based sensors. The systems helped meet customers’ expectations for defect free product.

“With 100% automated inspection we can detect problems immediately and rectify them quickly. The need to inspect all upstream product after a defect is discovered in manual inspection is minimized or eliminated,” said QPSI’s quality assurance manager Karen Kopitskie.

Catalent Pharma Solutions deployed three vision systems and a checkweigher for 100% automated inspection on blister production lines in expanding production at its Aprilia, Italy facility in 2012. Cameras check for correctly filled blisters, leaflet presence, and that leaflets and labels are correctly matched on saleable unit boxes of prescription and OTC product with Bollini labels.

And Almac Pharma Services featured advanced inspection on a new high speed blister line with Uhlmann Packaging Systems’ UPS4 blister line integrated with an C2206 cartoner. A Hapa 237 Hybrid combines flexographic printing and digital printing to support the line’s capacity for large and small blister format production in short runs or multiple shifts.

A Hapa solution for 100% verification on print coding of individual product cavities is coupled with the Uhlmann VisioRead image inspection system to ensure that printed information is accurate, legible, and grades to an acceptable level. Leaflet and booklet feeding is electronically verified. The line includes a Total Quality Control Centre incorporating a checkweigher and integrated print and vision system for auto-rejection of incorrect print/serialization data.

Supply mandates

As automated inspection has transformed expectations, it has made Allowable Quality Levels obsolete. Manufacturer requirements for zero defects in supplied materials have become the norm.

“We are actively engaging our suppliers in increasing their use of automated vision inspection to support defect-free supply,” Michael Forehand, principal packaging engineer, packing and device technology, AstraZeneca said in 2011.

Clondalkin Pharma and Healthcare implemented best practice solutions in quality systems and vision technology across facilities globally in 2012. An EyeC America 100% vision system installed on a new high-speed, large format printing press ensures print quality. Clondalkin deployed a vision system from ISRA Vision for 100% post fold-and-glue inspection of cartons.

In label print and inspection, the converter installed an LVS 7000 In-line Print Quality Inspection System from Label Vision Systems. The LVS 700 makes on-the-fly print adjustments as print errors are detected at full press speed. For automated label roll finishing, LVS’s Roll Inspection Mapping System (RIMS) references a local data base to halt high-speed rewinding at defective labels identified by the LVS 7000.

Machine vendors have partnered with printer companies and vision providers to offer integrated solutions.

Multivac featured the R535 horizontal form-fill-seal packaging machine as an automated solution end-to-end. A Multivac H240 robotics portal equipped with twin Delta robot pickers is guided by an integrated vision system from Multivac Marking and Inspection. After packages exit the sealing head, a scanning system performs contact-less seal inspection, for detecting incomplete sealing seams, imperfections in the seal area, and contaminants as small as 0.5 sq mm. Non-conforming packs are documented in the line’s motion control system, marked, and ejected.

Bar coding drives inspection

As manufacturers prepare for serialization and traceability, they aremigrating from 1-D bar codes to 2-D symbols such as Data Matrix codes, preferred for their large data capacity, scalability, and error correction features.

Although printing technologies have continuously improved, code quality inspection is paramount to a successful track and trace line in order to ensure that all supply chain parties are able to scan and retrieve the code information successfully. Substandard code printing in addition decreases line throughput.

“No matter which type of printing system is used it must contain components that are designed to inspect, verify, and validate. Even a simple printing process that uses a traditional in-line flexographic printer with a printing plate requires at least some amount of statistical process control,” said George Wright IV, vice president, Product Identification & Processing Systems Inc. (New York City).

“In digital, variable-data printing, such as with a track and trace or pedigree application, 100% automated inspection, including data validation and bar code print quality verification in accordance with ISO/IEC standards is essential,” Wright adds.

With improvement in camera resolutions and processing speeds, systems capable of grading bar codes to ANSII print standards in process were introduced. Customers can address code quality and erosion of code quality in real time, with alarms to signal when the print is outside of tolerance.

“There are many excellent printers but no printer can ensure the quality of the print 100%. An independent inspection device is required. This can be on the press, which is the best location, or on a rewind inspection system,” said Tim Lydell, CEO, Label Vision Systems.

As industry geared up for serialization, vision companies leveraged their technology to offer traceability solutions. Cognex, Optel Vision, Xyntek-Antares, Laetus, and Mettler-Toledo partnered with machine manufacturers, printer makers, and software providers to offer line, plant, and enterprise level solutions.

Coesia Group sister companies Laetus and G.D developed Laetus Secure Track and Trace Solutions (S-TTS) for pharma packaging applications, encompassing line-level item-level serialization with vision technology, containment aggregation and control from warehouse to shipping, with MES and ERP integration.

To provide a flexible approach for meeting global pharma product serialization requirements, Uhlmann VisioTec featured the VisioCIT solution. Featured with an Uhlmann L250 bottle labeling system as a turnkey track and trace system installed after the cartoner, the stand-alone station supports either pre-printed labels or direct coding.

Filled and closed cartons are evaluated by an OCS checkweigher, after which VisioCIT directs the application of serialized codes; an on-board vision inspection system captures and verifies the codes then stores them as active serial numbers that can be recognized during further packaging and data-processing procedures.

While investigating in recent years the latest technologies for traceability, packagers have identified opportunities to expand automated inspection to other applications.

Conclusion

Manufacturers have achieved reduced costs, productivity gains, and reduced errors through their investments in automated inspection technology. In deploying sensors and cameras in the supply chain, they have realized in addition assurance that the quality of product shipped out the door is acceptable and living up to the brand name standard.