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Serialization is coming?  Will you be ready?  Be sure to contact our serialization experts / engineers to discuss your readiness.  At Pack Expo International in November we will show a serialization and aggregation line demonstration.  

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Equipment Partnership Readies Cetylite for DSCSA Deadlines

Posted On: November 03, 2016

By partnering with its printing equipment and software supplier, this pharmaceutical manufacturer is on track to apply serial numbers to meet the 2017 DSCSA deadline.

By Jim Butschli 

During the last quarter of this year, pharmaceutical manufacturer Cetylite Industries Inc. [9] plans to test the application process of serialized numbers on its packaged drug products, with the intention of applying serial numbers in the first quarter of 2017 to meet November’s deadline for DSCSA (Drug Supply Chain Security Act) regulatory requirements.

A key to meeting DSCSA deadlines for this third-generation, family-owned Pennsauken, NJ, firm is its partnership with Nutec Systems, Inc. [10]

“Nutec equipment provides software, product-specific programming, and printing solutions for our product labels, individual folding cartons (IFCs) and case labels,” explains Bruce Epley, Cetylite’s Director of Operations.

After obtaining proposed serialization solutions and quotes from three other suppliers, Cetylite selected Nutec and commenced installation late last year.

“Nutec provided a flexible solution that best matched our packaging practices at a very reasonable price in comparison to the competitors,” says Epley. “Nutec was very informative and did not try to ‘upsell’ or provide equipment or solutions that were not required.”

Equipment portability adds flexibility

Cetylite packages exclusively out of its 28,000 sq-ft facility, which includes production, warehouse space and offices. The company produces about 20 products in all, both drug and non-drug varieties. Its product line includes prescription topical anesthetics, infection control products, and other complimentary dental products. In all, 18 of the products are liquids, one is an aerosol and one is a gel.

A majority of Cetylite’s products are labeled bottles packed inside of a carton, which get filled into a case. The company also packages kits that contain a labeled bottle, tips and syringes, as well as one offering that includes two products within a single carton.

Epley notes, “We operate in a flexible environment with one packaging room. Depending on the product, we will move the needed (portable) equipment in and out of the packaging room based on the packaging configurations.

“We have four filling machines with two in fixed locations and two different types of labelers with one in a fixed location. This equipment will be configured to support and feed the packaging line but we run one packaging configuration at a time. We configure the line to meet the packaging needs of the product.”

According to Epley, a key challenge for Cetylite “was to find a flexible solution to implement into our manufacturing process that would allow us to meet the current and future regulatory requirements of the DSCSA. With just one packaging room handling all of our packaging configurations, finding the coding and vision equipment solution at a reasonable cost was a time-consuming process. We could not afford nor did we have the space to implement multiple standalone solutions.”

‘BlackBox’ solution

To address those needs, Cetylite installed print and vision systems on two of its labelers. “Nutec designed and built the print station for coding all of our cartons, which includes a vision system and reject station,” says Epley.

All of this is controlled through Nutec’s BlackBox print/vision inspection/line control system for labels, cartons and cases. Its functions include the following:

  • 2D barcode printing, inspection, and line stop control of two existing labelers. One of these machines, an Accraply[11] labeler is configured with four printheads, one encoder, one print trigger, and one 2D code scanner. The other labeler, from Harland[12], is configured with one printhead, one encoder, one print trigger, and one 2D code scanner.

By reconfiguring printhead cable(s), encoder cable, trigger cable, and 2D code scanner cable, the BlackBox System can print and inspect on either labeler with the same controller. Special operator interface software allows the appropriate configuration to be selected for either labeler.

  • Print, inspect and reject of IFCs on a Nutec print-and-inspect conveyor system equipped with motorized top hold-down belt. The system includes a motorized conveyor assembly with synchronized top hold-down belt for product carton control through the print-and-inspect stations.

An optical character verification vision camera with integral lighting inspects both the printed 2D code as well as human-readable text. A vision inspection “PASS” allows the carton to continue through the system while a “FAIL” results in the carton being rejected from the line.

  • The Nutec case label print and manual 2D code inspect system is supplied with a stainless-steel work table on which a Zebra [13]GK420d printer and handheld 2D code scanner are mounted. Both the printer and scanner are connected to the BlackBox control, and all interconnects/drivers are integrated into the system.

The printer function provides entry, transfer, and printing of GTIN, lot code, and expiration date information via the touchscreen operator interface. The 2D Code and text “matchcodes” are automatically transferred to the scanners/camera as part of the data entry/transfer process. The line stop/reject functions are performed by the system PLC, and all process status and alarming is provided at the Operator control unit.

Ready for serialization

The BlackBox System, as installed, is serialization ready and track-and-trace-capable. The system generates print-serialized data for use in GS1 codes, and can perform track-and-trace functions (aggregation) by purchasing and installing the Nutec track-and-trace software module option.

For Cetylite, the BlackBox concept is “plug-and-play” in that the company can utilize Nutec components as needed based on the equipment required to support the specific packaging operation.

Epley explains, “Through multiple discussions and the understanding of our process, Nutec was able to design just one BlackBox control system for all printing and vision inspection functions associated with all of our packaging configurations. With Cetylite only packaging one product at a time, multiple standalone systems were not required. This was a significant cost savings benefit.”

Of course, serialization is a critical issue for the company—“part of meeting the future regulatory requirements,” says Epley. He says finding and clearing the required space on labels and cartons to apply the 2D codes and human-readable information is a major aspect of the serialization process.

Cetylite has the equipment in place to apply serial numbers and 2D codes to its drug products. However, he notes, “We have not yet tested or validated the serialization part of the process. Cetylite is currently applying 2D codes and human-readable information for the GTIN, lot, and expiration date for over 90 percent of our drug and non-drug products. We’ve taken the approach of ‘let’s walk before we run.’”

Does the company have specific plans to make all of its packaging lines/equipment “serialization-ready?” Yes, he says, adding, “With the Nutec equipment already being selected and installed, our next steps are to test the application process of the serial numbers. We will apply serial numbers to our drug products but we have no intention of aggregating products or communicating data downstream at this time.”

In the future, he acknowledges, “Aggregation and capturing of the data will need to be addressed.” He believes additional Nutec machinery will be helpful for Cetylite to meet aggregation regulatory deadlines.

Epley notes the DSCSA, serialization and aggregation issues all present challenges for Nutec and the Cetylite packaging lines. Among them: the effect of electrical interferences on print quality and getting the proper ink for the coding of the labels and cartons to ensure quality reproducible codes.

In terms of economic return-on-investment to meet DSCSA and serialization regulations, Epley’s response is not uncommon: “As for the justification of the investment, Cetylite has struggled with this considerably. We see no significant benefit to the business or return on our investment.”

View original article post here: http://www.healthcarepackaging.com/trends-and-issues/traceability-and-authentication/equipment-partnership-readies-cetylite-dscsa 

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BlackBox Live Line Demonstration @ PackExpo Las Vegas

Posted On: September 17, 2015

PackExpo Las Vegas 2015 / Live Line Demonstration / Booth C-2505

 

At Pack Expo in Las Vegas, September 28-30th, Nutec Systems will give a live line demonstration on how the BlackBox can help you meet the 2017 Federal Regulations for Serialization and a path towards meeting the 2023 traceability requirements.  The demonstration will not only show how the BlackBox can generate GS1 codes with unique identifiers, serialized codes, but how it can communicate this information with various systems along your production line.  Nutec will show the BlackBox communicating with various printing systems, and various vision inspection systems at the individual, carton and case level.  Aggregation and file transfer to a live server will be part of the demonstration as well.

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Nutec: Printing/inspecting/line control in one system

Posted On: February 10, 2015
With the BlackBox Series from Nutec, packaging lines can be equipped with a single-source input that can handle a variety of operations including printing, inspecting, line control, and track and track; and with the addition of cheQAssure, the company’s patented software suite, customers will have a high level of confidence that regulatory requirements relating to product labeling and identification are met.   Read More...
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Nutec in the news

Posted On: December 11, 2014

Nutec in the News

 

Preparing for Item-Level Coding

Nutec Systems Inc. introduced a new control system that can employ any print or vision inspection system. Black Box is print engine and vision system “agnostic” and can “serve as the front-end control device for any system,” explained Dennis McLaughlin, Nutec’s director of engineering/technical sales, at the show. “It can serve as the central location for trafficking all intelligent devices.” (If customers do not select particular vendors, Nutec will default to HP thermal-ink-jet printing and Cognex systems.)

Black Box can set up, configure, and monitor the status of all print engines and vision systems, and with one single user interface can distribute coding information to all devices, McLaughlin said.

Nutec can scale up the amount of capability as needed to suit customer applications, and the highest level of control can monitor up to 12 printing lanes, constantly perform optical character verification with an accuracy of 99.99%, and run Nutec’s CheQAssure software for batch verification, quality control, and solutions for anticounterfeiting, antidiversion, track and trace, and returns. (Read Full Story)

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New Product Release - The BlackBox Series

Posted On: November 01, 2014

Press Release

Date:  November 1, 2014

RE:  New Product Release @ Pack Expo

Press Release Contact Info:  Laura Rodgers, Director of Marketing / Sales

                                              laura@nutecsystems.com

New Product Release:  The BlackBox SeriesThe Blackbox series

Nutec Systems, Inc. introduces the BlackBox Series:


The BlackBox Series is a revolutionary solution to streamline packaging lines.  The BlackBox Series is available in several configurations:

  1.  A Printer utilizing HP® TIJ technology.  The BlackBox can be configured to include up to 12 print heads.
  2. A Printer and Vision Inspection, equipped with either a smart sensor or a smart camera.
  3. A Printer, Vision Inspection and Line Control
  4. Printer, Vision Inspection, Line Control and Track & Track

The BlackBox has a touch screen HMI which allows for a single input for your print, vision inspection and line control.  If validation is required, the BlackBox will decrease the time and money necessary, as it has taken what would have been several pieces of equipment and combined them into one.

For inquiries on this product call Nutec Systems @ 609-912-0145 or visit our booth (S-4014) at Pack Expo in Chicago.

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New Product Release: cheQAssure™

Posted On: July 15, 2013

APS Press Release

New Product Release: cheQAssure™

July 15, 2013

Nutec Systems, Inc. introduces our new software suite cheQAssure™ which has been developed for use in regulated industries (i.e. Pharmaceutical, Medical Device, Food, etc) which provides users with a high level of confidence that regulatory requirements relating to Product Labeling and Identification are met. cheQAssure™ various software suites provide batch verification and quality control. Secondary suite applications include solutions for anti-counterfeiting, diversion, track & trace and returns. For inquiries on this product call Nutec @ 609-912-0145 or visit our booth (C-1838) at Pack Expo in Las Vegas.

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Nutec systems, Inc. track and trace program instrumental in identifying diversion of product

Posted On: February 08, 2008

February 8, 2008 [Contact: Dr. Albert H. Ahn – (201) 242-8409]
(article from Summit VetPharm press releases)

This week, Summit VetPharm identified the first instance of a veterinarian who was diverting its veterinary exclusive Vectra 3D™ flea and tick product. This situation, where product was found available for sale on a popular website targeting pet owners, is a clear violation of the Company’s anti-diversion policy.

Summit VetPharm, after confirming the identity of the California veterinarian, swiftly implemented corrective action against this individual. By utilizing the proprietary Summit VetPharm Bloodhound™ track and trace technology, the company was able to immediately pinpoint where the violation had occurred. Within six hours of legal notification to the veterinarian, the diverted product was no longer available for sale. 

“I am delighted that our Bloodhound track and trace technology provided us with rapid identification which allowed us to pursue immediate action against this individual who appears to have willfully violated our signed anti-diversion contract and placed our product outside the veterinary channel for sale,” stated Julia Stephanus, president and CEO of Summit VetPharm. Vectra 3D and all Summit VetPharm products are exclusively dispensed by licensed veterinarians. We will not tolerate product diversion because it undermines the relationship between veterinarians and pet owners and raises questions about product integrity.”

“Veterinary response across the country has been unanimously positive about Summit VetPharm’s commitment to the profession,” stated Dr. Albert Ahn, Senior Director of Veterinary Services. “Over the years, veterinarians have expressed their concerns to me that companies were unwilling or unable to stop unauthorized product diversion. The veterinarians I have spoken with are genuinely impressed with the commitment that Summit VetPharm has made. One of the core principles upon which our company was founded was the commitment to ensure that our products are developed and made available exclusively through licensed veterinarians. By securing our supply chain, we are able to protect the veterinary professional, maintain authenticity of our products, and enhance the role of veterinarians in the lives of the animals they treat,” continued Dr.  Ahn.

“We will remain vigilant for future instances of product diversion. Our goal is to keep companion animal health exactly where it belongs — in the hands of professionals. The terms of our Anti-Diversion Agreement strictly prohibit the sale of Vectra 3D outside of the veterinary-client-patient relationship. This agreement explicitly states that sales outside of this relationship will result in legal action against the identified veterinary diverter and any third parties involved in that diversion,” continued Julia Stephanus.

Vectra 3D’s new triple-action topical ectoparasiticide formula is available to pet owners only through licensed veterinarians.  Vectra 3D is available in four different sizes: for dogs and puppies over 7 weeks of age weighing 2.5 to 20 pounds; 21 to 55 pounds; 56 to 95 pounds, and for dogs over 95 pounds.  Vectra 3D is currently available to veterinarians from the following distributors: NLS Animal Health, Henry Schein Animal Health, Midwest Veterinary Supply, Inc., Merritt Veterinary Supplies, Inc., Associated Medical Supply, Great Western Animal Health Supply, Northeast Veterinary Supply Company (NEVSCO), Victor Medical Company, PCI Animal Health and Sanum Puerto Rico, Inc.

Summit VetPharm

Founded by veterinarians and experienced industry professionals, Summit VetPharm is committed to protecting the health and welfare of both companion animals and companion animal veterinary practices.  As a wholly-owned subsidiary of the Sumitomo Corporation and part of the Sumitomo Corporation group of companies, Summit VetPharm is backed by a longstanding reputation for values and ethics in business and is dedicated to raising the standards in animal health. Summit VetPharm is headquartered in Fort Lee, New Jersey, USA.   For more information, visit Summit VetPharm at www.summitvetpharm.com

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Nutec systems, Inc. creates track and trace program for animal health company

Posted On: July 14, 2007

July 14, 2007 [Contact: Dr. Albert H. Ahn – (201) 242-8409]
(article from Summit VetPharm Archives)

Summit VetPharm, LLC, a newly formed animal healthcare company, introduces its proprietary Bloodhound™ Technology — an innovative track and trace system developed by Nutec Systems that will help ensure the veterinary exclusivity of its products. This groundbreaking technology differs from similar tracking systems in that it ensures all Summit VetPharm products can be traced from the point of manufacture to veterinary purchase. Bloodhound™ tracks individual clinics that purchase its products and guarantees sale to consumers only through licensed veterinarians.

Bloodhound™ Technology will allow Summit VetPharm to guard against counterfeiting, and maintain the integrity of its products through a secure distribution channel. Veterinary exclusivity improves compliance by ensuring appropriate product usage and increasing awareness with more client visits and opportunities for education.

“By securing our supply chain, we are able to protect the veterinary professional, maintain authenticity of our products, and enhance the role of veterinarians in the lives of the animals they treat. Through our Bloodhound™ Technology, we can help keep companion animal health exactly where it belongs — in the hands of professionals,” states Julia Stephanus, President of Summit VetPharm.

Bloodhound™ Technology is a state-of-the-art product track and trace system developed by Nutec Systems, a company with extensive experience in “start-to-finish” hardware and software implementation of product “print and inspect” systems.  The system uses Unique Individual Identifiers (UID) which,together with a built-in covert anti-counterfeit feature, enables Summit VetPharm to identify counterfeit products with custom design software. Bloodhound™ is a service provided entirely and uniquely by Summit VetPharm, guaranteeing complete reliability and traceability with nothing additional required of its customers.

Summit VetPharm

Founded by veterinarians and experienced industry professionals, Summit VetPharm is committed to protecting the health and welfare of both companion animals and companion animal veterinary practices.  As a wholly-owned subsidiary of the Sumitomo Corporation and part of the Sumitomo Corporation group of companies, Summit VetPharm is backed by a longstanding reputation for values and ethics in business and is dedicated to raising the standards in animal health. Summit VetPharm is headquartered in Fort Lee, New Jersey, USA .   For more information, visit Summit VetPharm at www.summitvetpharm.com

Nutec Systems, Inc.

Nutec Systems has been the leader in the industrial thermal inkjet market and continues to develop inventive solutions by providing quality product handling systems combined with vision inspection. With a range of capabilities that includes the ability to fulfill all vision inspection requirements, Nutec consistently meets the printing specifications and quality demands of their clients. Nutec Systems is located in Lawrenceville, NJ, USA . For more information visit www.nutecsystems.com.

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