Author: John Hartwig

John Hartwig has a BS in Electrical Engineering from St. Cloud State University and has 20+ years of process, equipment and packaging engineering experience. John’s career involves custom equipment design through engineering leadership position in the consumer products, beverage and pharmaceutical industries. With King Pharmaceuticals, John was the Technical Operation’s Team Leader for a new drug platform with responsibility for pilot scale facilities construction, tech transfers, scale-up to commercial capacities, and product launch readiness. John has led engineering teams in capital projects, automation, reliability, qualifications, network strategy development and product track and trace (serialization) programs.

Packaging in the Pharmaceutical Industry

Properly packaging a product of any sort can be one of the most overlooked aspects in manufacturing across the board. It is easy to become focused on the product itself but many simply overlook the delivery model. Even if a product is of the highest quality and most effective in their market, these accolades are obsolete if the packaging process is not fine tuned. In the Pharmaceutical Industry, it is absolutely imperative that the drug is delivered properly and most accurately due to the sensitivity of the end consumer and potential adverse outcomes downstream.

Below are six key aspects to the validation of packaging for pharmaceuticals:

  1. Preservation– The product must remain uncontaminated from exterior elements such as moisture, light and gases. This is key to maintaining the integrity of the medication located inside the packaging. For example, cold-formed aluminum blocks and vials block out light. Other products are more fragile and require an insert inside the bottle to protect tablets from breaking during the shipment.
  2. Containment– The product cannot be subject to leakage due to seals or other faulty packaging. There must be consistent measures in place to validate the packaging itself to avoid a containment failure downstream.
  3. Identification– The product must be properly identified and have traceability due to the federal serialization standards. 2D DataMatrix barcodes must be graded to maintain a uniform level of quality. Offline or online grading is strongly recommended.
  4. Security– With evolving national epidemics, such as the increased use of opioids for recreational use, security of a product has never been more important. The product should be secured for tampering but also for traceability.
  5. Information– The product must have proper documentation on file to be able to be properly traced and be accounted for in production and distribution. Automating this process is preferred due to the rigorous standards that have been put in place to be DSCDA compliant.
  6. Delivery Convenience– The product must be convenient for clinicians to be able to administer with ease of use. The packaging plays a crucial role in patient delivery and should not be overlooked.

These six elements are key to high quality pharmaceutical packaging. Sometimes there are only a few areas that manufacturers struggle with remaining compliant. RemTech has worked with hundreds of manufacturers, large and small, to manage packaging processes and make sure that clients are not only DSCDA compliant but also prepared for new rules and regulation changes down the road.

For questions, contact John Hartwig at jhartwig@remtechllc.com

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Why Quality Coding Counts!

Even though it seems that barcoding systems and processes seem heavily emphasized industry wide, it is still very common that we partner with tenured companies who have subpar processes. Often times, it’s simply the lack of resources or technology that prevent the proper grading, printing and tracking. For the sake of continual improvement within our industry, we wanted to discuss the importance of the 2D code within pharmaceutical serialization and aggregation.

Why is Grading Important?

With the human eye, a barcode can be seen as simple lines or designs that are scanned to be read by a machine. However, a poorly printed barcode can not only mean a halt in the delivery of service but also a supply chain nightmare. The quality of the grading may be one of the most important factors in the entire process. Due to the potential impact, many suppliers have urged partnering manufacturing organizations to have their 2D DataMatrix barcodes graded to maintain a uniform level of quality control.

Offline or Online Grading?

Offline grading is a method that should be used for several reasons. Not only does it allow for repeatability of test conditions (per ISO standards) but the label can be placed in the same spot every time for the image capture to be optimized. If using this method, there is a requirement to manually pull samples from the line to bring to the grader meaning that not all 100% of codes will be verified. Online grading would be considered the high-end solution due to the fact that every barcode is inspected when printed. However, false negatives have been detected because of on-line conditions such as lighting, mechanical vibrations and other factors. We recommend using the off-line method as a baseline approach to set a reliable foundation to your system and later, implement an online verification system to provide continuous checks of each barcode. These methods should continue to be assessed and reassessed as technology improves.

Factors that would contribute to an unreadable barcode:

Quiet Zone Violations
Improper Reading Position
Print or Mark Inconsistency
including:Axial Non-Uniformity,Contrast and Grid Non-Uniformity
Modulation
Damage or Distortion
Fixed Pattern Damage

If your company has been experiencing any of these recurring issues with your barcode processes, please feel free to contact John Hartwig at jhartwig@remtechllc.com.

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Introducing SAW: Serialization Aggregation Workstation

With so many changes in the pharmaceutical industry as well as aggregation requirements coming quickly, it can seem difficult to feel prepared for future market production demands.

If you’re a pharmaceutical manufacturing company that has been around a long time or looking to pivot your operations into growth mode, production needs to be refined at every single level. If you don’t know or measure your data points or have expert personnel trained in key areas, it can not only be extremely costly but an inefficient use of labor.

When we visit partner production sites, manual aggregation processes are almost always the source of many errors. The new Serialization Aggregation Workstation, or SAW, developed by Remtech solves this problem allowing companies the opportunity to make the required upgrades to their processes without needing additional space.

What does this new piece of technology mean for the pharmaceutical industry and for packaging as a whole? Because SAW works in such an efficient and nearly closed system, labeling, packaging, and inspection scanning repeatedly occur within moments of each other. So, when a change is needed in one section of production, it can be implemented in only that small step, without needing to reset or rebuild the entire production line. This results in minimal downtime, reduces costs of labor and materials and expands the potential for more output for future growth benchmarks.

By the time serialization aggregation requirements are in place, companies using this system will be running efficiently and in complete DSCDA compliance.

For questions, contact John Hartwig at jhartwig@remtechllc.com

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Thought Leadership

Bob Matje, RemTech LLC is part of the University of Georgia at Atlanta College of Pharmacy Curriculum Advisory Board. Bob had the pleasure of speaking at the Adents Serialization Innovation Summit in June. He also spoke on Serialization Readiness including how to validate your serialization system.

Front Row (Left to right)
Dr. Aqeel Fatmi
Dr. Gurvinder Singh Rekhi; International Biomedical Regulatory Sciences Director
Dr. Brad Phillips
Dr. Y. George Zheng
Dr. Nirdosh Jagota, Vice President, Merck

Back row (left to right)
Dr. Michael Bartlett; BSPS Program Director
Mr. Bob Matje, RemTech LLC
Mr. John Nine,
Mr. Mark Fitch
Mr. Britt Petty, Director, Biogen

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Racing to Market, with a Quality Finish

With R&D successfully completed, a pharmaceutical company needed to launch a full-scale commercial operation promptly. With intense competition for their high value narcotic, there was time pressure to convert their facility swiftly. RemTech quickly mobilized, providing hands-on strategy and implementation, including the planning, design and construction of the new facility. Despite the threat of a natural disaster, conversion of the R&D facility to an operational manufacturing space was completed on time and on budget. With RemTech’s assistance, the client was able to successfully launch its fully-compliant CNS drug faster than anticipated, allowing it to capture a significant market share. The company is now planning the next phase of its expansion with our assistance.

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