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As we exit past the ‘surprise and shock’ phase of Covid-19, there will be several factors to be monitored as new regulations, medicines and tracking requirements are discussed during the shift of the pandemic towards improved treatments and potential vaccines. Some states are showing a decline of cases and others areas with a more dense […]
Changes in Packaging and Serialization

As we exit past the ‘surprise and shock’ phase of Covid-19, there will be several factors to be monitored as new regulations, medicines and tracking requirements are discussed during the shift of the pandemic towards improved treatments and potential vaccines. Some states are showing a decline of cases and others areas with a more dense population are still heavily impacted as doctors and nurses travel in from other areas to help relieve fatigued health care workers and clinicians. Other industries have changed their focus to help aid efforts such as automobile factories shifting production to make face shields and even spirit distilleries making hand sanitizer. It is clear that this pandemic will have not only a great impact on health care but also many suppliers in various industries. 

 

One way to help with these changes is serialization. World Pharma Today sums up serialization as “a process in which a unique number is assigned and marked directly on a product or its packaging – typically achieved through barcoding technology. Serialization promotes item-level traceability and represents a departure from normal manufacturing processes whereby products are assigned to batches and lots. The theory behind serialization is that by assigning unique serial numbers to each product and introducing scanning at various points in the supply chain, the potential for counterfeit products to get through undetected is substantially reduced.” 

 

A few trends that we feel will be important to pay attention to as we move forward towards a new era of products and packaging and how serialization come into play:

 

  1. The authentication of medication: While there is much discussion and research towards a Covid-19 vaccine, medications to help treat side effects are just as important. This is especially true because of the great need of clinical treatments in demand and the amount of financial gain that counterfeit producers could potentially earn. Having a very efficient serialization process helps to keep the medicines secure and untampered.
  2. Food Supply packaging moving forward: Not only has the food supply been in high demand but the industry as a whole has been forced to adapt to a direct to consumer model. While some farmers are hurting because they have no way to get the food into the hands of customers directly, others, such as meat farmers, are able to sell out for weeks at a time. 
  3. Medical Device production & supply: Health care supplies have been in high demand since the beginning of the pandemic. We believe that there will be more standardized equipment plans even beyond medical facilities if a situation like this were to ever arise again. More regulation, protocols and a higher demand means that errors will need to be reduced and tracking improved. 

 

Achieving the goals of your company’s overall manufacturing and go to market strategy while maintaining compliance not only in times of need but every day is critical. RemTech’s serialization difference is the unique combination of technical services to address the understanding of the requirements, the compliance and regulatory expertise to develop an implementable strategy that meets compliance requirements and margin protection along with the project management skills to implement, validate and train on a safe, compliant, cost-effective solution. RemTech decreases downtime, increases productivity, reduces costs, provides better results and stable compliance and is a leader in serialization. We would like the opportunity to discuss further with you and your team on how we can help prepare you for the future. → Contact Us

Reference: https://www.worldpharmatoday.com/articles/authenticating-covid-19-vaccines-will-be-just-as-important-as-the-vaccine-itself/

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Now, more than ever, serialization and packaging are at the forefront of the COVID-19 epidemic. With the world’s best scientists rapidly working on developing a vaccination and treatment plan for this deadly virus, a large majority of the population are staying confined to their homes and shortages in grocery outlets are becoming normalized. The packaging […]
Serialization and Supply Chain in Times of Need

Now, more than ever, serialization and packaging are at the forefront of the COVID-19 epidemic. With the world’s best scientists rapidly working on developing a vaccination and treatment plan for this deadly virus, a large majority of the population are staying confined to their homes and shortages in grocery outlets are becoming normalized. The packaging and tracking of products will be absolutely crucial to the distribution chain during this time. Below are a few key elements that will directly impact the disease mitigation to society in relation to serialization.

  1. Tracking of healing medicine: If a vaccine or treatment medication is developed, it will be imperative that it is shipped, tracked and delivered as efficiently as possible. Proven serialization methods should be implemented to help manage the entire lifespan of the product from creation to ingestion. Not only will this impact the economic footprint of the drug but even more importantly, it will ensure the delivery process to the patients that are needing it most.
  2. Distribution of food supply: It is not uncommon to find grocery outlets (storefront and online retailers alike) to have shortages of daily staples such as toiletry products, foods such as beans, rice and pasta, and cleaning products. Serialization methods can help the supply chain to track real-time inventory so that those that are in need can have access to these important products.
  3. Conservation of packaging: When a global epidemic causes such a shift in balance affecting normal routines for millions of people, it can bring out so much positive comradery but unfortunately, also negative reactions. These negative reactions include counterfeiters and those who would be willing to take advantage of people in a time of need. Now more than ever, packaging of medicines and food supply need to maintain the highest quality packaging so that the integrity of items are not jeopardized.

Through any kind of situation that affects so many lives in such a short period of time, strengths and weaknesses of an organization are exposed. If your company is in the pharmaceutical, food supply or medical device industries, you could particularly be feeling an extreme amount of organizational stress relating to serialization and keeping things on track. As the leaders in strategic serialization implementation, RemTech can help decrease downtime, increase productivity, reduce costs, providing better results and stabilizing compliance.

If you have any questions, please contact John Hartwig at jhartwig@remtechllc.com and we would be glad to help!

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RemTech Employees Give Back

The holiday season is not only a great time to spend time with family but also a time to take an opportunity to give back to our local communities. RemTech has served companies located in over 20 cities this year and employees come to work at RemTech from several different states. Our company encourages employees to remain actively involved and serve in various capacities for non-profits and other charitable organizations.

Jason Carpenter, RemTech Director of Engineering, recently volunteered at an event for a non-profit called Kids Hunting For A Cure. He serves on his local committee for KHFAC, which is a non-profit organization that provides financial support to research hospitals/foundations dedicated to developing cures for cancer and childhood diseases. Monies are raised by children and adults through community-sponsored outdoor events designed for youth. The organization donates its proceeds to Children’s Hospitals including St. Jude’s and to local research hospitals and foundations, upon approval of the Board of Directors.

We are so proud of our employees taking time out of their busy schedules to serve their communities all over the nation during this busy time of year!

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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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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 […]
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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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 […]
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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