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, itâ€™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
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 firstname.lastname@example.org.
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 youâ€™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 donâ€™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 email@example.com
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.
Tablets in aÂ blister packÂ in foldingÂ carton
Pharmaceutical packagingÂ (orÂ drug packaging) is the packages and theÂ packagingÂ processes forÂ pharmaceutical preparations. It involves all of the operations from production through distribution channels to the end consumer.
Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the country of origin or the region. Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intendedÂ shelf life, uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture, heat, etc., prevention ofÂ microbialÂ contamination, sterility, etc. Packaging is often involved in dispensing, dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are also regulated. Packaging is an integral part of pharmaceutical product.