How to choose a solution

In order to meet the upcoming deadlines of the Traceability Law, pharmaceutical companies need to quickly evaluate the various traceability systems that are on the market. With differing production lines, packaging, and departments responsible, selecting the right product and supplier can be quite a complex decision. Consequently, this article tries to simplify the process of choosing between the available solutions.

When you look at different traceability systems, you need to consider certain variables in order to decide which solution is suitable for your production line. For example, you need to consider:

  • the space available in your production area;
  • the speed of your packaging line;
  • the sizes of the cartons;
  • the design and material of the cartons;
  • where they are to be printed; and, naturally,
  • your budget.

So, where do you start? Below, we have selected three key questions to help you decide which type of system makes sense for your production line.

Consider the speed at which the lines run in practice, not the equipment’s maximum speed. This speed will determine whether the solution should be manual, semi-automatic, or automatic. In the table below, we list the most appropriate type of equipment depending on the line speed and the estimated space required by the solution.

WHAT IS THE NORMAL RUNNING SPEED OF YOUR SECONDARY PACKAGING LINE?

1

SPEED

  • 0 – 30 packages per minute (PPM)

RECOMMENDED EQUIPMENT TYPE

  • Semi-automatic serialization and manual boxing

APPROXIMATE SPACE NEEDED

  • 1.5 m x 1.2 m
2

SPEED

  • 30 – 40 PPM

RECOMMENDED EQUIPMENT TYPE

  • Semi-automatic or automatic serialization and aggregation

APPROXIMATE SPACE NEEDED

  • 0.9 m additional line width
3

SPEED

  • Above 400 PPM

RECOMMENDED EQUIPMENT TYPE

  • Customized solution

APPROXIMATE SPACE NEEDED

  • Dimensions would be determined as needed

WHAT IS THE PACKING SPEED? AND WHAT TYPE OF PACKING PROCESS IS IT (SHIPPING BOXES)?

If it is 0-2 boxes per minute, there are two possibilities: manual aggregation with a scanner for slower lines or where there is no space for additional equipment; or semi-automatic aggregation, as with our PackStation SAP product.

If the speed is 3-5 boxes per minute and there is space available on the line, we suggest aggregation with the PackStation SAP or aggregation using a system that is embedded in a semi-automatic packing machine.

If it is above 5 boxes per minute, the traceability system can be embedded in an automatic packing machine.

* Note that the use of packing machines is usually restricted by the dimensions of the shipping boxes.
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WHAT IS THE PALLETIZING SPEED? AND WHAT TYPE OF PALLETIZING PROCESS IS IT?

If there is a palletizing robot in the operation, we can integrate the OPTEL PalletMaster into the system so that aggregation on the pallet occurs automatically.

If the palletizing operation is manual, this can be done with the same system already being used in the aggregation system at the box level, or with an additional station such as the OPTEL PackStation FMP.

Answering these questions makes it possible to deduce the best traceability solution for the realities of each line and move on to writing the user requirement specification (URS) for the traceability project. Contact us to receive our training on how to write a full URS for drug traceability that complies with RDC 319/19.

FINAL TIP

Simplicity becomes a very important factor when dealing with such a complex project, and for that reason pharmaceutical companies end up seeking a “one-stop” solution. What does that mean? It means being able to solve all your traceability issues with just one supplier. This is exactly what OPTEL offers, turnkey solutions at levels 1 to 4. From serializing each unit to sending data to Anvisa, OPTEL ensures that you are compliant with the traceability law.

In addition, our solutions can easily interact with different Level 4 corporate systems, such as enterprise resource planning (ERP) systems. In the final analysis, this approach by OPTEL means faster integration, less training, more efficiency and lower costs.

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Contact us for a free assessment of your line.