Serialization and Pharma Industry – Are you ready for changes?

Over 40 countries have laid down track-and-trace laws in order to protect drug integrity and trace the product through the supply chain. It is excepcet that by 2019, these laws will affect 75% of the world’s prescription medications. Law requirements vary depending on a country, but they all focus on one key aspect: Serialization.

Implementing serialization might appear simple; it is all about assigning unique numeric codes to each individual product. Yet, there are a lot of details you must pay attention to, before you begin with serialization of your products.

Until now, manufacturer’s main concern was to produce identical units that follow an exact standard. New rules demand that after production, each item is to be identified and marked with unique code which is then further communicated to supply chain partners. Manufacturers are also held responsible for that data for a period of time that may last for several years. 

Line Upgrades

Appling serialization requires upgrading your packaging line, and in order to do that, you need to precisely define your requirements and answer a few questions.

Equipment. For start, what are your new equipment needs?  Can your current printing equipment produce the required 2-D bar codes? Are your vision systems ready for the challenge?  

Downtime. You cannot upgrade a packaging line without certain amount of downtime, depending on how much time each upgrade takes. Try to adjust production schedules to ensure you will have enough products in stock while your machine is being upgraded.

Artwork. Changes in design do not directly affect the packaging process, but they aren’t to be overlooked. Quite a number of pharmaceutical companies have to redesign their labels to ensure there is enough space for the 2-D bar codes and other human-readable components. How much time will it take for your designers to redesign the label and how much time will it take for FDA to approve your new layout?  

With all of this in mind, implementing serialization might seem like a real hassle. Yet, be aware that serialization brings many improvements to your management data, so try not to see it as just a law enforced obligation.

1.       Recall Management       

Recalling bad, tainted or spoiled products is a challenge for any manufacturer.  If you don’t track the product through distribution and retail channels, you cannot do the recall accurately which results in costly general recall of all products. Serialization helps you to reduce the impact of a recall, reduce the time to complete the recall and save the brand image.

2.       Alerting

The sooner you receive an information that something went wrong, the sooner you can fix it and thus reduce costs or errors and prepare and plan for issues before they occur.

Controlling your supply chain and tracking the product allows you to alert your partners when things are not going as planned.

3.       Expiration Management              

For products with limited shelf-life, the batch number can be used to determine product’s End-Of-Life (EOL) and help to implement certain management disciplines and strategies. True, this may require certain supply chain partners to capture, monitor, communicate, and act on expiration data, but in the long run it reduces obsolescence, reduces returns, and improves replenishment planning and accuracy.

4.       Supply Chain Planning   

Unique product codes are helping you to always know how many of your products are left, for example, in the in-store inventory and to predict when and where to replenish the stocks. It also helps you to asses all sorts of merchandizing issues, from displays to distribution patterns.    

As a conclusion: Implementing serialization is a serious process, but the benefits are worth it. And thought it seems complicated, all you really need is a trusting partner who will help you to prepare your packaging lines in order to respond to these new requirements. Tishma Technologies is a first choice, so check out Tishma Technologies' cartoners, tray packers, case packers or palletizers, available with laser and ink jet printers and Serialization vision and tracking capabilities.

New Technology and New Standards - Packaging Machine Safety

Safety standards in the packaging industry are changing at a fast pace. Once, safety was a matter of a few requirements and maintenance, but today this topic is wider and much more complexed. Packaging industry needs cartoners, case and tray packers and palletizers with greater speeds, faster change overs and less downtime, while the market demands new products and packaging styles.

Shutting down a machine is not just a minor step back anymore. With today’s automation of packaging lines, shutting down a machine is impractical and it leads to productivity loss. Bringing newer packaging machines and systems back online may in some cases be a more complex and time-consuming than with older machines. Not to mention that if you shut the machine down while there is product in it, before you can turn it on again you will have to clear the product from the machine. Apparently, the matter of safety cannot simply be reduced to an "emergency off switch".

Anyway, machines do require maintaining and servicing, and we simply have to find a way to perform safety related tasks without stopping the production. A modular design approach can be handy in theese cases. Some parts of the machine can be slowed down or put in a different mode of operation, so that a downtime is kept to a minimum. The operator is safe and when he is done, the machine can run faster again.

What about the standards?

The only standards that have the support of law in USA are the standards set by the Occupational Safety and Health Administration. Yet, multinational companies are quite persistent in demanding compliance with various sets of standards. Non compliance can even shut the door for some markets, for example Europe. On the other side, new technologies can make packaging machines safe and productive, according to demands and new safety standards.

The two most important standards in this field are ANSI/PMMI B155.1 2011 and EN ISO 13849-1. Other standards might refer to a specific aspect of a machine or system operation, such as robotics, but these two standards are the main drivers in redefining safety requirements for packaging machine manufacturers and users.

Zoning and optoelectronics – New way of doing things

New safety technology utilizes the same Ethernet network as the machine control system. Moving to a networked safety system allows packaging machines and lines to be zoned, replaces wiring and provides additional diagnostic information.

With the zoning approach you can safely control speeds, torques and motion in specific sections of machines or lines without having to stop the entire line. This way the system can be safely slowed down rather than e-stopped and restarted.

We are already familiar with the importance of robotics in packaging. What you may not know is that the great percentage of robot-related injuries occurs not during production but during programming and maintenance. To access the robot, workers must expose themselves to risk, because they need to turn off some or all of the old, binary on/off safety devices. New technology and new standards allow workers to access robots and still be protected. The Robotics Industry Association (www.robotics.org) has recently revised its ANSI/RIA R15.06 2012 Industrial Robot Standard according to the risk assessment methodology of EN ISO 13849-1 to adjust to this new reality and allow today’s advanced programmable safety devices to be used.

Light curtains, laser scanners, safety cameras and other similar devices are becoming more and more reliable and coupled with integrated controllers, they provide more flexibility as well.

Optoelectric devices such as safety light curtains are getting cheaper while adding additional features making these devices more affordable to incorporate. 

Introduction of new safety technologies like safety controllers allow these and other devices to be easily incorporated into machines and systems. Advanced communications and the flexibility of the safety controller reduce the machine down time thus improving manufacturing efficiency. The safety controller is expendable, so it allows a customer to standardize on a single platform for all their machines.

New technology equals new options, so when you set off on a hunt for a new packaging machine, ask for a machine's safety specification and choose the machine that can meet your requirements in terms of safety and productivity. Start now; get a quote on Tishma Technologies' cartoners, tray packers, case packers or palletizers.