Secure Medicine Production with RFID at Engelhard

Access, User Management and Secure Medicine Production with RFID

Engelhard Arzneimittel

Engelhard Arzneimittel Increases Precision in Production and Security in Factories.

The pharmaceutical manufacturer Engelhard has been successfully producing over-the-counter medication for 150 years. In order to cope with increasingly complex production processes, Engelhard has automated part of its production with protocols from Beckhoff Automations since 2019.

Shortly thereafter, RFID was introduced as a user permissions management system at the operator panels and hose connections. Read heads from Balluff are used in the panels and readers from EMF at the hose connections.

Success Story powered by: the Think WIOT Group and Engelhard

Engelhard has optimized access to the buildings and control panels as well as parts of the production itself with RFID.

The new company buildings in Niederdorfelden near Frankfurt in Hessen.

The manufacturing steps for pharmaceuticals have potential for error at many points, which Engelhard minimizes with RFID and automation.

High Demands on Safety and Precision

The production of pharmaceuticals is subject to the most stringent quality and safety requirements. Active ingredients often consist of chemicals that must be handled with the utmost care. Parts of the production are marked as "potentially explosive" or Zone 1 according to the explosion protection directives ATEX.

All components in this area must be inspected and certified according to Zone 1 requirements. Relevant parameters for certification include temperature, the distinction between gas and dust, and between electrical and non-electrical equipment. Access to these areas is subject to strict safety requirements.

Access

Engelhard has optimized access to the buildings and control panels as well as parts of the production itself with RFID. An access solution with transponders was already in use. The transponder board actively triggers a signal for identification when "pressed on". This ensures access control to the building.

In addition, an RFID chip was integrated into the transponder, which takes over the identification at the operating panel on the machines. 15 control panels are in production. The read heads on them are manufactured by Balluff and are integrated into the panels (with an exception in the Ex-area, where the Balluff read heads were "refined" by Wesitec).

In Production, employees identify themselves at the panel, which recognizes the user profile including access rights. After logging in, employees are immediately in their area of responsibility for active control. Since they can only access the areas there that belong to their tasks, the error rate is considerably lower than before. In addition, this system performs time recording, identification at the printer system and contactless payment in the canteen.

Engelhard has created a comprehensive solution for many areas in the company with RFID.

Hoses

One of the most common components in medicine production are hoses. They are needed for active ingredient production, tincture filling and the production of fluid medications or liquids and enable flexible connections, for example, between a permanently mounted tank and a mobile tank. It is important to ensure that the connection between the hose and the connection point is properly and reliably closed, and that the correct hose is selected.

The potential for error is relatively high here. A wide variety of certifications are available for hoses used in medicine production: Some hoses are vacuum-proof, while others are only to be used for cleanrooms due to the particularly smooth and easy-to-clean material. To rule out errors and ensure correct hose connections, Engelhard has fitted the ends of the hoses with RFID tags.

Engelhard Arzneimittel

Founded October 31^st 1872
One of the leading manufacturers of over-the-counter medication
More than 450 employees
Annual sales of approx. 110 million €
Owner-managed by the fifth generation
Focus: Respiratory diseases, skin diseases, gastrointestinal ailments, concentration disorders
Key products include Prospan, Isla, Tyrosur, Muxan and Esprico
Products available in over 100 countries
Construction of new administration

RFID in the Hose Connection

Production Zones at Engelhard

The pharmaceutical production is housed in a large building with a production area of 8,000 m². The area for liquids is set up so that everything is produced on the 1st floor and then brought directly to the product filling lines via downpipes. Next to it on the top floor is the production area for solid pharmaceuticals.

The solids are mixed and pressed into tablets in the adjacent room. One floor below, the tablets are packed on blister lines. Ointment production takes place in another zone on the top floor. The raw materials are filled into transport drums and then also dosed into ointment tubes one floor below.

The RFID Tag

In Engelhard's hose connection, 36 valves are accommodated with as little dead space as possible. The challenge was to find a passive RFID tag that could be easily read in a confined space and, if possible, could not be confused with another tag. Together with the explosion protection expert WeSiTec, Rüdiger John, Head of Engineering at Engelhard, found a solution.

The hose sleeve from WeSiTec is equipped with two guide rings in the final area. The inner one is a loose ring that can rotate freely and is weighted with weights. The RFID chip moves with the loose ring to ensure that no matter how the employee turns the hose, headsit is always on the correct side.

The reader head is attached to the hose coupling in such a way that it can read the tag. Therefore, only one read head is needed; a second would be difficult to accommodate at the hose connection.

The operator connects the hose and immediately confirms this step in the control system, which then reads the tags. Only when the control software recognizes that the correct hose has been attached is the next process step initiated.

Self-Certification for Read Heads

Since the hose station is classified as Zone 1, "potentially explosive" according to ATEX, components with certification for Zone 1 were required. The read head also had to be IO-Link-capable, since the IO-Link was an integral part of the software. As a read head with these properties was difficult to find, the WeSiTec company advised Rüdiger John to aim for in-house certification.

The basis for this was a standard read head from the company EFM, which WeSiTec wanted to mold in an ATEX-approved plastic. The external technical review showed that the read head had minimal current requirements and a sufficiently low heat generation. It was therefore approved without a plastic housing. It meets all legal and statutory requirements for use at this location in Zone 1.

The hose connection is classified as "potentially explosive" according to ATEX. Finding a certified read head that may be used there was difficult.

The panel is equipped with a holder for the RFID reading head

The panel from Pepperl+Fuchs is equipped with a holder for the RFID reading head from Wesitec. The sensors are from Balluf. The stop buttons from the company Bartec.

Frontal view of the hose connection with IFM read heads.

Rear side of the hose connection with IO-Link units.

The image shows the prototype of the RFID tag holder. The stainless steel design is used in production operations.

Automation in Medicine production

In Engelhard's medicine production, limit values are now collected automatically and via sensors.

The batch tanks are equipped with control panels and RFID user identification from Beckhoff Automation.

Greater Precision with Automation

In order to keep the potential for errors as low as possible during the weighing, mixing, sieving, granulating, tabletting, coating and packaging of solids – and analog processes for liquids – Engelhard decided to automate production in 2014. This is achieved with the proprietary TwinCat and EtherCat automation protocols from Beckhoff Automations. The process automation includes 335 drives (valves and actuators), 17 pumps and agitators, as well as around 240 measuring points (for pressure and temperature as well as mass flow meters, ultrasonic flow meters, level sensors, etc.) and 13 trace heaters.

Also integrated into the technology are assemblies such as the clean water supply, product transfer via four pigging systems, waste water treatment, and ethanol storage, which is required for the production of alcohol-based cough drops. IO Link is used as a standardized communication system to connect the various sensors and actuators and does not require any additional cabling.

Sensors in Production

Engelhard uses different types of sensors in the production of fluid pharmaceuticals. The sensors are wired and the generated data runs directly into the control system.

The fill level is monitored with limit switches in the pipelines behind the pumps. Foaming is controlled optically and with radar sensors that detect surfaces by frequency. It is a necessary part of the production of liquids. This is because when substances are incorporated, air is also incorporated and foam is produced.

Too much foam can cause problems with pumping because there is too much air in the substrate. This is why sensors with limit switches were retrofitted. If the limit switch on the pump reports "not enough liquid", a valve is automatically opened, from which foam/air is discharged until the switch detects that the pump can deliver properly again.

Pigs for Cleaning

Engelhard uses pigging systems for cleaning the lines between the feed tank and the storage tanks. The pigs, which are slightly larger in diameter than the pipe, are flushed in under pressure and immediately close the line so that the product that is still in it can be drained in a controlled manner.

This can be up to 70 liters – or 700 100 ml medicine bottles – which would be lost if drained without the pigging system. The pig pushes the product into the storage area and is then retracted. Pipelines can be cleaned more effectively and less medicine needs to be processed in the wastewater treatment plant.

Interview

Higher Security, Less Downtime

Rüdiger John, Head of Engineering & Technical Site Management at Engelhard, designed the RFID solution for the hose station and access. RFID & Wireless IoT Global talked to him about the initial ideas and the implementation of the RFID project.

1. Mr. John, Engelhard Arzneimittel has implemented a comprehensive RFID solution on the company premises. How did the demand for this solution come about?

developed the first ideas for this in 2010, and they became more concrete between 2012 and 2014. Unfortunately, the project then had to be put on hold for the time being. Since production was becoming increasingly complex, we decided on automation in 2018 and implemented it with Beckhoff Automations in the new production plant that was built in 2019. I then realized: if we have the central hose connection where the connection is made, we would need a solution for this.

2. Why is this so important, particularly in the hose connection?

In the previous production building, where a lot of manufacturing was still done by hand, harmless mix-ups sometimes occurred at the hose connection. A vacuum-resistant hose was perhaps used for an application for which a non-pressure-resistant one would have sufficed. Such a hose is certified and costs about 500 euros each. For that reason alone, proper handling of hoses is important. Perhaps a connection was not closed properly. Such errors can lead to a whole batch of medicine becoming unusable. This is what we want to prevent.

3. Was it clear from the start that RFID was the best solution?

No. The first idea was to ensure the correct connection via a position detector. It would report that there is a hose between valve A and valve B. However, unfortunately, a system like that is not able to check whether it is the right hose. Only then did we come up with the idea of giving each hose an RFID chip at both ends and thus a tool number that is the same at both ends.

The hose number is matched and only when both valves that we want to connect have reported to the control system that the number is identical, is there a 100 percent certainty that the hose is in the right position. We have thus achieved a very high level of process reliability.

4. That being said, what did the implementation look like for the RFID solution?

With concrete project plans that started in 2019, it was clear that RFID would be used for user identification at the control panels and for the hose connection. The access control system from Siemens & Voss had already been installed and was retained. The payment system for the canteen was a new development. Essentially, the hose connection had to be there for production, but at the end of 2019 a new requirement presented itself: How can we ensure that the hoses can no longer be mixed up? This now works via RFID.

The complete system is now in use. The user identification has been in place since the end of 2021, but it will not be fully activated until the last four read heads are in place. The solution at the hose connection has been in place since September 2022. Delivery problems caused by COVID-19 have caused slight delays.

5. It was also hard to find the suitable tag; why? There are plenty in the market.

That's true. However, if I have an RFID chip cast into a hose sleeve, for example, I can only read it at exactly one point. This is inconvenient, because I may not be able to reach this spot well with the read head, or I may read out the wrong hose without my knowledge, or I may not even recognize it at all. This is why we have developed our own tag holder with WeSiTec.

Furthermore, our production is classified as Zone 1 according to ATEX, so we can only use devices that are approved for Zone 1.

6. What improvement do you see in the control panels with the Auto-ID solution?

Everything is faster when you do not have to enter a password. Not long ago, an employee entered his password incorrectly three times, as a result of which his user account was locked. The administrator also happened to make a mistake, so his admin password had to be re-enabled by the manufacturer. This all took a very long time.

With a read head solution in the control panel, this is much easier to deal with. The transponder is held close and there is no risk of incorrect entry. We now have higher security with less downtime. And the nice thing is, we have one system for everything instead of several systems.

7. Where are you headed next? What new ideas do you have for the RFID solution at the hose connection?

I have actually already started thinking ahead. Other parameters can be controlled via the hose number that is programmed into the system. For example, a hose might only be used for certain products in the future. It could also be given a cleaning status "cleaned/not cleaned" and an age certificate in the control system. In this case, the employee would not have to think about whether the hose is too old, instead, the hose would simply not be released.

An increased level of automation, controlling and production safety will lead to fewer human errors. Another idea involves the use of robots to monitor the production facility. Instead of an employee for routine rounds, we could use a robot to open doors independently.