Pharmaceutical Device Manufacturer STERIS Finn-Aqua: “Quality Means That Everyone Does What They Have Agreed To”
The fault tolerance at the STERIS Finn-Aqua plant is microscopically small. The company manufactures equipment that is meant for sterilizing bacteria and microscopic organisms – and there is no room for mistakes.
The pharmaceutical device manufacturer STERIS Finn-Aqua is one of the industry’s leading players in the world. Nearly all major pharmaceutical companies are among its customers.
The company is a part of the American STERIS Corporation Life Sciences-business division. This division includes investment equipment, after-sales service and chemical products for sterilization. The manufacturing and product development of these investment products is located in Tuusula, Finland.
STERIS Finn-Aqua’s history has evolved in several stages.Oy Santasalo-Sohlberg Ab was initially a family-owned company founded in 1932 that through a series of business acquisitions has become a part of the STERIS Group. The name Finn-Aqua was introduced already in the 1970s and the prefixing of STERIS came about naturally after the most recent company acquisition.
The company’s current name STERIS Finn-Aqua offers a very good description of the company’s modern-day activities. The “STERIS” section refers to the sterilizers that the company produces; the word “Aqua” refers to the injection water that the company develops for distillers, and the “Finn” part obviously tells that all operations and manufacturing processes for this take place in Finland.
What is the link between FinnProfiles and its seal solutions and STERIS Finn-Aqua?
“Actually, we work together with FinnProfiles on the doors of our sterilizers”, explains the Purchasing Manager Petri Aatola.
A steam sterilizer is a device that sterilizes the customers’ products by using hot steam. The sterilization process destroys all the microorganisms, their spores and particles that were in the product. The process is extremely sensitive, because, even the smallest impurity can cause an infection. For STERIS Finn-Aqua’s customers, the products that need to be sterilized are mainly medical packs and the medicines themselves.
“The door seal manufactured by FinnProfiles is a very critical component for the whole sterilization process. Excess pressure and negative pressure is created alternately inside the sterilizer chamber in order to make sure that all the products are steamed. The door seal has to be completely hermetic and it needs to have excellent durability. If the seal leaks, the steam does not spread evenly, and the sterilization fails”, Aatola recounts.
“In the pharmaceutical industry, there can be no introduction of a new product based simply upon the assumption that the product will work. All the devices that end up in all industries have to go through extensive validation processes in order to ensure that they will function properly time after time, just as they should.”
The door opening of the sterilizer is surrounded by the green seal manufactured by FinnProfiles.
FinnProfiles and STERIS Finn-Aqua had already come into contact in the early 2000s when the company was deciding on updating its door seal solutions. At that time, several new seal manufacturers were given an opportunity.
“We are assessing our subcontractors very comprehensively, but in all simplicity, our requirements could be summarized into three main criteria: Quality, Reliability, and Security of Supply. Obviously, the price is an important criterion as well”, Aatola adds.
According to Aatola, in the pharmaceutical industry, there can be no introduction of a new product based simply upon the assumption that the product will work. All the devices that end up in all industries have to go through extensive validation processes in order to ensure that they will function properly time after time, just as they should.
“This requirement extends to all our subcontractors. For instance, with FinnProfiles, together we have gone through the whole manufacturing process of our door seals. If they want to modify something in that process, we are notified about it, so that – when necessary – we can inform our customers about this modification and have their approval in advance.”
The requirement for the operational reliability and the security of supply, on the other hand, refers both to the production capacity and to the solvency of the partner.
“We must be able to trust our partners’ solvency and long-term functional capacity. Most door seals are supplied in spare parts and these deliveries must be carried out accordingly”, Aatola emphasizes and continues: “When all these things are guaranteed to run smoothly, we can move on to discussing the price”.
“The high-quality connection of the sealing junction and its holding at high pressure and at high temperature is crucial for the sterilizer’s functionality.”
The seals for both the steam and the VHP-sterilizers are made of silicone due to the material’s good heat resistance. In addition, the seals are joined together during the post-production carried out by FinnProfiles. The joining is done by vulcanization, which ensures that the seal has a good tensile strength.
FinnProfiles’ Post Production Services in Practice
More specifically, FinnProfiles provides Steris Finn-Aqua with two different door seal solutions. One of the seals is used in the steam sterilizer mentioned above and the other seal is used in the VHP-sterilizer that uses vaporized hydrogen peroxide.
The biggest difference between these two sterilization methods is the temperature that is used in the process. In the steam sterilizer – by far the more common of the two – the temperature can rise to as much as 150°C.
The high temperature and the humidity can set, however, some limitations on the utilization of this method. While the steam sterilizer kills even the smallest microbes with the hot steam, the VHP-sterilizer achieves the same result but by oxidizing the microbes with hydrogen peroxide.
FinnProfiles’ Post-Production Services have been used in the sealing solutions for both kinds of sterilizers, joining the sealing profiles into connected links. The joining occurs by vulcanization, which provides the seam with a good tensile strength. The VHP-sterilizer’s door seal is further vulcanized and completed with a compressed air supply pipe.
The biggest functional difference between the steam sterilizers and the VHP-sterilizers is the way in which they utilize compressed air.
In the steam sterilizer, the pressure is created between the seal and the door frame, whereas in the VHP-sterilizer, the pressure is released into the seal itself. In both cases, however, the air pressure pushes the seal against the door and makes the closure airtight.
“The high-quality connection of the sealing junction and its holding at high pressure and at high temperature is crucial for the sterilizer’s functionality. Fortunately, we have a great partner who has made sure that our seals work really well!”