Getinge went back to the drawing board to develop a Steam Sterilizer that the company believes is one of its biggest Life Science product launches in decades.
Medicinal products serve as the first and last lines of defense in patient care. Manufacturers require maximum uptime, performance, and safeguards against microbial and particulate contamination to guarantee the safety and efficacy of lifesaving medicinal products produced from chemical and biological sources. As a result, experts say that the steam sterilization industry will experience a decisive expansion in forthcoming years. Pharmaceutical Technology Europe recently spoke with Jens Knobe, vice present of business development in Life Science, and Joakim Larsson, product line manager of Life Science sterilizers, both at Getinge, about how the company developed a steam sterilizer that is fully aligned with today’s needs of biopharmaceutical production and biomedical research.
Pharmaceutical Technology Europe: What is new within Getinge Life Science?
Knobe: As of April 1, 2017, everything is new. Life Science became a business area in Getinge. This is quite a big deal because Life Science is now one of only three business areas in Getinge. We have, therefore, invested and strengthened much in the organization to better support our customers. This has allowed us to revitalize our focus on key segments: pharmaceutical production, where the specific focus is on biotech and biomedical research; laboratory solutions; and medical device production.
Pharmaceutical Technology Europe: How did the development process of this new Steam Sterilizer begin?
Knobe: Getinge is the market leader in sterilization and we leveraged our extensive experience as we initiated the new generation of steam sterilizers. Beyond improving the performance of the actual product, we also dramatically improved two areas that we know are important for our customers: lead-time and documentation. Meeting lead-time expectations is important when being part of pharmaceutical projects because the overall time to market for the drug is crucial.
Larsson: Drawing on Getinge’s decades of knowledge in the production of both lab science and healthcare sterilizers, along with input from customers, we began developing the new sterilizer from a blank sheet of paper. Thus, we were not, as is typical with these type of projects, lim- ited by the current design. In the end, this has led to a product fully aligned with the market expectations of future solutions.
Pharmaceutical Technology Europe: How can this product contribute to improved production performance within the Life Science industry?
Larsson: The GSS sterilizer is developed to be easily inte- grated into the customers’ production facility and with an ease of qualification as its cornerstone. We understand that the product is more than the sterilizer; it’s the whole execution, including documentation and project management. Ease of qualification is an important part of the complete delivery.
Pharmaceutical Technology Europe: What are the product´s key features?
Larsson: It is a flexible steam sterilizer with a range of sizes and set of options to adapt to customers’ individual needs. Additionally, it is a high-performance GAMP 5-compliant sterilizer with a top-of-the-line documentation package.
Pharmaceutical Technology Europe: What is new about the Steam Sterilizer?
Larsson: Many features are new and upgraded. In particular, the control system has been upgraded to include connectivity to customers’ IT systems, data integrity, as well as the support structure. The documentation package has also been improved with ease of qualification in mind.
Pharmaceutical Technology Europe: What does "Service without borders" mean for Getinge?
Knobe: Our customers are worldwide and have activities around the globe, and one unique strength of Getinge is our global foot-print. Therefore, we are always there for our customers throughout the full lifecycles of our solutions.
Pharmaceutical Technology Europe: How does the future look for Getinge Life Science?
Knobe: We already see very good progress with positive feedback from our customers. In addition to increased orders, we have many new interesting solutions coming up, including exciting products for our unique DPTE® system for sterile transfer. The future looks bright, so stay tuned for more innovative solutions from Getinge.
Getinge is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. The company employs more than 10,000 people and has operations in more than 40 countries.
