Sartorius Stedim Biotech launches Flexsafe 3D Pre-Designed Solutions for storage and shipping applications
New S80 film features consistent cell growth, robustness and high quality.
Single-use bags are increasingly used in all process steps of biopharmaceutical manufacturing. Their robustness, performance and quality consistency are crucial for ensuring the safety and economy of bioprocesses. This is why Sartorius Stedim Biotech (SSB) has developed a new polyethylene film and the Flexsafe family of bags that provide outstanding quality and significantly facilitate implementation of next-generation single-use factories. The complete control of the resins, film, bags and their final assembly, as well as dedicated supply chain and quality management for critical fluid-contact components, provides assurance of supply, reliable performance and a consistent extractable/leachable profile of Flexsafe across all process steps.
Designed for storage and shipping of biopharmaceutical fluids, SSB’s new Flexsafe 3D Predesigned Solutions (PDS) meet all the functional and validation requirements of the biopharmaceutical industry. These solutions feature the appropriate components, functionalities and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling. Fluid-contact components are available off the shelf and their availability is backed by at least 24-month change notification to provide the best delivery reliability and business continuity.
The three-dimensional single-use bags are available in a range of sizes from 50 L to 1000 L and are made of exceptionally robust, yet highly flexible, 400 µm thick co-extruded film structure. The strength of this film reduces the risk of damage to the bag, and its flexibility ensures easy installation and self-deployment of bags in containers, such as SSB’s stainless steel or plastic Palletanks. The outstanding robustness of Flexsafe bags has been demonstrated by shipping tests conducted in both airplanes and trucks and by applying the most stringent ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. This standard is designed to reflect worst-case conditions at several temperatures.
“With our Flexsafe PDS, customers can easily select and safely implement single-use solutions proven for each process step. They will fully benefit from excellent cell growth in upstream, robustness in downstream and a consistent extractable profile in final drug products,” stated Jean-Marc Cappia, Vice President of Marketing for Fluid Management Technologies at SSB.
Related News
-
News Women in Pharma: Moving beyond discussions and into best practice at CPHI Milan
In this second CPHI Milan special of our monthly series, we cover the key takeaways from the Diversity & Wellbeing track held on October 10, 2024. -
.png)
News AstraZeneca invests in AI collaboration for cancer drug trials
The British-Swedish pharmaceutical giant is partnering with biotechnology firm Immunai Inc to increase the efficiency of some cancer drug trials. -
News Ozempic and Wegovy prices questioned as Novo Nordisk faces US Senate hearing
The CEO of Novo Nordisk was grilled during a US Senate committee hearing on September 24, 2024, in which the exorbitant prices of the Danish company’s blockbuster drugs Ozempic and Wegovy were called into question. -
News The BIOSECURE Act: implications for the pharma supply chain
On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin... -
News On Track at CPHI Milan: Thermo Fisher Scientific Track Sponsor interview
With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma. -
News CPHI Milan Speaker Spotlight: Pharma Manufacturing and Localisation in Africa
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Eli Lilly licenses rheumatoid arthritis manufacturing in Africa
American pharmaceutical company Eli Lilly has signed a partnership with Egyptian organisation Eva Pharma to localise manufacturing of rheumatoid arthritis treatments in Africa.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance