In early April I attended Interphex (International Pharmaceutical Expo), a trade fair in New York for the biotechnology and pharmaceutical industries. Interphex is the event for learning about new technologies, products and services in pharmaceutical manufacturing, biotechnology, drug development and cellular agriculture, bringing together thousands of professionals from all over the world. During my visit I focused mainly on quality, sustainability and ready-to-use assemblies.
Innovative products for quality, user-friendliness and specialized applications
I noticed growing interest from our partners, both suppliers and customers, in jointly exploring how to meet emerging market demands. Pre-Use Post-Sterilization Integrity Testing (PUPSIT), a key step in sterile filtration, is currently a hot topic. Discussing requirements with various stakeholders revealed how quickly expectations around PUPSIT are shifting, driving substantial innovation. The biggest gains are being made in the design of assemblies for PUPSIT and sterile filtration. Additionally, new products, such as optimised components for better connections, are being developed to enhance process quality. Validation testing for these components is expanding in parallel.
The trade fair also featured several recently launched products, including easier-to-use pinch clamps and tri-clamp fittings. Simplifying these high-quality items improves both the quality and the user-friendliness of single-use assemblies. I also see suppliers broadening their portfolios to keep up with the demand, especially for bottles/carboys and bags. Last year, the Advantapass stole the spotlight. A system facilitating sterile liquid transfer from one cleanroom to another, even through a wall. This year a smaller version was unveiled, enabling more compact cleanroom-to-cleanroom transfers.
Single-use assemblies for PUPSIT and final fill
At Hitma we specialize in single-use assemblies – systems that boost process efficiency, safety and quality – so I paid extra attention to assembly developments. A major theme was assemblies and accompanying filter skids for PUPSIT. Standardizing these assemblies and skids can make filtration processes far more efficient.
There is also extensive experimentation with overmolding, in which two or more components are molded in such a way that they fit seamlessly over one another. I’m seeing ever-smarter overmolding designs, such as tri-clamp molds and tubing split molds, that deliver more efficient and leak-proof flow. This is a very promising development for critical applications like final fill and PUPSIT.
Developments, new product and certification for a more sustainable process
More and more often I have conversations with suppliers and customers about making the supply chain more sustainable, and Interphex reflected this focus. Discussions covered reducing transport within supply chains as well as options for re-using single-use products or recycling their materials.
The Ecovadis rating, a score that evaluates companies on environment, labor & human rights, ethics and sustainable procurement, was another hot topic. Depending on supply-chain sustainability, a company can earn bronze, silver or gold status. The certification shows how actively an organization maps and reduces its carbon footprint.
A standout new product was presented at Interphex that was the result of a collaboration between our suppliers Advantapure and Carolina Components: biodegradable tubing. This more sustainable tubing can replace TPE tubing (in assemblies), reducing a process’ environmental impact.
Preparing for USP <665> quality testing
It was recently announced that the USP <665> classification will become mandatory for pharmaceutical production in 2026. USP <665> tests will be offered alongside the already available BPOG tests, which incorporate USP <88> and USP <87>. This major change in single-use product testing was a central topic in many of my booth discussions. More and more companies, including many of our suppliers, are preparing for USP <665> to become compulsory on May 1st, 2026.
Another quality-driven development is testing dimethylacetamide (DMAC) on single-use products. DMAC is widely used in manufacturing antibody-drug conjugates (ADCs), yet its compatibility with single-use components remains under-researched, prompting increasing demand for dedicated tests from different parties.
Interphex once again demonstrated how rapidly the world of single-use technology is moving and developing. If you’d like to brainstorm about developments in quality, sustainability, assemblies or any other topic, feel free to get in touch.