News

DHM® Analysis Method for Syringe Silicone Coatings

Stevanato Group — Tue, 17 Mar 2026 23:15:00 GMT

Executive Summary

Pre-filled syringes (PFSs) are a preferred way to administer parenteral drugs like therapeutic proteins due to benefits like dosing accuracy, patient convenience, and reduced risk of contamination. However, they have the challenge of being both the drug storage container and the drug delivery device. To ensure proper functionality, the inner surface is often coated with silicone oil but this may degrade over time, especially in the presence of drug product. A new method to measure the coating is by using Digital Holographic Microscopy (DHM^®), a patented technology by Lyncée Tec (Lausanne, Switzerland). Specialized 3D interferometers are used to characterize the entire inner surface area, allowing quantitative measurements of the quality of the deposition, such as coating volume and homogeneity of the distribution. To investigate its suitability for silicone-coated syringes, Stevanato Group’s EMEA TEC (Piombino Dese, Italy) compared its performance against traditional silicone weighing for 29 syringes.

ITC EIC Syringe for IV Drug Delivery | Stevanato Group

Stevanato Group — Thu, 23 Oct 2025 22:00:00 GMT

Addressing FDA Concerns in IV Drug Delivery

Recent communications from the U.S. Food and Drug Administration (FDA) have highlighted connection issues involving certain needleless prefilled glass syringes and intravenous drug delivery systems*. These concerns underscore the importance of reliable device compatibility in clinical settings, especially during emergency situations. In response to these challenges, Stevanato Group has developed an ITC syringe featuring an Enlarged Inner Cone (EIC), designed to improve compatibility with needleless access devices.

Vial Mechanical Resistance Research Study | Stevanato Group

Stevanato Group — Tue, 07 Jan 2025 23:15:00 GMT

Executive Summary

Introduction: Ensuring the mechanical resistance of pharmaceutical glass vials is crucial for safe and efficient drug delivery. While allowing for high throughput and efficiency, the bulk Fill & Finish process exerts high level of stress on glass containers, such as glass-to-glass contact and vertical loads, which can lead to cosmetic defects and breakages. Superior vial quality mitigates the negative impact of this stress, improving filling process performance and output as well as reducing the risk of container breakage during transport.

2R Vials Under Deep Cold Storage | Stevanato News

Stevanato Group — Thu, 14 Nov 2024 23:00:00 GMT

Executive Summary

Evaluating the performance of containers on a case-by-case basis is always recommended. But increased assurance about the compatibility of glass containers with cold storage conditions is key for pharmaceutical companies facing development issues with mRNA vaccines. In this increasingly complex application, Stevanato Group glass vials are a proven solution to make life easier for customers.

Innovating Compendial Testing in Pharma | Stevanato Group

Stevanato Group — Tue, 27 Aug 2024 22:15:00 GMT

Executive Summary

As the pharmaceutical industry shifts towards advanced therapeutic solutions utilizing monoclonal antibodies and cell and gene therapies, there is a growing shift towards personalized, smaller batch sizes in contrast to larger batch sizes associated with traditional medicinal products.

Improving Drug Delivery Device Development | Stevanato Group

Stevanato Group — Mon, 15 Jul 2024 22:15:00 GMT

Time to market is critical in the fast-paced world of drug delivery devices – so streamlining the product development process by having design and development teams under one roof makes business sense.

How We Optimized RTU Cartridges Nests | Stevanato Group

Stevanato Group — Tue, 02 Apr 2024 22:00:00 GMT

Opportunity

RTU cartridges undergo effective, fast and eco-friendly steam sterilization, which exerts thermal stress on the nest. The temperature of the plastic is raised to a point where the material characteristics are permanently modified. Optimizing this natural phenomenon is crucial to meet the dimensional control targets of ISO 11040-7 and guard against glass handling issues and potential breakages.

RTU Packaging and EU GMP Annex 1 | Stevanato Group

Stevanato Group — Wed, 28 Feb 2024 23:15:00 GMT

With much of the innovation coming in the form of smarter solutions for aseptic manufacturing, combined with the constant evolution of regulatory requirements, there is ever-greater demand in quality; specifically in terms of protecting the integrity of medication and reducing contamination via particulates.

CDMO Benefits from EZ-fill® Solutions | Stevanato Group

Stevanato Group — Tue, 09 Jan 2024 23:15:00 GMT

Interview to Eugenio Starita, Pharmaceutical Consultant; Industrial Operations & CDMO Expert.

Enjoy the journey of a CDMO choosing EZ-fill® pre-sterilized vials and syringes. A story of a perfect match for quality, flexibility and ROI.

10 Years of Nexa® EZ-fill® Innovation | Stevanato Group

Stevanato Group — Wed, 29 Nov 2023 23:00:00 GMT

The continued growth of biologics and biosimilars is placing pressure on the performance of primary packaging and the effectiveness of fill-finish operations due to their complex properties.

Managing these typically high-value products means addressing the risk of container breakages, and the risk of particle contamination which is an increasing area of concern for regulatory bodies, as highlighted by the introduction of the revised GMP Annex 1 for the manufacture of sterile medicinal products. In the context of these growing pressures, ready-to-use (RTU) containers are experiencing growing demand.