Coating Technology Reduces Product/Packaging Interactions

Stevanato Group combines products, technologies, and services to create tailored solutions for pharma clients. The latest addition to the company’s syringe portfolio is the Nexa Flex? pre-sterilized polymer syringe, available in both cyclic olefin polymer (COP) and cyclic olefin copolymer (COC) materials – complementing the Nexa? platform’s existing glass container solutions.

“Nexa Flex? has an optimized silicone oil distribution along the barrel that improves gliding performance while minimizing particles – while its 100% camera inspection guarantees consistent cosmetic quality,” says Silvia Gallina, Product Manager for the syringe platform at Stevanato Group.

“Moreover, it uses a tungsten-free polymer molding process to guarantee compatibly with even the most sensitive drugs.” To address the complex needs of new biologic drugs, Stevanato Group’s portfolio includes the Alba? pre-fillable syringe platform. “This solution features a cross-linked coating technology, based on standard silicone, that significantly reduces the interaction between the drug product and the container surface – a crucial development for ophthalmic drugs and highly concentrated formulations prone to silicone aggression,” says Ms. Gallina.

Another development is the growth in at-home treatment, driving a renewed focus on usability and a switch from intravenous to subcutaneous drug delivery to improve the patient experience.

“User-friendly and automatic delivery systems, such as auto-injectors, are becoming increasingly important to increase treatment adherence and improve the patient experience, enabling a successful transition from hospital to at-home treatment,” says Enrico Barichello, Product Manager for the syringe platform at Stevanato Group.

“The rapid growth of autoinjector use requires drug products to be stable in liquid form, a staked-in needle syringe for example, can accommodate a maximum dosage volume of 2mL-2.2mL, and it is becoming more important that drug containers are well fitting and do not react with the medication to avoid functionality and delivery challenges.” For this reason, Stevanato Group introduced ready-to-use vials, cartridges, and syringes that respond to the life cycle management strategies of the industry.

Technology is key to ensuring large volumes of prefilled syringes can be distributed with consistently high-quality standards. To that end, Stevanato Group implemented technology solutions into its glass processes to ensure reliable inspection and detection of dimensional and cosmetic defects, as well as particle contamination, with 100% in-line control or in-process controls. “Combining technology innovations on both process and product enables delivery of a high value-added system that provides superior performances in terms of mechanical resistance, functionality (smooth break loose and gliding forces, i.e. inferior to 5 N), and container geometries suitable for device integration in all the critical contact parts,” says Mr. Barichello.

“Additionally, a robust manufacturing process and improved controls help reduce the risk of rejection of containers, thus decreasing costly re-inspection of products.”

To further enhance the quality of its products, Stevanato Group is currently undergoing an evaluation to implement Artificial Intelligence in the glass primary packaging manufacturing processes. Beyond the manufacturing facility, primary container traceability is critical for improving production efficiency and quality. “Glass container traceability marks each primary container with a unique identity,” explains Mr. Barichello. “This machine-readable 2D barcode code allows each container to be tracked at every manufacturing process, from forming through to filing and automated inspection. This delivers significant process and quality benefits for both the glass container producer and pharma companies.”

Source: https://drug-dev.com/wp-content/uploads/2023/05/May-2023-WEB.pdf#page=59