What is required to qualify primary packaging materials for Large Volume Parenterals (LVPs)? What factors should be considered when selecting the appropriate material? In this webinar, Dr. Bianca Schweiger and Christian Kunz from PolyCine, a pharmaceutical film manufacturer, will provide valuable insights into the requirements for IV-solution primary packaging materials.
The presentation will cover the entire production and qualification process for pharmaceutical films used in LVPs. Attendees will learn about the specific requirements these materials must meet to ensure they are suitable for use in IV solutions. This includes understanding the production processes involved in manufacturing these films and the rigorous regulatory requirements that apply.
Dr. Schweiger and Mr. Kunz will discuss how pharmaceutical films are produced, highlighting the critical steps in the production process that ensure the films meet the necessary standards for safety and efficacy. They will also delve into the regulatory landscape, explaining the various regulations that govern the use of these materials in medical applications.
The webinar will provide a comprehensive overview of the factors to consider when selecting primary packaging materials for LVPs. This includes the material’s compatibility with the drug product, its ability to maintain the integrity and sterility of the solution, and its compliance with regulatory standards.
This session is essential for professionals involved in the production, qualification, and regulatory compliance of primary packaging materials for Large Volume Parenterals. By attending, participants will gain a deeper understanding of the critical considerations and requirements for selecting and qualifying materials that ensure the safety and effectiveness of LVPs.