Accelerated and Real Time Aging / Stability Studies

This presentation will cover the critical steps to follow when qualifying a product for the irradiation sterilization process: Qualification of the sterilization dose Qualification of the maximal acceptable dose The presentation will: -Explain the current process mainly used in the medical and pharmaceutical industries and challenge the status quo. -Demonstrate the benefit on throughput and process capability which are two critical factors in the supply chain. -Cover a case study will be used to demonstrate the principle.

The recent move by the FDA to reclassify VHP sterilization as an Established Category A technology is a significant development for makers of single use medical devices and packaged, prefilled syringes. VHP’s ongoing technology journey and the ever-increasing growth of innovative medical devices are well aligned for the benefit of the industry. The next step for VHP sterilization standards is EN 17180 - Sterilizers for medical purposes — Low temperature vaporized hydrogen peroxide sterilizers — Requirements and testing, currently estimated by the end of 2024. There is also a new work item for the ISO 11138-6 standard for VHP biological indicators. Regardless of being validated per ISO 22441 or ISO 14937 - the same basic guideline is followed. This presentation mainly provides insight and guidance on how to approach VHP sterilization process validation per ISO 22441, but also provides an overview to VHP sterilization technology and applications and current developments in regulatory field.

The validation of healthcare sterile barrier packaging prior to placing on the market is of the upmost importance to the safety of end user and patient. This presentation will give an overview of the tests that support this validation and provide guidance on the standards typically used during OQ, PQ, after transportation testing and shelf life studies.

Vaporized Hydrogen Peroxide (VHP or VH2O2) is a growing option for sterilizing pre-filled syringes that contain an aseptically filled biological product. The sterilization of the syringe exterior surfaces, packaging, and associated components allows for a sterile presentation to the patient reducing the risk of infection. The recently published ISO 22441 standard defines the development, validation, and controls for VHP sterilization, however, there are several steps to consider as part of the feasibility process for pre-filled syringe products. This presentation will focus on the key areas to consider for pre-filled syringe designs used in a VHP sterilization process. Items discussed will include best design practices for vacuum tolerance, materials, and flow path considerations.

Proper definition of sterilization and max dose values is critical to the creation of a robust radiation sterilization process as part of your product’s route to market. Radiation Technology Center Senior Manager Pierre Reppert shares best practice for processing samples to define these values for gamma, e-beam and X-ray radiation processing.

The validation of healthcare products and sterile barrier packaging prior to placing on the market is of the upmost importance to the safety of end user and patient. This presentation will give an overview of supporting testing and provide guidance on conducting successful studies.

In this webinar, originally broadcast as a part of Pharmapack Europe 2022, speakers from STERIS will be describing the methodology for transferring the sterilization process of medical or pharma products from one radiation technology to another (e.g. gamma to X-ray).

In this webinar, originally broadcast as part of the Pharmapack Europe show, speakers from STERIS will discuss: Transportation testing accelerated aging and package integrity testing overview How to construct a packaging validation protocol What new requirements are there for the recent releases of ASTM F1980 and ASTM D4169 Device test considerations

This webinar will address: Current state of X-ray sterilization General industry approach to sterilization validation Technology transfer requirements How STERIS can support this approach This webinar originally aired as part of Pharmapack Europe 2021

This webinar will address: Transportation / Distribution Testing Accelerated and Real-Time Aging Package Integrity and strength testing This webinar originally aired as part of Pharmapack Europe 2021

This webinar will address: Device and Application Feasibility Cycle Development Validation This webinar originally aired as part of Pharmapack Europe 2021