Scope of the ISO Technical Comity 76 (ISO/TC 76) is: Standardization of containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.
This presentation provides an overview of key self-injection devices, such as auto injectors, and how they support the growing trend of injectable biologics coming to market.
The session starts with an introduction of different types of auto injectors and pen injectors, including some products that have helped to revolutionize the industry. Trends such as the increased importance of human factors, regulatory changes, alternative materials for primary drug containers and speed to market demands related to an influx of generic injectable and biosimilars will be highlighted.
Based on the practical experience of working with leading biopharmaceutical companies to develop such devices, the speaker will provide advice on what to look for when identifying suitable partners to support these combination product programs.
Auto-injector devices are made up of complex and delicate components which require a well-orchestrated balance in order to perform properly.
Failures within auto-injector devices have lead to costly product recalls as well as delays in product commercializations. Stalled device activations, long injection times, foreign particle contamination, and improper dosings are all symptoms of undetected problems during the production life cycle.
Many factors are required to be analyzed which may necessitate the use of advanced statistical and data mining tools in order to correctly identify the root of the problem. Causes may include variations in plunger diameter and compressibility, variations in needle length and diameter, non-uniform barrel geometry, poor barrel siliconization, as well as variations in auto-injector spring forces.
This presentation outlines recommended methodologies for root cause investigations including required sample sizes, types of tests and their efficiency, and introduces new tools for use in statistical analysis.
The presentation will first very briefly go over some basic definitions of Extractables and Leachables, the importance of Extractable Leachable testing and the most important Regulatory Guidelines (US, EU) for container/closure systems for parenteral applications.
In a second part, the set-up of extractable studies for parenteral applications will be touched upon.
Subsequently, the presentation will illustrate how the list of extractable compounds, obtained after a carefully designed extractable study, can be narrowed down to a list of target compounds that can be subject to a toxicological assessment or a targeted leachable study.
In a last part, the approach of how to design leachable studies for primary packaging of parenterals will be explained and illustrated.
Fill-finish new concept for RTF vials, syringes and cartridges (IMA)
The presentation focuses on a new, innovative fill-finish concept to alternatively process nested syringes, vials, and cartridges for small to medium batch sizes.
STERI LIF3 is a fully automatic, highly flexible filling, stoppering and capping machine applying dedicated robotics to efficiently ensure product transfer/handling operations and single-use disposables to deliver state-of-the-art processing of sterile injectables.
The compact integrated capping operations offers the reliability of an automated production line, minimizing space and preserving cross-contamination risks.
The machine is designed for aseptic environments and suitable for barrier technology implementation, thus answering to the cGMP regulatory expectations and current FDA guidelines.