Following the more frequent request for ready for filling containers, ISO TC76 published in 2015 the standards for sterilized sub-assembled ready-to-fill glass syringes ISO 11040-4 and ISO 11040-7, including the corresponding packaging system. These two standards define the production of the glass syringes and the related test methods, as well as the “ready for filling” packaging.

In November 2016, ISO TC76 published ISO 11040-8 Requirements and test methods for finished prefilled syringes.Due to the increasing market presence of syringes “ready for filling” and the associated advantages of this product for the pharmaceutical industry, the suppliers of packaging materials started to develop systems of this type for vials.

ISO TC76 is developing two International Standards to specify the characteristics of sterile and ready for filling empty glass vials and cartridges, including the minimum requirements of materials, the packaging systems and analytical test methods (ISO CD 21881 and ISO CD 21882).

After a short introduction to DuPont Tyvek® and its applications, the presentation will address various sterile packaging applications for pharmaceutical containers, ranging from nested syringe tubs, stopper and closure bags to the new offerings of sterile cartridges and vials.

The author will summarize basics of packaging design, process development and validation per ISO 11607, the international standard for packaging of terminally sterilized medical devices and will also provide an inside into upcoming revisions. Testing of integrity and microbial barrier of materials through transportations and stability tests are critical to provide evidence for maintenance of sterility of ready-to-fill containers.

Maintaining a status of validation requires continuous verification and control as well as dedicated change management. Addressing all life cycles stages in a quality-bydesign, science and risk based approach as well as applying adequate controls and change management form the basis of state-of-the-art maintenance of sterility until the point of use.

In an evolving healthcare environment, Drug Delivery Systems as Auto-injectors have the potential to generate a significant reduction in total national medical costs by allowing patients to self-inject a therapy without medical supervision or additional equipment. Enabling a patient to self-administer during the course of their normal daily lives, such as at home, work or even at a café, can significantly improve quality of life and increase therapy compliance.

Nevertheless, the development of a Drug Delivery System is rather complex and may pose some technical challenges related to the different set of components involved, beyond the classical primary packaging. Only the companies that can offer an holistic view and a combined set of capabilities, from project management to manufacturing readiness through device integration, can help to mitigate the risk associated to the development challenges.

This paper will explain how SG covered these challenges in recent developments.

As healthcare evolves, drugs have become more and more complex.  The complexity, has led the industry to analyze in depth the different possible interactions of the drug with its environment.  Hence, the analytical services for Glass Containers has become fundamental in understanding the physical, chemical, and biological performance of the drug.

The analytical services of the glass container can guarantee a superior Know-How about the primary packaging system in other to guarantee the efficacy and performance of the drug, as well as the patient’s safety. Regulatory entities across the world are pushing for a deeper understanding and testing of the primary packaging performance.

The primary packaging system need to be understood from all the different components; the glass, rubber closures, and / or other treatments (example: silicone, coatings, etc..).  A profound scientific knowledge of all the system is mandatory to be able to provide accurate and reliable data.

This presentation aims to provide how the knowledge and scientific partnerships are necessary to be able to guarantee the wellbeing of the patient.

The design of extractables and leachables studies for Pre-Filled Syringes depends on the intended application. Therefore, every specific case requires a tailor-made study set-up.

This presentation will initially discuss the basic definitions of extractables and leachables, before going over the most important regulatory guidelines, on to the actual design of the E/L studies. It will focus on the most important variables to consider (type of extraction solvents, material-to-solvent ratio, temperature, extraction times…) and how to obtain correct and useful extractable information for further assessments.

Subsequently, it will demonstrate how the list of obtained extractable compounds can be narrowed down to a list of target compounds that can be subjected to a toxicological assessment or be used in a targeted leachable study. In a last part, the set-up and time line of leachable studies for pre-filled syringes will be explained and illustrated.

In the global sterile injection manufacturing field, Europe, the United States, Japan and other high regulatory markets are featured with the increasing development of flexible manufacturing model with the rise of bio-pharmaceuticals - the basic characteristics include: high value, low yield, automation, complete isolation, flexible manufacturing, the use of pre sterilization parts and the application of disposable technique.

Flexible manufacturing is the direction of the development of future high-end pharmaceutical plants, which not only refers to certain equipment or workshop, but covers all aspects from the pharmaceutical plant construction to equipment manufacturing and software engineering.

The features of flexible manufacturing are mainly reflected in the “Modular design concept”, “Easy-to-expand production mode”, and “Reproducible best effect”. This speech will from the equipment manufacturing, software engineering, etc., to explore the pharmaceutical plant for the latest equipment and equipment needs, and its solutions.

As the race for biosimilars, new biologics and other self-injected drugs is on, many pharma companies build up portfolios of injectable drug candidates many of them requiring a self-injection device for successful market launch. As the number of devices reaching the market increases, pharmaceutical and biotech companies are looking to source state-of the-art devices that are available quickly and at low risk for both clinical trials and commercial launch. A self-injection device should provide safe and effective dosing as well as product differentiation through improved human factors and increased safety compared to vial-syringe.

This presentation provides an introduction into the field of self-injection devices and explains the main requirements and technologies for the different therapies. The important device categories and features are presented and the interaction with the glass primary packaging will be explained. The presentation explains the differences between multidose devices for small, daily injections with variable dosing and fixed single dose autoinjectors in regard on the self-injection device.

Further the presentation gives an outlook on the future trends for self-injection with smart connected devices and large volume patch injectors.