This presentation summarizes the changing trend of the GMPs of EU and major countries, not to mention Korea. And the background and the reasons of changes have been examined and interpreted. The prospect of further development and the challenge to industry are also studied.
Overview of the standard of ISO11040-4:2015 and ISO11040-7:2015 ISO 11040-4:2015
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040 4:2015.
ISO 11040-7:2015 Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of ISO 11040-7:2015.
Prefilled syringes are industry's choice of platform for further innovating your product and adding value. With biological drug products being so complex, a huge amount of consideration needs to be taken regarding delivery method, design of primary packaging, device and analysis of product stability, safety and efficacy.
A system approach is needed because of the interaction between the biodrugs unique features (i.e. viscosity), drug delivery devices, such as autoinjectors, and syringes different geometries and elemental compositions.
All these are critical aspects that need to be carefully evaluated in order to guaranteed an effective, safe and painless injection to the patient.
This paper will highlight how to set critical parameters to fulfill these requirements.
West realizes that many of the chronic disease treatments will be administered by patients or family members. We have focused on unique devices to enable the end user to easily and safely prepare and administer the injections.
The goal of drug manufacturers is to not only deliver the best drug treatment but to offer it with administration systems for the patient and create a unique advantage for their product in the market place.
There are also many regulatory concerns regarding safe handling that need to be considered. West has devices that will help achieve these goals and is able to prepare customer devices to meet your unique needs.
Autoinjector, Pen and Dual-Chamber Custom Devices – Market Update and Lessons from Recent Customization Projects
Pen, Autoinjector and Dual-Chamber Platform Devices: Lessons from Recent Customisation Projects - Current market and recent device successes - The interface between the device and the drug container - Examples of recent device projects and lessons learned
The presentation will cover different processing solutions for ready to fill containers. For laboratory use the latest generation of semi-automatic processing modules will be explained.
Furthermore, a highly-flexible and fully-automatic system for processing clinical trials and minor batch sizes will be described followed by a small scale processing platform with flexible production trolleys that are operated in a standard isolator system.
Our medium and high speed production machines will conclude the presentation. Amongst the main systems the presentation will also touch base on available options and auxiliary equipment for processing ready to fill containers.
The presentation will cover processing solutions for the different pre-sterilized container types that are available on the market such as syringes, vials and cartridges.
The principle that Terminal Sterilization provides a higher degree of sterility assurance than aseptic processing is well understood and leads regulatory agencies around the world to require that if a product may be terminally sterilized, it must be.
Product packaging and commercial issues may not be provided as reasons for not performing a final sterilization step in the production of a sterile drug product, if the product itself can be sterilized.
Similar principles apply for sterile ophthalmic products and medical devices. As packaging and delivery systems become more sophisticated in the continuous effort to ease drug administration and improve patient safety, so the challenges to perform terminal sterilization grow: prefilled syringes, blister packaging and new plastic materials with intricate shapes require new and more sophisticated sterilization process control.
This session on Terminal Sterilization targets on Pre-Filled Syringes and will cover: How to get your PFS fast, sterile and in good shape? The physics behind Steam & Air Mixture sterilization for PFS Cycle optimization for PFS What can we achieve today and beyond?
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. This will be illustrated examples of materials, used in the manufacture of containers and closures used for parenteral applications.
It is therefore important to design the extractable study (with variables such as the type of solvents/extraction vehicles, use of drug product vehicle in extractable studies, material-to-solvent ratio, extraction times) in order to obtain correct and useful extractable information for further assessments.
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.
A new generation of automatic and semi-automatic visual inspection machines with continuous handling increases the Optrel portfolio for the next years.
New high speed and high resolution sensor technology in conjunction with more powerful real-time dedicated processing electronics open opportunities to increase the performances of the syringes inspection machines by implementing not only detection algorithm but also classification strategies in real-time.