Japanese regulatory issues for prefilled-syringes, and what is different in Japanese regulations from the USA and Europe (Taikisha Ltd, Japan, PDA Member)
The pharmaceutical market is being globaly developed, especially in Asian countries such as China, India, and some others, and ICH has continually acquired a healthy activity.
On the other hand, pharmaceutical quality is variant from every aspect of regional customs under the respecvive regulations. Mr. Daikichiro Murakami will describe some major difference between the regulations of Japan, USA, and EU on prefilled syringes, which is highly expected for future quality demand as well as in quantity.
He would also mention a few matters to challenge the latest frontiers of medicine from the viewpoint of prefilled syringe technology.
The use of container closure systems for self-injection devices (Mads Reedtz Espersen, Novo Nordisk)
From a customer/patient point of view, the quality and safety of a drug product is often linked very close to the quality and appearance of the container closure system. Drugs administered with self-injection devices by non-professionals are encumbered with a much higher risk profile than drugs administered by professionals.
This is due to the facts that the common, non-professional user may not have the same practice of use, nor the same competence or awareness to assess whether the closure integrity of the container closure system or the function of the self-injection device may be impaired prior to use.
In order to mitigate the increased risk and meet the high expectations and derived quality requirements to the primary packaging materials, the pharmaceutical industry must apply a total quality view on primary packaging. What are the regulatory requirements to primary packaging and how is an appropriate quality level achieved in practice.
Pre-filled application system and increasing market demand (Dr. Claudia Roth, Vetter Pharma-Fertigung)
International pharmaceutical market developments, characterized by growing competition and new technology, are a crucial factor for decisions concerning primary packaging and drug delivery for injectables. Dr. Claudia Roth, Vetter Pharma-Fertigung GmbH & Co. KG, describes decisive factors for launching new drugs’ and their continuing market success.
Besides a typical developmental overview and role of project management, she describes state-of-the-art application systems as essential active lifecycle management components. She also provides a helpful summary for pharmaceutical companies in a primary packaging launch situation.
The external and internal surface of glass containers: cosmetic and chemical requirements (Andrea Sardella, Nuova Ompi)
Glass containers are the primary packaging choice for drugs and vaccines in the pharmaceuticals market due to the intrinsic inert nature of glass, referring in particular to Type 1 borosilicate glass with respect to Type III soda-lime.
Essential requirements of the new biotech formulations are high hydrolytic resistance, high neutrality and chemical resistance of the inner surface to preserve drugs potential, increase shelf life and reduce rejection rate for leachable.
The “ready to fill” concept is gaining market shares not only for syringes but also for cartridges and vials and asserts the need of a highly controlled dimensional accuracy for automating processes and the highest cosmetic level to reduce more expensive end-of-line rejection rate and assuring market acceptability.
Selecting the best device for self-injection (Nila-Pia Krstulovic, Ypsomed)
This presentation gives you an insight into the world of self-injection devices, the benefits of a device for the patients and your company. In the presentation the different considerations to be made to choose the right device are highlighted.
Not every patient group has the same needs and not every device is suitable for your specific drug/primary container combination. Device considerations should therefore be made early in the project. The choice of the right device can strongly influence your success on the market.
With over 20 years of experience in the field we have assisted many customers in finding the right device for their drug. We would be happy to support you in your decision process and look forward to meeting you.
Sterile Filling and Closing under cGMP aspects (Hans Thomas, Bausch & Stroebel)
This presentation deals with Sterile Filling and Closing under cGMP aspects.
In particular Mr Hans Thomas will talk about machine design according the current cGMP guideline concerning parenteral products carrying out the FDA requirements and the safety regulations valid in the EU and he will touch reliable solutions able to handle almost every kind of pharmaceutical container available on the market, from semi-automatic to fully automatic systems, for every output required by the customer.
In relation with these topics Mr Thomas will speak about the complete production of Bausch + Stroebel comprises the individual steps: washing, sterilizing, depyrogenation, filling, closing, conveying, buffering and loading in trays.
Besides he will speak about production on line and stand-alone machines. He will also touch Qualification performance (IQ/OQ) of Bausch + Stroebel.