Quality assurance and validation of Prefilled Syringe (Daikichiro Murakami, PDA Japan Chapter)
Although the spread rate of prefilled syringes is not so high as those in USA and Europe, some points should be discussed in the technical and theoretical respects.
Even if the marketing situation is apparently different between Japan and Western countries, some distinct PFS characteristics could be expressed under the Japanese mind of precision as common subjects in pursuit of quality pharmaceutical products.
Case Study: Development of a pen device / autoinjector - what needs to be considered ? (Ralf Kuenzi, Ypsomed)
This presentation describes how a self-injection device is developed from the first idea all the way to a fully industrialized product.
The key criteria for selecting the appropriate primary container and the corresponding device type, the essential parameters for the container–device interface and the main rationale for selecting either a disposable or reusable device are explained.
Advanced label solutions for pre-filled syringes (Rainer Alberth, Schreiner MediPharm)
The presentation provides an overview on state of the art technologies for the labeling of syringes. Customized label solutions with integrated functionalities can add value to the product, considering regulatory as well as marketing aspects. Labels including documentation segments can for instance play an important role in patient safety.
In the field of anti-counterfeiting and track & trace, integrated security features help increase the hurdle for counterfeiters. As regards the important topic of needlestick injury prevention in healthcare environments, labels with integrated needle protection offer benefits to end users as well as pharma manufacturers, combining safety and cost efficiency.
Besides, barcoding on unit doses is increasingly demanded by the market, and interactive electronic communication with labels will become more important in the future.
In-Line Sterilization Tunnels using Electron Beam for the Pharmaceutical Industry (Philippe Fontcuberta, Getinge Linac)
In-line sterilization by electron beam was introduced to the PFS industry in the early 2000's, with low energy self-shielded systems for surface treatment of tubs containing pre-sterilized syringes in the nest, at the point of entry into the fillling line under isolator.
The technology brings benefits to pharmaceutical manufacturers since e-beam sterilization is fast, continuous, repeatable, economical, recordable, can be monitored and is easy to validate.
Over 20 low energy systems have been installed These benefits have now been extended to the terminal sterilization of pre-filled syringes by in-line systems using medium energy electron beam accelerators. On-going projects include the sterilization of primary packaging (plastic vials and containers).
New concepts for aseptic processing of syringes (Hans Thomas, Bausch & Stroebel)
Bausch + Ströbel, one of the world’s leading manufacturers of pharmaceutical equipment, will present their new concepts for aseptic processing of syringes. Today’s principal topics will be the processing of syringes in bulk and in nests.
The processing in bulk with an individual transport system comprises the following steps: removal of syringes from the trays, washing, sterilizing, filling, closing and insertion of syringes into trays.
The high speed processing in nests comprises the steps: tub debagging, removal of foil lid and liner, filling and closing of syringes. Further processing of syringes consists of labelling, plunger rod insertion, assembly of safety devices and back stops.