PDA Event Covers all Aspects

The homecare sector is rapidly growing and, in parallel, the demand for pharmaceutical syringe systems which are easy-to-use and safe for self-injection is on the rise around the world. At this year’s US syringe conference held by the Parenteral Drug Association (PDA) in San Diego – “The Universe of Pre-filled Syringes & Injection Devices” – the Gerresheimer Group presentation deals with the highly topical subject of self-injection from a technical viewpoint. At the exhibition, Gerresheimer also displays RTF® (Ready to Fill) syringes with the latest track-and-trace features, multi-colour printing and intelligent accessories .

Planning and design of efficient systems which facilitate that drug, syringe and autoinjector device with their complex interactions work together smoothly is a challenge from the very start. Key considerations for pharmaceutical manufacturers and the ideal configuration of combination products is outlined by two experienced specialists from Gerresheimer’s competence centre in Bünde: Dr. Arno Fries, originally from the pharma industry himself, is responsible in the Group’s syringe business for running the US sales organisation and is Director of International Product Management, and Erik Brandhorst is directly involved in developments and tests as Project Engineer. Their joint presentation (“Pre-filled syringes and autoinjectors – what is important for an efficient system?”) examines both market developments and users’ needs – but above all it covers the multifaceted questions which have to be addressed as an integral whole in drug-delivery systems. When an increasing number of components are combined, entirely new aspects need to be harmonised in order to ensure that the medication and its automated drug delivery system work together in a synergetic manner.

Recent comparative studies on the functionality of complex autoinjector systems provide valuable information. The speakers present scientifically founded data and analyses documenting gliding forces as well as effectiveness of different siliconisation methods for smooth plunger movement. The evaluation provides new findings about processes which have been tried and tested over a considerable time and now been refined to perfection.

Gerresheimer has by the way just been awarded a patent for another siliconisation process in the USA. It involves baked-on siliconisation where the lubricant is permanently fixed to the glass surface by means of heat. The technology is ideally suited to reduce undesired interactions between silicone oil and proteins, peptides or other sensitive biopharmaceuticals.

Laser encoding and heat-transfer printing: How syringes will communicate in the future
With high-tech for injections Gerresheimer is ranked among the pioneers in an internationally important market segment of drug delivery. Syringe technologies such as RTF®, intelligent accessories - such as TELC (the tamper evident Luer lock closure) and TERNS (the rigid needle shield based on thermoplastic elastomer) - and special process technologies are showing steady growth. In addition, the Group’s combined glass and plastics competence today means that complex systems for self-injection such as insulin pens can be conceived, developed and manufactured completely in-house.

Highlights from glass out of this comprehensive range on exhibit by Gerresheimer in San Diego include also two other state-of-the-art features: one a barely perceptible identity code and the other, by contrast, highly visible multi-colour printing.

 

• On one square millimetre of the surface of the finger flange on pre-filled syringes Gerresheimer can by means of laser encoding accommodate all the data required for reliable identification of a drug dose. Baked indelibly into the glass during production and scanner-readable like a barcode, the innovative squares show all the time origin and designation of use for the product, thus avoiding confusion and providing track-and-trace information, currently a key requirement particularly for the FDA (Federal Drug Association) and the EMEA (European Medicines Agency).
• Heat-transfer printing on the other hand optimises direct communication between product and end-user. The new process allows multi-colour printing directly onto glass – of course in a continuous work process and even with customary colour types. The advantages are obvious: specifications, information on applications, use-by dates, barcodes and calibrations in different colours are easier to understand and record compared to single coloured codes – a clear security plus. Marketing aspects are also important: even multi-colour company logos can be perfectly reproduced.

“As we can clearly see, demand-oriented system development for the pharma and life-science industry has an infinite number of facets, and the market in the field of injections is constantly moving”, says Burkhard Lingenberg, Director of Marketing and Communication for the Gerresheimer Group: “This is why symposiums like this are so important.” Gerresheimer was after all one of the initiators of the PDA series of events which had its premiere in Germany in 2004 and was imported to the PDA’s home country two years ago. The concept has proved its worth. This time there is certainly no shortage of objectives, requirements and development successes which merit discussion.