Safety syringe packer launched by Marchesini
handle safety syringes, which are underused in Europe compared to
the US despite their proven benefits in reducing needlestick
injuries, reports Phil Taylor. It has been developed by
Corima, which became part of Marchesini last October.
"The APS200 is able to package safety devices such as the UltraSafe Passive Delivery System produced by Californian company Safety Syringes," said Marchesini in a statement.
Syringe safety devices have been obligatory since 2000 under US legislation signed in by President Bill Clinton, but are just starting to be required in Europe. In recent months Germany became the first (and so far only) European country to require the use of safety syringes.
The reason for this slow take-up is cost, according to George Perros, managing director of market research firm Greystone Associates which published a report on the safety syringe sector earlier this year.
"Legislation has been a significant factor in the growth of safety syringes in the US, but penetration in most of Europe remains low," he explained. "European buying influences are still driven primarily by direct device cost, where traditional disposables maintain a significant price advantage."
Thanks to a spring which is automatically activated at the end of an injection, safety syringe systems allow the needle to be covered, rendering the used syringe harmless and zeroing the risk of doctors and nurses being pricked by a dirty needle.
The safety device therefore allows safe use of syringes not just for doctors and nurses, but also for those persons with chronic illnesses, who have to inject themselves and risk injury due to incorrect disposal of used syringes.
Marchesini's new APS200 comes in two versions: 200 or 300, according to the number of items produced per minute. It inserts the syringes, ready for use (with the plunger and drug in place, liquid or freeze-dried) into the safety device and uses a video camera to check that everything is assembled correctly.
If just one of the supports is out of place, the mechanism is tripped and the syringe becomes unusable. In addition to this function, the video camera can be programmed to carry out other checks according to customer requirements. The APS can also process cylindrical safety devices (they may have a square cross-section as well as a circular one) and is equipped for labelling round safety devices.
Marchesini said that the new system is easily included in existing lines, downstream of the filling and labelling machines (if the customer decides not to select the version with labeller incorporated) and upstream of the thermoformer.
The Corima APS200 has been in use in Germany where, since June 2003, it has been packaging safety devices for a leading local pharmaceutical company, and is now available for more widespread sale.
Greystone's report notes that safety syringes are growing in importance in the overall market for syringes, which exceeds 12 billion units a year and is second only to oral drugs for the delivery of pharmaceuticals.
New drug formulations, particularly large molecule biologicals that cannot tolerate the digestive tract, will keep syringes growing for the remainder of this decade, it predicts.
"But sales of traditional syringes will continue to contract as more practitioners and healthcare facilities adopt safety syringes to address the sharps cross-contamination issue."
"This market shift is being driven by regulatory activity and user awareness of the risks associated with blood-borne exposure to such pathogens as HIV and hepatitis," according the report.
While more than 50 companies compete in the safety syringe sector, the number of manufacturers that actually influence the competitive landscape is smaller, perhaps just over 20 companies, and headed in the passive device market by the likes of Retractable Technologies and Becton Dickinson. Consolidation in the safety syringe market has been a factor in shaping this sector, with mergers, acquisitions and technology licensing expected to continue to play an important role in the marketplace.
And on a technical level, the development of retractable syringes by European companies has been plagued with difficulties. For example, UK firms Medisys and New Medical Technologies have both experienced a number of difficulties bringing safety syringe products to market.