OmniCure Assembly Solutions

Transcription

1 OmniCure Assembly Solutions Needle Assembly of Pre-filled Auto-injectors Challenge Rapid attachment of the needle to pre-filled, auto-injector pens. Solution The OmniCure S2000 UV Spot Curing System with Closed-Loop Feedback technology and a four-leg High Power Fiber Light Guide along with a light curable adhesive. Benefit A high speed, repeatable curing process with reduced manufacturing costs. Application Note: OMNICURE INJ003/08 Aug 11, 2008

2 Light curable adhesives are commonly used in the assembly of needles and syringes to provide bonds with high pull strength, as well as to hermetically seal these important joints. UV spot curing systems have traditionally been used to provide a very fast tack of the adhesive, holding the needle in proper alignment as it moves down the production line. Large area UV curing systems are then used to fully cure the adhesive. There is a growing demand for syringes that are pre-filled with the medicine, for ease-of use and to insure an accurate dosage. Developments in self-injection devices, such as pens and auto-injectors, allow patients added convenience to self-administer their medications. The ultimate in convenience for self injection devices is the disposable auto-injector, where the pre-filled syringe is packaged into the auto-injector. This application note provides a brief overview of a new and innovative process for assembling needles onto pre-filled auto-injectors, and highlights the important role of UV spot curing. Manufacturers can benefit from using a UV curable adhesive along with the OmniCure S2000 UV Spot Curing System and a four-legged High Power Fiber Light Guide to make the assembly of auto-injectors a more costeffective, repeatable process. Application Note: OMNICURE INJ003/08 Aug 11, 2008 Page 2

3 Market Overview UV spot curing provides significant benefits in the assembly of needles and syringes. A rapid and repeatable process is required to meet the global demand for needles; estimated to be over 20B units annually. 1 The global market for pre-filled syringes is estimated at 1B units for 2008 with a forecast of 10% compound annual growth rate. 2 provided by a UV spot curing system and final cure of the adhesive is provided by a large area UV cure system. The pre-filled syringe is then added to the auto-injector in a separate process. These processes need to be separated because the medicine within the pre-filled syringe would be adversely affected by the high UV exposure from passing under the large area UV curing system. The market for self-injection devices such as pens and auto-injectors is also enjoying above average growth. Insulin is the largest use for self-injection devices followed by human growth hormone (HGH) and newer therapies such as fertility treatment (follicle stimulating hormone [FSH]) and osteoporosis. 3 There is expected to be continued growth in this segment, as the World Health Organization (WHO) estimates that more than 180 million people worldwide have diabetes. This number is likely to more than double by In the US, it is estimated that 23.6 million children and adults, or 8% of the population, have diabetes. This is an increase of more than three million people in two years. 5 Figure 2 :: Auto-injector pens However, new UV spot curing systems such as the OmniCure S2000 UV Spot Curing System and High Power Fiber Light Guides now allow manufacturers of auto-injectors to combine these steps for a more streamlined, cost effective assembly process. The needle assembly can now be attached and the adhesive completely cured using two OmniCure S2000 UV Spot Curing Systems, each with a four-legged High Power Fiber Light Guide. This can be done with the pre-filled syringe already inserted. Figure 1 :: Insulin pens / glucose meter Assembly Process for Pre-filled Auto-injector Pens The manufacturing process for pre-filled, disposable auto-injector devices required separate steps for a) tacking, b) fully curing the needle to the auto-injector, and c) filling the auto-injector with the required medicine. The needle is attached using a UV curable adhesive. An initial tack to hold the needle in place is The process is simplified by eliminating the need for a secondary large area UV system to fully cure the adhesive. The pre-filled syringe can be inserted prior to assembling the needle because spot curing systems focus a precise spot of UV light onto the needle hub joint only, so the medicine is not exposed to UV light. A UV spot curing system must be integrated into this fully automated process and provide enough energy to fully cure the adhesive in under a second in order to realize the cost benefits of moving to this simplified process. The powerful 200W lamp used in the OmniCure S2000 System provides plenty of curing power to fully cure the adhesive in under a second. Multiple options for 1. Article Maxxon to Receive Safety Syringe Delivery, In-Pharma Technologist.com, Jan Article Suitability for Use, Considerations for Prefilled Syringes, PharmTech.com, Article Market Trends for Self-injection Technologies: Pens and Auto-injectors, Ian Thompson, July Diabetes Fact Sheet, World Health Organization website, Sept Diabetes Statistics, American Diabetes Association website, 2007 Application Note: OMNICURE INJ003/08 Aug 11, 2008 Page 3

4 controlling remotely allow it to be easily integrated into any automated system. In this assembly process, the adhesive must be cured evenly along the entire bond-line to maintain the proper alignment of the needle. Uneven curing of the adhesive could pull the needle out of alignment, creating a defective part. Proprietary technology found within the four-legged High Power Fiber Light Guide delivers equal energy to each of the four legs. Two sets of OmniCure S2000 Systems with four-legged light guides are used. The four legs for each system are oriented 90 degrees from each other for even curing over the entire bond line. The second set of legs is rotated 45 degrees from the first set. This will provide fast, even curing of the adhesive. The assembly process for any medical device must be controlled and repeatable. The OmniCure S2000 System includes Closed-Loop Feedback technology to automatically maintain a repeatable dose of UV energy to each needle assembly. UV curing systems without this feature require additional user intervention to maintain a constant dose or risk changes in their process which could result in inconsistency in the finished parts. Manufacturing of pre-filled auto-injectors requires that the UV adhesive be cured fast, evenly and without exposing medicine to UV light. Lumen Dynamics OmniCure technology offers unique benefits over and above standard UV curing, ensuring fast, even, repeatable curing of the needle to the hub for optimal assembly of specialized disposable medical devices. LUMEN DYNAMICS UV CURING TECHNOLOGY PRECISE AND REPEATABLE The OmniCure S2000 UV System cures UV adhesives in seconds and can easily be integrated into fully automated production processes. The four-leg High Power Fiber Light Guide ensures that the adhesive is cured evenly so that the needle is maintained in proper alignment. The Closed-Loop Feedback technology found in the OmniCure S2000 System ensures constant irradiance levels, for a repeatable curing process with consistently strong bonds. The OmniCure S2000 Spot Curing System can focus the light on the needle joint only, so that the medicine is not exposed to UV light. Application Note: OMNICURE INJ003/08 Aug 11, 2008 Page 4

5 2260 Argentia Road, Mississauga, Ontario, L5N 6H7 Canada Telephone: Toll Free (USA and Canada): Facsimile: