Prefilled Syringes, p. 40 - Safety Syringes, Inc.

Drug DeliveryIncreased demand for the BD Hypak syringedrove BD to open a new facility.dled by others. Even at home, patientsare concerned about possible risk tochildren in the household. Therefore,the demand is growing for needlesafetydevices not only on productsdestined for administration in OSHAregulatedhospitals or clinics but alsoon those marketed for home use.SSI, which introduced the manuallyactivated UltraSafe Needle Guard in1999, now offers a passively activateddesign, the UltraSafe Passive DeliverySystem, which is integrated with Pharmacia’sFragmin. (The integratedUltraSafe/Fragmin product has beenon the U.S. market since August 2002).SSI offers the UltraSafe Passive DeliverySystem to other users and canaccommodate a broad range ofsyringe sizes and staked or luerlock/slip needle configurations.“We believe that the UltraSafe PassiveDelivery System offers the highestlevel of compliance,” SSI’s Miller says,“because as long as the clinician administersthe full dose of product, he or shecan be assured of safety guard activationwith no thought or further actionrequired. When the plunger bottomsout, the syringe slides back into thebody of the device, and the needle iscovered by the guard portion of thedevice. Our market research supportsthe belief that clinicians want needlesafety and ease of use. The UltraSafePassive Delivery System maintains currenttechnique, thus it is familiar andrequires little or no training.” SSI’s currentcustomer base includes Abbott,Amgen, Bayer, Pharmacia, and Ortho.The UltraSafe Passive Delivery Systemwill be integrated with a Europeanpharmaceutical prefilled syringe andlaunched in 2003.”BD supplies the BD Preventis safetydevice that Aventis is using on Lovenoxprefilled syringes, the largest-selling prefilltherapy in the United States. Thecompany offers BD Preventis as a stockitem for use with BD Hypak prefilledsyringes. BD designed and manufacturedboth the syringe and safety device,ensuring that they work together optimallyas a system, both for the pharmaceuticalcompany’s processing needsand for end-user safety and ease of use.West offers a captured-needle versionof its Clip’n’Ject prefilled diluentsyringe. In this design, a safetydevice that contains the syringemates to the vial. When the userwithdraws the syringe after reconstitutingthe drug and drawing it backinto the syringe, the needle remainsshrouded within the safety device.The user may then attach a new needlefor drug administration.In January of this year, TAPannounced the availability of LupronDepot packaged with an integratedneedle-safety device, the LuproLoc.Specialized Health Products International(SHPI; Bountiful, UT), a manufacturerof needle-safety devices,custom engineered this device for TAP.Mark Ferguson, SHPI’s director ofproduct development, says the deviceis a modification of SHPI’s FlexLocdesign, a manually activated foldingplastic needle-safety shield that isadvanced over the needle by the userfollowing the use of the syringe. Thecompany’s safety needle devices forprefilled syringes are suitable for virtuallyany syringe, particularly customsyringes with or without stakes needles.Dennis Kim, TAP’s manager ofpackaging development, says thesyringes are manufactured, sterilized,and filled in Japan. Secondary packagingand primary labeling, however,occur in the United States. It is duringthis secondary operation that theLuproLoc is integrated with thesyringe. Ensuring that the devicescould be attached without compromisingproduct sterility was essential, aswas developing a design that wouldwork with the existing syringe.“We were unable to use a snap fit,because that would have required us tochange the syringe,” Ferguson relates,“so we opted for a spin weldingprocess.” TAP added a rotary tablethat incorporates a spin welder (BransonUltrasonic Corp., Applied TechnologiesGroup, Danbury, CT) intothe packaging line.Choosing a material for the safetydevice was not easy, either. “We neededto find a resin that had a low meltindex and good injection-moldingproperties and was compatible withthe resin of the syringe hub,” Kimsays. “Fortunately, Branson and SHPIhad experience in this area.”EXPANDING CAPACITYMany suppliers are adding capacityto accommodate market growth.Wright says Baxter currently hasabout 120 to 130 million units ofcapacity and is expanding that significantly.By the end of the year, she says,Baxter will have three high-speedsyringe fillers in operation.Turns says Vetter, which is an FDAapprovedsite for prefilling syringes inRavensburg, Germany, commissionedits latest two filling suites just this year,which added approximately 75 to 80million units. “With what we havein place, we can make around 300million pieces a year. Just last monthwe began construction in a third facilityto be completed and making FDAapprovableproduct in 2007,” he adds.BD just built a new BD Hypakfacility, located in Columbus, NE. “Wehave two other large plants: one inFrance, one in Mexico,” Mayer says.“These plants, using the same manufacturingtechnologies, can operate virtuallyindependent of one another andare designed to meet world demandfrom multiple locations.” ■Reprinted from Pharmaceutical & Medical Packaging News, May 2003 Copyright © 2003 Canon Communications LLC