Proven MedTech Projects

How Früh helped a lead­ing medtech man­u­fac­tur­er val­i­date a com­plex dou­ble pouch pack­ag­ing and get it right.

Chal­lenge

The cus­tomer had pri­or expe­ri­ence with pack­ag­ing val­i­da­tions and knew what they need­ed. When it came to their implant prod­uct, a dou­ble pouch con­fig­u­ra­tion designed to meet the high­est ster­ile bar­ri­er require­ments, they reached out to Früh based on an exist­ing rela­tion­ship. Time was a fac­tor, and the val­i­da­tion had to be com­plet­ed with­in a defined window.

Dou­ble pouch val­i­da­tions are inher­ent­ly more com­plex than sin­gle bar­ri­er con­fig­u­ra­tions. Every mate­r­i­al com­bi­na­tion has to per­form under trans­port sim­u­la­tion, aging and ster­il­iza­tion con­di­tions, and any inter­ac­tion between inner and out­er pouch can affect seal integri­ty in ways that only become vis­i­ble under rig­or­ous testing.

What We Did

Früh car­ried out the full per­for­mance val­i­da­tion for the dou­ble pouch pack­ag­ing under ISO 11607 and ISO 13485, includ­ing gam­ma irra­di­a­tion ster­il­iza­tion. The test pro­gram cov­ered ster­ile bar­ri­er integri­ty, pack­ag­ing mate­r­i­al per­for­mance under sim­u­lat­ed dis­tri­b­u­tion con­di­tions and accel­er­at­ed aging.

Dur­ing the process, the team iden­ti­fied that the inner pouch mate­r­i­al had to be changed from a PET-OPA-PE con­struc­tion to OPA-PE to achieve the required seal integri­ty. This is exact­ly the type of find­ing that a thor­ough val­i­da­tion process is designed to sur­face. Rather than treat­ing it as a prob­lem, the team addressed it direct­ly: a sec­ond val­i­da­tion run was ini­ti­at­ed with the revised mate­r­i­al. Früh car­ried it through to com­ple­tion and deliv­ered a ful­ly doc­u­ment­ed result.

Result

The cus­tomer received a full val­i­da­tion report con­firm­ing suc­cess­ful per­for­mance val­i­da­tion of their pack­ag­ing. The mate­r­i­al change iden­ti­fied dur­ing the process was not a set­back but a find­ing that made the final pack­ag­ing more robust. A ster­ile bar­ri­er that has been test­ed under real-world con­di­tions, refined where need­ed and val­i­dat­ed to the rel­e­vant stan­dards is one that both the man­u­fac­tur­er and their cus­tomers can rely on. The pay­off for the cus­tomer is tan­gi­ble: low­er risk of field com­plaints, a smoother reg­u­la­to­ry path and con­fi­dence that the pack­ag­ing will hold up across the pro­duc­t’s full shelf life. The prod­uct is sched­uled to launch in ear­ly 2027.