Proven MedTech Projects

How Früh Pack­ag­ing trans­ferred a gam­ma-ster­il­ized med­ical device pack­ag­ing process from Switzer­land to the US on time and on spec.

Chal­lenge

A long-stand­ing cus­tomer need­ed to move cus­tomized / ded­i­cat­ed pack­ag­ing con­cept and process from our Swiss facil­i­ty to Fruh Pack­ag­ing in Exton, PA. The tran­si­tion had to hap­pen simul­ta­ne­ous­ly includ­ing man­u­fac­tur­ing site change, with no addi­tion­al safe­ty stock and no room for delays. Any slip­page would have meant stock-out and put rev­enue at risk on the mar­ket at the cus­tomer’s end. The time­line was fixed. Miss­ing it was not an option.

For a process trans­fer of this scope, that lev­el of con­straint requires more than basic project man­age­ment. It requires a part­ner who can build a local com­pli­ant oper­a­tion from scratch while ramp­ing up onsite process­es and coor­di­nat­ing with var­i­ous stake­hold­ers includ­ing report­ing to steer­ing committees.

What We Did

We built the full con­tract pack­ag­ing oper­a­tion from the ground up at our Exton facil­i­ty. That meant new SOPs, FMEA, mate­r­i­al flow doc­u­men­ta­tion, TMV, FAI and a com­plete gam­ma ster­il­iza­tion val­i­da­tion under ISO 11137 – 1 and ISO 13485. Every doc­u­ment was cre­at­ed specif­i­cal­ly for the Exton site, reflect­ing local process­es, team struc­ture and equipment.

New team mem­bers were onboard­ed and trained to the cus­tomer’s exact stan­dards. We brought the proven Swiss process to Exton and val­i­dat­ed it end to end for US pro­duc­tion, so the same stan­dards now run local­ly. We reviewed and refined all SOPs to make sure they met the cus­tomer’s require­ments at the high­est lev­el. Through­out the project, we worked on-site with the cus­tomer to make sure every require­ment was cap­tured and doc­u­ment­ed in real time, with no gaps that could slow down the reg­u­la­to­ry path. That doc­u­men­ta­tion is not paper­work. It is what allows the cus­tomer to place the prod­uct on the mar­ket as a med­ical device, with the CP part­ner car­ry­ing full respon­si­bil­i­ty for the pack­ag­ing process.

Result

The cus­tomer released the project to pro­duc­tion on sched­ule. The project team received for­mal recog­ni­tion from the cus­tomer for deliv­er­ing on time, reflect­ing the lev­el of coor­di­na­tion and com­mit­ment across all sites involved.

Every­thing avail­able at our Swiss facil­i­ty is now avail­able to them local­ly in Exton: full doc­u­men­ta­tion, gam­ma ster­il­iza­tion, and the tech­ni­cal respon­sive­ness to adapt quick­ly when it mat­ters. For a cus­tomer with ongo­ing pro­duc­tion needs, hav­ing that full capa­bil­i­ty on US soil reduces lead times and sim­pli­fies sup­ply chain man­age­ment. The trans­fer is com­plete, and the line is running.