Turnkey solutions for cleaning and sterile packaging of medical devices

With the new Med­ical Device Reg­u­la­tion (MDR), which has been in force since the end of May 2021, the require­ments for the clean­ing and label­ing of parts for med­ical devices as well as for the qual­i­fi­ca­tion, doc­u­men­ta­tion and trace­abil­i­ty of the process­es have increased sig­nif­i­cant­ly. At the Med-Tech Inno­va­tion Expo (Hall 2, Booth B28) in Birm­ing­ham, the SBS Eco­clean Group will pro­vide infor­ma­tion on inno­v­a­tive, glob­al­ly avail­able com­plete solu­tions for the clean­ing and pack­ag­ing of med­ical devices, with which the require­ments of the MDR and FDA can be met in a process-safe, sta­ble and effi­cient manner.

The man­u­fac­tur­ing of med­ical devices involves var­i­ous tech­nolo­gies such as pri­ma­ry form­ing, form­ing, machin­ing, extru­sion, injec­tion mold­ing and addi­tive man­u­fac­tur­ing, which leave par­tic­u­late and filmic residues on the sur­face. These con­t­a­m­i­nants, such as pro­cess­ing media, release agents, par­ti­cles, chips, burrs, abra­sion, dusts, fin­ger­prints or pow­der residues, pose vary­ing lev­els of poten­tial risk to patients depend­ing on the risk class into which a med­ical device is clas­si­fied and must there­fore be removed.

The new Med­ical Device Reg­u­la­tion (MDR) has not only brought about var­i­ous changes in the clas­si­fi­ca­tion sys­tem, but also with regard to clean­li­ness. In addi­tion to biobur­den and cyto­tox­ic val­ues, par­tic­u­late and filmic con­t­a­m­i­nants from man­u­fac­tur­ing process­es are now also tak­en into account. Require­ments have also increased for process val­i­da­tion and qual­i­fi­ca­tion, com­po­nent iden­ti­fi­ca­tion and traceability.

At the Med-Tech Inno­va­tion Expo, which will take place at the NEC in Birm­ing­ham from Sep­tem­ber 28–29, 2021, the SBS Eco­clean Group will pro­vide infor­ma­tion on its com­pre­hen­sive and glob­al­ly avail­able range of qual­i­fied clean­ing sys­tems for pre-clean­ing, inter­me­di­ate clean­ing, final clean­ing and ultra-fine clean­ing in med­ical tech­nol­o­gy in Hall 2, Stand B28. Soft­ware solu­tions spe­cial­ly devel­oped for med­ical tech­nol­o­gy appli­ca­tions as well as RFID tech­nolo­gies, audit trail and CFR 21 ensure com­pli­ance with all process para­me­ters and guar­an­tee seam­less auto­mat­ic pro­duc­tion data acqui­si­tion and trace­abil­i­ty. This port­fo­lio is round­ed off by clean­room and pack­ag­ing solu­tions that include already val­i­dat­ed pack­ag­ing mate­ri­als for implants and instru­ments. The expert team of the SBS Eco­clean Group also pro­vides infor­ma­tion on sup­port for plant qual­i­fi­ca­tion accord­ing to IQ, OQ and PQ, which are part of the scope of deliv­ery upon request.