Technical cleanliness in medical technology

Con­t­a­m­i­na­tion and dirt par­ti­cles almost inevitably arise in man­u­fac­tur­ing process­es due to abra­sion or oth­er influ­ences. For this rea­son, spe­cial atten­tion is paid in med­ical tech­nol­o­gy to the require­ment of “tech­ni­cal cleanliness”.

Because: short-cir­cuit pro­tec­tion, no spark­ing, device safe­ty, etc.- — the trou­ble-free oper­a­tion above all of the elec­tron­ics in med­ical devices and clean­room suit­abil­i­ty in man­u­fac­tur­ing and pro­cess­ing “are basic require­ments that con­nect­ing parts, fas­ten­ing ele­ments and clo­sures must also meet,” says Denis Hein­rich, Busi­ness Devel­op­ment Man­ag­er at the fas­ten­ing spe­cial­ist Bossard Ger­many with branch­es in Iller­rieden and Velbert

No malfunctions and violations of regulations and guidelines

Con­t­a­m­i­na­tion can hap­pen at almost any stage of the man­u­fac­tur­ing process. Be it dur­ing thread milling of micro­screws, pack­ag­ing and ship­ping, or prod­uct assem­bly, accord­ing to Denis Hein­rich, “the risk of dirt par­ti­cles not only aris­ing but also being over­looked should not be under­es­ti­mat­ed.” The worst con­se­quences: Mal­func­tions, expen­sive rejects, vio­la­tions of reg­u­la­tions and guide­lines — and dis­sat­is­fied cus­tomers along with assert­ed war­ran­ty claims.

In prac­tice, tech­ni­cal clean­li­ness defines the per­mis­si­ble “degree of con­t­a­m­i­na­tion” or the per­mis­si­ble dirt par­ti­cle size. It is ensured by a wash­ing process with sub­se­quent resid­ual dirt analy­sis and (vac­u­um) packaging.

In con­crete terms, the parts are usu­al­ly vac­u­um-packed after clean­ing to pre­vent fur­ther abra­sion (parts rub­bing against each oth­er) dur­ing trans­port. For Bossard Ger­many, its engi­neers and brands such as PEM, it is a mat­ter of course to meet the require­ments for “tech­ni­cal clean­li­ness” from with­in its prod­uct range safe­ly and reli­ably. For exam­ple, PEM® in Gal­way has invest­ed specif­i­cal­ly in equip­ment to be able to reli­ably check resid­ual par­ti­cle sizes.

Thinking about “Technical Cleanliness” as early as the part geometry stage

Once again, the key­word is “tech­ni­cal clean­li­ness”. It is a holis­tic issue that extends from pur­chas­ing and short sup­ply chains, through mate­ri­als and man­u­fac­tur­ing meth­ods, to pack­ag­ing and the con­struc­tion of clean­rooms. Opti­miz­ing part geom­e­try is also an impor­tant approach here:

“For exam­ple, with our engi­neer­ing ser­vices ‘Expert Tear­down’ and ‘Expert Design’, we pro­vide ear­ly sup­port in the selec­tion and best pos­si­ble arrange­ment of con­nect­ing and fas­ten­ing ele­ments, which not least helps keep the total cost of own­er­ship low.”

- Denis Heinrich