We under­stand the impor­tance of com­pre­hen­sive val­i­da­tion process­es to ensure the qual­i­ty and safe­ty of our pack­ag­ing solu­tions for med­ical tech­nol­o­gy and phar­ma­ceu­ti­cals. We ful­fill the manda­to­ry require­ments for Swissmedic’s GPA guide­lines. Our offer includes var­i­ous types of val­i­da­tions that are specif­i­cal­ly tai­lored to the needs of our customers.

Hygiene val­i­da­tion
Thanks to our many years of exper­tise in pack­ag­ing phar­ma­ceu­ti­cal and med­ical prod­ucts under con­trolled clean­room con­di­tions in accor­dance with ISO 7 and ISO 8 and the con­tin­u­ous improve­ment of our envi­ron­men­tal mon­i­tor­ing sys­tem, we ensure the high­est safe­ty stan­dards for the prod­ucts to be pack­aged. Our aim is to pro­vide our cus­tomers’ prod­ucts with the best pos­si­ble pro­tec­tion against par­tic­u­late and micro­bi­o­log­i­cal con­t­a­m­i­na­tion from the outside.

Process val­i­da­tion
The effec­tive­ness of a process always depends on the qual­i­ty of its indi­vid­ual com­po­nents. For this rea­son, we devote the utmost atten­tion to the qual­i­fi­ca­tion of all key process­es, such as the seal­ing process and the qual­i­fi­ca­tion of our clean rooms and pack­ag­ing machines. This care­ful prepara­to­ry work forms the basis for the actu­al val­i­da­tion of the prod­uct pack­ag­ing process.

Prod­uct val­i­da­tion
Our focus is on con­firm­ing all prod­uct require­ments and, in par­tic­u­lar, the indi­vid­ual cus­tomer require­ments for the prod­ucts to be pack­aged. In addi­tion to the qual­i­fi­ca­tion of process com­po­nents, this val­i­da­tion also includes sta­bil­i­ty and per­for­mance tests such as pack­ag­ing integri­ty tests. Our aim is to ensure max­i­mum prod­uct and process safe­ty for the pack­aged cus­tomer products.

Ster­il­iza­tion val­i­da­tion
Prod­ucts that under­go final ster­il­iza­tion, such as gam­ma or X‑ray irra­di­a­tion, under­go ster­il­iza­tion val­i­da­tion in col­lab­o­ra­tion with our cus­tomers in accor­dance with the stan­dard spec­i­fi­ca­tions of the EN ISO 11137 series. This val­i­da­tion ensures that the nor­ma­tive require­ments for reduc­ing micro­bial con­t­a­m­i­na­tion are met in order to be able to label a med­ical device as ​‘STER­ILE’.