We under­stand the impor­tance of com­pre­hen­sive val­i­da­tion process­es to ensure the qual­i­ty and safe­ty of our pack­ag­ing solu­tions for the med­ical devices and phar­ma­ceu­ti­cal indus­tries. In doing so, we com­ply with the manda­to­ry require­ments for the GPA guide­lines of Swissmedic. We offer var­i­ous types of val­i­da­tions that are tai­lored to the needs of our customers:

Hygiene val­i­da­tion
Thanks to our many years of exper­tise in pack­ag­ing phar­ma­ceu­ti­cal and med­ical devices under con­trolled clean room con­di­tions accord­ing to ISO 7 and ISO 8 as well as the con­tin­u­ous improve­ment of our envi­ron­men­tal mon­i­tor­ing sys­tem, we ensure the high­est safe­ty stan­dards for the prod­ucts we pack­age. We are com­mit­ted to pro­vid­ing the best pos­si­ble pro­tec­tion against exter­nal par­tic­u­late and micro­bi­o­log­i­cal con­t­a­m­i­na­tion for our cus­tomers’ products.

Process val­i­da­tion
The effec­tive­ness of a process always depends on the qual­i­ty of its indi­vid­ual com­po­nents. We there­fore pay par­tic­u­lar atten­tion to the qual­i­fi­ca­tion of all key process­es (e.g. the seal­ing process) as well as 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 require­ments of the prod­ucts and, in par­tic­u­lar, the indi­vid­ual cus­tomer require­ments for the prod­ucts to be pack­aged. In addi­tion to the qual­i­fi­ca­tion of the process com­po­nents, this val­i­da­tion also includes sta­bil­i­ty and per­for­mance tests such as pack­ag­ing integri­ty tests. Our goal is to ensure the high­est lev­el of prod­uct and process safe­ty for the pack­aged cus­tomer products.

Ster­il­iza­tion val­i­da­tion
Prod­ucts sub­ject­ed to final ster­il­iza­tion (e.g., gam­ma or X‑ray radi­a­tion) under­go ster­il­iza­tion val­i­da­tion in accor­dance with the EN ISO 11137 series of stan­dards in coop­er­a­tion with our cus­tomers. This val­i­da­tion ensures that the nor­ma­tive require­ments for the reduc­tion of micro­bial con­t­a­m­i­na­tion are met to mark a med­ical device as ​‘STER­ILE’.

Our com­pre­hen­sive val­i­da­tion process­es ensure the qual­i­ty and safe­ty of our pack­ag­ing solutions.