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.