Case study challenge
Different interpretation of product classification by local EMA representatives in Poland and other EU countries.
Solution
Escalating the topic and situation to the EMA Committee and consulting a 3rd EU member of the EMA to resolve the dispute resulting in common agreement between local EMAs. Product final classification fell under ISO 13485.
Scope
- Automatic syringe assembly
- FFS packaging to inner blister (with pharma component closed in a vial)
- FFS Packaging to outer blister
- Vision system implemented for 100% inspection
- Automatic labelling system
- Sterilization: ETO
Case study challenge
Matching pharma quality expectations with quality of medical grade components within expected short lead time.
Solution
Pro-active approach to vendor management
Scope
- Sourcing of primary packed needle + syringe
- Sourcing of packaging components
- Pouching (secondary packing) and labelling
- Printing variable data on single pouch and unit box
- Packing single pouch + IFU into the unit box
- Packing unit boxes into the shipper box
SteriPack's expertise:
complementary medical devices for pharmaceutical products.
