Accessories Assembly, Packing and Sterilisation

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.

Accessories assembly, packaging and sterilization