Process Development

Process development belongs to SteriPack’s core business competences. Incorporated with supply chain planning, preceded and followed by any required product cycle stages assures reliability and certainty of Customer outsourced manufacturing. The ultimate goal is to improve the process and it can only be achieved by end-to-end management.

SteriPack end-to-end management guarantees:

  •  Matching production line
  •  Complete risk identification (pFMEA)
  •  Setting production line to minimise the risk
  •  Setting the control plan for In Process Control based on pFMEA (Dynamic Control Plan)
  •  Production test trials
  •  Corrections of production line (LEAN)
  •  Observed risk elimination and risk analysis after line improvement
  •  IPC (In Process Control) – quality control during standard production

SteriPack engineers focus on the manufacturing process design and validation. That’s why it’s crucial to always be updated with the latest technology solutions. Other processes that are used to comply with the Customer’s highest requirements:

  •  Machines and equipment qualification
  •  Production process validation
  •  Laboratory test method qualification
  •  Optimal use of material
  •  Quality compliance according to law (ISO, cGMP)
  •  Proven track record of FDA and CE Mark approvals for Customers

With extensive in-house product and process design and development, as well as packing capabilities and sterilisation management, the experts at SteriPack have experience in the following areas:

  •  Orthopaedics (cleaning, rinsing)
  •  Vascular access and closure devices (injection moulding, assembly, plasma coating, kitting)
  •  Wound care systems (component manufacturing & filling, assembly, kitting)
  •  Diagnostics (assembly, kitting)
  •  Pharmaceutical and combination products (assembly, kitting, serialisation and aggregation)
  •  Wet-filled medical devices (formulating, filling)

Typical application areas:​

innovative solutions and proactive attitude.

Medical device process development.