Production Process Development

The medical device and pharmaceutical manufacturing processes require high levels of expertise. A thorough understanding and an ability to couple together all of the elements is required to ensure at the end of the road the patient will receive a safe and properly working product.

As a trusted partner, SteriPack places a large importance on developing a complete picture of our customers’ needs, conditions and business. In order to develop manufacturing processes for new launches or transfers, we need to walk in the client’s shoes and have a deep understanding of the situation. And as every product is a new challenge, there are never two identical situations.

Process development is a key part of SteriPack’s core business competences. Our services range from supply chain planning and management through to the final stages of the product cycle, providing our customers with reliability and certainty. The ultimate goal is to set up a robust process and this can only be achieved by end-to-end management.

SteriPack end-to-end management guarantees:

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

SteriPack engineers focus on the manufacturing process design and validation. That’s why it’s crucial for us to be aware of and understand 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 laws (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 sterilization management, the experts at SteriPack have experience in the following areas:

•  Orthopedics (packaging design, cleaning, rinsing, sterilization)
•  Vascular access and closure devices (injection molding, assembly, plasma coating, kitting)
•  Wound care systems (component manufacturing and filling, assembly, kitting)
•  Diagnostics (assembly, kitting)
•  Pharmaceutical and combination products (assembly, kitting, serialization and aggregation)
•  Wet-filled medical devices (formulating, filling)