From concept development through FDA approval, the early stages in the lifecycle of a medical device or pharmaceutical product can be
extremely challenging. SteriPro Consulting can help. Through a unique blend of consultative analysis, technical assistance and laboratory
services, our SteriPro program focusses on the pre-sterilization aspects of the supply chain. We work with you to develop and maintain the
most effective sterilization processes for your products, bringing them to market in the fastest, most efficient way possible.
Our Primary Goal? Creating a More Efficient Supply Chain
We'll help you navigate the key stages of product development, including:
- Material characterization - Prior to selecting materials for a product, we'll help you understand the effect sterilization
will have on those materials.
- Biocompatibility - Testing evaluates biocompatibility with the intended use of the component material or finished product.
Evaluation programs follow FDA guidance and ISO 10993 standards.
- Manufacturing, Environmental Process Control - Testing verifies that manufacturing process controls are sufficient for
pre-production quality assurance requirements and product specifications.
- Audit and Release Testing - Final range of testing to satisfy all regulatory requirements (ISO and QSR) for finished product
distribution and batch release to ensure product consistency and compliance.
No matter the size of your company or product idea, SteriPro® Consulting Services has your back. The expertise reflected by our
Consultant CVs speaks for themselves. Our people are not only active contributors to Sterigenics and the businesses of our customers,
they are also influential leaders and trendsetters in the industries we serve.
To arrange for a Consultant Meeting please call: 1-(951) 340-0700 for North America or +32 16 525220 for Europe and Asia.
All test methodologies and procedures are executed in strict accordance with
ISO, USP, AAMI and/or specific customer supplied requirements. For more
information on our full range of SteriPro Consulting Services, contact
local Sterigenics representative.