Sterling Manufacturing

Sterling Manufacturing Develops Proprietary Accelerated Validation Process for Medical and Biotech Injection Molding

Fully customizable, scalable manufacturing plan improves speed-to-market


Lancaster, MA -- (ReleaseWire) -- 05/04/2017 --Sterling Manufacturing is delighted to announce that it has partnered with leading medical and biotech original equipment manufacturers (OEMs) to develop a proprietary Accelerated Validation Process (AVP). This process provides detailed evidence that specific molding methods are capable of consistently producing quality products, while simultaneously improving overall speed-to-market.

Medical product validations, driven by U.S. Quality System regulations and ISO standards, typically utilize an Installation/Operational/Performance Qualification (IQ/OQ/PQ) format. Increasingly common is the Production Part Approval Process (PPAP), which originated as a process for automotive component validation.

Sterling's AVP utilizes critical features of highly effective IQ/OQ/PQ and PPAP processes to develop, document and verify a robust, repeatable, capable process while reducing overall time and cost.

"We've taken the critical frameworks of IQ/OQ/PQ and PPAP, and we've reworked them into an accelerated process that yields the same high-level results at an expedited rate," said John Gravelle, Chief Operating Officer at Sterling Manufacturing. "The goal is to improve the overall speed-to-market for custom injection-molded products, while simultaneously adhering to efficacy standards and minimizing production defects."

Sterling utilizes state-of-the-art injection molding and metrology equipment to prove mold functionality, establishing an acceptable process window in the quickest time possible. While most injection molders and contract manufacturers rely on OEMs to define validation requirements, Sterling recognizes that component manufacturers have the most insight into key aspects of their processes.

Sterling achieves greater efficiency by utilizing targeted, documented ranging studies for key process parameters that have proven to have the greatest impact on the molding process output. Included with a qualification DOE is a complete First Article Inspection and Capability Study.

"OEMs are willing to allocate significant resources to expedite product development and shorten tooling lead times, but pre-production process validations can also cause significant delays," said Gravelle. "Our AVP relies on the experience of our team and their ability to apply their expertise within the structure of a quality-controlled process. With an efficient methodology in place, we're able to mitigate many pre-production setbacks and quickly get to work producing high-quality, low-cost results."

The effectiveness of Sterling's proprietary AVP has been proven and successfully utilized by many of the world's leading medical and biotech OEMs. The plan is fully customizable and can be expanded or condensed as needed, depending on the needs of each customer.

For more information about Sterling Manufacturing or its Accelerated Validation Process, please visit the company's website at

About Sterling Manufacturing
Sterling Manufacturing is an injection molding solutions partner serving the healthcare, aviation, defense and commercial industries. Sterling supports the entire product lifecycle with rapid prototyping, tool development, validation, production molding and automated secondary operations. We increase speed-to-market, improve your margins and deliver superior quality products on time and are equipped to provide unique and effective engineering-driven solutions for complex technical issues.