Quality-assurance

BLOG: Process Validation

If you’re a market-leading life sciences company searching for the right quality plastic parts manufacturer or custom manufacturing services provider, you already know how difficult it can be. Just trying to find a qualified provider you can trust can be time intensive and, well… frustrating.

At Enplas Life Tech, we know that trust is one of the most important services we can offer. We understand that your products’ success relies on the service providers you choose to trust.

That’s why Enplas Life Tech has an established quality control procedure built on proper industry-standard validation procedures: to statistically ensure that each part coming out of the line will fall within strictly-set standards for your project.

Precision quality parts from Enplas Life Tech are a trusted, reliable choice for your important diagnostic and medical devices. We know that your component production must continue without interruption. Therefore, we created a rigorous validation process that will enable us to provide you with an uninterrupted supply of the components critical to the shipment of your products that may ramp up volume over time.

Enplas Life Tech complies with the increased requirements of documentation and traceability in the medical industry. Our four-part process—DQ, IQ, OQ, and PQ—is the standard for validation and quality assurance in the medical/biotech industry. Enplas Life Tech took the basics of this standard process and added other procedures we consider necessary to have a truly rigorously validation process. These validation steps establish documented evidence of a high degree of certainty that the manufacturing process will consistently yield a product of predetermined quality. Enplas Life Tech records each step of the process and provides our customers with complete documentation in the form of the “Process Validation Protocol (PVP).”

Our validation process begins with the DQ (design qualification) stage. In this stage, our priority is to properly understand our customer’s unique, specific requirements and expectations. This includes areas such as production volume (e.g., including whether the production volumes might remain stable or increase with time, and resulting in decisions such as number of cavities), tool life, required levels of tolerance, and the minimum-required “CpK value”—a value that statistically indicates the capability and likelihood of the produced part coming in at required specifications. This information is used to determine how to build and set up the molds (e.g., what type of steel, which press, what support equipment is needed, cost, how many operators). All of the following processes—IQ, OQ, and PQ—are conducted to achieve the goals set in DQ. 

In addition, a failure mode and effects analysis (FMEA) is conducted as part of the design-for-manufacturability (DFM) process to minimize failure risk for critical functions or dimensions. 

The second stage is the IQ (installation qualification) stage. This stage is where the tools are built and evaluated, all production related equipment is set up, and various injection molding parameters are tested to determine a safe range of settings. It confirms that the tools are built to meet all inputs from the DQ stage and that the molding process is appropriately set up to begin producing sample parts with the injection molding machines. 

This stage marks the beginning of “scientific molding”: a practice to identify a range of injection molding parameters that would achieve the highest yield of precise parts. In other words, testing the limits of parameters to retain highest levels of quality in the products’ precision and dimension while running the presses in the most efficient manner. In the scientific molding process, data is collected from various studies (e.g., gate seal, cavity balance, back pressure, and melt flow) as outputs to create a “process window”—a general range of statistically-tested process parameters that produce products within the required tolerances. 

Other studies (such as the cooling study, used to determine the smallest amount of time required for the dimensions to become most stable) are also conducted.

The OQ (operation qualification) stage further refines the parameters to achieve certain operational performance requirements. OQ takes the data from the previous stages further: it obtains objective evidence that a defined, optimal process window allows the consistent production of acceptable products. A design of experiments (DOE) study is conducted, in which software statistically calculates many process variables to identify the optimal ranges. Following that, a full-dimension, first-article inspection derived from a set number of sample parts is conducted and the CpK is measured. If the CpK does not meet the initial goal set in the DQ stage, improvement plans are created and implemented.

PQ (performance qualification), the final stage, challenges the equipment similar to the OQ phase, but now does so under load. Finally, longer-run trials are conducted to confirm that key dimensions are maintained under a longer production period. Another first-article inspection and capability study are conducted on samples. The process is then officially validated to ensure it meets the customer inputs provided at the DQ stage. The degree to how much time and effort we devote to the PQ stage depends on customer requirements. We are happy to conduct the right level of validation to meet your specific needs.

Is your life sciences company searching for a quality plastic parts manufacturer or custom manufacturing services provider? Consider Enplas Life Tech’s engineering and design services and trusted validation process. Contact us today to learn more.

Want more proof of our dedication to product performance and quality? Download our TPE case study, “Life Science Diagnostic Device Development: Challenges and Solutions for Fluid Interfaces.”