All manufacturers know that product contamination is a risk at any stage of the production process. However, when a contamination issue does arise, it can sometimes be difficult to pinpoint the exact source—and that’s where we aim to help.
At Innovatech Labs, our team of scientists have been performing a broad range of analytical lab testing techniques since we opened our doors in 1990. As a result of our work, we’ve identified common themes and patterns when it comes to contamination sources, across all industries. Understanding the causes of product contamination can help you accurately troubleshoot when issues arise in production.
Below we dive into some of the most common sources of product contamination and share tips for troubleshooting.
1. Water Sources
From cleaning and rinsing products, parts and vessels to an essential product ingredient, water is an important production resource for all manufacturers. But water sources can be a contamination culprit during the manufacturing process, namely leaving behind microcontaminants on electronics, hard drives or medical devices that can impact function and safety. One of the most common issues we run into during our surface contamination analysis is hard water.
For example, hard water can leave stains on parts that appear as very thin films. In the case of one of our medical device manufacturing clients, we found a stain on a titanium electrode. Using Auger electron spectroscopy analysis, we found high levels of calcium, chlorine and potassium within the sample. In this case, the contamination was caused by hard water used in the rinse cycle.
Tip: If you notice stains or thin films forming on parts during production, the first step is to examine your water sources. If you don’t have an on-site testing lab, submit a sample to a lab partner like Innovatech Labs for contamination analysis testing for confirmation.
2. Residual Solvents
From cleaning assembly line equipment to engineering products, solvents are widely used in the manufacturing industry. For example, in glue and adhesive manufacturing solvents can be used to control the drying properties. As another example, solvents are often used at the beginning of the pharmaceutical manufacturing process to create the active ingredients for ointments and other topical products. However, if they’re not properly removed, residual solvents can compromise the quality or safety of a product.
At Innovatech Labs, we often work with pharmaceutical companies to test for the presence of residual solvents. Recently, we analyzed a sample of a powdered drug to determine if the ethanol used in the manufacturing process was still present. Using gas chromatography mass spectrometry (GC/MS) coupled with static headspace analysis, we were able to quantify and confirm that ethanol was in fact present in the drug.
Tip: If you’re concerned about the concentration or presence of residual solvents in your manufacturing, engage an experienced lab to conduct residual solvent testing to ensure product quality and safety before shipment.
3. Bad Ingredients
Think about all the steps within the manufacturing process before you’re able to present your final product to the world. No matter the industry, your product is only as good as the sum of its ingredients and components. For example, when designing or manufacturing medical devices, the smallest imperfection in a single component can have a big impact on the product. When it comes to food processing, changing a single ingredient can impact food taste, safety and quality.
To elaborate on the latter example, a food service vendor came to us for oil analysis when they were thinking about switching to a new vegetable oil in their production. Using GC/MS analysis, we performed a vegetable oil analysis.
This was a critical analysis for our client because differences between the two cooking oils could have potentially impacted the food preparation process or the food itself. After our analysis, we recommended switching to the new oil for two reasons: 1) A longer shelf life, which meant cost benefits. 2) Better nutritional value.
Tip: If you’re thinking about making a change to individual components or ingredients in your products, make sure you’re considering all the factors. Even the most minute difference can have a bit impact on the final product. Reach out for analysis before incorporating the new components into your manufacturing process.
4. Dirty Production Lines and Human Error
We’ve already established that cleanliness is a critical factor in maintaining product quality. From your water sources to a misstep in the production process, contamination can considerably impact the quality of your final product.
In our experience, some of the most common production contamination problems are caused by cross-contamination, improper sanitization processes, and improper storage—which often comes down to human error.
Tip: Develop, implement and monitor a set of detailed standard operating procedures (SOPs) that account for local and federal requirements. For example, when it comes to food safety, the FDA outlines good manufacturing processes, which include rigorous cleaning of the production line. In medical device manufacturing, there are also good manufacturing processes, but the FDA regulation only provides the framework that all manufacturers must follow, requiring manufacturers develop and follow procedures. In addition, ensure your crew is engaged in ongoing training programs.
Innovatech Labs is Your Product Contamination Troubleshooting Partner
There’s no question about the extensive work that goes into manufacturing a quality product. When we opened our doors nearly three decades ago, we made a commitment to finding the answers to your materials analysis questions. That begins with helping you recognize the issue and troubleshoot to find the best solution for you and your product.