Sample6 Manufacturing: Delivering Quality Detection and Control
At Sample 6 we’re designing and manufacturing the first enrichment free environmental pathogen diagnostic. This test is designed to be used in-plant to deliver accurate, actionable results to the user in a single shift. Over the last couple years the product development team has been working diligently to optimize the performance of DETECT/L and validate its performance with a number of food-processing facilities across the country.
Working along side the product development team is the manufacturing team. We are responsible for building and shipping a high quality consistent product. My manufacturing team, which also includes the quality team and supply chain team, has been working extensively with product development to transfer and scale up new product formulations and ensure that the appropriate quality metrics are in place for repeatable production processes. At Sample6, we are proud to deliver not only revolutionary technology but finished products that you and your organization can depend on.
Here are some of the controls and best practices in place at Sample6 Manufacturing:
- SOP: Using our standard operating procedures, work instructions, and batch records we’ve created consistency in our manufacturing processes for the DETECT/L solutions and buffers.
- Inventory Control: Our inventory systems are electronic and automated to expedite our component ordering process and eliminate inventory stock outs.
- Organization: Our manufacturing facilities are organized using 5S methodology reducing waste and optimizing productivity.
- Continuous Improvement: We’ve adopted 6 sigma techniques to allow for continuous improvement and minimizing variability.
- Quality testing: Every product from Sample6 is 100% tested.
- Traceability: All of our solutions and buffers are labeled with expiration dates and serial numbers for lot tracking and traceability.
Through the use of these tactics, we are able to meet standards comparable with pharmaceutical and therapeutics industry.
Partnering With Suppliers
The other critical element of our manufacturing strategy is to leverage commonly available materials in order to reduce the development burden and product risk. Our core competency is biotechnology. However, to run DETECT/L, the user needs sample collection bags and disposable plastics as well as a few small pieces of equipment. We have leveraged world-class suppliers for these consumables and equipment. A critical element of my manufacturing effort is to ensure that suppliers can meet the standards in the quality and supply that we are committed to delivering.
Here are some of the key elements to our supplier selection and management:
- Try it first: We evaluated many different types of consumables to determine the best compatibility and performance with our product.
- Quality testing: Once a component was tested, multiple lots were requested and side by side testing was completed to ensure consistent performance.
- Supply Chain: Supply agreements are put in place whenever possible so that we can develop a partnership with critical suppliers with well aligned expectations.
- Lead Times: Lead times are tied into our electronic tracking to ensure that the materials we need are in place.
With my background in medical device design and manufacturing, I know how critical design decisions effect the quality of your product. Just as our customers strive to ensure that their chicken or lettuce that’s purchased on a daily basis is containment free, we at Sample 6 strive to deliver a high quality products. We have generated a rigorous set of quality measures to ensure 100% of our product is tested and complies with our quality standards.