Eurofins Central Laboratory has over 20 years of experience in Kit Packing and Distribution Services. We provide sample collection kits for Clinical Trials, Commercial DNA Testing, Clinical Monitoring Programs and Post Marketing Surveillance, both inside and outside Eurofins. Eurofins Central Laboratory is a turnkey provider which deploys lean, globally standardized processes, enabling high quality GMP and FDA compliant specimen and transportation kits to be distributed worldwide.
Eurofins Central Laboratory has 3 wholly-owned and managed Kit Packing facilities in Louisville, KY, USA, Oosterhout, the Netherlands and Shanghai, China. Every year, Eurofins Central Laboratory produces and ships greater than 1 million specimen collection and transportation kits to investigator sites all over the world. Mary Thomassen, Senior Packer, has been with Eurofins Central Laboratory for 10 years.
Mary is one of Eurofins’ Quiet Heroes, standing between you and the hazards of an ever-changing, highly complex world, making sure you can trust the medicines you depend on.
Q: Mary, what is your role with Eurofins?
In my role as Senior Packer I primarily focus on the assembly of specimen collection kits. But I also focus on a number of additional tasks overseeing and coordinating the full team of Packers on a daily basis. Every new production day, I am triaging and overseeing the daily orders and priority orders and decide on the line-up. As we deploy color coding for priority orders, these can be easily tracked on the work floor.
Q: This is a huge building, could you describe what is happening here?
This building owned by Eurofins houses the WAREHOUSE with our inventory of all kit components as well as our inventory of shipping boxes. Based on input provided by Scientific Affairs and Sponsor recommendations or preferences, Eurofins Central Laboratory works with a global network of manufacturers and distributors to leverage our global footprint in support of the distribution of harmonized, specialized, and custom material solutions. We deploy internal Materials Experts to accommodate customized sample collections materials to meet our Client’s requirements for their standard and specific needs.
We also have a dedicated area for ASSEMBLY of kits using dedicated workstations manned by Packers. First, a team of Pickers collect all needed materials from the warehouse. We then assemble visit specific collection kits and we provide bulk supplies as well. Depending on the Study and or Sponsor specific needs, supplies are typically a mixture of both strategies. Visit specific collection kits are intuitive and easy to use for Investigator Site staff, and we add bulk supplies [e.g. urine collection cups] for [cost] efficiency. Our kits can also be built to provide materials for PK testing, Genomics, Home Collection and so on. So you can imagine that watching over our inventory is very important!
After the assembly process, the kit order physically moves to a third dedicated area for QUALITY CONTROL [QC1].
Q: Can you tell us a bit more about the QC process?
For each new kit design introduced at the Kit Packing facilities an extensive QC process takes place.
A so called dummy kit is produced for each individual new kit. The dummy kits, the associated protocol specific instruction as well as the related labels are 100% QC-d for their correctness. Once this QC process is completely finished then the protocol specific instruction is released to the Kit Packers and ready for operation.
In the assembly process itself, each kit type in a specific kit supply order is QC-d by an independent QC person using a proven sample methodology. In case a deviation is detected then the kits are returned, corrected and thereafter QC-d again. Following our extensive QC program during the Kit Assembly process, over 99% of our kits are shipped out being 100% correct.
The next step in the process is to prepare OUTBOUND SHIPMENTS to over 85 countries worldwide include Shipping Supplies. The last and final step is again a QC of the complete outbound shipment and its paper work; QC2.
All steps in the production process each have their individual code connected with their physical location. This allows me to keep a close eye on the status of kit order completion. I also review the performance metrics of the team at 3 different time points during the day, and identify anticipated hold-ups in one of the steps before they are clogging up the flow of the whole process. Of course, I take into account the complexity of the actual kits being assembled, as the level of complexity will influence the time needed for assembly. As all our Kit Packing staff is fully trained on all steps of the process, I can decide to pull some of the team members and re-assign them e.g. to the QC step to fix a hold-up.
Q: What are Shipping Supplies?
Shipping Supplies are provided for ambient, cooled and frozen sample shipments. These supplies consist of shipper boxes, pre-printed Air Way Bills, courier satchels and customs invoices for applicable countries. Everything an Investigator Site needs to ship collected specimens back to a Eurofins Central Laboratory testing site, or third party laboratory in some cases. All provided Shipping Supplies meet IATA standards. The necessary Shipping Supplies are provided in the start batch of collection kits to Sites and can be ordered in further resupplies as well.
Q: How many kits would the team typically pack per day?
Our baseline capacity is 65 thousand per month globally and we use 2 shifts per working day to scale up production as needed. Every day is different! Our company supports 450 study protocols at the same time, and some studies need their starter batches produced, some need resupplies, some are priority…
Globally, we ship over 1 Million kits per year. We prepare starter batches for Investigator Sites that include manuals, flow charts, visit specific kits, bulk materials, and all items needed to ship samples back to Eurofins Central Lab. And of course, we prepare all Resupply orders. Also, we do not just use the sample tubes as provided by the manufacturers. Our sample collection tubes are pre-labelled by our Packers with a barcode that is linked to the Study, Investigator Site code, Visit and Subject for easy requisition registration. Our flexible study set up even allows customization of these labels! We just need to make sure if fits on the label in a readable format.
Q: There are markings with tape on the floor, can you explain what they mean?
This Kit Packing facility in its current building is operational since 2011. It was designed to efficiently manage the increased demand and future projections of kit requirements for our clinical trials. At the time, when we moved to a new and larger facility, we had full discretion to use a green field approach. This translates into a clear design of the work floor based on the Kit Packing work flow, color based zoning to support the processes and an optimized lay-out of our warehousing. The design of the facility is based on the lean principles that create value, efficient flow, and continuous improvement to better meet the needs of our Clients.
Q: Why does Eurofins have 3 regional Kit Packing sites and not just 1?
3 regional Kit Packing sites offer global coverage, regional compliance, and best timelines for shipping and costs compared to just having one. The site in Shanghai is our most recent addition and is currently supporting domestic China clinical trials. We are looking into expanding that function to the greater APAC region in the future.
“I really like to be the connecting link between “the office” and production work floor. Our team of Pickers, Packers and QC staff work together in good spirit to meet or exceed the daily goals for production of specimen collection kits and I really like the kick I get when by the end of the day, I see that all orders are Code 6: shipped. We may not be the actual scientists developing new medicines, but we feel privileged to be at the start of the supply chain in providing Clinical Laboratory Testing Services and contribute to the greater good.”
To learn more about our global Kit Packing and Distribution Services, please click here.