Pharma Kit Manufacturing and Distribution Services
Eurofins Kits Manufacturing and Distribution
Eurofins Central Laboratory has over 20 years of experience in Kit Packing and Distribution Services. 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 uses 3 wholly-owned and managed Kit Packing facilities in Louisville, KY, USA, Oosterhout, the Netherlands and Shanghai, China.
Kit Build Specifics
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 can supply visit/subject collection kits as well as bulk supplies. Depending on the Study and Sponsor specific needs, supplies are typically a mixture of both strategies. Visit/subject 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 etc.
Pre-labelled sample collection tubes
The provided sample collection tubes are pre-labelled with a barcode that is linked to the Study, Investigator Site code, Visit and Subject for requisition registration. Standard data that is captured during requisition registration are: Study ID, Subject ID, Screening Number, Investigator, Visit Code, Gender, Sample date/time, Receipt date/time, Name (Initials) and Ethnic Origin.
Upon sample receipt at one of our Central Laboratory Test Facilities, after scanning the pre-labeled barcode, all samples are then relabeled with a new unique barcode for our internal Chain of Custody that is blinding previous information and linking a specimen tube to the required chain of analysis in our laboratory, [long-term] storage and or forwarding to a third laboratory location.
The tube label of pre-labelled tubes includes the following information:
1] Barcode/ Requisition number
2] Specimen description
3] Protocol number
4] Site number
5] Subject ID number
We have the flexibility to adapt the label to include Sponsor specific label requirements, taking into account the physical dimensions of the label itself.
Shipping Supplies
Shipping Supplies are provided for ambient, cooled and frozen sample shipments. These supplies consist of shipper boxes, pre-printed Air Way Bills and courier satchels. 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.
Kit Manufacturing QC
For each new kit design introduced at the Kit Manufacturing facilities an extensive QC process takes place. A 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 at the Kit Manufacturing teams and ready for operation.
In the Kit Manufacturing 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 has been detected then the kits are returned, corrected and thereafter QC-d again. Following this extensive QC program during the Kit Assembly process, over 99% of our kits are shipped out being 100% correct.
