Quality
INCOMING INSPECTION
PRODUCTION (IN-PROCESS) INSPECTIONS
Incoming inspection of our Film, Tubing and Components is a requirement of our quality system. Film is checked for proper thickness, tensile strength and appearance. Tubing, Ports and Connectors receive a visual inspection and dimensional measurements are checked.
FINAL INSPECTION
100% of our Single-Use Products are carefully analyzed on a light table. The final product is inspected for seam integrity, particulate and film defects before final packaging.
ENDOTOXIN TESTING
We do LAL testing in our controlled Quality Lab using the Charles River Endosafe® Gel Clot test.
NO ANIMAL DERIVED COMPONENTS (ADCF)
We certify that all of our films, tubing, and components contain no animal derived components.
CERTIFICATE OF COMPLIANCE (COC) & LOT TRACEABILITY
Our Production Control Process requires that we supply a Certificate of Compliance with each shipment to ensure adherence to specifications and for Lot Traceability.
ANNUAL AUDITS
Our Quality System requires that we do Internal quality audits annually. In addition, we receive External audits conducted by our ISO registrar on an annual basis.
