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.