Part of Thermo Fisher Scientific

BPC Quality Control and Assurance

Only the highest quality components are used in the manufacturing of HyClone BioProcess Container™ Systems. Each component is given a unique HyClone part number and has a controlled material specification. HyClone actively promotes communication with component vendors, conducts audits and maintains a vendor evaluation program. Incoming Inspection Component Inspection Film > Contamination > Gels or carbons > Width and gusset dimensions > Film thickness > Tensile strength and elongation > Chemical composition using FT-IR spectrometer Ports, fittings, tubing > Appearance and visual inspection > Dimensions In Process Inspections QC and production perform in-process quality testing Product Inspection Flexible container chambers > Appearance > Seam and port seal strength > Dimensions > Leak and burst testing* Finished flexible containers > Correctness > Completeness > Particulate debris > Defects and damage > Correct packaging > Hydro-burst testing* *According to statistical process control sampling plan   Quality Section Navigation > Quality Control and Assurance   Product and Process Validations   Endotoxin and Particulate   Irradiation   Certification   Audit   Lot Record and COA