NEWS
For stem cell and cell therapy manufacturers, a culture vessel is a raw material. QA teams ask three questions first: what leaches out, how much endotoxin, and how many particles. FeiFanT™ multi-layer chambers are built to answer all three.
< 0.001 EU/mLEndotoxin, robot-made with no human contact
E&L reportFull extractables & leachables study on file
Every lotInsoluble particulates reported on the COA
The three QA checkpoints
| Checkpoint | FeiFanT™ |
|---|---|
| Extractables & leachables | Complete E&L study report to support material qualification and regulatory filings |
| Endotoxin | < 0.001 EU/mL. Every step from GPPS pellet to sealed chamber is done by robots |
| Insoluble particulates | A release test on the Certificate of Analysis for each lot |
Zero-touch manufacturing
- Automated molding and surface treatment (Ultra TC or TC)
- Robotic stacking and sealing, 100% leak tested
- Gamma sterilized to ISO 11137, SAL 10⁻⁶
Traceable to the unit
Each chamber carries a unique code on the first layer with lot number, unit sequence and production time, linked to process conditions, raw materials and batch records. Case labels carry catalog number, lot and case number.
Formats: 1, 2, 4, 5, 10 and 40 layers · wide-mouth, narrow-mouth, barbed and MPC ports.
Shop FeiFanT™ chambers → Request the E&L report, a sample or a quote →
Shop FeiFanT™ chambers → Request the E&L report, a sample or a quote →