AICON-BIO® FeiFanT™ Cell Culture Chambers, Wide Mouth Ports

$366.00 – $878.00

SKU: AIB100111-1 Category:
Description

Robot-made cell culture chambers for clinical-grade cell production

AICON-BIO® FeiFanT™ multi-layer cell culture chambers are manufactured on a fully automated line, from GPPS resin to finished, sealed chamber, with no human contact. The result is the three things stem cell and cell therapy manufacturers check first: documented extractables and leachables, endotoxin below 0.001 EU/mL, and insoluble particulates tested on every lot.

Robotic, zero-touch productionE&L study reportEndotoxin < 0.001 EU/mLParticulates on every COAUnique serial number per chamberGamma sterilized, SAL 10⁻⁶

Built for what cell therapy QA asks about

Extractables & leachables

Full E&L study on file

A complete Extractables and Leachables Study report is available to support your material qualification and regulatory filings.

Endotoxin

Endotoxin < 0.001 EU/mL

Every step from GPPS pellet to formed chamber is performed by robots. No operator touches the culture surfaces, so endotoxin is held below 0.001 EU/mL.

Insoluble particulates

Tested and reported per lot

Insoluble particulate testing is a release item on our Certificate of Analysis, so you see the result for the exact lot you receive.

Automated, zero-touch manufacturing

1. ResinGPPS resin pellets fed automatically
2. Molding & surface treatmentTrays formed and treated (Ultra TC or TC) on the automated line
3. Robotic assemblyLayers stacked, sealed and 100% leak tested without manual handling
4. SterilizationGamma irradiated to ISO 11137, SAL 10⁻⁶

Lot-level and unit-level traceability

  • Every chamber carries a unique traceability code on the first layer, encoding lot number, unit sequence and production time to the minute.
  • Each code traces back to the process conditions, raw materials and components used for that unit.
  • Equipment monitoring data is archived for every production run.
  • Batch production records document every workstation.
  • Each shipping case is labeled with catalog number, lot number and case number, so every case can be tracked to its destination.
  • Quality audits available on request; validation binders provided under a signed confidentiality agreement.

Specifications

Formats1, 2, 4, 5, 10 and 40 trays; 632 cm² per tray, up to 25,280 cm²
Surface treatmentUltra TC: highly hydrophilic, for demanding adherent cells such as primary cells, MSC, iPSC and serum-free culture.
TC: hydrophilic, for general adherent culture
PortsWide-mouth ports for direct pouring and harvesting in a biosafety cabinet; compatible with AICON-BIO® filling caps for tubing assembly
SterilityGamma irradiated per ISO 11137, SAL 10⁻⁶; single use
Endotoxin< 0.001 EU/mL
Integrity100% leak tested; self-venting caps prevent pressure build-up in transit
HandlingMedium and trypsin level out quickly between trays during filling
DocumentationLot COA (including insoluble particulates), E&L study report, validation binder under CDA

Packaging & shipping

Each chamber is individually bagged and gamma irradiated. Bag labels carry the catalog number, lot number, production, irradiation and expiration dates and a QR code; each shipping case is labeled with catalog number, lot number and case number.

Trays per chamberChambers per case · approx. case weight · case dimensions (L × W × H)
1 tray6 per case · 5.5 kg (12.1 lb) · 42 × 40 × 50 cm
2 trays6 per case · 6.5 kg (14.3 lb) · 42 × 40 × 50 cm
4 trays4 per case · 6.8 kg (15.0 lb) · 42 × 40 × 50 cm
5 trays4 per case · 7.5 kg (16.5 lb) · 42 × 40 × 50 cm
10 trays6 per case · 20 kg (44.1 lb) · 42 × 55 × 82 cm
40 trays2 per case · 22 kg (48.5 lb) · 42 × 55 × 82 cm

Ordering information

Cat.No.No.of TraysSurface TreatmentCulture Area, c㎡Units per pack/case
AIB1001111ultra TC6321/6
AIB1002112ultra TC12641/6
AIB1004114ultra TC25281/4
AIB1005115ultra TC31601/4
AIB10101110ultra TC63201/6
AIB10401140ultra TC252801/2
AIB1T01111TC6321/6
AIB1T02112TC12641/6
AIB1T04114TC25281/4
AIB1T05115TC31601/4
AIB1T101110TC63201/6
AIB1T401140TC252801/2
Qualifying FeiFanT™ for a GMP process? Request the E&L study report, a sample COA or a validation binder: request a quote or contact our team.