Manufacturing & Production¶
Migibio manufactures its own fluorescence immunochromatographic (FICT) test strips and analyzers end-to-end. This domain documents how products are made — the facility, the equipment, the raw materials, and the quality gates that every lot passes before it ships.
The Manufacturing Facility¶
| Item | Detail |
|---|---|
| Location | Guangzhou Science City, Huangpu District, Guangzhou, China |
| Area | 2,000 m² standardized R&D & production workshop |
| Certification | ISO9001 (quality management) + GMP (good manufacturing practice) |
| Environment | Controlled temperature & humidity with industrial-grade rotary dehumidification |
Core Production Equipment¶
| Equipment | Function | Quality impact |
|---|---|---|
| Automatic laminating machine | Assembles membrane, conjugate pad, and sample pad into a continuous card | Consistent alignment, no manual variance |
| Continuous film stripper (dispenser) | Dispenses T-line/C-line reagents and conjugate onto membrane | Uniform line width & volume — directly affects CV% |
| High-speed strip cutter | Cuts laminated cards into individual 3–5 mm strips | Precise strip width, clean edges |
| Industrial rotary dehumidification | Maintains low-humidity production environment | Protects hygroscopic reagents and membrane |
The Production Workflow (Overview)¶
Raw material IQC → Membrane coating → Drying → Conjugate pad prep → Lamination
→ Cutting → Cassette assembly & pouching → Labeling → FQC/OQC → Batch release
Every step is documented in the batch record and gated by in-process quality control. The full sequence is detailed in FICT Test Strip Production Process.
What Makes Our Manufacturing Different¶
- End-to-end control — from membrane coating to final packaging, nothing is outsourced that affects assay performance.
- Documented traceability — every lot traces back to its raw-material lots, equipment, and operator.
- Lot-to-lot consistency — process validation and in-process QC target tight CV% across batches (see Lot-to-Lot Consistency).
Explore This Domain¶
- FICT Test Strip Production Process — the step-by-step manufacturing workflow
- Raw Materials & Supply Chain — the critical inputs and their quality requirements
- In-Process Quality Control — the QC gates from incoming inspection to outgoing inspection
- Batch Release & Traceability — how a lot is released and traced to the end user
FAQ¶
Is manufacturing done in-house? Yes — membrane coating, conjugation, lamination, cutting, and assembly all happen in our Guangzhou facility.
What certifications apply to production? GMP (manufacturing) and ISO9001 (organization-wide quality management).
Where can I find structured manufacturing data? See the Data Hub.
For the user-side QC program, see Domain 07 · Quality Control & Compliance.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-14
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.