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TURNKEY RAPID DIAGNOSTIC MANUFACTURING

Rapid Test Production Facilities

Infinity IVD develops project-specific facilities for lateral-flow and cassette-based rapid tests—from reagent preparation and membrane processing to assembly, packaging, quality control and operational transfer.

Automated rapid diagnostic test production facility
Representative production environment. Final line design is configured by assay format, capacity and regulatory pathway.
Manual to automatedScale matched to demand
End-to-endReagent to final kit
Quality-ledProcess and release controls
Transfer-readyDocumentation and training
FACILITY STRATEGY

A production system designed around the test—not a collection of machines.

We coordinate process, equipment, clean-area requirements, utilities, in-process controls and quality documentation as one manufacturing architecture. The scope can support a single product or a flexible multi-assay platform and can be phased as local demand grows.

01

Product & Capacity Architecture

Portfolio, demand, localization level, line speed and expansion phases translated into one factory concept.

02

Reagent & Conjugate Preparation

Controlled mixing, filtration, dispensing and hold-time workflows configured around the selected assay chemistry.

03

Membrane Dispensing

Contact or non-contact platforms for conjugate and capture lines with controlled position and volume.

04

Lamination & Strip Cutting

Membranes, pads and backing cards laminated, slit and cut with dimensional and alignment controls.

05

Cassette Assembly

Manual, semi-automatic or automated loading and closure selected for product format and throughput.

06

Buffer & Accessory Preparation

Buffer filling, dropper assembly, swab and accessory kitting integrated into the final workflow.

07

Primary Packaging

Desiccant feeding, foil-pouch sealing, coding and seal-integrity controls for product protection.

08

Final Kit Assembly

Instructions, accessories and packaged devices counted, labeled, cartoned and prepared for release.

09

Quality-Control Laboratory

Readers, pipettes, incubators and stability chambers supporting in-process and finished-product verification.

10

Technology Transfer & Training

Process mapping, trial batches, SOPs, operator training and maintenance planning for operational handover.

Lateral flow dispensing cutting cassette assembly and packaging line
INTEGRATED PRODUCTION LINE

From treated membrane to sealed diagnostic kit.

The line is engineered around membrane width, strip dimensions, cassette design, batch size and packaging presentation. Automation is applied where it improves repeatability, throughput and traceability.

01Reagent mixing and filtration02Precision line dispenser03Controlled drying systems04Lamination platform05Programmable strip cutter06Cassette assembly platform07Buffer filling equipment08Foil-pouch packaging09Labeling and coding10Machine-vision inspection11Environmental monitoring12Readers and stability chambers
REPRESENTATIVE WORKFLOW

Ten controlled stages.

01Product design lock02Reagent preparation03Membrane treatment04Line dispensing05Drying & lamination06Strip cutting07Cassette assembly08Pouch sealing09Kit assembly10QC & release
QUALITY CONTROL

Built for consistent production and evidence-based release.

The quality-control strategy is finalized for the intended assay and market. Infinity IVD can plan the laboratory, instruments, workflow and documentation for raw-material, in-process, finished-product and stability evaluation.

  • Line position and dispensing consistency
  • Strip dimensions and assembly integrity
  • Functional control-panel testing
  • Reader-supported signal assessment
  • Pouch seal and desiccant verification
  • Environmental and stability monitoring
  • Lot traceability and retention samples
  • Documented release and deviation workflow
Rapid test quality control laboratory with strip reader pipettes and stability chamber
TURNKEY DELIVERY

From investment concept to trained operations.

Our team aligns facility design, equipment configuration, quality systems and implementation sequencing around the local investment case.

01Feasibility and demand model02Capacity and equipment architecture03Facility zoning and material flow04Clean-room, HVAC and utility design05Equipment integration and commissioning06URS, qualification and SOP framework07Pilot batches and process transfer08QC and stability program planning09Maintenance and calibration strategy10Operator and quality-team training
BUILD LOCAL RAPID-TEST CAPACITY

Define the product portfolio, capacity and localization path with our project team.

Request a project consultation ↗
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