Portfolio & Capacity Planning
Singleplex, multiplex, syndromic and quantitative PCR portfolios mapped to demand, batch size and localization phases.
TURNKEY MOLECULAR DIAGNOSTIC MANUFACTURING
Molecular Test Production Facilities
Infinity IVD develops integrated PCR and molecular-test manufacturing facilities covering reagent formulation, precision filling, kit assembly, molecular quality control, cold chain and technology transfer.
Contamination-controlledSeparated molecular workflows
Flexible formatsTubes, strips, plates and kits
Quality integratedProduction and functional PCR QC
Localization-readyTransfer, training and ramp-up
FACTORY ARCHITECTURE
Production, molecular QC and cold chain designed as one controlled platform.
The project begins with the intended assay menu, required output, fill format and localization depth. From there, Infinity IVD coordinates clean-area zoning, process equipment, utilities, quality controls and digital traceability into a scalable manufacturing system.
Controlled Reagent Preparation
Dedicated workflows for buffers, enzymes, oligonucleotides and master-mix formulation with defined hold times and traceability.
Primer & Probe Handling
Protected preparation, dilution, aliquoting and storage strategies designed to preserve identity and reduce contamination risk.
Precision Filling & Sealing
Manual, semi-automatic or automated dispensing into tubes, strips, plates or cartridges with weight and closure controls.
Lyophilized & Liquid Formats
Facility and equipment concepts can be configured for liquid, dried or mixed portfolios according to the transferred process.
Extraction Consumables
Optional integration of extraction reagents, magnetic-bead workflows and compatible sample-preparation consumables.
Kit Assembly & Cold Chain
Controlled labeling, component counting, secondary packaging, monitored storage and shipment preparation.
Molecular Quality Control
Extraction, real-time PCR, contamination monitoring, functional release and stability infrastructure planned as one system.
Quality-System Readiness
URS, qualification protocols, SOPs, batch records, deviation controls, calibration and maintenance framework.
Technology Transfer & Training
Assay transfer, engineering batches, process verification, operator training and controlled production ramp-up.
INTEGRATED MOLECULAR PRODUCTION
From oligonucleotide preparation to released PCR kit.
Infinity IVD combines process engineering, clean-area planning, equipment selection, assay transfer and operator training in one project. Process design protects sensitive reagents, separates higher-risk molecular activities and builds traceability into every stage. Automation is selected where it improves dispensing accuracy, consistency and throughput.
01Pre-PCR controlled suites02Reagent formulation vessels03Automated liquid handling04Precision tube and plate filling05Tube capping and plate sealing06Labeling and serialization07Nucleic-acid extraction platforms08Real-time PCR instruments09Cold rooms and monitored freezers10Environmental monitoring11LIMS and batch traceability12Stability chambers and retain storage
Ten linked control points.
01Portfolio design lock02Raw-material receipt03Primer/probe preparation04Master-mix formulation05Reagent filtration06Precision dispensing07Tube/plate sealing08Kit assembly09Functional PCR QC10Cold-chain release
CONTROLLED ZONING
Flows that protect reagents, products and results.
Personnel, raw materials, oligonucleotides, formulated reagents, amplified material, waste and finished kits follow defined routes. Exact classification and pressure strategy are finalized for the transferred process and national requirements.
01Material quarantine and sampling02Oligonucleotide preparation03Master-mix formulation04Filling and closure05Packaging and labeling06Extraction laboratory07Pre-PCR preparation08Amplification and analysis09QC and stability storage10Cold room and finished goods11Wash-up and waste handling12Technical and utility rooms
MOLECULAR QUALITY CONTROL
Functional evidence from incoming material to stability.
Infinity IVD plans the QC laboratory around the intended assays, extraction methods, instruments and acceptance criteria. The framework can support development transfer, in-process checks, release testing and lifecycle monitoring.
- Incoming material identity and suitability
- Dispense weight and fill consistency
- Seal, label and kit-component verification
- Extraction and internal-control performance
- Amplification curve and Ct assessment
- Positive, negative and no-template controls
- Contamination and environmental monitoring
- Stability, retain and cold-chain verification
PROJECT DELIVERY
Built to move from feasibility to routine production.
The final package is configured for the investor, selected assays and destination market without making unsupported product or regulatory claims.
01Market, portfolio and capacity feasibility02Facility layout and clean-area zoning03Equipment URS and procurement support04Utilities, cold chain and warehouse design05Installation and qualification support06Assay and process technology transfer07QC methods and documentation framework08Engineering and pilot-lot support09Operator, maintenance and quality training10Ramp-up and lifecycle support