Factory & Quality

Inside the factory

A virtual tour of the Gene Matrix GMP facility — cleanroom layout, production line, air-cascade design and the equipment that releases every lot.

Operators in full sterile gowning working at laminar-flow workstations inside the Gene Matrix cleanroom.

The Gene Matrix production hall — ISO 5 (Grade A) critical zones within an ISO 7 (Grade C) background.

Cleanroom Footprint

Five production zones in 700 m²

The facility is engineered around a unidirectional flow — material in one direction, personnel through airlocks, finished product out — with positive-pressure cascade protecting every critical zone.

GENE MATRIX · 700 m² GMP FACILITY · JEDDAHReagent Aliquoting Room30.4 m² · +20 PaMicrobial Testing Lab10.6 m² · +20 PaAssembly Room12.2 m² · +15 PaQC Laboratory12.3 m² · +15 PaSterilisation Room12.5 m² · +20 PaClean Corridor— · +15 PaBuffer / Airlock— · +10 PaGowning— · +5 PaN

Legend · pressure cascade

+5 Pa

Gowning

Personnel preparation — primary gown change.

+10 Pa

Buffer / Airlock

Material and personnel airlocks separating dirty and clean sides.

+15 Pa

Clean Corridor

ISO 7 (Grade C) circulation between production rooms.

+20 Pa

Critical Zones

Aliquoting, microbial testing and sterilisation — protected positive pressure.

Floor plan adapted from the engineered design package — illustrative only.

The Production Line

Six stations, one validated flow

Every Gene Matrix kit travels through six controlled stations — from raw-material intake to cold-chain dispatch — under continuous environmental monitoring.

Station 01: Raw Material Reception & QCStation 01

Raw Material Reception & QC

Inbound reagents and consumables are quarantined, identity-tested and lot-logged before release to manufacturing.

Station 02: Reagent Formulation (Grade A)Station 02

Reagent Formulation (Grade A)

Master mixes, primers and probes formulated under ISO 5 laminar flow with calibrated dispensing and traceable QC.

Station 03: Aseptic Filling under Laminar FlowStation 03

Aseptic Filling under Laminar Flow

Validated automated dispensing into PCR tubes / strip-tubes / 96-well plates inside the critical zone.

Station 04: Lyophilisation & CappingStation 04

Lyophilisation & Capping

Selected formats are freeze-dried for ambient shipping stability, then sealed under controlled atmosphere.

Station 05: Kit Assembly & LabellingStation 05

Kit Assembly & Labelling

Vials, controls, IFUs and barcoded labels assembled into finished kit configurations under the Grade C background.

Station 06: Final QC, Lot Release & Cold-Chain DispatchStation 06

Final QC, Lot Release & Cold-Chain Dispatch

Each lot undergoes performance verification before QP release and validated cold-chain dispatch.

Air Cascade & Pressure Control

Unidirectional positive-pressure design

Pressure rises step by step from the outside world toward the critical production zones — so air always flows outward from clean to less-clean. This protects products from contamination at every door.

+5 PaGowningPersonnel preparation — primary gown change.
+10 PaBuffer / AirlockMaterial and personnel airlocks separating dirty and clean sides.
+15 PaClean CorridorISO 7 (Grade C) circulation between production rooms.
+20 PaCritical ZonesAliquoting, microbial testing and sterilisation — protected positive pressure.

Equipment

Process-control equipment

Real-time PCR thermocyclers

Validated 96-well systems for assay development, in-process QC and lot release.

Laminar-flow workstations

ISO 5 critical zones for aseptic kit assembly and reagent handling.

Automated extraction & dispensing

Automated workflows for reproducible reagent formulation and filling.

Cold-chain & stability suites

Validated −20 °C / +4 °C storage and ongoing stability programme for every released lot.

700 m²
Total facility footprint
5
Production zones
ISO 5 / 7
Grade A within Grade C
Modon
Jeddah industrial city
24/7
Environmental monitoring

Schedule a facility audit

Distribution partners, hospital procurement teams and regulatory auditors are welcome to schedule an on-site visit to the Gene Matrix facility in Modon Oasis, Jeddah.