Built for
sterile precision.
Our 4,000 m² production facility in Stikland Industrial, Cape Town, is purpose-built for the manufacture of sterile single-use surgical products — combining ISO-classified clean rooms, validated sterilisation technology, and a rigorous quality management system.
4,000 m²
Production Floor Area
ISO 7
Clean Room Classification
EO + γ
Sterilisation Methods
100%
Locally Manufactured
6
Product Categories
SANS / ASTM
Regulatory Compliance
Contamination
has no place here.
Every ProSurgery product is manufactured within a fully classified clean room environment. Our controlled production zones maintain the stringent atmospheric conditions required for the production of sterile medical devices and single-use surgical items.
- ISO 7 (Class 10,000) classified clean room environment
- Positive-pressure HVAC with HEPA filtration
- Continuous particle monitoring and environmental logging
- Gowning protocols and personnel decontamination airlocks
- Segregated raw material and finished goods zones
- Temperature and humidity control within validated limits
Standards that protect
patients and clinicians.
Regulatory compliance isn't a checkbox — it's the framework around which our entire manufacturing operation is designed.
ISO 13485 QMS
Our Quality Management System is structured to ISO 13485 — the international standard for medical device manufacturers — ensuring every process, from raw material intake to final release, is documented, controlled, and auditable.
In-Process QC
Inline quality checks are performed at every production stage. Dimensional, visual, and functional inspections are conducted by trained QC technicians against validated acceptance criteria before products proceed to sterilisation.
Full Traceability
Every batch is assigned a unique lot number linked to raw material certificates, production records, sterilisation data, and release documentation — providing an unbroken chain of traceability from raw input to customer delivery.
SAHPRA & ASTM Compliance
Products are designed and tested to comply with SAHPRA registration requirements, ASTM F1671/F1670 barrier performance standards, and EN 13795 for surgical drapes and gowns, where applicable.
Ready to source
from the source?
Connect directly with our manufacturing and sales teams to discuss product specifications, MOQs, lead times, and custom configurations.
