Medical Devices
We design precision-engineered cleanrooms, sterile assembly zones, contamination-controlled flows, and validated sterilization areas to support safe and scalable medical device manufacturing. Facilities are optimized for molding, assembly, packaging, and traceability with controlled bioburden and hygienic utilities.
Facilities to produce
- Syringes, IV sets, catheters, infusion lines, blood bags
- Diagnostic kits, swabs, cartridges, test strips
- Respiratory consumables, filters, tubing sets
- Surgical disposables: gloves, drapes, gowns, masks
How PPlus engineers medical device facilities
- Grade‑controlled cleanrooms with pressure zoning and HEPA filtration
- Sterile assembly lines integrated with RABS/isolators where required
- Validated sterilization areas with ETO/Gamma/Steam logic
- Hygienic utilities: clean air, nitrogen, PW, controlled HVAC
Regulatory Compliance
US FDA, EU MDR / IVDR, ISO 13485, ISO 14644, Indian CDSCO, TGA (Australia), MHRA (UK), sterilization validation (ETO, Gamma, Steam)
Why PPlus?
PPlus integrates cleanroom engineering, sterilization expertise, global regulatory alignment, and digital precision, delivering audit‑ready medical device facilities.
Emerging & Regulated Industries
FAQs
What cleanroom classes can PPlus design?
ISO Class 5–8 with controlled flows and validated HVAC.
How does PPlus ensure sterility assurance?
Through HEPA filtration, pressure zoning, validated sterilization cycles, and contamination‑proof flows.
Can PPlus design molding + assembly + packaging lines?
Yes, complete integrated layouts with traceability and hygienic utilities.