Thermoplastic Extrusion for the Healthcare Sector
Biocompatibility, cleanroom purity and ESD protection for medical and pharmaceutical equipment.
Critical Materials for the Healthcare Value Chain
At CANDEA Plastics we manufacture technical-grade extruded sheets and rolls designed to comply with the most demanding regulatory frameworks in the healthcare sector: FDA 21 CFR, EU MDR 2017/745 and ISO 10993. Our materials integrate into the value chain of medical device manufacturers (OEMs), pharmaceutical companies and cleanroom operators that require full traceability, low particle emission and sustained chemical resistance.
From ISO 5-7 cleanroom panels to diagnostic equipment housings and pharmaceutical packaging trays, our thermoplastics enable production of components that withstand aggressive disinfection cycles, gamma sterilization and autoclaving while maintaining dimensional stability and mechanical properties. We also offer ESD formulations to protect sensitive laboratory equipment and antimicrobial options for high-touch surfaces in hospital environments compliant with GMP standards.
- Hygiene and Biocompatibility: Materials suitable for patient and biological fluid contact, with ISO 10993 and FDA 21 CFR certification pathways.
- Cleanroom Compliance: Ultra-low particle emission formulations compatible with ISO 5 to ISO 7 environments and GMP processes.
- Regulatory Compliance: Polymers with full batch traceability and documentation for FDA, EU MDR and notified body audits.
Technical Challenges: Hygiene and Reliability in Critical Environments
Biocompatibility and Cleanroom Purity
Components in contact with patients or in pharmaceutical manufacturing environments must guarantee biocompatibility per ISO 10993 and generate particle levels compatible with ISO 5-7 cleanrooms. Cross-contamination or cytotoxicity are unacceptable risks.
- Our Solution: Medical-grade polymers formulated with high-purity, low-outgassing resins, compatible with cytotoxicity, sensitization and irritation testing per ISO 10993-5/-10/-12.
- Benefit: Materials ready to facilitate medical device certification under FDA 21 CFR and EU MDR 2017/745, with particle generation below ISO 7 cleanroom thresholds.
Chemical Resistance to Disinfectants and Sterilization
Healthcare equipment undergoes aggressive and repeated disinfection cycles with agents such as vaporized hydrogen peroxide (VHP), peracetic acid and sodium hypochlorite. Additionally, many components must withstand gamma sterilization (25-50 kGy) or autoclaving (134 °C) without degradation.
- Our Solution: High chemical resistance thermoplastics (PP, PET, PETG) formulated to maintain surface and mechanical integrity after thousands of cleaning cycles and multiple sterilizations, including gamma and autoclaving.
- Benefit: Extended service life of panels, trays and housings without cracking, yellowing or property loss, reducing replacement costs and downtime.
ESD Protection for Diagnostic and Laboratory Equipment
In vitro diagnostic (IVD) equipment, clinical analyzers and laboratory systems contain precision sensors and electronics highly sensitive to electrostatic discharge. Static build-up during handling can damage components and skew analytical results.
- Our Solution: Permanent conductive and dissipative materials (PET ESD, ABS ESD) with controlled surface resistance of 10⁵ to 10⁹ Ω/sq, maintaining ESD properties even after deep-draw thermoforming and disinfectant exposure.
- Benefit: Housings and handling trays that protect high-value IVD equipment and analyzers, ensuring reliable analytical results and ANSI/ESD S20.20 compliance.
Technical Material Catalog for Healthcare
We develop formulations that balance purity, chemical resistance and regulatory compliance for each stage of the healthcare value chain.
| Material Family | Key Properties | Typical Applications |
|---|---|---|
| Medical-Grade ABS | High impact resistance, thermoformability, ISO 10993 certification pathway. | Medical equipment housings, clinical instrumentation panels, device covers. |
| Conductive PET ESD | Permanent antistatic protection, chemical resistance, partial transparency. | Diagnostic trays, laboratory carriers, IVD equipment fixtures. |
| Antimicrobial Compounds | Bacteriostatic action integrated into the matrix, disinfectant resistance. | High-touch hospital surfaces, clinical furniture panels, handles and trays. |
| Chemical-Resistant PP | Resistance to VHP, peracetic acid, hypochlorite; autoclave compatible at 134 °C. | Pharmaceutical packaging trays, sterilization containers, cleanroom components. |
| Smooth Finish (Low Particle) | Ultra-low particle emission, non-porous surface, easy cleaning. | Cleanroom wall panels, ISO 7 ceiling cladding, clean zone dividers. |
CANDEA Materials for this sector
HDPE ESD Conductivo CA-755
CA-755
Polietileno de alta densidad (HDPE) con protección ESD conductiva y excepcional resistencia química. Diseñado para entornos agresivos donde la exposición a químicos, disolventes o electrolitos exige materiales que combinen seguridad electrostática con durabilidad a largo plazo.
View all materialsTPE-H-ABS ESD Soft-Touch CA-572
CA-572
Mezcla de elastómero termoplástico y ABS con protección ESD conductiva y superficie soft-touch distintiva. Combina una calidad táctil similar a la del caucho con la resistencia al impacto del ABS, uniendo confort ergonómico y seguridad electrostática.
View all materialsApplications Across the Healthcare Value Chain
From in-line protection to final parts in the end product.
Medical Equipment
Materials for housings, panels and structural components of medical devices that must comply with FDA 21 CFR and EU MDR 2017/745. Solutions that withstand daily disinfection, contact with biological fluids and the wear typical of high-turnover hospital environments.
- Imaging equipment housings (X-ray, ultrasound, CT).
- Clinical furniture panels and hospital bed components.
- Patient monitoring device covers and frames.
Pharma & Clean Industry
Solutions for GMP environments and cleanrooms where air purity and absence of cross-contamination are production requirements. Materials with low outgassing and particle emission that facilitate validation of pharmaceutical and biotechnology processes.
- ISO 5-7 cleanroom wall and ceiling panels.
- Pharmaceutical packaging trays with low extractables.
- Separators and dunnage for sterile product logistics.
Diagnostics & Laboratory
ESD protection and chemical resistance for in vitro diagnostic (IVD) equipment and clinical analysis systems. Materials that guarantee the integrity of sensors and precision electronics, essential for the reliability of analytical results.
- ESD housings for clinical analyzers and IVD systems.
- Sample and reagent handling trays.
- Protective components for microscopy and laboratory optics.
Why choose CANDEA Plastics in Healthcare?
Beyond plastic extrusion, we are your partner in innovation and material development.
Regulatory Knowledge: We understand the FDA 21 CFR, EU MDR 2017/745 and ISO 10993 frameworks. We provide supporting documentation and traceability to facilitate medical device certification.
Full Batch Traceability: Exhaustive control of raw materials and processes, with complete records for GMP quality audits and Notified Bodies.
Custom Healthcare Formulation: Ability to adjust antimicrobial properties, ESD levels, chemical resistance and surface finish according to the specific requirements of each medical application.
Validated Sterilization Compatibility: Materials tested to withstand gamma sterilization (25-50 kGy), autoclaving (134 °C) and VHP cycles without property degradation.
Ready to take your project to the next level?
Contact our experts to meet your technical and regulatory requirements.