Precision Medical Device Pad Printing Systems
Engineered for cleanroom-grade precision, micrometer registration, and strict regulatory compliance. We provide turnkey medical printing workcells combining high-repeatability Kent Turbo platforms with fully certified USP Medical Class VI and toy-safe biocompatible inks for diagnostic housings, dials, syringes, and clinical disposables.
Turnkey Medical Cell Architecture
Reliable healthcare marking requires stable ink viscosity, exact fixture repeatability, and minimal airborne contamination:
- Kent G-Turbo Sealed Cup System: Utilizes precision-ground ceramic doctor rings within hermetically sealed ink cups. This locks in solvents, eliminates VOC vapour spread, and maintains stable viscosity across long medical batches.
- Anti-Static & Cleanroom Compatibility: Designed with smooth, chemical-resistant anodised and powder-coated surfaces for rapid wipe-down sterilization and cleanroom boundary operation.
- Custom-Machined Part Mandrels: Delrin or anodised aluminium nesting fixtures ensure 360° rotational stability and micro-registration without marring sterile polymer surfaces.
Coates TP 400 Series
Specifically engineered for invasive and non-invasive medical equipment requiring biocompatibility testing:
- Certifications: USP Medical Class VI & EN 71-3 toy safety standard
- Formulation: Free from aromatics, cyclohexanone, butyl glycolate & BPA
- Substrates: Polycarbonate (PC), Polyamides (PA), PMMA, and treated PP/PE
Kent G-Turbo Series
Precision single- and multi-colour pad printers designed for clinical and technical mouldings:
- Configurations: 1-Colour (Turbo 90) or 2-Colour Shuttle (G-Turbo-90S2)
- Control: Microprocessor control with variable pad stroke and dwell times
- Cup Size: 90 mm sealed cup for efficient, low-waste ink management
Process Validation & Tooling
Comprehensive tooling support to satisfy installation and operational qualifications:
- Repeatability: Hard-anodised nesting blocks with micron-fine adjustments
- Adhesion Testing: Cross-hatch and chemical wipe validation support in Sunbury
- Documentation: Full MSDS, technical data sheets, and compliance certificates
Frequently Asked Questions: Medical Device Pad Printing
What makes Coates TP 400 suitable for medical device manufacturing?
Coates TP 400 is independently certified according to USP Medical Class VI standards for biocompatibility. Its formulation is completely free from aromatics, cyclohexanone, butyl glycolate, and BPA. It also adheres to strict European safety criteria including AfPS GS 2014:01 PAH (Category 1) and EN 71-3.
Can the Kent G-Turbo series be operated in cleanroom environments?
Yes. The Kent G-Turbo line incorporates hermetically sealed magnetic ink cups with ceramic doctor rings, virtually eliminating airborne solvent emissions into the room. Its pneumatic exhausts can be filtered or piped out of the cleanroom zone, and smooth exterior casework allows standard surface sanitization.
How do 2-component medical inks resist sterilization and autoclave cycles?
When Coates TP 400 is mixed with Hardener TP 219 (at a 10:1 ratio), it undergoes a chemical cross-linking reaction. Once fully cured, the ink film achieves high resistance to alcohol wipe-downs, disinfectant sterilization, and common medical wash chemicals.
Which medical plastics can be pad printed with this setup?
The system prints directly onto medical-grade Polycarbonate (PC), Polyamides (Nylon/PA), PMMA (Acrylic), and rigid PVC. For non-polar polyolefins like Polypropylene (PP) and Polyethylene (PE), inline corona or flame surface activation is applied prior to stamping to achieve high bond strength.