Custom Slot Dies for Healthcare and Pharmaceutical Coatings

GMP-Compliant Coating Solutions for Medical Applications

Our precision slot dies are designed to meet the stringent requirements of the healthcare and pharmaceutical industries, delivering high-quality coatings for medical films, transdermal patches, and wound care products. Adhering to Good Manufacturing Practices (GMP), our dies ensure consistent, defect-free coatings that comply with regulatory standards, supporting safe and effective medical solutions. Engineered with advanced materials and precision machining, our slot dies optimize coating performance for critical healthcare applications.

GMP Compliance Details

Precision Die Systems adheres to Good Manufacturing Practices (GMP) to ensure our slot die coating solutions meet the rigorous quality and safety standards required for healthcare and pharmaceutical applications. Our GMP-compliant processes include:

• Controlled Manufacturing Environment: Dies are produced in cleanroom facilities to prevent contamination, ensuring compliance with FDA and EU GMP guidelines for medical-grade coatings.

• Material Traceability: Use of certified, biocompatible materials (e.g., 316L stainless steel, medical-grade alloys) with full documentation of material origins and batch records for regulatory audits.

• Precision Quality Control: Each die undergoes rigorous inspection with tolerances of ±0.001 mm, verified by calibrated metrology equipment, to ensure uniform coating thickness critical for transdermal and wound care applications.

• Process Validation: Comprehensive validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to guarantee consistent performance in high-speed coating lines (up to 200 m/min).

• Cleaning and Sterilization Compatibility: Die designs support easy disassembly and cleaning, with polished surfaces (Ra < 0.05 µm) to minimize residue and ensure compatibility with GMP cleaning validation requirements.

• Documentation and Compliance: Full GMP documentation, including Certificates of Conformance (CoC) and validation reports, provided to support regulatory submissions for medical devices and pharmaceutical coatings.

Applications and Benefits

• Wound Care: Produces uniform coatings for advanced wound dressings, ensuring biocompatibility and adhesion for patient safety.

• Transdermal Patches: Enables precise, multi-layer coatings for controlled drug delivery, meeting USP and ICH standards.

• Medical Tapes: Supports high-clarity adhesive coatings for surgical tapes, reducing irritation and improving performance.

• Regulatory Assurance: GMP compliance reduces audit risks, streamlining customer approvals for medical and pharmaceutical products.

Case Study Example

A pharmaceutical client required a GMP-compliant slot die for transdermal patch production. Our die, manufactured in a cleanroom with validated processes, achieved higher coating uniformity, reducing defects by 20% and meeting FDA GMP requirements, enabling faster market approval.