CTM Mixers for the Medical Sector
- Clean Room Compatibility:
- Specifically designed for installation in clean rooms
- Meets stringent requirements of the medical and pharmaceutical industries
- Ensures contamination-free processing environments
- Regulatory Compliance:
- Fully compliant with:
- cGMP (current Good Manufacturing Practice)
- FDA (Food and Drug Administration) standards
- EMA (European Medicines Agency, formerly OMS) guidelines
- 21 CFR Part 11 – Ensures electronic records and signatures are trustworthy and equivalent to paper records
- Fully compliant with:
- Material & Surface Specifications:
- All parts in contact with the product are:
- Made from FDA-approved materials
- Available with various surface treatments based on specific needs:
- Special coatings for chemical resistance or easy cleaning
- Stainless steel for hygiene and durability
- Nickel-plated surfaces for corrosion resistance and cleanliness
- All parts in contact with the product are:
- Process Control & Supervision:
- Integrated with Colmec Supervision System:
- Centralized monitoring and control of all mixer components
- Real-time tracking of process parameters
- Automated data logging for compliance and traceability
- Supports audit trails and validation processes required by regulatory authorities
- Integrated with Colmec Supervision System:
- Key Applications:
- Pharma & Medical:
- Manufacturing of medical-grade silicones and elastomers
- Production of components for medical devices, implants, tubing, etc.
- Compounding & Mixing:
- Accurate blending of sensitive ingredients under controlled conditions
- Suitable for high-purity silicone and rubber compound processing
- Pharma & Medical:
