Quality that protects your process
Pamax delivers high-quality, reliable products and services that meet the requirements of NBR 14990 and EN 868. All our suppliers are approved. We operate a quality management and control system (QMS) and provide all the raw-material documentation required for your certification and/or audit.
- Standards
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- Documents
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Standards
Materials compliant with NBR ISO 11607-1, NBR 14990 and EN 868, and processes aligned with RDC 665 (GMP).
In-house laboratory
Set up to verify, monitor and guarantee every requirement that characterises our products. Tests performed and recorded by trained professionals.
Approved raw materials
Medical-grade paper from 100% virgin cellulose, films and inks from approved suppliers, with documentation available for your dossier.
Traceability
Every batch is identified from raw material to finished product, with test records stored in a database.
Production control
Good manufacturing practices (GMP), qualified professionals and quality management system procedures at every stage.
Documentation
We provide all the raw-material and product documentation required for your certification, registration or audit.
Batch traceability
- 01Raw material
- 02Production
- 03Testing
- 04Batch
- 05Shipping
Standards and requirements
- NBR ISO 11607-1
- Packaging for terminally sterilized medical devices: requirements for materials and sterile barrier systems
- NBR 14990-3
- Packaging systems and materials for sterilization of healthcare products
- EN 868
- Packaging materials and systems for medical devices to be sterilized (parts 3 and 6)
- AFE 808457-7
- Company Operating Authorization granted by ANVISA
- RDC 665
- Good Manufacturing Practices for healthcare products (ANVISA)
- ISO 9000
- Basis of our quality management policy
Documentation
Valid documents authorized for publication. Data sheets and test reports are sent on request.
Technical data sheets, test reports and raw-material documentation are provided on request for your certification or audit.
Request technical documentation