GMP USP Functional and Performance Testing of Metal Tubes

A laboratory is needed to perform GMP-compliant functional and performance testing of metal tubes in accordance with applicable USP, BS EN, and ISO standards.

Required Testing:

1. Particulate Matter: Testing per applicable USP requirements.

2. Coating Continuity (Porosity): Evaluation per applicable USP requirements, BS EN 15384-1, and BS EN 15384-2.

3. Coating Adhesion: Testing per applicable USP requirements and BS EN 15421.

4. Coating Thickness: Measurement per applicable USP requirements and ISO 2360.

5. Closure Airtightness: Testing per applicable USP requirements and EN 12377.

6. Deformation: Evaluation per applicable USP requirements and EN 16285.

The laboratory should confirm its GMP testing capabilities, availability of the specified test methods, and ability to provide the corresponding analytical test reports.