Know what's inside:
Cleanliness Validation FDA / MDR Readiness
Cleanliness as a prerequisite for safe medical devices
Ensuring proper cleanliness during the manufacturing process is essential to delivering medical devices that are safe for patients, users, and third parties. Cleanliness is essential for successful sterilization, reprocessing, and ensuring biocompatibility.
Our services include:
✓ Bioburden
- Standards: DIN/TS 5343, ISO 11737-1, USP (61), EP 2.6.12
- Tests: Bioburden determination, validation of recovery
- TAT*: 2-3 weeks
✓ LAL endotoxin test (LAL)
- Standards: DIN/TS 5343 (ISO 19227): ISO 11737-3 (ANSI/AAMI) ST72, USP (85), EP 2.6.14
- TAT*: 2-3 weeks
✓ Particle Test
- Standards: DIN/TS 5343 (ISO 19227): USP (788) (AAMI TIR42)
- TAT*: 2-3 weeks
✓ Cytotoxicity Test
- Standards: DIN/TS 5343 (ISO 19227): EN ISO 10993-5, -12
- Tests: BCA/MTT
- TAT*: 3-5 weeks
✓Organic Chemical Analysis
- Standards: DIN/TS 5343 (ISO 19227): EN ISO 10993-1, -12, -18; TOC/THC (USP (643), ASTM F2847/ ASTM D7066, ASTM F2847)
- Test: GC-MS/GC-FID, TOC/THC
- TAT*: 4-6 weeks
✓ Inorganic Chemical Analysis
- Standards: DIN/TS 5343 (ISO 19227): EN ISO 10993-1, -12, -18
- Test: ICP-MS/ICP-OES
- TAT*: 5 weeks
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
