Validations & Documentation

Validations

The validations comply with the specifications and, together with the qualifications, ensure a consistent high quality of products.
Through extensive documentation of the validation processes, we are able to provide our customers with the evidence necessary for the approval of their products.
The customer also has the option of having specially tailored validations carried out.
From cleaning and packaging to sterilisation or mechanical strength, we offer all the desired validation steps and customised documentation that complies with the guidelines. These include in particular:

Cleaning validations:

• Investigation of bioburden, ISO 11737-1, USP [61]
• Investigation of particle reduction, USP [788]
• Investigation for cytotoxic substances, ISO 10993-5
• Investigation for endotoxins, USP [85]
• Investigation for organic and inorganic residues, ISO 10993-12, -15, -18
• Biocompatibility, ISO 10993-1

Packaging tests:

• Visual inspection, ASTM F1886
• Seal strength, DIN EN 868-5 or ASTM F88/F88M
• Dye penetration test, ASTM F1929, ASTM F3039
• Burst test,ASTM F2096
• Investigation of the microbiological barrier property, DIN EN 58953-6

Packaging validation:

• Packaging tests, DIN EN ISO 11607-1,2 (packaging validation), EN 868-5 (Seal strenght), ASTM F1140 (Burst test), ASTM F88/F88M (Seal strenght), ASTM F1929 (Bubble test)
• Seal strength
• Leakage test (Bubble test)
• Colour test (Dye test)
• Microbial barrier effectiveness depending on humidity (Investigation of the microbiological barrier property)
• Transport simulation tests (ISTA 2a, ASTM D4169, DC 13, ISTA 3a, with pre-conditioning according to ASTM D4332)
• Mechanical load tests
• Accelerated ageing, ASTM F1980
• Real-time ageing according to internal standard

Sterilisation validation:

• DIN EN ISO 11137 parts 1,2,3 (gamma)
• DIN EN ISO 11135 (ethylene oxide)

Transport simulations and transport tests:

• ISTA 2a, ASTM D4169 D C3 (TO DELETE), DC 13, ISTA 3a, with pre-conditioning according to ASTM D4332
• Drop test, ASTM D5276
• Vibration test, ASTM D999 A, ASTM D4728
• Compression test, ASTM D4169+D 642
• Shock pulse, ASTM D6344
• Vacuum test, ASTM D6653

Documentation

Quality is the determining factor in all our activities. Our employees implement our quality management EN ISO 13485 in every step. We document every process step according to the corresponding requirements of the validation documents.

As a basis for product accreditation, we make comprehensive documentation available to our customers and, upon request, explain this documentation in connection with the product accreditation audits.

The European Medical Device Regulation (MDR / Medical Device Regulation 2017/745) poses new challenges for medical device manufacturers and their suppliers and subcontractors. As a service provider for critical processes (sterile packaging), there are special challenges for us. The documentation of the processes carried out within our company must meet the new requirements and be structured accordingly. We have dealt extensively with the MDR requirements and adapted the documentation of the processes as well as general verification documents accordingly. This makes it easier for our customers to obtain approval for an MDR-compliant product.

The documents are prepared in English according to standard practice. Upon request, we can arrange for other languages.