Mecaplast

Depending on the properties of your product, such as raw material, design and functionality, the proper method of sterilisation is selected. Thanks to our partners, we take care of the whole sterilisation process, whether it is gas (Ethylene Oxide), irradiation (gamma, e-beam and X-ray) or steam.

Validation

 

MECAPLAST is also able to take care of the complete sterilisation and submit a full report, demonstrating evidence sterility of SAL 10⁻⁶

 

Sterilisation types

 

Ethylene Oxide Sterilisation:
Advantages
- does not degrade product or packaging
- generally cheaper than irradiation
Disadvantages:
- not appropriate with non-porous cavities or products with complex paths

Irradiation Sterilisation:
Advantages:
- fast turn time
- easily validated
Disadvantages:
- irradiation can degrade product or product packaging


Microbiology

Bioburden, sterility tests, pyrogen test (LAL) and EO residues are common microbiology tests that MECAPLAST can outsource and coordinate with our partner laboratories.