- EMA CLEAN - CERTIFIED CAPS are specifically processed caps, ensuring a low content of particulate- and bioburden contamination before sterilization.
- EMA CLEAN - CERTIFIED CAPS can be provided in
“Ready-to-be-sterilized” or “Ready-to-be-used” versions.
- If the capping process happens inside the aseptic core, the use of EMA CLEAN-CERTIFIED CAPS is appropriate.
The final sealing of the stoppered vial can be undertaken as a clean or as an aseptic process.
If the capping procedure is performed as an aseptic process, sterilized caps have to be used (annex 1, EU GMP).
The sterilization of the caps can be performed by ionizing radiation ( i.e. irradiation by gamma - or beta rays), gaz (ethylene oxyde, hydrogen peroxyde) or saturated steam.
The validated sterilization process is supposed to show a SAL (sterility assurance level) of 106, assuring though a "6-log reduction" (10−6) of the initial microbial population.
Therefore, to assure the efficacy of the sterilization process, the caps have to be dry, clean and their initial bioburden should be as low as possible prior to sterilization.
For this purpose, EMA Pharmaceuticals created the range: EMA CLEAN – CERTIFIED CAPS
The validated EMA CLEAN-CERTIFIED CAP Process provides the following features :
- A washing, rinsing and drying procedure of the aluminum shell
- The use of a gamma- and steam sterilizable polypropylene lid
- The assembling of aluminum and polypropylene parts in ISO 8 clean room environment
- The analysis of particle- and bioburden contamination on representative samples
- Double- packaging in heat-sealed PE-bags
- low bioburden before sterilization
- low particulate contamination level
Of course, EMA CLEAN-CERTIFIED CAPS provide you the benefits of EMA’s knwledge in terms of :
- Enhanced machinability on high speed filling lines
- A large variety of different designs and colors
- Ease of use (optimal Push-Off force of the plastic lid)
- Enhanced Tamper-Evidence.