EMA Clean-Caps

Ready-to-be-sterilized

EMA CLEAN - CAPS can be provided in “Ready-to-be-sterilized” or “Ready-to-be-used” versions.

Low content of particulate

EMA CLEAN - CAPS are specifically processed caps, ensuring a low content of particulate- and bioburden contamination before sterilization.

Aseptic core

If the capping process happens inside the ASEPTIC CORE, the use of EMA CLEAN - CAPS is appropriate.

Caps Ready-to-be-sterilized

Intended to be directly introduced into controlled environments and to undergo a steam sterilization process

Caps Ready-to-be-used

Intended to be directly introduced into the Class A clean room area of the aseptic process.

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 10^-6, 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 - CAPS

The validated EMA CLEAN - CAPS Process provides the following features :

The use of a gamma- and steam sterilizable polypropylene lid
The assembling of aluminum and polypropylene parts in ISO 8-like 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