This dossier covers the siliconisation process of glass containers for two medicinal products, MIRCERA® and NeoRecormon® that are commercialized in pre-filled syringes (PFS).

The inner surface of PFS are lubricated with silicone oil to allow the movement of a plunger stopper along the inner side of the glass containers, while at the same time allowing for a tight connection between the glass barrel and the plunger stopper. During the production of the PFS for the two affected medicinal products, RDG currently uses a silicone oil emulsion which contains the substance Octylphenolethoxylates (OPnEO) as emulsifier for the siliconisation of the glass containers.

For an alternative silicone oil emulsion to be considered as an appropriate replacement of the OPnEO containing emulsion, the following conditions should be fulfilled:

• The physicochemical behaviour of the silicone oil emulsion must be appropriate for the manufacturing process. This behaviour determines if the content and distribution of the silicone oil on the glass container can be achieved within the specified ranges.
• The functionality of the PFS must be fulfilled, i.e. the closing as well as the gliding properties of the plunger stopper must be within the specified range.
• The components of the silicone oil emulsion must be compatible with the medicinal product, i.e. stability studies have to demonstrate that the medicinal product meets the specified requirements at the end of shelf life.

An alternative silicone oil emulsion has been proposed by the supplier. First experiments regarding physicochemical properties of the alternative have shown positive results. However, the process required for the substitution of the OPnEO containing silicone oil emulsion requires extensive testing and generation of stability data of each medicinal product. Since medicinal products are subject to extensive regulation by the health authorities all over the world, change notifications have to be submitted to competent health authorities when any change is introduced in their production process. Substitution with an alternative silicone oil emulsion can only be completed after approvals from health authorities have been received.

Annual tonnage used: maximum 1.2 kg/a

Review period requested: 5 years