According to the requirements of 2010 GMP external preparation, eye ointment, eye gel and deep wound external preparation should be prepared according to the non final sterilization process.

1. Sterilisation of the matrix

Eye ointment: Eye ointment base is oil phase base, common petroleum jelly, liquid paraffin, lanolin, etc.. They need to be sterilised at 150°C.

Gel: Gel matrices are water-phase matrices, thickeners dispersed sterilisation, API dissolution using sterilisation 0.22um filtration.

2. Mixing

After the sterilization of the material mixing needs to ensure that the system is in a sterile state of protection, mixing equipment online SIP is in a sterile state of protection, sterile materials through the vacuum or pressure air sent to the mixing tank for mixing homogeneous mixing.

3. Aseptic powder addition

In the process of aseptic paste preparation, usually API raw materials are in a confused state. It is necessary to add API raw materials in the sterile isolator.

The emulsifying unit is the core part of the vacuum emulsifier. It consists of a high-speed rotating agitator and a fixed emulsifying knife. As the raw material rotates in the container, the emulsifying knife cuts and mixes it to produce a homogeneous emulsion.