Sterilisation & Sanitation

It is recommenced that parenterals are aseptically filled. If they are not terminally sterilised, they must be aseptically filled. To achieve this, all parts in direct or indirect contact with the product must be sterile (sanitised in certain circumstances).

Steam sterilisation is the most common method for sterilisation. Temperature and time is controlled.

Steam-in-Place (SIP): steam is added inside the pipework, tanks and equipment, which has had direct or indirect contact to the product. This tends to be used for fixed processes.

Autoclaves: removable parts such as utensils, change parts and pipework are placed inside the autoclave, where they are sterilised. Components, which are used to seal a product in its container, can be sterilised in specially designed equipment such as closure processors or within autoclaves. Media and product, sealed in a container, can also be sterilised in an autoclave. A product must be terminally sterilised, providing that this does not affect its properties.

Dry heat can be used, where temperature, air flow and time must be controlled. Dry heat is most common for depyrogenation.

A chemical sanitisation can be used, most commonly in the form of VHP, or even a manually sanitisation, using alcohol for example.

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