Sterilisation and Isolator Technology

Daman Pharma Summit 2023 also comprised technical sessions which are relevant to life sciences indusry. One of them was given by Sunil Karpe, Sr VP-Production & Projects, Sovevax Biologics. His topic at the event was sterilisation and isolator technology.

He began his presentation by explaining the process of sterilisation and need for it in the life sciences industry. Then, he went on to explain each type of sterilisation i.e. physical sterilisation, chemical sterilisation, sterilisation by radiation and sterilisation by filtration. He explained each process, their applications and their need in detail.

Karpe also spoke about different barrier systems such as open restricted access barrier system (ORAB), closed restricted access barrier system

(CRAB) and isolator system. In this session, he focussed on the different types of isolators and how they operate using negative pressure or positive pressure. He informed that isolators using negative pressure are used for oral solid dosage forms to handle toxic powders during sampling, dispensing, process, testing. They are also used for non aseptic compounding in case of injectables. Positive pressure, Grade A, VHP sterile isolators are used for handling of all aseptic activities like filtration, filling, lyo etc.

Elucidating on the usage of isolators, he said that they are used to create a physical barrier between two different environments, i.e. background environment vs actual Grade A environment, wherever aseptic injectable products are handled. He said that they provide high assurance on sterility, make it easy to handle toxic products, hormonal products and steroidal products, as well as ensure that biotech products are safe from contamination due to humans or background environment.