A history of isolator and containment technology, Part 6: Development of the validation of isolators

Abstract

This final section is devoted to the development of various validation methods conforming to GMP when applied to isolators and also a review of the methods in relation to validating the processes used in preparing for aseptic processing and sterility testing. There are brief comments on what the regulators expect.

Early aspects

Validation, as far as the pharmaceutical industry is concerned, started in the 1970s, initially in the field of large volumeparenterals. Up until that date no organised regulatory approved validation processes had been developed.

If we look at the isolator usage up to that point, it focused on the rearing of germ free animals, protection of patients with compromised immunological systems and also protection of staff in treating patients with highly contagious diseases.

Germ free animal technology depended on HEPA filtered air and air exchange rates with disinfection, either manually or, later, by the use of gaseous formalin or peracetic acid. These were validated, in a sense, by the success or failure of raising and holding germ free animals in a germ free environment.

For protection of compromised patients again reliance was placed on air filtration and exchange rates plus appropriate disinfection. Here some environmental microbiological testing was undertaken,
essentially to demonstrate freedom of bacteria and fungi.

For protection of operator, when dealing with seriously infected patients, there were barrier nursing techniques
and also the use of validated disinfectants for decontaminating any items removed from the environment of the isolator and for the washing of the nursing staff as a routine. […]

A courtesy of ‘Clean Air & Containment Review’ – www.cleanairandcontainment.com