Page 38 - Assurance of Sterility for Sensitive Combination Products and Materials

26 Assurance of sterility for sensitive combination products and materials

3.1.3 History of dry and moist heat sterilization
The use of both dry and moist heat to preserve food has been alluded to
since biblical times, though it was more magic than science. In Exodus XVI
16:23 and 24, Moses instructed “So bake what you want to bake and boil
what you want to boil. Save whatever is left and keep it until the morning.”
“So they saved it until the morning, as Moses commanded, and it did not
stink or get maggots in it.” Later in Roman times, physicians would boil their
instruments before treating the gladiators. In 1830, William Henry applied
scientific methods to devise a jacketed hot air sterilizer and demonstrated
that heat could disinfect cholera infected clothing. Although it was recog-
nized that the prognosis of patients improved when the medical instruments
were first heat treated, it took the convergence of discovery and technology
to really initiate the fundamental understanding of heat sterilization as we
know it today. The concept of linking microbes to disease and the subsequent
development of the pasteurization process by Louis Pasteur in 1862 was key
in the evolution of the technology. Later, another key discovery was the
development of the intermittent heating process to inactivate heat-resistant
bacteria by John Tyndall in 1876. The technology that enabled this origi-
nated from the food industry. In 1795 Nicholas Appert invented canning
as a means to preserve food and in 1860 Denis Papin invented the pressure
cooker. Louis Pasteurs’ pupil Charles Chamberland developed the first pres-
sure steam sterilizer (autoclave) in 1876 and Ernst von Bergmann, a German
physician, put it all together in 1885 when he steam sterilized surgical dress-
ings. Around this time, Robert Koch developed a silk thread impregnated
with anthrax spores to investigate the various sterilization methodologies.
He demonstrated that moist heat was much more efficient than dry heat
at inactivating the bacteria and was able to define the exact conditions re-
quired. In 1885, Gaston Poupinel developed a dry heat sterilizer which was
adopted by many hospitals in France. Another milestone that enabled the
validation of the sterilization process was achieved in 1891 by Fred Kilmer
who developed BIs. As the technology continued to improve, the approaches
to standardize the sterilization process followed. In the same year, Ernst Von
Bergmann began heat sterilization of surgical instruments.
In the early 1980s, the Parenteral Drug Association published its tech-
nical report on sterilization validation [PDA Validation of Moist Heat
Sterilization Processes: Cycle Design, Development, Qualification and
Ongoing Control (1980, revised 2007), PDA Validation of Dry Heat
Processes Used for Depyrogenation and Sterilization (1981, revised 2013)]
followed by the International Standards Organization with their standards