Page 93 - Assurance of Sterility for Sensitive Combination Products and Materials

80 Assurance of sterility for sensitive combination products and materials

5.1 History of sterile packaging
The purpose of packaging a sterile health-care product is to allow for ster-
ilization of the product, minimize the risk of ingress of microorganisms,
maintain integrity of the sterile barrier system (SBS) overtime and thru
environmental and transportation challenges, and allow for aseptic presenta-
tion of the product at the point of use. ISO 11607-1 [1, 2] defines the “ster-
ile barrier system” (SBS) as the minimum package that minimizes the risk
of ingress of microorganisms and allows aseptic presentation of the sterile
contents at the point of use. One of the first examples of an SBS would be
Pasteur’s swan-neck flask used during the studies he conducted in the 19th
century to disprove the theory of spontaneous generation. Pasteur boiled
meat broth that would support microbial growth in a flask where the flask
had been shaped into a gentle “s.” The curve of the glass allowed air into the
flask but collected dust and other particles in the bend of the neck. These
flasks remained uncontaminated with microorganisms until the neck was
removed allowing particles in the air to enter the flask and growth to occur.
This experiment also demonstrated the concept of a “tortuous path” which
is still utilized today in sterile packaging.
The history of sterile packaging follows the history of medicine and the
use of sterile medical instruments during surgery. In the 19th century, the
medical practices began the progression into modern medicine because of
the increasing knowledge of microbiology proven in the surgical setting by
Joseph Lister. Initially, all sterile devices were sterilized at the point of use
using carbolic acid and heat. The packaging was metal or glass containers
if any at all. Lister could prepare his dressing saturated with carbolic acid
within his facility but few other hospitals could copy this technique [3].
Fred Kilmer published his classic article, “Modern Surgical Dressings” in the
American Journal of Pharmacy in January 1897 [4] in which he describes
the first “commercial” production of sterile surgical dressings. Ultimately,
Kilmer joined Johnson & Johnson and true commercial production of
sterile medical dressings was started. These were packaged in glass jars and
maintained integrity to the point of use wherever they had been shipped.
Packaging of sterile devices also follows the evolution of sterilization
methods. In the 1940s, Drs Charles A Phillips and Saul Kaye were assigned
to work on biological decontamination at the military base of Fort Detrick
[3]. Their work on ethylene oxide (EO) was the basis for commercial use
of EO as a sterilant. This opened the doors for device design to incorporate
heat labile materials into their construction. EO and radiation sterilization