Chapter 12: Definitions

B

Bioburden:

is a population of viable presterilisation micro-organisms in the finished product, raw material, component and/packaging.

Biocompatibility:

is the state of the biomaterial within a physiological environment without the material adversely affecting the tissue or the tissue adversely affecting the material.

Biological Indicator (BI):

a solution or carrier consisting of a known concentration of spores that are highly resistant to moist heat sterilisation, which can be used to predict lethality to the presterilisation bioburden by use of the BI system.

C

Calibrated or Certified BI:

A BI spore population either in a spore strip or a suspension that has been laboratory tested for its D-value in a specialised chamber, e.g., Bier Unit, against a known ethylene oxide concentration, temperature, percentage relative humidity and time conditions.

Certification:

is a documented review and approval of a process carried out as final step in the validation programme to permit product release.

Chain Scission:

is the breaking of a molecular bond causing the loss of a side group or shortening of the overall chain. This results in a loss of strength and elongation, with irradiation of some polymers.

Commissioning (Installation Qualification):

Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification and that it functions within predetermined limits when operated in accordance with operational instructions.

Computer Control:

Control system that uses computer(s) to control time and initiate the electrical...