Validation of Radiation Sterilization Process
Validation of Radiation Sterilization Process
Validation of Radiation Sterilization Process
sterilization process
Iwona Kaluska
Institute of Nuclear Chemistry and Technology
Quality systems
z Process/equipment characterization
– The sterilization subcontractor has developed an
equipment specification, including a control system for
the equipment, which is capable of being programmed
to deliver a predefined process. A sterilizer
manufacturer has been contracted to manufacture and
install the specified equipment.
z Product definition
– The medical device manufacturer is responsible for
specification of the product and its manufacture.
The allocation of responsibilities might be
as follows: (3/ 5)
z Process definition
– The medical device manufacturer defines a process for the
particular medical device(s) to be sterilized. The medical device
manufacturer undertakes the biological safety assessments and
product compatibility studies. In this case, these studies are
conducted using experimental sterilization equipment.
z Validation
– The sterilization subcontractor undertakes installation qualification
and operational qualification in accordance with documented
procedures. The medical device manufacturer then undertakes
performance qualification using the installed sterilization
equipment conforming that the equipment is capable of delivering
the defined sterilization process. The medical device manufacturer
reviews and approves the validation exercise. A contract laboratory
might perform microbiological testing in accordance with methods
agreed with the medical device manufacturer.
The allocation of responsibilities might be
as follows: (4/ 5)
zSterilization
of health care
products - Radiation
Irradiator operator responsibilities
z Installationqualification
z Operational qualification
z Controlling the irradiation process
z Change control of the irradiator
z Certification of the radiation dose
Primary manufacturer responsibilities
• Establishing the sterilization dose
• Developing product families
• Establishing the maximum acceptable dose
• Performance qualification
• Controlling the manufacturing process including the
specifications for products submitted to the irradiator
operator, i.e., product density, orientation, dimensions
• Revision of specifications submitted to the irradiator
operator
• Change control of the product to include a review of
product-related variables that impact processing categories
• Product release
Installation Qualification