ISO/TS 13004-2013 pdf download.Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VD max SD.
4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General The establishment of a sterilization dose, for which sterilization dose selection and substantiation can be undertaken, and the carrying out of sterilization dose audits are activities that are part of process definition and maintaining process effectiveness (see ISO 11137-1). For these activities, product may be grouped into families; definition of product families is based principally on the numbers and types of microorganisms on or in product (the bioburden), the type being indicative of the microorganism’s resistance to radiation (see ISO 11737-1). Variables such as density and product configuration within its packaging system are not considered in the establishment of these product famillies because they are not factors that influence bioburden. In using product families for establishing the sterilization dose and for carrying out sterilization dose audits, it is important to be aware of the reduction in the ability to detect an inadvertent change within the manufacturing process that influences the effectiveness of sterilization. Furthermore, with the use of a single product to represent the product family, changes that occur in other members of the product family might not be detected. The effect of a reduction on ability to detect changes in other members of the product family should be evaluated and a plan for maintaining product families developed and implemented before proceeding.
4.2 Defining product families
4.2.1 The criteria for defining a product family shall be documented. Product shall be assessed against these criteria and the similarities between potential product family members considered. Consideration shall include all product-related variables that affect bioburden, including, but not limited to:
a) nature and sources of raw materials, including the effect, if any, of raw materials that might be sourced from more than one location; .
b)] components;
c} product design and size;
d) manufacturing processes;
e) manufacturing equipment;
f) manufacturing environment;
g) manufacturing location.
The outcome of the assessment and considerations shall be recorded (see 4.1.2 of ISO 11137-1:2006).
4.2.2 Product shall only be included in a product family if it is demonstrated that the product-related variables (see 4.2.1) are similar and under control.ISO/TS 13004 pdf download.