Sterilisation procedure

Packaging and validated sterilisation procedures to ensure sterility... 

Changes to an approved device that could affect its safety or effectiveness must be submitted to the FDA as a supplemental application. These include changes to the indications for use, changes to the labelling, packaging or sterilisation procedures. 

Note that all sterilisation procedures on packaging materials, e.g. heat, irradiation, do have an effect on the physical and sometimes chemical properties, e.g. plastics tend to go more brittle upon beta or gamma radiation. The sterilising of packaging materials is a specialised subject dealt with in Chapter 12. 

One of the most important requirements of bioceramics is their biocompa ability. This term encompasses not only the biological safety of a material as assessed by the ISO 10993 norm (2003, 2009, 2010) but also the mechanical and chemical characteristics, the design, sterilisation procedures and packaging of a medical device. 

During the sterilisation procedure the radiation dose should be measured. For this purpose, dosimetry indicators which are independent of dose rate should be used, giving a quantitative... 

Similarly, as these products do not undergo a terminal sterilisation procedure and do not usually contain preservative materials, it is extremely important that premises and staff are isolated from facilities handling or testing infectious virulent materials (e.g., challenge strains or diagnostic facilities). The checks on the health of staff in these production areas must also be more stringent than those for other production staff. 

The usual standard applied for pharmaceutical products is that the probability of a non-sterile unit should be less than 1 in 10 units (10 ). The sterilisation procedure necessary to reach this figure can be determined if the Z)-value is known using the inactivation factor (IF)... 

PAN is used in packaging (industrial, medical, and food) and as fibre (Orion), mainly because of its chemical and UV resistance, as well as for the retention of flavour and aroma and excellent durability under sterilisation procedures especially in packaging. PAN fibres have wool-like properties and are chemical precursors of high-quality carbon fibres. Almost all forms of PAN are copolymers with acrylonitrile as the main component. As copolymers of acrylonitrile, there is SAN to mention which will be discussed next. 

Some important considerations in choosing a PVC stabiliser are its effectiveness at low concentrations, its cost, conformity with food contact regulations, compatibility with the sterilisation procedures used with medical products, and its effect on product transparency and moisture absorption. In the case of cable insulation, nothing must happen that increases the electrical conductivity. 

Equipment. Equipment may be contaminated if inappropriate cleaning, disinfection or sterilisation procedures have been performed. 

Sterilisation procedure must not impair the functioning of the biomaterial... 

Adhesives used for devices that may make contact with the bloodstream need to withstand sterilisation procedures, i.e., ethylene oxide, gamma-ray or steam autoclaving. For reusable devices, the ability to pass through multiple autoclaving cycles without losing bond strength is the ultimate test of an adhesive. Epoxy adhesives perform well in... 

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