Page 32 - Assurance of Sterility for Sensitive Combination Products and Materials

20 Assurance of sterility for sensitive combination products and materials

Biotech Info Tech
Pharmaceuticals Hardware
Diganostics Genomics Software
Research/info Bioinformatics Communications
Tools Proteomics
Industrial
Biosensors
Bioelctronics Biochips Nanodevices
Microfluidics Nanosensors
Nanobiotech Nanoelectronics
Drug delivery
Nano tech
Electrical
Structural
Biomedical
Energy & environment

Fig. 2.8 The ascendance of combination products by convergence of technology plat-
forms [18].

new biomaterials for medical devices, novel routes of administration to bet-
ter target drugs, through to wholly tissue engineered solutions.
Combination products with electrical components have been around
for some time, often, as in the case of photodynamic therapy, the drug is
provided separately from the electronic device that generates the light that
is used to activate it, the two being cross-labeled for use in specific indica-
tions. Some newer technologies, however, have integrated electronics and
methods to sterilize such products can be challenging. Steam, EtO, chem-
icals with moisture, and irradiation methods can all adversely affect elec-
tronics. The use of low-temperature dry-heat processes (below 160°C) for
sterilization has been used for some medical implants and can be suitable for
some electronic materials that are heat resistant as long as the new process
is adequately qualified and validated. The same goes for novel polymers that
would otherwise perish under some of the harsher sterilization conditions.
For instance, silicone prostheses are sterilized by dry heat as they undergo
radiation-induced cross-linking or retain high levels of ethylene oxide if
treated using EtO. Bioabsorbable polymers will degrade by design and pro-
cesses used to sterilize these materials can accelerate the degradation process