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The validation and substantiation of sterilization dose for lyophilized human amnion membrane by gamma irradiation delivered
by Co60 source were investigated. The validation experiments were conducted according to ISO 13409 method B. A total of 120 human
amnion membranes were collected. Of these, 10 membranes were used for estimation of bioburden and 20 membranes were used for
the individual sterility test at verification dose. The average bioburden per product unit with sample item portion (SIP = 1)
for lyophilized human amnion membrane was 572 cfu. The verification dose experiments were done at dose of 8.1 kGy and the
results of sterility tests showed that human amnion membrane got one positive. Consequently, the sterilization dose of 25 kGy
was confirmed and substantiated. 相似文献
2.
Background ISO 11137-2006 (ISO 11137-2a 2006) provides a VDmax 15 method for substantiation of 15 kGy as radiation sterilisation dose (RSD) for health care products with a relatively low
sample requirement. Moreover, the method is also valid for products in which the bioburden level is less than or equal to
1.5. In the literature, the bioburden level of processed bone allografts is extremely low. Similarly, the Queensland Bone
Bank (QBB) usually recovers no viable organisms from processed bone allografts. Because bone allografts are treated as a type
of health care product, the aim of this research was to substantiate 15 kGy as a RSD for frozen bone allografts at the QBB
using method VDmax 15—ISO 11137-2: 2006 (ISO 11137-2e, Procedure for method VDmax 15 for multiple production batches. Sterilisation of health care products – radiation – part 2: establishing the sterilisation
dose, 2006; ISO 11137-2f, Procedure for method VDmax 15 for a single production batch. Sterilisation of health care products – radiation – part 2: establishing the sterilisation
dose, 2006). Materials 30 femoral heads, 40 milled bone allografts and 40 structural bone allografts manufactured according to QBB standard operating
procedures were used. Method Estimated bioburdens for each bone allograft group were used to calculate the verification doses. Next, 10 samples per group
were irradiated at the verification dose, sterility was tested and the number of positive tests of sterility recorded. If
the number of positive samples was no more than 1, from the 10 tests carried out in each group, the verification was accepted
and 15 kGy was substantiated as RSD for those bone allografts. Results The bioburdens in all three groups were 0, and therefore the verification doses were 0 kGy. Sterility tests of femoral heads
and milled bones were all negative (no contamination), and there was one positive test of sterility in the structural bone
allograft. Accordingly, the verification was accepted. Conclusion Using the ISO validated protocol, VDmax 15, 15 kGy was substantiated as RSD for frozen bone allografts manufactured at the QBB. 相似文献
3.
For several decades, a dose of 25 kGy of gamma irradiation has been recommended for terminal sterilization of medical products,
including bone allografts. Practically, the application of a given gamma dose varies from tissue bank to tissue bank. While
many banks use 25 kGy, some have adopted a higher dose, while some choose lower doses, and others do not use irradiation for
terminal sterilization. A revolution in quality control in the tissue banking industry has occurred in line with development
of quality assurance standards. These have resulted in significant reductions in the risk of contamination by microorganisms
of final graft products. In light of these developments, there is sufficient rationale to re-establish a new standard dose,
sufficient enough to sterilize allograft bone, while minimizing the adverse effects of gamma radiation on tissue properties.
Using valid modifications, several authors have applied ISO standards to establish a radiation dose for bone allografts that
is specific to systems employed in bone banking. These standards, and their verification, suggest that the actual dose could
be significantly reduced from 25 kGy, while maintaining a valid sterility assurance level (SAL) of 10−6. The current paper reviews the methods that have been used to develop radiation doses for terminal sterilization of medical
products, and the current trend for selection of a specific dose for tissue banks. 相似文献
4.
Validating a Low Dose Gamma Irradiation Process for Sterilizing Allografts Using ISO 11137 Method 2B 总被引:1,自引:0,他引:1
This paper describes the validation of an allograft sterilization method specifically designed for the processing methods
used at AlloSource in Centennial, CO. The methods used for this validation followed ISO Standard 11137, Method 2B. Three hundred
allografts, collected from three defined production batches were dosed using a series of five incremental doses, beginning
at 1 kGy and increasing by 1 kGy until 5 kGy was achieved. Following sterilization dosing, each allograft test article was
analyzed using a sterility test to identify any viable microorganisms. The number of positive sterility samples was used to
calculate the verification dose (1.27 kGy), which was then verified by an additional batch of 100 allografts. The results
from this validation indicate that sterility (10−6 SAL) on human allograft tissue using gamma 60Co radiation can be achieved when a dose of at least 9.2 kGy is employed. 相似文献
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