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Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden.

Marsit N, Dwejen S, Saad I, Abdalla S, Shaab A, Salem S, Khanfas E, Hasan A, Mansur M, Abdul Sammad M - Cell Tissue Bank (2014)

Bottom Line: Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required.The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP.The donor's type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %).

View Article: PubMed Central - PubMed

Affiliation: Tissue Banking Research Group, Biotechnology Research Center, Tweisha, Libyan Authority for Research, Science and Technology, P. O. Box 30313, Tripoli, Libya, nagimarsit@yahoo.com.

ABSTRACT
Preparation of amniotic membrane (AM) by air drying method followed by radiation sterilization is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation sterilization dose (RSD) for tissue allografts is an essential step for the development and validation of the standard operating procedures (SOP). Application of SOP is perfectly relying on trained staff. Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required. AM were processed by four different couples of the tissue bank technicians. The AM grafts were randomly selected and subjected to bioburden test to validate and substantiate the 25 kGy RSD. Bioburden test for AM grafts were also useful to evaluate the skill of the tissue bank technicians and thus, to validate the current SOP for air dried AM. Moreover, the effect of placental source on bioburden counts on AM grafts was assessed. Substantiation of the 25 kGy RSD at a sterility assurance level of 10(-1), and sample item portion = 1, was carried out using Method VD max (25) of the International Organization for Standardization, document no. 11137-2 (ISO in Sterilization of healthcare products-radiation-part 2: establishing the sterilization dose, Method VDmax-substantiation of 25 kGy or 15 kGy as the sterilization dose, International Standard Organization, 2006). The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP. The 25 kGy RSD was validated and substantiated as a valid sterilization dose for the AM prepared with the current established SOP at the Biotechnology Research Center experimental tissue bank. The donor's type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %).

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a Amniotic membrane stretched over sterile gauze and tightened into sterilized dual circular wooden frame. b, c Amniotic membrane graft cutting, trimming and packaging in inner polyethylene packs
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Fig1: a Amniotic membrane stretched over sterile gauze and tightened into sterilized dual circular wooden frame. b, c Amniotic membrane graft cutting, trimming and packaging in inner polyethylene packs

Mentions: Subsequently, inside the Class II safety cabinet (HERASAFE KS9, Thermo Scientific, Germany), the membranes were spread over sterile cotton gauze (Winner industries, Shenzhen Co., LTD, China) on a sterile glass plate and sterile saline was used to prevent amnion sticking to the glass plate. The gauze with amnion was then mounted onto sterilized dual circular wooden frames (Ø = 16 cm), “the ones used in textile stitching crafts” (Fig. 1a) and air dried in biosafety cabinet for overnight (≥18 h), then, the membranes were cut, trimmed and packed in inner polyethylene packs (Fig. 1b, c) which were enveloped in pre-autoclaved self-seal sterilization pouches (Sigma medical supplies corp., Taiwan). The AM grafts envelopes were then labeled, heat sealed using (ALLPAX PT-MJ-4 DS, Gm bH&Co. KG, Germany) machine and stored at room temperature, small pieces remained after cutting was used as quality control samples.Fig. 1


Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden.

Marsit N, Dwejen S, Saad I, Abdalla S, Shaab A, Salem S, Khanfas E, Hasan A, Mansur M, Abdul Sammad M - Cell Tissue Bank (2014)

a Amniotic membrane stretched over sterile gauze and tightened into sterilized dual circular wooden frame. b, c Amniotic membrane graft cutting, trimming and packaging in inner polyethylene packs
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4221624&req=5

Fig1: a Amniotic membrane stretched over sterile gauze and tightened into sterilized dual circular wooden frame. b, c Amniotic membrane graft cutting, trimming and packaging in inner polyethylene packs
Mentions: Subsequently, inside the Class II safety cabinet (HERASAFE KS9, Thermo Scientific, Germany), the membranes were spread over sterile cotton gauze (Winner industries, Shenzhen Co., LTD, China) on a sterile glass plate and sterile saline was used to prevent amnion sticking to the glass plate. The gauze with amnion was then mounted onto sterilized dual circular wooden frames (Ø = 16 cm), “the ones used in textile stitching crafts” (Fig. 1a) and air dried in biosafety cabinet for overnight (≥18 h), then, the membranes were cut, trimmed and packed in inner polyethylene packs (Fig. 1b, c) which were enveloped in pre-autoclaved self-seal sterilization pouches (Sigma medical supplies corp., Taiwan). The AM grafts envelopes were then labeled, heat sealed using (ALLPAX PT-MJ-4 DS, Gm bH&Co. KG, Germany) machine and stored at room temperature, small pieces remained after cutting was used as quality control samples.Fig. 1

Bottom Line: Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required.The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP.The donor's type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %).

View Article: PubMed Central - PubMed

Affiliation: Tissue Banking Research Group, Biotechnology Research Center, Tweisha, Libyan Authority for Research, Science and Technology, P. O. Box 30313, Tripoli, Libya, nagimarsit@yahoo.com.

ABSTRACT
Preparation of amniotic membrane (AM) by air drying method followed by radiation sterilization is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation sterilization dose (RSD) for tissue allografts is an essential step for the development and validation of the standard operating procedures (SOP). Application of SOP is perfectly relying on trained staff. Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required. AM were processed by four different couples of the tissue bank technicians. The AM grafts were randomly selected and subjected to bioburden test to validate and substantiate the 25 kGy RSD. Bioburden test for AM grafts were also useful to evaluate the skill of the tissue bank technicians and thus, to validate the current SOP for air dried AM. Moreover, the effect of placental source on bioburden counts on AM grafts was assessed. Substantiation of the 25 kGy RSD at a sterility assurance level of 10(-1), and sample item portion = 1, was carried out using Method VD max (25) of the International Organization for Standardization, document no. 11137-2 (ISO in Sterilization of healthcare products-radiation-part 2: establishing the sterilization dose, Method VDmax-substantiation of 25 kGy or 15 kGy as the sterilization dose, International Standard Organization, 2006). The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP. The 25 kGy RSD was validated and substantiated as a valid sterilization dose for the AM prepared with the current established SOP at the Biotechnology Research Center experimental tissue bank. The donor's type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %).

Show MeSH
Related in: MedlinePlus