Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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2.1.2 Skin in 85% glycerol

Factor

1

3

5

7

9

score

Risk that contaminants will not be detected in the tissue due to limitations of sampling method

10% destructive testing in compliance with

European  Pharmacopea.

Tissues preserved in culture

medium (contamination visible)

A biopsy of tissue tested  from every individual graft processed

 

Pieces of tissue tested for each process run (< 1% of the run)

Swabbing of final tissue

5

Risk of contamination during manipulation*

Tissue exposed to the processing environment for < 1 hr

Tissue exposed to the processing environment for 1-3 hr

Tissue exposed to the processing environment for 3-5 hr

Tissue exposed to the processing environment for 5-7 hr

Tissue exposed to the processing environment for > 7hr

5

Use of antimicrobials

Agents

with validated reduction of microbial contamination (by >3 logs)

Agents with published evidence of effective reduction of microbial contamination

(85% glycerol for skin processing)

Validated antibiotic

Cocktail treatment

Fluid storage and conditions in final container not promoting microbial growth (e.g. low temperature)

Fluid storage and conditions promoting microbial growth (temperature > 10 °C)

3

Risk of transfer of contaminants at transplantation a. Type of tissue

Acellular

No vital cells

Vital cells but no vessels

Vital cells and minor

vessels

Fully vascular with vital cells

3

Risk of transfer of contaminants at transplantation b. Type of use

Temporary superficial coverage < 3 weeks

Durable superficial coverage > 3 weeks

Durable implant in a poorly vascularised site

Small durable implant in a well vascularised site

Large durable implant in a well vascularised site

1

 

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