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Validation and assessment of an antibiotic-based, aseptic decontamination manufacturing protocol for therapeutic, vacuum-dried human amniotic membrane
- Source :
- Scientific Reports, Vol 9, Iss 1, Pp 1-11 (2019), Scientific Reports
- Publication Year :
- 2019
- Publisher :
- Springer Science and Business Media LLC, 2019.
-
Abstract
- Amniotic membrane (AM) is used to treat a range of ophthalmic indications but must be presented in a non-contaminated state. AM from elective caesarean sections contains natural microbial contamination, requiring removal during processing protocols. The aim of this study was to assess the ability of antibiotic decontamination of AM, during processing by innovative low-temperature vacuum-drying. Bioburden of caesarean section AM was assessed, and found to be present in low levels. Subsequently, the process for producing vacuum-dried AM (VDAM) was assessed for decontamination ability, by artificially loading with Staphylococcus epidermidis at different stages of processing. The protocol was highly efficient at removing bioburden introduced at any stage of processing, with antibiotic treatment and drying the most efficacious steps. The antibacterial activity of non-antibiotic treated AM compared to VDAM was evaluated using minimum inhibitory/biocidal concentrations (MIC/MBC), and disc diffusion assays against Meticillin-resistant Staphylococcus aureus, Meticillin-resistant S. epidermidis, Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis. Antibacterial activity without antibiotic was low, confirmed by high MIC/MBC, and a no inhibition on agar lawns. However, VDAM with antibiotic demonstrated effective antibacterial capacity against all bacteria. Therefore, antibiotic decontamination is a reliable method for sterilisation of AM and the resultant antibiotic reservoir is effective against gram-positive and –negative bacteria.
- Subjects :
- 0301 basic medicine
Vacuum
Corneal diseases
medicine.drug_class
Antibiotics
Colony Count, Microbial
lcsh:Medicine
Microbial Sensitivity Tests
medicine.disease_cause
Article
Enterococcus faecalis
Microbiology
Bioburden
03 medical and health sciences
Raffinose
0302 clinical medicine
Staphylococcus epidermidis
medicine
Humans
Amnion
lcsh:Science
Decontamination
Multidisciplinary
biology
Antimicrobials
Pseudomonas aeruginosa
business.industry
lcsh:R
Reproducibility of Results
Sterilization
Human decontamination
Translational research
Sterilization (microbiology)
biology.organism_classification
6. Clean water
Anti-Bacterial Agents
3. Good health
030104 developmental biology
lcsh:Q
Antibacterial activity
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 20452322
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- Scientific Reports
- Accession number :
- edsair.doi.dedup.....707cb49a947053c85588a5b6077042be