Lyophilised Amniotic Membrane distributed by FBTV is packaged in the form of an injectable patch or homogenate and can be stored at room temperature (+15°C/+30°C). The shelf life is stated on the package.
Used in:
The human amniotic membrane is a unique, thin, collagenous membrane derived from the submucosa of the placenta, t h e area where the human foetus grows and develops. It is made up of layers of collagen including: basement membrane and stromal matrix. The amniotic membranes used for clinical applications come from placentas harvested only from elective caesarean sections following careful selection of the d o n o r , who has consented to the donation, in accordance with tissue quality and safety regulations. In addition to standard screening including: Ac anti-HIV 1/HIV 2, Ac anti-HCV, HBsAg, Ac anti-HBc, Ac anti-HBs, Ac anti-Treponema pallidum, Ac anti-HTLVI/HTLVII, HBV-DNA, HCV-RNA, HIV- 1 RNA, additional Ac anti-Toxo IgG and IgM and Ac anti-CMV IgG and IgM tests are performed. Microbiological screening and, if deemed necessary, additional tests are also performed on each donor and tissue.
Lyophilised tissues are prepared in sterile double packaging, supplied with an instruction leaflet with all the characteristics of the tissue. The packaging is stored at room temperature. Each package bears the date of validity.
The tissue is sent in an athermic container, certified to ensure temperature maintenance during transport. Freeze-dried tissue must be stored at room temperature between
+15°C and +30°C, protected from light, excessive humidity and heat sources until the expiry date stated on the packaging.
The Bank guarantees proper preservation until receipt of the tissue; in the event of any problems occurring during transport, the user must immediately notify FBTV. All tissues distributed to implantation centres are accompanied by documentation describing: suitability of the donor, origin and characteristics of the tissue, expiry date, serological and microbiological tests performed, method of preservation, specific instructions for preservation and implantation, documentation for follow- up of the implanted tissue.
Each tissue must be used for a single patient.
The results obtained to date show that the amniotic membrane, thanks to the processing techniques, retains its original properties and can be considered a material of choice. All preparation, handling and storage operations are carried out in an environment with facilities in accordance
to national regulations. Laboratory activities are carried out in environments classified as Grade A according to the European Guide to Good Manufacturing Practices (GMP), the classification of the environments is verified with continuous checks in order to minimise the risk of contamination. Access to classified environments requires specific clothing to minimise possible contamination from outside and to safeguard the safety of personnel. Entry to the processing rooms is strictly limited to persons involved in the process or visitors accompanied by internal staff. The processing of amniotic membrane comprises: an extraction phase, an antibiotic decontamination phase (Gentamicin, Vancomycin, Meropenem) before packaging the tissue, scheduled freezing and storage
quarantined until all quality controls performed are reviewed and approved. Quality assurance and safety are performed:
The clinical use of human tissue offers important benefits for recipients. Like any product of human origin, their use is not without risks, although these are rare. A control system is needed to ensure traceability and identification of the tissue at any stage of the process, from donation to recipient. Each tissue is identified with a unique code to allow traceability from origin to destination. Once the tissue is transplanted the code must be attached to the recipient’s medical history. FBTV must be informed when the tissue has been transplanted, through the completion of the “Traceability Card” attached to the tissue. The bank must be informed if the tissue has not been implanted.
If there is suspicion or evidence of a serious adverse reaction or an effect in the recipient possibly related to the safety and quality of the transplanted tissue, the physician should contact immediately and complete the ‘Rapid Notification of Suspected Serious Adverse Events of Suspected Serious Adverse Events” or “Rapid Notification of Suspected Serious Adverse Reactions”.
FBTV is registered on the list of Tissue Banks accredited by the National Transplant Centre; regulated activities include donation, collection, evaluation, preparation, preservation and distribution of homologous tissues. It operates in compliance with international standard ISO 9001:2015 and has a certification process in place to certify that tissues meet predefined safety, traceability and morphological requirements. Homologous tissues procured, processed, stored and distributed meet the requirements of Italian legislation (Law 91/99, Legislative Decree 191/97, Legislative Decree 15/11/2016, Legislative Decree 256 16/12/2016, State/Regions Agreement 66/CSR 8/3/2018) and European Directive 2004/23 and Directives 2006/17/EC, 2006/86/EC, 2012/39/EU, 2015/565/EU, 2015/566/EU. FBTV follows the standards of the main scientific associations: European Association of Tissue Banks (EATB), American Association of Tissue Banks (AATB), and the recommendations of: Good Tissue Practices (Euro-GTP) and the Council of Europe EDQM Guide to the quality and safety of tissues and cells for human application.
Il trattamento di liofilizzazione offre numerosi vantaggi.
I tessuti possono essere conservati a temperatura ambiente
per lungo tempo, senza la necessità di strumenti per la conservazione a basse temperature.
Le loro caratteristiche biologiche e biomeccaniche restano inalterate.
Tutte le info per richiedere un tessuto incluso il modulo da compilare. Dopo aver ricevuto il vostro modulo, il nostro team procederà con una valutazione iniziale e vi contatterà.
oppure Accedi per scaricare il tariffario.
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