Monday, May 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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C.3.1.1. Reception

See generic requirements in section A.5.1.5.

C.3.1.2. Access to the processing facilities

See generic requirements in section A.5.1.2.

C.3.1.3. Processing

C.3.1.3.1. General

See generic requirements in section A.5.1.3.

C.3.1.3.2. Processing methods

See generic requirements in section A.5.1.3.2

Proof is required that the validated procedures are performed by the tissue bank staff in a uniform manner in accordance with the approved standard operating procedures.

The amniotic membrane should be processed in a sterile manner under laminar air flow.  The whole placenta should be rinsed several times and the amnion and chorion should be mechanically separated according to a documented standard operating protocol.  The amnion should be placed on a suitable carrier membrane (e.g. nitrocellulose membrane) and divided into smaller pieces.

C.3.1.3.2.1. Organ culture and cell culture

Not applicable for placental tissue.

C.3.1.3.2.2. Decontamination of tissues and cells

Amniotic membrane may be decontaminated using antibiotics during processing and storage.

C.3.1.3.2.3. Sterilization/disinfection of tissue

Freeze-dried amniotic membrane may be sterilized by radiation.

C.3.1.3.2.4. Viral inactivation
C.3.1.3.2.5. Prion inactivation
C.3.1.3.2.6. Other processes

 

C.3.1.3.3. Cross contamination

See generic requirements in section A.5.1.3.3.

To keep the contamination risk including cross contamination between individual donors as low as possible, appropriate measures are to be taken.  They also include the potential risk of tissue contamination with a transmittable disease by infected staff.

Principally, contamination is possible through contact with surfaces of the retrieval and processing areas, via the staff, via material and via contact to other donor material.

Direct contact of the donor tissue and a person must be avoided.  For this reason, manipulations are principally made using instruments avoiding contact of the person performing the manipulation with the part getting into contact with the tissue.  All materials and surfaces coming into contact with the tissue must be sterile.  The process steps and material used are to be designed in such a way that cross contamination is avoided.

The methods for discarding donor tissue are to avoid any contamination of other donor tissue, processing environment and staff.

C.3.1.4. Quality control

C.3.1.4.1. Microbiological control

During preservation of placental tissue at least one sterility test of a placenta sample stored in preservative is to be performed.  It is also recommended to collect samples of different rinsing solutions and pieces of tissue for microbiological testing.  In these tests, a sensitive microbiological method for detection of bacteria and fungi is to be applied.

C.3.1.4.2. Other controls

Within the frame of retrieval and preservation of human amniotic membrane, a reliable macroscopic examination of the donor placenta to exclude visible pathological changes is to be performed.

C.3.1.5. Packaging and labelling

See generic requirements in section A.5.1.5.

C.3.1.6. Storage / preservation

See generic requirements in section A.6.

C.3.1.6.1. General

See generic requirements in section A.6.1.

C.3.1.6.2. Methods of preservation and storage

For each kind of storage condition the maximum storage duration is to be specified.  Among other features, when selecting the time interval, the potential deterioration of the required cell and tissue characteristics needs to be considered.

C.3.1.6.2.1. Preservation and storage at +37°C

Not applicable for amniotic membrane preservation.

C.3.1.6.2.2. Preservation and storage at +4°C

Not applicable for amniotic membrane preservation.

C.3.1.6.2.3. Cryopreservation

Amniotic membrane should be stored in sterile organ culture medium or sterile glycerol in a freezer at -75°C to -85°C or in liquid nitrogen, vapour phase.  The function of the preservative is to ensure the quality and safety of the human amniotic membrane.

Principally, storage / transport temperatures of cryopreserved human amniotic membrane above -60°C are to be strictly avoided to ensure the stability of the product and maximum safety for the recipient.  The tissue bank is to ensure that all storage processes are performed under controlled conditions.

A preservation and expiry date for amniotic tissue should be indicated.  For cryopreserved human amniotic membrane, a total period of twelve (12) months is applicable.

Additionally, for the distribution of cryopreserved human amniotic membrane, tissue banks should adhere to the subsequent minimal transport conditions necessary to maintain the required membrane’s biological properties:

a)     Transport of human amniotic membrane, within 10 minutes to the OR: at room temperature;

b)    Transport of human amniotic membrane, to be given to a third party or with a transport time of more than 10 minutes: temperatures between -60°C and -85°C to be maintained, e.g. using dry ice.

Principally, transport temperatures of cryopreserved human amniotic membrane above -60°C are to be strictly avoided to ensure the stability of the product and maximum safety for the recipient.  The tissue bank is to ensure that all storage processes are performed under controlled conditions.

Freeze dried amniotic membranes should be transported at ambient temperature.

C.3.1.6.2.4. Glycerolization

See chapter 3.3.6.2.3.

C.3.1.6.2.5. Freeze drying and dehydration

Freeze dried amniotic membranes should be stored at room temperature.

C.3.1.6.2.6. Other methods of preservation and storage

Not applicable for amniotic membrane preservation.

C.3.1.6.3. Storage area

See generic requirements in section A.3.3.6.3.

C.3.1.7. Documentation and release

C.3.1.7.1. General

See generic requirements in section A.5.1.6.1.

C.3.1.7.2. Release

See generic requirements in section A.5.1.6.2.

Additionally, it must be ensured that the human amniotic membrane cannot be released by the person responsible before the below requirements have been met:

a)     Full donor screening for contraindications with normal result;

b)    Negative serological or molecular biology diagnosis of the donor shortly before and six (6) months after the donation.  If initially tests for HIV 1/2 and HBC and HCV using nucleic acid amplification methods are performed in addition to the required serological tests, repeated testing after six (6) months is not required;

c)     Negative microbiological test result of one tissue sample in preservation medium per placenta;

d)    No relevant, macroscopically detectable, pathological changes in the tissue to be transplanted.

As long as these requirements have not been met, the human amniotic membrane is quarantined.  The applicable quarantine period should be six (6) months or more, unless initially HIV1/2 and HBV and HCV testing was performed using the nucleic acid amplification method in addition to the required serological tests.  In such cases, quarantine is required until all serological and molecular biology test results are available.

C.3.1.7.3. Processing file contents

See generic requirements in section A.5.1.6.3.

C.3.1.7.4. Availability for inspection

See generic requirements in section A.5.1.6.4.

C.3.1.7.5. Traceability

See generic requirements in section A.5.1.6.5.

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