Euro GTP Guidance - Euro GTPs

A.2. FACILITIES AND EQUIPMENT
A.2.1. FACILITIES, EQUIPMENT AND MATERIALS FOR RECOVERY
A.2.1.1. Facilities
A.2.1.1.1. General
1. ‘Procurement shall take place in appropriate facilities, following procedures that minimise
bacterial or other contamination of procured tissues and cells.’ 7
2. Procurement should take place in appropriate facilities, following procedures that
guarantee the anonymity of the donor.
3. Access to the facilities where the recovery, or any process that could affect the recovery
process (e.g. gowning room, materials storage, pre-recovery areas, etc.), is carried out, should
be controlled by restricting entrance only to authorized personnel. Access should be strictly
controlled once recovery operations have begun.
4. The area where the recovery is performed should have sufficient space and adequate
conditions to allow a safe operation and to prevent any contamination of the tissues retrieved
and the samples taken.
A.2.1.1.2. Operating room
1. The temperature, humidity and ventilation of the facilities where the donor is manipulated
should be adequate so as not to negatively affect the donor.
4. Temperature, humidity and pressure should be controlled. The temperature ranging from
22 ± 3ºC and humidity ranging from 50 ± 20% are recommended. The pressure should allow
the airflow from the cleanest area to the lowest level of cleanliness. A pressure gradient of
15 Pa should be guaranteed with the surrounding areas which should be kept in an adequate
level of cleanliness.
2. It is highly recommended that the facilities where the recovery takes place should be
provided with an environmental control system to ensure at least a GMP D grade
classification in ‘at rest’ situations. It should guarantee the donor manipulation and
examination, manipulation of the material and equipment and a comfortable working
conditions during tissue procurement and packaging.
7 Commission Directive 2006/17/EC (Art. 2)
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