Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.2.1.1. Facilities

A. General

1. ‘Procurement shall take place in appropriate facilities, following procedures that minimise bacterial or other contamination of procured tissues and cells.’[1]

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. 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.

3. This classification should be guaranteed by establishing adequate procedures and schedules.  The objective of airborne particles monitoring is to ensure that the facilities fulfil the sufficient level of cleanliness just before processing.  Therefore these monitoring operations should be scheduled to be performed immediately before the processing activities.

5. The operational parameters of the operating room should be checked at least annually.  This qualification should include at least the integrity test of the absolute filters, incoming air flow and air renovation per hour measurement, differential pressures measurement, airborne particles count, temperature and relative humidity measurement and classification recuperation time. 

6. The facilities should be properly cleaned, maintained and designed and located getting the maximum protection against contamination and animal pests.

7. The cleaning programme should take into account the initial cleaning just before any recovery process, the cleaning between recovery processes and the cleaning after a recovery process.  An adequate alternation of disinfectants should be established and the efficacy of the cleaning procedures should be demonstrated by validation studies.

A. Unusual place of recovery

When the recovery takes place in an unusual place (e.g. mortuary, funeral home, donor residence, hospital bed), an enclosed space should be prepared considering the asepsis.

A. Ancillary areas

1. The ancillary areas should be fixed to a cleaning programme that minimises the risk of incoming contamination to the operating room.

2.’Rest and refreshment rooms should be separate from other areas.

3. Facilities for changing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users.  Toilets should not directly communicate with recovery or storage areas[2].

A.2.1.2. Equipment

1. Procurement equipment shall be managed in accordance with the standards and specifications laid down in the directives and with due regard to relevant national and international regulation, standards and guidelines covering the sterilisation of medicines and medical devices.  Qualified, sterile instruments and procurement devices shall be used for tissue and cell procurement.  The appropriate equipment and instruments should be used, in order to guarantee the quality of the specific recovered tissue.

2. Wherever possible, only CE marked medical devices must be used and all concerned staff must have received appropriate training on the use of such devices.

3. Sterile instruments and devices must be used for tissue and cell procurement.  Instruments or devices must be of good quality, validated or specifically certified and regularly maintained for the procurement of tissues and cells.

4. When reusable instruments must be used, a validated cleaning and sterilisation procedure for removal of infectious agents should be in place.[3]

5. The TE or ORHA must have equipment adapted to the operations for which they are intended, in accordance with the requirements of this general quality standard and in accordance with the standard specific for each tissue type.

6. Measuring, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods.  Adequate records of such tests should be maintained.  The parameters affecting the quality or safety of tissues and cells (e.g. temperature, pressure, particle count) are defined, monitored and recorded.  When appropriate, the equipment will be provided with an alarm system.

7. Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the donors.  They should be cleaned and, where applicable, disinfected according to detailed SOPs.  They will be inspected regularly and maintenance will be performed according to manufacturer's instructions and / or to the specifications established by the TE or ORHA.

8. After any major repair or modification, the equipment or critical equipment should be re-checked and validated before its release.

9. Calibration and maintenance operations should be carried out according to written procedures and scheduled on an annual basis.  Temperature should be monitored with calibrated probes to ensure that during the entire period of time the range has been properly kept.

10. If there is any electronic system in place to manage environmental conditions or any donor data, a validation study of the system should be assessed.

A.2.1.3. Materials

1. Procurement materials and equipment shall be managed in accordance with the standards and specifications laid down in Annex IV, section 1.3 of Commission Directive 2006/17/EC, and with due regard to relevant national and international regulation, standards and guidelines covering the sterilisation of medicines and medical devices. Qualified, sterile instruments and procurement devices shall be used for tissue and cell procurement. [4]

2. The specifications of the materials used to perform any evaluation of the donor should be described and these materials should not have any negative impact on the maintenance of the donors and reliability of the evaluation results.

3. Specifications for starting and primary or printed packaging materials should include, if applicable:

a)    a description of the materials, including;

                        i.     the designated name and the internal code reference;

                       ii.     the reference, if any, to a pharmacopoeia monograph;

                     iii.     the approved suppliers and, if possible, the original producer of the products;

                     iv.     a specimen of printed materials.

b)    directions for sampling and testing or reference to procedures;

c)     qualitative and quantitative requirements with acceptance limits;

d)    storage conditions and precautions;

e)     the maximum period of storage before re-examination.[5]

4. The TE or ORHA must have the materials adapted for their intended use, in accordance with the requirements of this general standard of quality and, when appropriate, in accordance with the tissues specific standards.

5. When the materials have an influence on the quality or safety of tissues and cells, they should be validated.

A.2.1.4. Safety and Environment

1. The working environment must be safe and conform to labour laws.  Data on this subject can be mentioned in the manual.

2. In order to minimize the risk for the staff and/or for the environment, residues of human tissues and cells during their transformation must be destroyed in a specific and traceable way in accordance with current legal regulations concerning the disposal of clinical waste.  The removal of discarded tissue will follow the same procedure.

[1] Commission Directive 2006/17/EC  (Art. 2)

[2] EU Good Manufacturing Practices Guidelines

[3] Directive 2006/17/EC of the European Parliament and of the Council (Annex IV)

[4] Commission Directive 2006/17/EC (Art. 2)

[5] EU Good Manufacturing Practices Guidelines


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