Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
Enter Title Minimize

Table of Contents

PURPOSE AND SCOPE 1
SECTION A: GENERAL REQUIREMENTS 3
A.1. PERSONNEL 3
A.2. FACILITIES AND EQUIPMENT 8
A.2.1. FACILITIES, EQUIPMENT AND MATERIALS FOR RECOVERY 8
A.2.1.1. Facilities 8
A.2.1.1.1. General 8
A.2.1.1.2. Operating room 8
A.2.1.1.3. Unusual place of recovery 9
A.2.1.1.4. Ancillary areas 9
A.2.1.2. Equipment 9
A.2.1.3. Materials 11
A.2.1.4. Safety and Environment 11
A.2.2. FACILITIES, EQUIPMENT AND MATERIALS FOR PROCESSING 12
A.2.2.1. Facilities 12
A.2.2.1.1. General 12
A.2.2.1.2. Processing area 13
A.2.2.1.3. Environmental airborne control 15
A.2.2.1.4. Environmental microbiological control 18
A.2.2.1.5. Sanitation 19
A.2.2.1.6. Isolator technology 19
A.2.2.1.7. Ancillary areas 20
A.2.2.2. Equipment 21
A.2.2.3. Materials 22
A.2.2.3.1. General 22
A.2.2.3.2. Material requirements 23
A.2.2.4. Safety and Environment 23
A.2.3. FACILITIES, EQUIPMENT AND MATERIALS FOR STORING 24
A.3. DONOR SCREENING 24
A.3.1. ACTIVITIES 24
A.3.1.1. Donor detection 24
A.3.1.1.1. Determination of death 25
A.3.1.1.2. Donor identification 25
A.3.1.1.3. Post Morten donor maintenance 26
A.3.1.2. Donor consent; judicial and familiar 27
A.3.1.2.1. Deceased donor 29
A.3.1.2.2. Living donor 30
A.3.1.3. Data protection and confidentiality 31
A.3.1.4. Advertising 32
A.3.1.5. Prohibition of financial compensation for donors 32
A.3.1.6. Donor evaluation; medical, social and physical 33
A.3.1.6.1. General 33
A.3.1.6.2. Medical and social evaluation 35
A.3.1.6.3. Physical evaluation of cadaveric donors 38
A.3.1.6.4. Exclusion criteria 40
A.3.1.6.5.1. Deceased donor 40
A.3.1.6.5.2. Additional exclusion criteria for dead children donors 42
A.3.1.6.5.3. Living donors 42
A.3.1.6.5.3.1. Allogeneic use donation 42
A.3.1.6.5.3.2. Autologous use donation 43
A.3.1.6.6. Autopsy 43
A.3.1.7. Donor evaluation; biological 43
A.3.1.7.1. General 43
A.3.1.7.2. Allogeneic Donation 45
A.3.1.7.2.1. Heart beating donors 45
A.3.1.7.2.2. Non-heart beating donors (Post-mortem removal) 46
A.3.1.7.2.3. Living donors 46
A.3.1.7.3. Autologous Donations 47
A.3.1.7.4. Serum Bank 47
A.3.1.8. Documentation and release for recovery 47
A.3.1.8.1. General 47
A.3.1.8.2. Release 48
A.3.1.8.3. Donor Screening File Contents 48
A.3.1.9. Availability for inspection 49
A.3.1.10. Traceability 49
A.4. RECOVERY 50
A.4.1. ACTIVITIES 50
A.4.1.1. Access to the operating room 50
A.4.1.2. Access to an unusual place of recovery 51
A.4.1.3. Recovery 51
A.4.1.3.1. General 51
A.4.1.3.2. Deceased donors 52
A.4.1.3.2.1. Recovery procedure of tissues 52
A.4.1.2.3.2. Reconstruction of the donor's body 53
A.4.1.3.3. Living donors 53
A.4.1.4. Processing during recovery 53
A.4.1.5. Packaging and labelling 53
A.4.1.5.1. Primary packaging and labelling operation 55
A.4.1.5.2. Secondary packaging and labelling operation 55
A.4.1.6. Storage and transport 56
A.4.1.6.1. Storage 56
A.4.1.6.2. Transport 56
A.4.1.7. Documentation and release for processing 57
A.4.1.7.1. General 57
A.4.1.7.2. Release 58
A.4.1.7.3. Recovery File Contents 58
A.4.1.7.4. Availability for inspection 59
A.4.1.7.5. Traceability 59
A.5. PROCESSING 59
A.5.1. ACTIVITIES 59
A.5.1.1. Reception 59
A.5.1.1.1. Receipt of tissues and cells at processing centre 60
A.5.1.1.2. Verification of tissues received 61
A.5.1.1.3. Identification of tissues and cells 62
A.5.1.2. Access to the processing facilities 62
A.5.1.3. Processing 63
A.5.1.3.1. General 63
A.5.1.3.2. Processing methods 64
A.5.1.3.3. Cross contamination 64
A.5.1.4. Quality Control 65
A.5.1.4.1. Microbiological control 65
A.5.1.4.1.1. General Principle 65
A.5.1.4.1.2. Microbiological controls 65
A.5.1.5. Packaging and labelling 65
A.5.1.5.1. Packaging and labelling materials management 66
A.5.1.5.2. Primary packaging and labelling operation 67
A.5.1.5.3. Secondary packaging and labelling operation 67
A.5.1.6. Documentation and release in distribution 68
A.5.1.6.1. General 68
A.5.1.6.2. Release 69
A.5.1.6.3. Processing File Contents 69
A.5.1.6.4. Availability for inspection 70
A.5.1.6.5. Traceability 70
A.6. STORAGE AND DISTRIBUTION 72
A.6.1. GENERAL 72
A.6.2. DISTRIBUTION 73
A.6.3. IMPORT AND EXPORT 74
A.6.4. DOCUMENTATION AND RELEASE 79
A.6.4.1. General 79
A.6.4.2. Release 79
A.6.4.3. Storing and Distribution File Contents 79
A.6.4.4. Availability for inspection 80
A.6.4.5. Traceability 80
A.7. QUALITY MANAGEMENT 80
A.7.1. QUALITY ASSURANCE 80
A.7.1.1. General 80
A.7.1.2. Documentation 82
A.7.1.3. Non-compliance management 84
A.7.1.4. Internal Audit 84
A.7.1.5. Product Quality Review/Process Quality Review 85
A.7.1.5.1. Donor screening 86
A.7.1.5.2. Recovery 86
A.7.1.5.3. Processing 87
A.7.1.5.4. Distribution 88
A.7.1.6. Recalls 88
A.7.1.7. Complaints and returns 89
A.7.2. QUALITY CONTROL 90
A.7.2.1. General 90
A.7.2.2. Documentation 91
A.7.2.3. Sampling 91
A.7.2.4. Testing 92
A.7.2.5. Stability Monitoring 93
A.7.2.6. Expiry Date 94
A.7.3. QUALITY RISK MANAGEMENT 95
A.7.4. VALIDATION 95
A.7.4.1. General 95
A.7.4.2. Documentation 96
A.7.4.3. Facility, system and equipment qualification 97
A.7.4.3.1. Qualification for new facilities, systems and equipment 97
A.7.4.3.2. Qualification of established (in-use) facilities, systems and equipment 99
A.7.4.3.3. Qualification of Clean Rooms 99
A.7.4.3.4. Qualification of Laminar Flow Hoods 100
A.7.4.4. Process validation 100
A.7.4.4.1. Prospective validation 100
A.7.4.4.2. Concurrent validation 101
A.7.4.4.3. Retrospective validation 101
A.7.4.5. Cleaning and Disinfection Validation 102
A.7.4.6. Revalidation 103
A.7.5. CRITICAL THIRD PARTY AGREEMENTS 103
A.7.6. CONTINUITY PLANS / CESSATION OF BANK 105
A.8. BIOVIGILANCE 106
A.8.1. SERIOUS ADVERSE EVENTS/REACTIONS 106
A.8.2. NOTIFICATION OF SERIOUS ADVERSE REACTIONS (RECIPIENTS) 107
A.8.3. NOTIFICATION OF SERIOUS ADVERSE REACTIONS (LIVING DONORS) 108
A.8.4. NOTIFICATION OF SERIOUS ADVERSE EVENTS 108
SECTION B: SPECIFIC OCULAR REQUIREMENTS 110
B.1 DONOR SCREENING 110
B.1.1. ACTIVITIES 110
B.1.1.1.Donor detection 110
B.1.1.2.Donor consent 110
B.1.1.3. Donor evaluation 110
B.1.1.3.1.General 110
B.1.1.3.2. Medical evaluation 110
B.1.1.3.2.1.Anamnesis 110
B.1.1.3.2.2.Social evaluation 110
B.1.1.3.2.3. Physical evaluation 110
B.1.1.3.2.4.Exclusion criteria 111
B.1.1.3.2.5. Exclusion criteria for scleral tissue donors 114
B.2. RECOVERY 114
B.2.1. ACTIVITIES 114
B.2.1.1. Access to the operating room or other recovery room 114
B.2.1.2. Recovery 114
B.2.1.2.1. General 114
B.2.1.2.2. Deceased donors 114
B.2.1.2.2.1. Donor identification 114
B.2.1.2.2.2. Gowning 114
B.2.1.2.2.3. Donor preparation 115
B.2.1.2.2.4. Whole eye retrieval by enucleation 115
B.2.1.2.2.5. Corneoscleral disc retrieval by in situ excision 115
B.2.1.2.2.6. Scleral tissue recovery 115
B.2.1.3. Processing during recovery 116
B.2.1.4. Quality control 116
B.2.1.5. Packaging and labelling 116
B.2.1.5.1. Primary packaging and labelling 116
B.2.1.5.1.1. Packaging for organ culture 116
B.2.1.5.1.2. Packaging for hypothermic storage 116
B.2.1.5.1.3. Whole eye packaging / Moist Chamber Storage 116
B.2.1.5.1.4. Scleral tissue packaging 117
B.2.1.5.2. Packaging for cryopreservation 117
B.2.1.6. Storage and transport after recovery 117
B.2.1.6.1. Storage after tissue recovery 117
B.2.1.6.1.1. Storage temperatures 117
B.2.1.6.1.2. Storage time 117
B.2.1.6.2.Transport after tissue recovery 118
B.2.1.7. Documentation and release for processing 119
B.3. PROCESSING 119
B.3.1. ACTIVITIES 119
B.3.1.1. Reception 119
B.3.1.2. Access to the processing facilities 119
B.3.1.3. Processing 119
B.3.1.3.1.General 119
B.3.1.3.2. Processing methods 119
B.3.1.3.2.1. Processing of tissues and cells 119
B.3.1.3.2.2. Decontamination of tissues and cells 120
B.3.1.4. Quality control 120
B.3.1.4.1. Microbiological control 120
B.3.1.4.1.1. General Principle 120
B.3.1.4.1.2. Methods 121
B.3.1.4.2.Other controls 122
B.3.1.4.2.1.Other controls for cornea 122
B.3.1.4.2.2. Evaluation of scleral quality 124
B.3.1.5. Packaging and labelling 124
B.3.1.6. Storage/ preservation 124
B.3.1.6.1. General 124
B.3.1.6.2. Methods of preservation and storage 124
B.3.1.6.2.1. Preservation and storage of corneal tissue 124
B.3.1.6.2.2. Preservation and storage of scleral tissue 125
B.3.1.6.3. Storage area 126
B.3.1.7. Documentation and release 126
B.3.1.7.1. General 126
B.3.1.7.2. Release 126
B.3.1.7.2.1. Release of cornea 126
B.3.1.7.2.2. Release of sclera 127
B.3.1.7.3. Processing file contents 127
B.3.1.7.4. Availability for inspection 127
B.3.1.7.5. Traceability 127
SECTION C: SPECIFIC AMNIOTIC MEMBRANE REQUIREMENTS 127
C.1.DONOR SCREENING 127
C.1.1. ACTIVITIES 127
C.1.1.1.Donor detection 128
C.1.1.2.Donor consent 128
C.1.1.3. Donor evaluation 128
C.1.1.3.1. General 128
C.1.1.3.2. Medical evaluation 128
C.1.1.3.2.1. Exclusion criteria 128
C.2.RECOVERY 129
C.2.1. ACTIVITIES 129
C.2.1.1.Access to the operating room 129
C.2.1.2. Recovery 129
C.2.1.2.1. General 129
C.2.1.2.2. Deceased donors 129
C.2.1.2.3. Living donors 129
C.2.1.3. Processing during recovery 129
C.2.1.4. Quality control 129
C.2.1.5. Packaging and labelling 130
C.2.1.5.1. Primary packaging and labelling operations 130
C.2.1.5.2. Secondary packaging and labelling operations 130
C.2.1.6. Storage and transport after recovery 130
C.2.1.6.1. Storage 130
C.2.1.6.2. Transport 130
C.2.1.7. Documentation and release for processing 131
C.3.PROCESSING 131
C.3.1. ACTIVITIES 131
C.3.1.1. Reception 131
C.3.1.2. Access to the processing facilities 131
C.3.1.3. Processing 131
C.3.1.3.1. General 131
C.3.1.3.2. Processing methods 131
C.3.1.3.2.1. Organ culture and cell culture 132
C.3.1.3.2.2. Decontamination of tissues and cells 132
C.3.1.3.2.3. Sterilization/disinfection of tissue 132
C.3.1.3.2.4. Viral inactivation 132
C.3.1.3.2.5. Prion inactivation 132
C.3.1.3.2.6. Other processes 132
C.3.1.3.3. Cross contamination 132
C.3.1.4. Quality control 132
C.3.1.4.1. Microbiological control 132
C.3.1.4.2. Other controls 133
C.3.1.5. Packaging and labelling 133
C.3.1.6. Storage / preservation 133
C.3.1.6.1. General 133
C.3.1.6.2. Methods of preservation and storage 133
C.3.1.6.2.1. Preservation and storage at +37C 133
C.3.1.6.2.2. Preservation and storage at +4C 133
C.3.1.6.2.3. Cryopreservation 133
C.3.1.6.2.4. Glycerolization 134
C.3.1.6.2.5. Freeze drying and dehydration 134
C.3.1.6.2.6. Other methods of preservation and storage 134
C.3.1.6.3. Storage area 134
C.3.1.7. Documentation and release 134
C.3.1.7.1. General 134
C.3.1.7.2. Release 134
C.3.1.7.3. Processing file contents 135
C.3.1.7.4. Availability for inspection 135
C.3.1.7.5. Traceability 135
SECTION D: SPECIFIC SKIN REQUIREMENTS 136
D.1. DONOR SCREENING 136
D.1.1. ACTIVITIES 136
D.1.1.1.Donor detection 136
D.1.1.2.Donor consent 136
D.1.1.3. Donor evaluation 136
D.1.1.3.1.General 136
D.1.1.3.2. Medical evaluation 136
D.1.1.3.2.1.Anamnesis 137
D.1.1.3.2.2.Social evaluation 137
D.1.1.3.2.3. Physical evaluation 137
D.1.1.3.2.4. Exclusion criteria 137
D.1.1.3.2.5. Post Morten Time 138
D.1.1.3.2.6. Laboratory test results 138
D.2. RECOVERY 139
D.2.1. ACTIVITIES 139
D.2.1.1. Access to the operating room 139
D.2.1.2. Recovery 139
D.2.1.2.1. General 139
D.2.1.2.2. Recovery 139
D.2.1.2.2.1. Donor identification 139
D.2.1.2.2.2. Gowning 139
D.2.1.2.2.3. Donor preparation 139
D.2.1.3. Reconstruction of the donor 139
D.2.1.4. Quality control 140
D.2.1.5. Packaging and labelling 140
D.2.1.5.1. Primary packaging and labelling 140
D.2.1.6. Storage and transport after recovery 140
D.2.1.6.1.Transport after tissue recovery 140
D.2.1.7. Documentation and release for processing 140
D.3. PROCESSING 141
D.3.1. ACTIVITIES 141
D.3.1.1. Reception 141
D.3.1.2. Access to the processing facilities 141
D.3.1.3. Processing 141
D.3.1.3.1.General 141
D.3.1.3.2. Processing methods 141
D.3.1.3.2.1. Processing of tissues 141
D.3.1.3.2.2. Decontamination of tissues 142
D.3.1.3.2.3. Sterilisation of tissues 142
D.3.1.3.2.4. Inactivation with regard to prions 142
D.3.1.4. Quality control 142
D.3.1.4.1. Microbiological control 142
D.3.1.4.1.1. General principle 142
D.3.1.4.1.2. Microbiological controls 142
D.3.1.5. Packaging and labelling 144
D.3.1.5.1. Primary packaging and labelling 145
D.3.1.6. Storage/ preservation 145
D.3.1.6.1. General 145
D.3.1.6.2. Methods of preservation and storage 145
D.3.1.6.2.1. Preservation and storage at 37ºC 145
D.3.1.6.2.2. Preservation and storage at +4°C 146
D.3.1.6.2.3. Cryopreservation at between -60°C and -80°C 146
D.3.1.6.2.4. Cryopreservation in liquid nitrogen 146
D.3.1.6.2.5. Glycerolisation with a high glycerol concentration 146
D.3.1.6.2.6. Lyophilisation and dehydration 146
D.3.1.6.2.7. Decelluralisation 146
D.3.1.6.2.8. Other preservation and storage procedures 146
D.3.1.6.3. Storage area 147
D.3.1.7. Documentation and release 147
D.3.1.7.1. General 147
D.3.1.7.2. Processing file contents 147
D.3.1.7.3. Availability for inspection 147
D.3.1.7.4. Traceability 147
SECTION E: SPECIFIC CARDIOVASCULAR REQUIREMENTS 148
E.1 DONOR SCREENING 148
E.1.3. ACTIVITIES 148
E.1.3.1.Donor detection 148
E.1.3.2.Donor consent 148
E.1.3.3. Donor evaluation 148
E.1.3.3.1.General 148
E.1.3.3.2. Medical evaluation 148
E.1.3.3.2.1.Anamnesis 148
E.1.3.3.2.2.Social evaluation 148
E.1.3.3.2.3.Exclusion criteria 148
E.1.3.3.2.4.Donor age 149
E.2. RECOVERY 149
E.2.1. ACTIVITIES 149
E.2.1.1. Access to the operating room 149
E.2.1.2. Recovery 149
E.2.1.2.1. Recovery 149
E.2.1.2.1.1. Donor identification 149
E.2.1.2.1.2. Gowning 149
E.2.1.2.1.3. Donor preparation 149
E.2.1.2.1.4. Living Donors 150
E.2.1.3. Processing during recovery 150
E.2.1.4. Quality control 150
E.2.1.5. Packaging and labelling 150
E.2.1.6.1. Storage after tissue recovery 150
E.2.1.6.2.Transport after tissue recovery 150
E.2.1.7. Documentation and release for processing 150
E.3. PROCESSING 151
E.3.1. ACTIVITIES 151
E.3.1.1. Reception 151
E.3.1.2. Access to the processing facilities 151
E.3.1.3. Processing 151
E.3.1.3.1.General 151
E.3.1.3.2. Processing methods 151
E.3.1.3.2.1. Processing of tissues and cells 151
E.3.1.3.2.2. Decontamination of valves and vessels 157
E.3.1.4. Quality control 158
E.3.1.4.1. Microbiological control 159
E.3.1.4.1.1. General principle 159
E.3.1.4.1.2. Microbiological controls 159
E.3.1.4.1.3. Methods 159
E.3.1.4.2.Other controls 159
E.3.1.5. Packaging and labelling 159
E.3.1.6. Storage/ preservation 159
E.3.1.6.1. General 159
E.3.1.6.2. Methods of preservation and storage 160
E.3.1.6.2.1. Storage at +4°C 160
E.3.1.6.2.2. Cryopreservation and storage at -80°C 160
E.3.1.6.2.3. Cryopreservation and storage in Liquid Nitrogen 160
E.3.1.6.3. Storage area 161
E.3.1.7. Documentation and release 161
E.3.1.7.1. General 161
E.3.1.7.2. Release 161
E.3.1.7.3. Processing file contents 161
E.3.1.7.4. Availability for inspection 161
E.3.1.7.5. Traceability 161
E.3.1.7.6. Archive 161
SECTION F: SPECIFIC MUSCULOSKELETAL REQUIREMENTS 162
F.1 DONOR SCREENING 162
F.1.1. ACTIVITIES 162
F.1.1.1.Donor detection 162
F.1.1.2.Donor consent 162
F.1.1.3. Donor evaluation 162
F.1.1.3.1.General 162
F.1.1.3.2. Medical evaluation 162
F.1.3.3.2.1. Anamnesis 162
F.1.3.3.2.2. Social evaluation 162
F.1.3.3.2.3. Physical evaluation 162
F.1.3.3.2.4. Exclusion criteria 162
F.2. RECOVERY 164
F.2.1. ACTIVITIES 164
F.2.1.1. Access to the operating room or other recovery room 164
F.2.1.1.1. General 164
F.2.1.1.2. Deceased donors 164
F.2.1.1.2.1. Donor identification 164
F.2.1.1.2.2. Gowning 165
F.2.1.1.2.3. Donor preparation 165
F.2.1.1.2.4. Procurement of long bones of the lower limb 165
F.2.1.1.2.4.1. Procurement of the femur 165
F.2.1.1.2.4.2. Procurement of the tibia and the fibula 165
F.2.1.1.2.5. Procurement of the iliac crest or hemipelvis 165
F.2.1.1.2.6. Procurement of long bones of the upper limb 165
F.2.1.1.2.6.1. Procurement of the humerus 166
F.2.1.1.2.7. Procurement of the rib 166
F.2.1.1.2.8. Procurement of the fascia lata 166
F.2.1.1.2.9. Procurement of Achilles tendon 166
F.2.1.1.2.10. Procurement of the patellar tendon 166
F.2.1.1.2.10. Procurement of the menisci 166
F.2.1.1.2.11. Reconstruction of the donor’s body after procurement 166
F.2.1.2.3. Living donors 166
F.2.1.2.3.1. Living allogenic donors 166
F.2.1.2.3.1.1 Femoral head donors 167
F.2.1.2.3.2. Living autogenic donors 167
F.2.1.3. Processing during recovery 167
F.2.1.4. Quality control 167
F.2.1.5. Packaging and labelling 167
F.2.1.5.1. Primary packaging and labelling 167
F.2.1.5.1.1 Packaging for hypothermic storage 167
F.2.1.5.1.2. Packaging for cell culture 167
F.2.1.6. Storage and transport after recovery 168
F.2.1.6.1. Storage after tissue recovery 168
F.2.1.6.1.1. Storage temperatures 168
F.2.1.6.1.2. Storage time 168
F.2.1.6.1.2.1. Storage time for hypotermic storage 168
F.2.1.6.1.2.2. Storage time for cell culture 168
F.2.1.6.2.Transport after tissue recovery 168
F.2.1.7. Documentation and release for processing 169
F.3. PROCESSING 169
F.3.1. ACTIVITIES 169
F.3.1.1. Reception 169
F.3.1.2. Access to the processing facilities 169
F.3.1.3. Processing 169
F.3.1.3.1.General 169
F.3.1.3.2. Processing methods 169
F.3.1.3.2.1. Processing of tissues and cells 169
F.3.1.3.2.2. Sterilisation or decontamination of musculoskeletal tissues and cells 171
F.3.1.4. Quality control 171
F.3.1.4.1. Microbiological control 171
F.3.1.4.1.1. General Principle 171
F.3.1.4.1.2. Methods 171
F.3.1.5. Packaging and labelling 171
F.3.1.6. Storage/ preservation 171
F.3.1.6.1. General 171
F.3.1.6.2. Methods of preservation and storage 171
F.3.1.6.2.1. Preservation and storage in hypotermic conditions 171
F.3.1.6.3. Storage area 171
F.3.1.7. Documentation and release 171
F.3.1.7.1. General 171
F.3.1.7.2. Release 171
F.3.1.7.2.1. Release of musculoskeletal tissue grafts 171
F.3.1.7.3. Processing file contents 171
F.3.1.7.4. Availability for inspection 171
F.3.1.7.5. Traceability 171
SECTION G 171
G.1. GLOSSARY 171
G.2. ACRONYMS 171
European Group of Blood and Marrow Transplantation 171
European Quality System for Tissue Banking 171
Organization responsible for human application 171
Penetrating Keratoplasty 171
G.3. REGULATION OF REFERENCE 171
G.3.1. EUROPEAN UNION 171
G.3.2. COUNCIL OF EUROPE 171
G.3.3. WORLD HEALTH ORGANIZATION 171
G.3.4. REFERENCE STANDARDS 171
G.4. TISSUE ESTABLISHMENT DOSSIER 171
G.5. EQSTB CHECKLIST
Print  
A3f Engine ::Terms Of Use::Privacy Statement