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pathology sop template mb91p202 - Leeds Tissue Bank

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					 File name : SOP/GB/023.01                    Page 1 of 3
 Date printed 18/08/11

                        STANDARD OPERATING PROCEDURE (SOP)


 Title: Packaging of Human Tissues for Dispatch. Category B / UN3373 Biohazard
         Procedures
 Area of application                              GIFT Tissue Bank
 Index code/version number                        SOP/GB/023.01
 Reason for change                                New Procedure
 Date of implementation                           1st October 2010
 Review interval                                  Annual
 Authorised by
 Author                                           Aidan Hindley, Tissue Bank Nurse.
 This copy issued to                              Master Copy: Laboratory Manager, LIMM Wellcome
                                                  Level 4.




                  Document review history – completed when no changes required
 Review date                            Reviewed by                              Signature




This is a controlled document, dates of review and locations of authorised copies are recorded in the Pathology and Tumour Biology
Quality Management System. It is forbidden to photocopy or write on SOPs.
                               Department of Pathology and Tumour Biology
                                                     SOP/GB/023.01


1.        CLINICAL RELEVANCE/PURPOSE OF PROCEDURE
          To ensure that GIFT Tissues are packaged in a safe and lawful manner that complies with
          Category B (UN3373) Biohazard procedures.


2.        PRINCIPLE OF PROCEDURE
          To prevent any Biohazard or potential risk to persons during the transportation of Human
          tissues from GIFT to recipient researchers.

3.        PERSONNEL / TRAINING REQUIREMENTS
          All staff involved in the packaging of samples must be aware of appropriate procedures
          detailed in this document.

4.        SPECIMEN REQUIREMENTS
          Applicable to all human tissues for transport.

5.        EQUIPMENT
          As detailed in this and other relevant SOP’s.

6.        HEALTH AND SAFETY
          As detailed in this and other relevant SOP’s including departmental SOP’s

7.        REAGENTS
          N/A

8.        QUALITY CONTROL
          Feed back from recipients

9.        COMPUTER / TELEPATH CODES
          N/A

10.       PROCEDURE OR METHODOLOGY
          THIS APPLIES TO ALL HUMAN TISSUE SAMPLES FOR TRANSPORT EXCEPT
          DRIED BLOOD SPOTS OR IRRADIATED SAMPLES DEEMED TO BE STERILE.
             The packaging must be of good quality, strong enough to withstand the shocks and
               loadings normally encountered during transport. Packages must be constructed
               and closed to prevent any loss of contents or leakage that might be caused under
               normal conditions of transport by vibration or by changes in humidity,
               temperature or pressure. (i.e. being dropped)
             Packaging must consist of at least 3 components
               (1) primary receptacle
               (2) secondary packaging
               (3) an outer packaging
               The secondary or outer packaging must be rigid.
               Individual primary and the secondary packages should be tightly closed and sealed
               with tape or other means to prevent leakage (zip lock or heat sealed bags are
               acceptable). Outer packaging should be securely closed by means such as clasps,
               catches or tape.
             Primary receptacles must be packed in secondary packaging in such a way that
               under normal circumstances/conditions of transport they cannot break, be
This is a controlled document, dates of review and locations of authorised copies are recorded in the Pathology and Tumour
Biology Quality Management System. It is forbidden to photocopy or write on SOPs
                               Department of Pathology and Tumour Biology
                                                     SOP/GB/023.01


                    punctured or leak there contents into the secondary packaging. The secondary
                    packaging must be secured in outer packing which has suitable cushioning
                    material and or absorbent material if possible leakage might occur. Any leakage
                    must not compromise the integrity of the cushioning material or the outer
                    packaging. Cushioning and absorbent material must be compatible with the
                    tissues/substances being transported. For examples of packaging please Appendix
                    A at the end of this document.
                   For transporting the mark illustrated below must be displayed on the external
                    surface of the outer packaging on a background of a contrasting colour and be
                    clearly visible and legible. The wording:
                    “BIOLOGICAL SUBSTANCE, CATEGORY B”.
                    SHOULD ALSO BE MARKED ON THE OUTER PACKAGING.




                                                             UN3373




                  The complete package must be capable of passing the drop test. For drop test
                   requirements please see Appendix B at the end of this document.

11.        APPENDICES
           Appendix A
           For Liquid Substances;
      1.   Primary Receptacle/s must be leak proof
      2.   The Secondary packaging must be leak proof
      3.   If multiple fragile primary receptacles are placed in a single secondary packaging they
           shall be either individually wrapped or separated to prevent contact between them.
      4.   Absorbent material must be placed between the primary receptacle/s and the secondary
           packaging. The absorbent material must be of a sufficient quantity to absorb the entire
           contents of the primary receptacle/s so that any release or the liquid substance will not
           compromise the integrity of the cushioning material or the outer packaging. Examples of
           cushioning material include cotton wool, wadding and vermiculite
      5.   The outer packaging must not contain more than 4 litres of fluid. Exceptions are Ice, Dry
           Ice or Liquid Nitrogen to keep specimens cold.

         For Solid Substances;
      1. The primary receptacle/s must be sift proof. “sift proof” means impermeable to dry
         contents
      2. The secondary packaging must be sift proof.
      3. If multiple fragile primary receptacles are to be used please see above (3)
      4. If there is any doubt whether or not there is any residual liquids present then a packaging
         in line with Liquid Substances recommendations must be used including absorbency layer
      5. Please see part (5) above

This is a controlled document, dates of review and locations of authorised copies are recorded in the Pathology and Tumour
Biology Quality Management System. It is forbidden to photocopy or write on SOPs
                               Department of Pathology and Tumour Biology
                                                     SOP/GB/023.01


        Refrigerated or Frozen Specimens, Ice, Dry Ice and Liquid Nitrogen;
      1. When dry ice or liquid nitrogen is used to keep specimens cold all applicable
         requirements of the specific modal requirements must be met. When used Ice or Dry Ice
         must be placed outside the secondary packagings or in the outer packaging or an
         overpack. . Interior supports must be used to secure the secondary packaging in the
         original position after the ice or dry ice has dissipated. If ice is used the outside packaging
         or overpack must be leak proof. If solid carbon or dry ice is used the packaging must be
         designed and constructed to permit the release of carbon dioxide gas to prevent a build up
         of pressure that could lead to rupture and the outer packaging must be marked
         “CARBON DIOXIDE, SOLID or DRY ICE”.
      2. The primary receptacle and secondary packaging must maintain their integrity at the
         temperature of the refrigerent used as well as the temperature and pressures which could
         result if refrigeration is lost.

          Appendix B
          Drop Test Requirements
      1. The samples must be subjected to free-fall drops onto a rigid, non resilient , flat, horizontal
          surface from a height of 1.2 meters. Where the samples are in the shape of a box, five
          must be dropped in sequence:
               Flat onto the base
               Flat onto the top
               Flat onto the longest side
               Flat onto the shortest side
               Onto the corner
          Where the samples are in the shape of a drum, three must be dropped in sequence:
               Diagonally onto the top chime, with the centre of gravity directly above the point
                  of impact,
               Diagonally onto the base chime,
               Flat onto the side
          Following the drop sequence there must be no leakage from the primary receptacle and
          this/these must remain protected by the absorbent material in the secondary packaging.
          While the sample must be released in the required orientation it is accepted that for
          aerodynamic reasons the impact may not take place in that orientation.

12.       REFERENCES
          Department of Transport; “Transport of Infectious Substances”
          Health and Safety Executive, “Transport of Human Tissues”
          UN regulations on transporting hazardous substances and human tissues




This is a controlled document, dates of review and locations of authorised copies are recorded in the Pathology and Tumour
Biology Quality Management System. It is forbidden to photocopy or write on SOPs

				
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