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II — Biological tests Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Biological tests

(1) A test for undue toxicity shall be carried out in the initial evaluation of plastics formulations intended for the fabrication of containers and taking and giving sets, using extract A, and on each new batch of materials of the approved formulations, using extract B, by the procedure specified in the national pharmacopoeia or some other method approved by the national control authority. (Extracts A and B are defined in the note below.)

(2) A test for freedom from pyrogens shall be carried out in the initial evaluation of plastics formulations intended for the fabrication of containers and taking and giving sets, using extract A, and on each new batch of materials of the approved formulation, using extract C, and in the routine control of containers and taking and giving sets, using extract C, by the procedure specified in the national pharmacopoeia or some other method approved by the national control authority.

The incidence of pyrogen testing, using extract C, shall be decided by the national control authority.

(Extracts A and C are defined in the note below.)

(3) A test for haemolytic effects in buffered systems shall be performed in the initial evaluation of plastics formulations intended for the fabrication of containers and taking and giving sets and on each new batch of materials of the approved formulations using the extract described in paragraph I.A above. (For method and acceptable limit, see Appendix to the present Annex.)

(4) A test for the in vivo survival of red cells shall be carried out in the initial evaluation of plastics formulations intended for the fabrication of containers for blood. If any change is made in the agreed formulation, the test shall be repeated. (For suggested methods and acceptable limit, see Appendix to the present Annex.)

Note

Extract A is prepared by adding to the extract described in I. A above pyrogen-free sodium chloride to a final concentration of 9 gram per litre.

Extract B:

Transfusion Set. Fill a transfusion set as completely as possible with sterile pyrogen-free solution containing 9 gram sodium chloride per litre, clamp the ends securely and immerse the filled set completely for 1 hour in water maintained at 85° C. Collect the contents on the set.

Plastics Container. If the container is filled with anti-coagulant solution it should be emptied and rinsed twice with 250 ml portions of 250 sterile pyrogen-free distilled water at a temperature of 20° C. Fill the container with 100 ml sterile pyrogen-free solution containing 9 gram sodium chloride per litre, close it securely and immerse it for 1 hour in a horizontal position in water maintained at 85° C. Collect the contents of the container.

Extract C:

Transfusion Set. Pass 40 ml portions of sterile pyrogen-free sodium chloride solution of a concentration of 9 gram per litre, at room temperature through not less than ten transfusion sets at a flow rate of approximately 10 ml per minute and pool the effluents. Test the solution obtained.

Plastics Container. Empty. Pass 100 ml portions of sterile pyrogen-free solution containing 9.0 gram sodium chloride per litre, at room temperature through the collecting tubes of not less than four plastic containers, allow to remain in the containers for ten minutes and pool the effluent by discharging through the transfer tubes. Test the solution obtained.

Plastics Container with anticoagulant (See paragraph III).

Regeling
Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd
Soort
Verdrag
Geldend vanaf
19-04-1982
BWB-id
BWBV0002901
Versie
1982-04-19_0

In de hele regeling · Officiële tekst op wetten.overheid.nl