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WHO Specifications for Immunization AD Syringes - an update

WHO Specifications for Immunization AD Syringes - an update. Gordon Larsen Technet/SIGN Meeting, New Delhi, 2001. DRAFT SPECIFICATION. revision. DRAFT SPECIFICATION. revision. materials used for ADs---. increasing concern over environmental impact of burning syringes

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WHO Specifications for Immunization AD Syringes - an update

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  1. WHO Specifications for Immunization AD Syringes - an update Gordon Larsen Technet/SIGN Meeting, New Delhi, 2001

  2. DRAFT SPECIFICATION revision

  3. DRAFT SPECIFICATION revision

  4. materials used for ADs--- • increasing concern over environmental impact of burning syringes • rubber piston seal identified as a main pollutant • launch of ADs without piston seals • switch by many manufacturers to non-rubber materials for piston seals

  5. new text ? ---

  6. field experiences --- • complaints from users of AD syringes with detachable needles • leakage & loss of vaccine • entry of air into syringe • needles coming loose during use • inconvenience & effort of assembly • refusal by a number of countries to accept this type of AD

  7. new text ? ---

  8. ensuring accurate dosing, reduction of errors and ease of use ... new text ? --- Colour contrast between piston and barrel of the syringe to be at least xxx colour shades. Transparent or near-transparent piston tips shall no longer be acceptable

  9. ensuring good standards for syringe manufacture ... new text ? --- all manufactures of ADs to possess current certification to ISO 9001 / 9002which extends for at least the period covered by any UNICEF contract

  10. DRAFT SPECIFICATION new spec

  11. AD Syringes for reconstitution - main features: • non-prefilled, disposable, auto-disable • for 2-dose, 10-dose, & 20-dose vials * 2 dose vials = 1ml capacity (+20%) * 10 dose vials = 5ml capacity (+20%) * 20 dose vials = 10ml capacity (+20%) • (For 1-dose vials, same as 0.5 ml AD injection syringes)

  12. continued --- • Non-Skin Penetration -- • needle, spike, or transfer device of a non skin-penetrating type • easy penetration of vial septa or rubber caps • septa/ cap re-seals following removal of needle/ spike • smooth entry, no coring to prevent damage to septa/ caps and avoid vial contamination

  13. AD Syringes for reconstitution - estimated needs 2001-2003: 1ml capacity = 25 million 5ml capacity = 40 million 10ml capacity = 0.5 million 0.5ml capacity = 40 million (regular AD injection syringes)

  14. new & revised specs ... • proposals only at present ... • consultative process ... - in-house (WHO,UNICEF,PATH, etc) - manufacturers (IASIT,ANFIM, etc) - WHO,UNICEF regional offices - Technet/SIGN-posts • comments, suggestions, corrections, etc ...

  15. ongoing quality control ... • regular re-evaluations (eg, every 2 years, etc) ... • random product testing ... • list of pre-qualified manufactures & licencees published & updated regularly ... • posted on WHO website ...

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