WHO Specifications for Immunization AD Syringes an update

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 / 9002 which 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 ...