YBB 00112004-2015 English PDF (YBB00112004-2015)

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YBB 00112004-2015: Assemblages for prefilled syringes (with stainless-steel needles)
YBB00112004-2015
YY / YBB
National Drug Packing Container (Material) Standard
Assemblages for prefilled syringes
(with stainless-steel needles)
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
3. No action is required - Full-copy of this standard will be automatically and
immediately delivered to your EMAIL address in 0~60 minutes.
Assemblages for prefilled syringes
(with stainless-steel needles)
This standard applies to prefilled syringe assemblages (with stainless-steel needles). The
assemblage consists of a glass needle, a rubber piston, a stainless-steel needle, a needle
cap, and a putter.
[Appearance] TAKE appropriate amount of this product; MAKE direct visual inspection
against the product in a bright place in natural light. The glass needle tube sleeve shall be
free from cracks or fractures AND the curling shall be free from deformation; the cone and
curling shall be free from cracks or breakage; the needle tube external surface shall be free
from spots, stains, or scratches; there shall be no printing defects which may affect normal
use; the needle shall be free from separation, reversing, or obstruction; AND the needle and
needle cap shall be free from separation.
[Glass needle tube] It shall meet the requirements for the borosilicate glass needle tube
which is used for the prefilled syringe (YBB00062004-2015).
[Rubber piston] It shall meet the requirements for the chlorinated butyl rubber piston
(YBB00072004-2015) or the brominated butyl rubber piston (YBB00082004-2015) which is
used for the prefilled syringe.
[Stainless-steel injection needle] It shall meet the requirements for the stainless-steel
injection needle (YBB00092004-2015) which is used for the prefilled syringe.
[Needle cap] It shall meet the requirements of the polyisoprene rubber needle cap which is
used for the prefilled syringe (YBB00102004-2015).
[Connection force between needle and needle seat] TAKE appropriate amount of this
product; FIX the syringe onto the test machine; at the rate of 100 mm/min ± 5 mm/min AND
the tensile force not less than 22 N, PERFORM the syringe pull test. There shall be no
loosening or separation between the stainless-steel needle and the needle seat of the glass
needle tube.
[Needle cap pull out force] TAKE appropriate amount of this product; FIX the needle cap
and the syringe tube onto the upper and lower fixtures of the test machine; the test rate is
100 mm/min ± 5 mm/min. The pull-out force of the needle cap shall be 4.0 ~ 45.0 N.
[Fit between piston and putter] (only for threaded pistons) TAKE appropriate amount of
this product; CONNECT the putter and the piston; INSERT the piston totally into the prefilled
syringe which had been lubricated by the silicon oil and filled with half water; EMPTY the air;
CAP the syringe needle; slowly WITHDRAW about 3 mm backwards. The putter shall be
kept stable AND not be separated from the piston.
[Piston lubrication] Take appropriate amount of this product; INSERT the piston into the
syringe tube which had been lubricated by silicone oil; USE the putter to push the piston into
the entire syringe tube. The putter piston shall be moved smoothly AND free from sudden
pause.
Connection force between needle
and needle seat S-2 2.5
Pull out force of needle cap S-2 0.65
Piston sliding performance S-2 6.5
Body sealability S-2 2.5
Syringe tube residue S-2 6.5
Indexing capacity accuracy S-2 2.5