TEST CRITETIA & QUALITY CONTROL WORK SHEET OF

DISPOSABLE SYRINGE & NEEDLE

1. TYPE OF PRODUCTION;
SEMI-AUTOMATIC SYSTEM

2. MATERIAL DESCRIPTION PER COMPONENT PART

SYRINGE ;
BARREL - POLYPROPYLENE, MEDICAL, INJECTION, VIRGIN GRADE
PLUNGER - POLYPROPYLENE, MEDICAL, INJECTION, VIRGIN GRADE
GASKET - TPE ELASTOMER

NEEDLE ;
NEEDLE TUBING - STAINLESS STEEL, 18 CHROMIUM/ 8 NICKEL
NEEDLE HUB - POLYPROPYLENE, MEDICAL, INJECTION, VIRGIN GRADE
NEEDLE CAP - POLYPROPYLENE, MEDICAL, INJECTION, VIRGIN GRADE

LUBRICATION FOR NEEDLE & GASKET

SILICON OIL, INERT, NON-TOXIC, PHARMACEUTICAL GRADE

INDIVIDUAL PACKAGE(1)
INDIVIDUAL UNIT PACKAGE - COMES IN "PEEL-BACK-PAPER" BLISTER
PAPER - MEDICAL GRADE (USING SPECIAL STRATCH AS PAPER FILLER),
ONE SIDE IS LAMINATED WITH POLYOLEFIN, AND FREE FROM
CHLORIDE, SULPHATE AND FLUORESCENT MATERIALS.
WINDOW FILM - POLYETHYLENE COATED NYLON, VIRGIN GRADE

INDIVIDUAL PACK(2)
CLEAR, COLORLESS POLYPROPYLENE BAGS

3. STERILIZATION
ETHYLENE OXIDE GAS MIXED WITH CARBON BIOXIDE

ALL ABOVE FEEDING MATERIALS ARE CONTROLLED, ASSESSED, AND REPORTED BY

FULL TIME ATTENDANT BY CHEMICAL ENGINEER.

4. ANALYSIS AND QUALITY CONTROL CERTIFICATE

RANDOM SAMPLING PICKED UP AND TESTED FOR 0.1% OF ACTUAL OUTPUT

ON THE FOLLOWING PHASES ;

1) SYRINGE

APPEARANCE
DIMENSION ACCURACY
SYRINGE TIP
GRADUATION MARKING & RADABILITY
COMPRESSION/ ABSORPTION
LEAKPROOF
PLUNGER MOVEMENT
PH DIFFERENCE
PYROGEN
KMnO4 CONSUMPTION
HEAT/COLD ENDURANCE
BIOLOGICAL & STERILITY TEST
 2) NEEDLE

TUBING GAUGE
TUBING LENGTH
NEEDLE POINTING & SHARPNESS
BEVELLING
TUBING ELASTICITY & YIELD
NEEDLE PULL TEST
TUBING WALL THICKNESS

3) DEFECTS AND REJECTS CRITERIA

NEEDLE CAP MISSING OR DISLODGED

NEEDLE CAP HAVING HOLES
NEEDLE CAP FROZEN TO NEEDLE OR SYRINGE
PLUNGER ROD, GASKET OR BOTH MISSING
PLUNGER OR GASKET FROZEN IN BARREL
BARREL INSIDE NOT COATED WITH SILICONE LUBRICANT
BARREL INSIDE CONTAINING EXCESSIVE LUBRICANT
SYRINGE TIP BLOCKED
MISSING, IMCOMPLETE OR ILLEGIBLE OF GRADUATION MARKING
TAPER OF SYRINGE TIP NOT SMOOTHLY FINISHED
SYRINGE HAVING PITS, SCRATCHES, AIR BUBBLES, FLASH, BURS
PLUNGER GASKET DETACHES FROM PLUNGER WHEN PUSHING BACK
PLUNGER GASKET NOT SMOOTH, FREE FROM FLASH, BUBBLES BREAKS,CRACKS
BENT NEEDLE
BLUNT NEEDLE
NEEDLE EPOXING INCOMPLETE
WRONG HUB COLOR CODING
EXCESSIVE BEVELLING
INCOMPLETE PACKAGE, SEALING, TAPING, CREASING, TORN APART

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