What is ISO 3749 - Method of determining extractable tungsten from glass syringes about?
A glass syringe is a glass barrel with a plunger. It is used to draw out or inject fluids and gasses. ISO 3749 specifies an analytical method to quantitatively determine the water-soluble amount of tungsten from the inner surface of glass syringes.
The method can be applied to Luer cone, staked needle or Luer lock syringes.
Who is ISO 3749 - Method of determining extractable tungsten from glass syringes for?
ISO 3749 on method of determining extractable tungsten from glass syringes is useful for:
- The medical industry
- Manufacturers and suppliers of syringes
- Product design / innovation teams
- Quality control and testing personnel
- Research laborites involved in the inspection of syringes
- Health and safety bodies
- Procurement teams
Why should you use ISO 3749 - Method of determining extractable tungsten from glass syringes?
Glass syringes are produced from glass tubing via a hot-forming process which is valid for the different syringe cone configurations such as Luer cone, Luer lock and also for staked needle syringes. Tungsten residuals is formed on the inner surface of the cone. ISO 3749 provides you with methods like extraction by ultrasonics that helps to determine the extractable tungsten from glass syringes as tungsten residuals can affect the effectiveness of the drug. For instance, causing aggregation of protein-based drugs. The level of soluble tungsten residues needs to be controlled in certain applications.
ISO 3749 guides you with sample preparation in terms of siliconization and filling of syringes. ISO 3749 also discusses the spiking of syringes. Report preparation guidelines have also been provided in ISO 3749.
The testing guidelines in ISO 3749 can serve as a guide for medical research, testing agencies, organizations and manufacturers of syringes.
