Sooner or later, we’re all dealing with each other. And beyond private or private use, syringes are used in many situations, especially in hospitals. Syringes, as full-fledged medical devices, have strict regulations in many respects. A world, from certain points of view, also fascinating of which we give you information.
Let’s start by dispelling a rumour: if it is true that devices on the market must be marked with the CE mark in accordance with the provisions of Directive 93/42/EC, it is also true that the CE mark is not a mark of quality but rather of suitability for free movement within the EU. The best way to distinguish between syringes on the market on the basis of their real overall quality is to comply with the specific voluntary reference standards.
Compliance with these standards, although it cannot constitute a barrier to the free movement of products, is certainly the most important indicator of the manufacturer’s willingness to pursue overall quality objectives to ensure the user and professional operators. Below is a summary table of the Standards applicable to single-use sterile syringes and their meaning.
SHAPE OF THE RUBBER CUSP (UNI EN 7886/1)
- Indications: must be conformed to the end of the cylinder
- Impact on quality: nonconformity increases the residual volume inside the syringe with the risk of preventing the total administration of care to the patient
EXTRA-VOLUME (UNI EN 7886/1)
- Indications: not less than 10% of the nominal capacity
- Impact on quality: the absence of extra-volume would not allow the suction of a volume greater than the nominal capacity, to eliminate air bubbles and to reposition the stem and grommet on the last notch of the graduated scale
- Indications: the silicone present must not exceed the quantity of 0.25mg/cm2
- Impact on quality: any surplus of silicone introduced into the patient’s body is not disposed of
ACCURACY OF THE GRADUATED SCALE (UNI EN 7886/1)
- Indications: it must be placed on the left and have the individual bars positioned so as to ideally divide the corresponding number symmetrically
- Impact on quality: inaccuracy in the grading scale can compromise the correct dosage of drugs
LIMIT OF ALKALINITY/ACIDITY (UNI EN 7864)
- Indications: The Ph value must be within +/-1 degree of Ph with respect to the sample liquid.
- Impact on quality: non-compliant pH values may have negative effects on the therapies administered
PACKAGING (UNI EN 7886/1)
- Indications: Blisters must be properly welded and ensure that the sterility of the syringe is not compromised when opened.
- Impact on quality: incorrect packaging negatively affects the sterility of the syringe
MARKING (UNI EN 7886/1)
- Indications: the individual package must bear: CE marking, description of the contents, name of the manufacturer’s mark, indication of sterile and disposable device
- Impact on quality: the absence or incompleteness of the indications on the packaging can negatively affect the correct traceability of the lot and the correct use of the syringe
SURFACE CYLINDER-STEM NEEDLE (UNI EN 7886/1)
- Indications: free from sharp burrs, particles and foreign bodies
- Impact on quality: the presence of burrs increases the painfulness of the syringe and the incomplete cleaning of the cannula increases the risk of introducing foreign particles into the body
EXTERNAL NEEDLE CLEANING (UNI EN 7864)
- Indications: At 2.5 magnifications, no foreign bodies or silicone drops should be seen
- Impact on quality: excess silicone or any foreign bodies or may be introduced into the patient’s body
EXTRACTABLE HEAVY METAL CONTENT (UNI EN 7864)
- Indications: Not more than 5 mg/l.
- Impact on quality: excessive percentages of heavy metals could be introduced into the patient’s body
COLOUR CODE (UNI EN ISO 6009)
- Indicazioni: ad ogni diametro deve corrispondere un colore identificativo codificato secondo norma
- Impact on quality: incorrect affixing of the reference colours can lead to an incorrect choice of the diameter to be used
PUNTA DELL'AGO (UNITED IN 7864)
- Directions: at 2,5 magnifications the tip of the needle must be free from defects, burrs and hooks.
- Impact on quality: burrs or hooks increase the painfulness of the puncture
MANUFACTURE OF STAINLESS STEEL NEEDLE TUBES (UNI EN 9626)
- Indications: The standard specifies the dimensions, surfaces and mechanical properties of stainless steel needle tubes
- Impact on quality: non-compliance with the standard may result in a lower quality of the needle made
At Farmo Res we build machines both for syringe packaging and for their other processes. Here are the machines we have built to optimize the production and business of our customers in the syringe trade.