Quality Needles Private Limited

The Company has specialized in the manufacture of surgical suture needles and is thus a ‘single product’ company in a way. However, its production range covers a very wide range of products and some 2,000 different types and sizes of needles for a large number of diverse customers located all over the world are produced every year. Typically, the Company manufacturers approx. 40 million needles per year.

Starting from a small factory shed of about 100 sq.m. area, it has grown steadily over the years and now stands on a total land area of around 3,200 sq.m. with a covered area housing the offices and manufacturing facilities of around 2,500 sq.m.

A strict Quality Control protocol is followed at each stage of manufacture. The tests include:

Sharpness testing :
which is done on a specially designed digital sharpnesscomparator where the force required for the needle point to penetrate a diaphragm of polyurethane standardized synthetic material (whose characteristics closely mimic the human skin) is measured.

Stiffness
of the needles is also evaluated with a special digital tester which enables the force-vs.-displacement of the needle to be determined, and which also determines whether the needle re-gains its original shape without any permanent set.

Corrosion Resistance
is tested in accordance with IS 7135-1998 and other international standards.

Ductility
is evaluated by bending the needle body through a sharp 90 degree angle,which it should withstand without cracking.

Hardness measurement
is done on a micro-Vickers hardness tester, which measures the dimension of the indentation made with a diamond pyramidal indentor which is applied to the polished surface of the needle with a pre-determined force.

Attaching strength:
In case of channel type atraumatic needles, test attaching of needles from each batch is done, and the attaching strength measured with a digital tensilometer to ensure that pull strength conforms to USP standards. This is also done with all suture attached products including sternotomy needles.

A Laboratory test certificate is sent with each lot of needles documenting the actual test results obtained with that batch. This certificate also bears the heat number of the raw material used to ensure traceability.