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The entire manufacturing area is designed to meet cleanliness standard equivalent to ISO Class 8. This provides an environment which protects from external contamination. Camark has implemented clean room manufacturing process according to ISO 14644-1 standard.
The production area is controlled in terms of air filtering and ventilating system, which provides constant concentration of particles inside the two different spaces of our clean room. In every space of the cleanroom different production processes are performed in order to ensure a high quality end product.
OUR WORK METHOD
CUTTING + TIPPING
The process of cutting and tipping the surgical sutures. A smooth cut of sutures to the desirable length and stiffening of the threads end secure an easy attachment into drilled needles.
Surgical sutures attaching machine provides a secure way to attach drilled end needles. The operation is performed by placing the needle between the attaching dies and the suture material is inserted into the needle hole. Then, thanks to the pressing machine, the needle is crimped to the suture.
Quality control is introduced in all aspects of production. Each production process is subject to a strict quality control. Quality inspections and tests are conducted throughout the entire production flow.
PACKAGING + STERILIZATION
Medical device packaging and sterilization. Certified medical packaging materials and efficient ethylene oxide sterilization process ensure the production of an excellent quality product.
Construction 2017 300 sq.m. EU GMP classification: Grade D
The air handling systems are designed according to the requirements of ISO 14644-1 and ISO 14698: ISO 8.
All areas have High Efficiency Particulate (HEPA) Filters. Temperature and relative humidity are controlled ensuring stability of the environmental condition during the manufacturing process.