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/home/o3n3rkbx148m/premier-med.com/system/engine/proxy.php on line 8 MANUFACTURING

PRODUCTION PROCESS:

CASTING OF PARTS (cylinder, stem, cuff)
PAD PRINTING ON CYLINDERS
ASSEMBLY OF SYRINGES
PACKING OF SYRINGES
STERILIZATION
STORAGE
LOGISTICS

CASTING OF PARTS

Casting of cylinders and rods takes place on injection molding machines "Selex", "NB 270", "LOG". The quality of the parts is carried out by a representative of the Quality Service, and is made by visual and instrument method. The parts must comply with the requirements of regulatory, technical and operational documentation.

CYLINDER PRINTING

Printing on cylinders is carried out by pad printing using special paints. The operator controls the print quality 100% visually.

ASSEMBLY OF SYRINGES

The syringes are assembled on automatic assembly machines. Operations are performed:

  • cylinder feed
  • siliconization of cylinders
  • rod feed
  • cuff feed
  • assembly of the stem and cuff
  • assembly of the cylinder with the rod

The assembly process is carefully and responsibly checked by the Quality Service.

PACKING OF SYRINGES

Automatic packaging is carried out on packaging lines. The polyform film is formed, a syringe and a needle are automatically placed in it. Gas-permeable paper is welded with a film and an individual "blister" type package is obtained. Variable data is applied automatically and blisters of packed syringes are cut. The quality of the weld, tightness of the package, completeness and absence of foreign inclusions are monitored. Manual packaging is made in a corrugated box in a multiple of 10.

STERILIZATION

The packaged products are delivered to the sterilizer, where they are sterilized by gas method in ethylene oxide. The sterilization cycle time is 9 hours. For proper and high-quality sterilization, the basic requirements of the manufacturer's instructions for the oxide sterilizer are followed. The production is carried out on the control of chemical and biological indicators. After receiving the conclusion on sterility, the products are valid for 5 years.

STORAGE

We use our own storage facilities, where the products are stored in a packed form in a place protected from the effects of aggressive environments, at a temperature of plus 5 °C to plus 40 °C and a relative humidity of no more than 80 % at a temperature of plus 25 °C. Our own storage facilities comply with cGMP requirements

LOGISTICS

Logistics is carried out by agreement with customers.