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Disposable Syringes & Needles has a large manufacturing unit, speared over an area of 65000 square feet with latest technology, complete manufacturing is almost automatic and entire process is backed by highly skilled, quality and trusted professionals.
Description of Production Process of Single use syringes
The raw material used for the production of single use syringes are polypropylene for the barrel and plunger and thermoplastic elastomer for gasket in form of granules. In the raw material store the granules are filled from the bags in to the containers and from there they are conveyed to the injection molding machine. During the filling into the containers, no dirt gets into the raw material.
Molding
The plastics raw material is filled into the material hopper of the injection molding machines in plasticized by the injection units of the machines. The plasticized material is injected under pressure into the closed precision injection molds. Due to the cooling water system linked with the mold, the plasticized material is cooled down again becoming the respective part, such as barrel, plunger, hub and cap. At the end of the cooling down time the mold is open hydraulically and the shaped parts are ejected.
The individual injection molded parts are filled in to storage containers for approximately 24 hours for further cooling down and shrinking to the definite measurement. First in first out system is followed.
Printing and Assembly
After storage the barrel are taken to the printing machines and plungers to the assembly machines. The barrels are placed onto in feed conveyer which takes the barrels to printing drums and the ink with the help of calibrated iron roller gets transferred from ink roller to the syringe
The printed barrel as well as plunger and gasket are taken to the assembly machines and automatically fed in to machines. In this machine the gasket is pushed into the plunger and assembled plunger pushed into the barrel then after a required size of needle fixed on the nozzle of syringe. After a functional test the assembled syringes separated into good and bad ones are ejected and collected in containers.
Packing
After assembly the hypodermic syringes with needle are ribbon packed using a laminated film suitable for thermoforming and paper which is gas permeable but impermeable for germs. The film and paper on rolls are hanging into the packing machine. In the next step paper roll gets unwound and conveyed to the printing device, where it gets all necessary data (Date of Mfd., Lot No., etc.) from here with laminate film the syringe on conveyer led to the sealing station. The film is sealed by a heated sealing plate. This sealing is done on all four sides of every pack. Several cut marks on paper which permits for the Ethylene Oxide gas in pack.
After sealing the packages, which are still interconnected are cut, crosswise, then the product leaves the clean room and is now protected all over against contamination. The packages are then placed into inner boxes; the inner boxes are already printed; only indications such as production date, lot no., expiry, etc. are stamped on.
The inner boxes are set into a dispatch carton which is also labeled with required data.
The dispatch boxes are closed and conveyed to sterilization area.
Sterilization
The syringes packed into the dispatch cartons are placed into the sterilization chamber. Sterilization is done by ethylene oxide.
After the sterilization chamber has been filled with syringes chamber door is closed and locked, then steam is led into the chamber which supplies the required humidity. The chamber remains in this state for approximately 1 hour so that the humidity (60% to 80%) and temperature (40ºC to 50ºC) can penetrate into packages.
At the end of this hour of humidification and required volume of gas is led into the chamber via the evaporator. When the whole determined volume/quantity of gas is in the chamber the exposure time starts. The pipes to the chamber are all closed and the chamber remains in this state for approximately 6 hour. By the remains vacuum in chamber it is granted that door can not be opened. In this course of the exposure time the vacuum pressure usually increases slightly.
At the end of the exposure time the chamber is evacuated again to approximately 0.05 bars with the vacuum pump, thus removing the main portion of the ETO. The fresh air is led into the chamber through a filter. Just before reaching the pressure balance the chamber evacuated to remove remaining gas rests. This is done twice in the third step fresh air in led is until the pressure balance is reached. Then the chamber is unloaded and sterilized products are taken to the quarantine store.
Testing
After sterilization the dispatch boxes are taken to the quarantine store. There the remain under quarantine until the microbiological controls have proven to be satisfaction. At the same time residual gas in the products are removed by a good aeration.
The products remain in this store for a fort night, depending on the results of the sterility test.
After the sterility of the products has been ascertained they are transferred to the dispatch store for sale.
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