POLYPROPYLENE CONTAINER FOR INTRAVENOUS FLUID

2. APPLICANT

(a) Name: Jedux Parenteral Private Limited

(b) Registered Address: Near Khhatriya Dharam Kanta, Faizabad Road, Tiwarigunj, Chinhat, Lucknow

(c) Country: INDIA

(d) Nationality: INDIAN

The following complete specification describes the nature of the invention and the manner in which it is to be performed: - 3. FIELD OF THE INVENTION

The present invention relates generally to the therapeutic medical apparatus for sterilizing the intravenous (IV) fluid at one hundred and twenty-one (121) degrees centigrade for fifteen (15) minutes and making it leakage free by providing helmet head shape to its dispensing end.

4. BACKGROUND OF THE INVENTION

The present invention relates to safe as per the sterilization standard, disposable, light, minimal damage like leak or breakage, and cost- effective means for the intravenous (IV) fluid dispensing.

Glass containers considered to be safe for filling the intravenous (IV) fluid at the sterilization standard temperature of 121-degrees centigrade. Besides, the cost, weight, and damage, the two-steps manufacturing of the glass containers in the first, and in the second step, before sealing filling the intravenous fluid in it provide ample scope for the fluid contamination. The chances of generation of particles either nonvisible and, visible during their transportation due to unusual shock remained a challenge with the glass containers. Environmental factors such as temperature and humidity play an important role during storage of the glass containers filled with the intravenous (IV) fluid. To hold and deliver IV fluid, Polyethylene container with nozzle head emerged as a convenient and cost-effective means. The Polyethylene sterilization takes 60 minutes at 108 degrees centigrade. Its sterilization requires to prove the sterility assurance level (SAL) during the product qualification with bacterial log reduction.

The destruction of all micro-organisms remains a challenge, as the chance of survival of an individual microorganism never becomes zero. A probability for Sterility Assurance Level (SAL) measures undergoing every single unit subjected to sterilisation, nevertheless it remains non-sterile. For the medical device sterilisation processes remain extremely low SAL, such as 10 ^-6 , which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilisation process.

The conventional processing of the IV fluid filled container consisting of two independent phases. In the first phase the container got prepared in a separate manufacturing and in the second phase the IV fluid gets filled and the container gets sealed. The process provides ample scope for contamination of either the container or both the fluid and the container.

Euro head bottles have a two-stage manufacturing process. In the first process, the bottles get filled with solution and in the second process, a euro head gets welded on the top of the bottle. The Euro Head bottles get sterilized at 108 degrees centigrade. Steriport bottles also used as an IV fluid container match the Euro head bottles features and drawbacks.

The Nozzle Head IV fluid container feasible in polyethylene (PE) material. The PE material holds the characteristics of softness, and on being heated holding heat for a long time, makes it an easy to seal the material. The leakage issues remained a challenge in the PE material as is a softer material and while pricking the material, the pricked hole tends to expand and contract leading to the leakage. A single port provided in the conventional design of the IV fluid container in PE material. The polymer (PE) containers get IV fluid sealed at 108 degrees centigrade leaving ample scope for contamination.

CN113232963 A proposes a high-density medical polypropylene (PP) bottle. The CN 202110329244 discloses a high-density polypropylene bottle with a threaded mouth cap. The said bottle contains magnetic suction heads and slots. The magnetic attraction clamping grooves and magnetic attraction heads attract one other to form fixation. The disclosure is limited to a firm polymer bottle. CN104906655B discloses no leakage soft transfusion bottle with low pressure drain. The document particularly pertains to fluid flow dynamics.

IN-DELNP-2006-07140A discloses a two-stage production of a clear, low-haze, injection stretch blow moulded polypropylene container articles with advantageous free shrink characteristics.

The above stated conventional IV fluid containers and the cited patents do not address the shortcomings highlighted hereinabove.

5. SUMMERY OF THE INVENTION

The embodiments of the invention disclosed herein relate generally to therapeutic medical procedure of intravenous fluid carrier. The first objective of the disclosed embodiments was to achieve optimum sterilization standards. The disclosed embodiments worked out on the principle of Form, Fill & Seal technology in a single process wherein Polypropylene (PP) granules form a containing medium.

The second objective addresses the leakage problem in both Polypropylene and Polyethylene containers. The Polyethylene does not sustain the sterilization standards of sealing the intravenous fluid at 121-degrees centigrade. The leakage problem in Polypropylene gets solved in the disclosed embodiments by the means of a novel head of the Polypropylene container. The third objective of reducing the cost of the Intravenous fluid container is achieved by using the Polypropylene granules in place of the conventional Polyethylene granules. Presently Polyethylene granules get imported whereas the Polypropylene granules get produced locally and remain available readily at a lesser price. The novel disclosed embodiments get achieved in a single Form, Fill & Seal process thereby further reducing the manufacturing cost. The wear-and-tear cost also gets reduced by addressing the leakage problem. The novel disclosed embodiments do not leak after being exposed to 121 -degrees centigrade for the fifteen (15) minutes, as prescribed in the Standards.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of an Intravenous Fluid Steriport Bottle in glass material.

Figure 2 is a perspective view of an Intravenous Fluid Euro Head Bottle in Polyethylene material.

Figure 3 is a perspective view of an Intravenous Fluid Glass Bottle. Figure 4 is a perspective view of an Intravenous Fluid Nozzle Head Bottle in Polyethylene material.

Figure 5 is a semantic diagram of the side view of the Container with the longitudinal view of the Crown. Figure 6 is a semantic diagram of the side view of the Container with the latitudinal view of the Crown.

Figure 7 is a semantic drawing of the container with the container head and manufacturing description.

Figure 8 is a semantic drawing of the helmet head in a top-down view.

6. DETAILED DESCRIPTION OF THE INVENTION

In accordance with the embodiments of the present disclosure described hereinafter with reference to the accompanying drawings. The drawings are exemplary only without creating any limitation to the disclosure.

There is disclosed herein an intravenous fluid polypropylene container with a helmet head [5 & 6]. The Form, fill, and seal the dispensing helmet head technology completes the entire process from polypropylene granules to intravenous fluid dispenser manufacturing at the standard sterilization temperature of one hundred and twenty-one (121) degree centigrade in a single go. The polypropylene granules are safe, economically cheaper, locally manufactured, available at a stable price, and can resist one hundred and twenty-one (121) degree centigrade temperature during the sterilization process that requires achieving Fo value without any requirement to prove sterility assurance level. The Fo value is used to determine the exposure time of material for sterilization at a particular temperature. The Fo value is the time in minute for the specified temperature that gives the same thermal lethality as at one hundred and twenty-one (121) °C in one minute. The sterilization at the temperature of one hundred and twenty-one (121) degree centigrade for fifteen (15) minutes lead to the killing of the microorganism and restricts the development of new microorganism colonies.

In comparison to polypropylene, polyethylene holds softness in the material. Due to the softness property, on pricking polyethylene the surface faces expansion and contraction leading to leakage. In the conventional dispensing end designs the leakage problem persists in the polypropylene container. However, when the helmet head design gets applied at the dispensing end, astonishingly the leakage problem gets resolved. As a result of the sealing of the dispensing end of the container, the dome shape helmet head carves out a radius profile. The radius sealing provide strength to the dispenser. The radial sealing [Fig. 7.3] process develops a detachable crown over the helmet head. The crown provides mechanical stability to the sealing. The heating and cooling phases provide hardness to the sealing area, further strengthening the dispensing end of the polypropylene container. When stacked horizontally, the domed shape helmet head of the disclosed embodiment remains resistant to bending or puncturing. The higher tensile strength in the polypropylene material also helps in solving the leakage problem when the intravenous fluid containers get stacked one over the other for storage.

In a specific embodiment of the container of this invention [5] depicts the side view of the Container with the longitudinal view of the radius seal over which the detachable Crown [ 5.1] subsists. Similarly, in a specific embodiment of the container of this invention [6] depicts the side view of the container with the latitudinal view of the crown [ 6.1]. A schematic illustration in [7] provides detail for manufacturing the intravenous fluid polypropylene container with a helmet head. The [7.1] depicts the die for the helmet head. The die conduiting between the die head and extruder which raises the pressure behind the die compresses the melted materials and uniformly distributes them into the die head entrance to ensure stability and quality status of the container so produced. The [7.2] depicting the dispensing side oval shape neck of the helmet head having eighty-one (81) millimetres by fifty-nine (59) millimetres dimension. The [7.5] depicts structural diagram of the embodiments. The dimensions provided herein are for manufacturing an intravenous fluid polypropylene container with a helmet head with a half a liter capacity. From top of the head to the means provided for top down hanging the length and the breadth of the container are two hundred and sixteen (216.5) millimeters and fifty- nine (59) millimeters. The outer and the inner diameters of the helmet head are thirty-one (31) and twenty-nine (29) millimeters respectively. The radius of the helmet head was fourteen and a half (14.5) millimeters. The length of the helmet head dome was seventeen (17) millimeters. The [7.5] depicts the diagram of the bottom of the intravenous fluid polypropylene container along with the means for hanging the container upside down.

A schematic illustration in [8] provides depiction of the helmet head. The seal in the helmet head divides the helmet head in two equal parts. On both sides of the detachable crown, the helmet head contains leakproof duel circular pricking nozzle ports [ 8.1 & 8.2], one each at the opposite side of the said helmet crown, for inserting Intravenous set into the said container. One of the nozzle ports [8.1 & 8.2], may be used for inserting the intravenous apparatus and the other for controlling the air pressure.

The sterilization process in the disclosed embodiments takes place at one hundred and twenty-one (121) degrees Centigrade whereas in the PE material container the sterilization gets done at 108 degrees centigrade. The standard time cycle of sterilization at one hundred and twenty-one (121) degree centigrade remains between thirty and forty (30- 40) minutes, whereas the time taken for the 108 degrees centigrade sterilization cycle remains between sixty (60) minutes and eighty (80) minutes. The sterilization inputs remain almost the same, like water air pressure and vacuum. Therefore, the shorter cycle of sterilization at one hundred and twenty-one (121) degree consumes less electricity, to run vacuum, air pressure machines and the lesser volume of water gets consumed. The sterilization at one hundred and twenty-one (121) degree centigrade not only achieve the sterilization standards but also makes the manufacturing economical.

The Best Production Method

The vertical Form, Fill, and Seal (FFS) machine works on the principle of ‘Form, Fill & Seal” technology. By the means of the FFS machine, Polypropylene containers get formed and IV fluid solution gets filled into the formed container aseptically and, sealed hermetically when the head mould seals the helmet part with crisscross lining and the extra tube that could be manually detachable.

The FFS machine uses Low Density Polypropylene granules for producing the Polypropylene containers [5& 6]. The Low-Density Polypropylene granules get fed into the granules bin from where the minimum level limit switch, the FFS machine starts sucking the granules till the level of the granules in the hopper touches the maximum level limit switch.

After cutting the parison the FFS Machine starts with Hydraulic pump and vacuum pump on. In the production cycle the mould comes back, takes the parison and parison got cut by a knife, and then moves forward. Then the filling mandrels enter each parison separately and air gets blown inside the parison. The parison takes the shape of a container, and the container starts formation from the bottom.

The FFS Machine automatically sucks the granules. Then Compressed air filtered through a Cartridge Filter zero-point-two (0.2) Micron and supplied into the FFS Machine. The IV Fluid filtered through cartridge filter zero-point-two (0.2) and fed into the buffer tank of the FFS machine located on the top of the FFS Machine. When the temperature of all the zones of the extruder reaches more than one hundred and seventy (170) °C, the extruder switches on and long parison of Polypropylene gets formed. Initially four to five times parison are cut and thrown so that the length of all the parisons formed thereafter be of almost equal size. When the extruder is on, the FFS Machine starts sucking granules into the granule hopper located at the top of the machine. In the granule hopper holds two limit switches. When the level of the granules in the granule hopper touches the minimum level limit switch, the FFS machine will start sucking the granules till the level of the granules in the hopper touches the maximum level limit switch.

The container formation begins from the bottom. On the formation of the parison, the fluid filling Mandrels gets inserted into it and the air flows inside the tube and the application of vacuum shapes up the walls of the parison. As soon as the parison takes the shape the mandrels fill in the IV fluid in the fixed quantity. After filling the fluid, the mandrels come out of the parisons. Immediately, the above part of the neckline [7.6] that up till now remained in the form of tube gets pressed by the head mould upon the fluid filled parison hermetically sealing the parison turned into a container [5 & 6]. In the sealing process a radial sealing [5.1 & 6.1] gets formed upon the helmet head [5.2], Then the mould that formed the below part of the neckline [7.6] gets separated. The helmet head [5.2] part still held by the head mould and as the head mould gets separated the container falls in the conveyer. On the conveyer the detachable crown [7.1] gets manually removed and stacked on the SS carriage.

This portion remains in the helmet head [5.2] mould form in the tube and, after filling the head mould seals the helmet part with crisscross lining [7.3] and the extra tube that could be manually detachable.

As soon as blowing of air completes, the filling starts from the dispensing end. After required quantity of solution gets filled, the fluid filling mandrels come out of the mould and instantly the helmet head [5.2] portion gets released by its mould joining with the intravenous fluid filled lower portion of the container causing complete sealing of the container at the neckline [ 7.6]. Then the mould opens leaving all the containers on the bottom pins which go down to remove the bottom scrap and hangers formed at the bottom of the bottles. Then the containers get fed on the conveyor belt for the removal of the top scrap. The containers get arranged on the stainless-steel carriages for autoclaving.

After filling operation, the containers get collected on the SS Trolley and taken for passing through the sterilization process at one hundred and twenty-one (121) °C for fifteen (15) minutes. Super-heated water spray sterilizer consists of steam sterilization jacket chamber. Demineralised water (DM) reservoir provided at the bottom. At pump for circulation also provided to the reservoir. Steam heats the DM water up to required temperature. Since the loop of water gets raised above the boiling point of water known as super-heated water spray sterilizer.

The resin-bonded glass wool provides insulation to the sterilization chamber. It helps in reducing the heat loss to the environment and ensuring uniform distribution of temperature inside the chamber. The SS cover plate provides cover to the insulation.

The sterilization chamber holds two sliding doors made up of SS reinforce with support structure. The door gets operated with the help of electro pneumatic cylinder. When the door reaches the end position gaskets pushes out automatically with the help of compressed air for sealing. Similarly, to open the door, gasket retracts with the help of vacuum created by the compressed air ejectors. When the gasket retracts, the sterilizer chamber door slides automatically. The system holds properly safety and alarms feature, as either the overshoots of temperature from the set value or temperature level falls below from the set value or water level low in chamber the alarm will be on.

The disclosed embodiments provide the highest standard achieving for the sterilization of the intravenous fluid contained in polypropylene material. The disclosed embodiments provide helmet head with radial sealing as a solution for the leakage and thus contamination problems in the contemporary IV fluid containers. The nozzles at the helmet head provide the specific points for inserting the Intravenous apparatus and another for pricking to maintain the fluid flow pressure. The disclosed embodiments technically achieve the safest intravenous fluid container reaching the highest standard of sterilization and solving the leakage problem with the helmet head shaped dispensing end. The sterilization at the 121-degrees centigrade requires lesser time for sterilizing the container with the IV fluid resulting in saving of energy, time, and water.

The comparatively economic cost of polypropylene and sterilization make the disclosed embodiments economically cheaper. The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.