MX2013007896A - Method for manufacturing tubular sterile glass containers free of particles for pharmaceutical use. - Google Patents

Abstract

Process for manufacturing tubular sterile glass containers free of particles for pharmaceutical use, which comprises: providing a glass tube closed by the end portions thereof; manufacturing the glass containers; transporting the containers to an electric furnace, passing through protecting air curtains for protecting the container from possible particles, the furnace being located in a class "C" area, before introducing the containers therein, the inner portion thereof being swept with clean air and class "C" filtration for extracting the possible visible and non-visible particles lower than 50 microns; sterilizing the containers in the furnace; sterilizing a packaging for the containers in a class "C" area; transporting the containers out from the furnace to a class "A" area, which is protected with a class "B"; packaging the containers with the packaging in the class "A" area.

Description

PROCESS FOR MANUFACTURING TUBULAR GLASS CONTAINERS STERILE AND PARTICULATE FREE FOR PHARMACEUTICAL USE FIELD OF THE INVENTION The present invention relates to methods for manufacturing glass products, and particularly to the manufacture of glass containers in a controlled environment area that is clean and free of particles.

BACKGROUND OF THE INVENTION.

Glass containers for pharmaceutical use such as vial and ampoules, are traditionally manufactured under uncontrolled environmental conditions or without classification by the converter companies, because these containers have been considered in the pharmaceutical industry as a packaging material to contain and protect a drug, who with their special facilities are obliged to install clean and sterile areas where they place the necessary equipment to make a process of washing the container with water.

In the washing process, a rinse is done to remove particles and free alkaline gases that were released during the transformation of the container: and it is expected that these washing equipment must be efficient to eliminate the largest amount of alkalis looking to leave a container as much as possible. clean as possible and avoid bad stability of the drug to be contained; Poor stability of the drug means a change in its hydrogen potential (pH) Once these containers have been washed, they go through a dry heat sterilization process. For this, a continuous or stationary oven is used, which normally works at 240 ° C for an average of 30 minutes and then passes the containers to another Special section also under controlled sterile environments where the filling will be done with the corresponding drug and finally the container is plugged to be transferred to other areas already ungraded for its conditioning.

On the other hand, and returning to the manufacture of tubular glass containers that converters do, normally after forming the container (ampoules or vials) it goes through an oven at 600 ° C to temper or align the molecular structure of the glass to improve its mechanical strength of the container, but at the same time it affects the quality of the container because these areas are dirty, their ovens are natural gas that generate carbon monoxides and the high temperature fix to the surfaces of the container the alkaline gases that are they detached from the glass during the transformation, affecting this to its hydrolytic resistance of the container. In addition to loose particles adhere to these walls when the temperature is exceeded.

Therefore, it is concluded that dirty, contaminated containers are manufactured and that they necessarily required the washing and sterilization process mentioned in the previous paragraphs.

The pharmaceutical industry traditionally and as a rule, is required to have several systems and areas to manage their products and packaging that will be used to manufacture or process a drug. This industry follows the following general steps: a) Receives a glass container (dirty) vial or ampoule or some other container processed by the converter companies to use it as primary packaging of their drug; b) Wash the containers with the support of special equipment; c) Sterilizes the container in special ovens with dry heat at a temperature of 240 ° C; d) With steps b and c it changes from a standard dirty container to a sterile container that places it in its special machines to fill it with the corresponding drug; e) Passes your semi-finished product to its conditioning stages for inspections and to place an identification tag or protect it in its individual or collective packaging; To achieve the above, the laboratories will require an infrastructure to produce, conduct and control the water with the aseptic characteristics that are required in the norm NO -059 SSA to be used in special machines that will rinse the container to eliminate alkaline gases and dirt of the container every time this container was manufactured in areas not controlled environmentally.

In addition to water, special high-cost equipment and specialized personnel are required to operate these washing equipment and control the quality of the water with which they will wash the container and then also have to invest in an oven to dry the container and sterilize it; These sterilization processes require controls, EPA terminal filters and special monitoring to document the conditions of this sterilization process and therefore also requires trained personnel for this control and monitoring.

Similar processes are not innovating at all since they propose sterile containers, but this is achieved by transferring the special equipment and clean facilities that pharmaceutical laboratories have to the areas of the converter companies, but in the end they continue to use dirty or conventional areas for manufacturing the container, continue to use gas furnaces for molecular orientation and continue to use the same equipment used by the pharmaceutical laboratory to wash the container and a second baking to achieve sterilization.

No savings are achieved since the investments are also being transferred to the glass converter plant.

The containers still require efficient systems for washing, the manufacturers fail to eliminate at root the problem of alkalinity of the containers.

This new manufacturing process that is proposed gives us a clean and sterile packaging from the converter plant, preventing pharmaceutical companies from investing in the expensive and complicated traditional processes described above to obtain a sterile, particle-free package; With this method, we obtain a container ready to be filled by the end user (the pharmaceutical laboratory). This method offers a sterile and protected product to travel to the point of use without losing its sterility and cleanliness characteristics.

Our manufacturing process offers a clean container from its formation, eliminating alkalis and particles while it is being formed and with the design of clean areas installed in cascade, changing new kilns that do not emit carbon dioxide and installing it in classified areas, Class B (classification according to standard NOM-059 SSA) and unloading the container to a class A aseptic area; from This way we achieve a clean, particle-free and sterile packaging without the need to go through a washing process and a second heating for its sterilization.

Therefore, the invention provides a process for manufacturing sterile and particle-free tubular glass containers for pharmaceutical use, comprising: providing a closed glass tube at its ends; make glass containers; transport the processed containers to an electric oven, in a path that includes protective air curtains that protect the container from possible particles, the oven is in a class "C" area and before entering the containers to this area calase "C" an internal sweep is made to the container with clean air and filtered class "C" to extract possible visible and non visible particles smaller than 50 microns; sterilize the containers in the oven; sterilizing a package for the containers in a class "C" area; transport the containers outside the oven to an "A" class area that is protected with a "B" class, pack the containers in the packaging in the "A" class area.

BRIEF DESCRIPTION OF THE FIGURES To give a better understanding of the invention, a description thereof is given below, together with the accompanying drawings, in which: Figure 1 is block diagram of the method of the present invention; Figure 2 shows a packaging manufacturing process before entering the area with a clean environment; Figure 3 shows the detachment of the lower part of the tube from the rest of the tube in the manufacture of containers; Figure 4 is a schematic diagram of a second cycle of the method of the present invention; Y Figure 5 illustrates the gas aspiration mechanism of the glass container of a manufacturing process.

DETAILED DESCRIPTION OF THE INVENTION With this new manufacturing process of the invention, we were able to obtain clean and sterile containers ready for filling in a pharmaceutical laboratory, reducing the process chain that is used between the container manufacturer or converter and the pharmaceutical laboratory itself; the process is described below in a block flow, with the help of figure 1: This new manufacturing process has several stages compared to the traditional process; we begin with step 301 described in figure 1; This stage requires a raw material with special finishing that includes using closed glass of the ends created from the origin of its manufacture, this finish that will have the raw material we It will take the first cleaning steps that this process will require and will require special systems in the forming machine for its proper use. The raw material must be protected with special packaging to take care of its cleaning during transport and storage.

The next step 302 is the manufacture of the container in traditional vertical forming machines from glass tube; In this manufacturing process, the cascade begins with regard to the quality of the areas where this process takes place.

The glass container manufacturing process can be the one provided by the applicant and found in the Mexican patent application No. MX / a / 2013/006088.

As shown in FIG. 2, the glass tube 11 which is used as a raw material is provided; the glass tube 11 must have the ends completely closed (traditionally open) to help in the process of micro explosion that will be done later; in stage 20 the glass tube goes down and with a heat flare 1, strong enough, the lower part of the tube opens, the rotary machine continues advancing to the next work station that would be 30, in this station it is placed a burner 2 at a predetermined height (sufficient to form the container at the height of its specification) for start a first preheating of three that will be given to the tube before detaching the bottom part of the rest of the tube as shown in figure 3.

In step 40 the second preheating is given with another burner 3, also placed at the same height of the previous stage; in step 50 there is a third burner 4 which will give the final heat and sufficient to make the cut of the tube with the aid of the mechanism represented as 100, who will pull the lower part 51 from the rest of the tube; this first lower part of the glass tube in the first cycle of the machine is only a section of glass without a mouth that is discarded, since it is the. start, and as seen in figure 2, in steps 80 and 90 is where the mouth of the container will be formed; After this, (already with the mouth formed) can continue with a second total cycle of the machine when the glass tube reaches the stage again with the lower end closed.

The position 60 represents the path taken by the glass tube between position 50 and 70; in this representation 60 the tube travels with the lower end capped and upon reaching station 70 it receives the burner 6 and 5 to cause a micro explosion: in the lower part of the tube because the burner 6, put the heat that gives, increases the internal pressure of the tube in question.

The machine continues its advance step by step and reaches position 80 and 90 where it forms the mouth of the container and gives way to continue its advance again until stage 10 as seen in figure 4 where the next cycle begins already with the mouth of the container formed in the lower part of the tube. Again, in step 20 the glass tube goes down and with a heat flame 1 enters the bottom of the tube for heating and the rotating machine continues advancing to the next work station that would be 30, in this station a burner 2 at a predetermined height (sufficient to form the container at the height of its specification) to initiate a first preheating of three that will be given to the tube with the burners 2, 3 and 4 before detaching the lower part 52 from the rest of the tube in stage 50.

Once it passed through position 100 where it pulled down the piece or container 52 from the rest of the tube and advanced to position 110, there the gas aspiration process begins as the container or piece of glass is heated with the burner 7 to finish forming the bottom of the container.

Because the rotary machine requires two more stations (the 120 with 8 and the 130 with 9) to finish forming the bottom of the container, we must also keep the gas aspirate in operation in these stages.

The steps 110, 120 and 130 are also carried out in the first initial cycle for the part 51, although the part 51 is subsequently discarded, because such steps are part of the cycle.

The mechanism for gas aspiration (see figure 5) is designed to create a ventury effect, since at the moment when the ventury nozzle 220 enters the bottle or glass container 200 and is prepared to make the injection of air 230 as soon as it passes through the inside diameter of the mouth 210 reducing the spaces between them so that when injecting air into the containers that are being formed at that moment, the gases released by the high heating leave 240; These gases, are alkaline residues that are detached from the glass, are gases that attack the glass reducing its chemical resistance of the internal surface of the container and causes delamination in combination with the drug that will contain the container.

From this point in the process, the vial container has been finished and it will be able to continue its handling according to the manufacturer's convenience and it will depend on whether other finishes have been requested to the container. So far we have a high quality packaging with all the qualities already described in the previous paragraphs.

Referring again to Figure 1, in step 302 there is a clean area, without classification but the machine and line of manufacture stage 303 8proteccion and sweeping) has protective curtains of clean air that protect the container of possible particles, this, while the transportation of the same line makes them arrive (the containers) to an oven that is in a class "C" area and before entering this area, an internal sweep is made to the container with aseptic air (clean and filtered class "C") to extract possible visible and non visible particles (less than 50 microns) that help us to obtain a particle-free container.

The process continues with stage 304 (electric oven) when the containers enter automatically to an oven that is already in a class "C" area where this oven will work at more than 500 ° C for at least 3 minutes, enough for achieve its sterility, and this furnace has its outlet connected to a conveyor that receives in the furnace container and transfers it to the next step 306 (accumulation and packing) where the packing will be accumulated and packaged. This stage 306 is in a class "B" and class "A" area to continue with the classification of areas, in cascade.

In this step 306 in addition to arriving at the sterile containers that passed through the oven, the packing material that was sterilized by Ethylene Oxide in step 305 (sterilization and packing) also arrived and that was also processed in class "C" areas but passing through a class "B" dynamic lock that protects the packaging material for its cascade classification, in addition to protecting the final packing critical area that is made in step 307 (final packaging) , area formed by laminar flow class "A" to end there the cascade of areas from manufacturing with clean area without classification, going through class C, continuing with class B and ending with class A.

The packaging materials that are sterilized in stage 5 are prepared with a special bag that protects them until they reach the area of stage 307 where they are integrated into the sterile package that reaches stage 306. Also in this stage 307 the containers are sealed packaged with double bag, where one of them will be the protection of the sterility of the container and its primary packaging, and the other will be its bag of protection for handling and transportation outside the area.

The cascade of the areas is represented 'in Figure 1: Class "A" is the cleanest area that complies with the parameters of particle level, pressure and temperature required by NOM 059 and this area is protected or covered by the class "B" area also described in NOM 059, subsequently these areas are protected by class "C" areas that are areas for entry dressing, it is the area where the oven is installed that will make the container sterile, It is an area where equipment areas are installed for packaging sterilization.

In stage 308 we already have a finished product, we have the sterile container, free of particles and protected to travel to the destination of the final customer, who (the client) receives these containers to take them to their sterile or aseptic areas where they are installed only its filling machines, there at that point opens the primary packaging that protects the sterility of the container and it is available by feeding it to your filling machine in a traditional way.

The relevant aspects of this invention is to provide the market with a clean and sterile package that does not require the investments and special and traditional facilities installed by all pharmaceutical laboratories for its use, this applies to the manufacture of vial vial and ampoules that have been manufactured under a process of constant protection from the characteristic of the raw material, continues with protective air curtains, during its manufacture, is subjected to an internal sweep with aseptic air, has passed through an oven for its sterilization and finally passes through clean cascaded areas represented in figure 3 until reaching a level d class A area.

The present invention has been described and illustrated in its preferred embodiment, however, variations can be made to manufacture glass containers of different configuration but based on glass tubes, for example syringes or ampoules, which fall within the scope of the following claims.

Claims (4)

1. Process for manufacturing sterile and particle-free tubular glass containers for pharmaceutical use, comprising: Provide a closed glass tube at its ends; make glass containers; transport the processed containers to an electric oven, in a path that includes protective air curtains that protect the container from possible particles, the oven is in a class "C" area and before entering the containers to this area calase "C" an internal sweep is made to the container with clean air and filtered class "C" to extract possible visible and non visible particles smaller than 50 microns; sterilize the containers in the oven; sterilizing a package for the containers in a class "C" area; transport the containers out of the oven to an area class "A" that is protected with a class "B; pack the containers in the packaging in the class area "TO" .

2. The process of claim 1, wherein the sterilization of the containers is carried out at more than 500 ° C.

3. The process of claim 1, wherein the packaging sterilization is performed with ethylene oxide.

4. The process of claim 1, wherein the packages are packaged with double sterile pouch. SUMMARY OF THE INVENTION process for manufacturing sterile and particle-free tubular glass containers for pharmaceutical use, comprising: providing a closed glass tube at its ends; make glass containers; transport the processed containers to an electric oven, in a path that includes protective air curtains that protect the container from possible particles, the oven is in a class "C" area and before entering the containers to this area calase "C" an internal sweep is made to the container with clean air and filtered class "C" to extract possible visible and non visible particles smaller than 50 microns; sterilize the containers in the oven; sterilizing a package for the containers in a class "C" area; transport the containers outside the oven to an "A" class area that is protected with a "B" class, pack the containers in the packaging in the "A" class area. 1/3 cation Fig. 1