Sterilization system for a blow/fill/seal machine
阅读说明:本技术 用于吹气/填充/密封机器的消毒系统 (Sterilization system for a blow/fill/seal machine ) 是由 C·H·里德 A·W·戈尔 J·D·斯坦利 于 2015-01-19 设计创作,主要内容包括:本分案申请利用包含气体的消毒剂的闭环循环的用于吹气/填充/密封机器的填充组件消毒系统。一般的消毒剂是二氧化氮。闭环包括限定了充气室并封闭了填充系统的护罩和至少一个高效微粒吸收(HEPA)过滤器。10<Sup>-6</Sup>的灭菌保证水平可以通过使填充系统受到在大约18℃.至大约30℃.范围的温度下的消毒气体至少20分钟来获得。(The present divisional application utilizes a fill assembly sterilization system for a blow/fill/seal machine that utilizes a closed loop cycle of a sterilant containing gas. A common disinfectant is nitrogen dioxide. The closed loop includes a shroud defining a plenum and enclosing a fill system and at least one High Efficiency Particulate Absorption (HEPA) filter. 10 ‑6 Can be obtained by subjecting the filling system to a sterilizing gas at a temperature in the range of about 18 c to about 30 c for at least 20 minutes.)
1. A method of sterilizing a fill assembly in a blow/fill/seal machine, the method comprising contacting the fill assembly with a sterilizing gas comprising humid air and nitrogen dioxide in an amount of about 10 to about 20 mg/l and having a relative humidity in the range of about 50% to about 75% for a period of at least 20 minutes.
2. The method of claim 1, wherein the fill assembly is contacted with the humidified nitrogen dioxide for a period of 20 to about 30 minutes.
3. The method of claim 1, wherein the fill assembly is contacted with the humidified nitrogen dioxide gas at a temperature of about 18 ℃ to about 30 ℃.
4. The method of claim 1, wherein the fill assembly is contacted with the humidified nitrogen dioxide gas at ambient temperature.
5. The method of claim 1, wherein the sterilizing gas is passed through a HEPA filter prior to contacting the fill assembly.
6. The method of claim 1, wherein air at a temperature of at least 65 ℃ purges the fill assembly for at least 20 minutes to remove residual nitrogen dioxide after sterilization.
Technical Field
The present invention relates to a blow/fill/seal machine and to an aseptic packaging using such a machine.
Background
Blow/fill/seal machines are often used for aseptic packaging of pharmaceutical products; in particular biological agents, proteins and the like. To ensure aseptic packaging conditions, the product path and filling assemblies of these machines must often be sterilized. This sterilization is usually carried out with high-pressure steam at 110 ℃ to 125 ℃; however, the available steam sterilization processes are cumbersome and time consuming when applied to large open spaces.
Disclosure of Invention
A sterilization system for a blow/fill/seal machine includes a shroud around a container fill assembly of the machine that defines a plenum in limited fluid communication with an external sterilization gas conduit.
The shroud, together with the gas conduit and the at least one High Efficiency Particulate Absorption (HEPA) filter, defines a closed loop of circulation of the sterilizing gas.
In particular, the sterilization system includes a shroud enclosing the fill assembly and defining a sterilization gas inlet and a sterilization gas outlet. The outer conduit defines at least one sterilizing gas flow path between the sterilizing gas inlet and the sterilizing gas outlet. A blower is provided on the external conduit proximate the sterilizing gas inlet for circulating the sterilizing gas through the shroud and one or more HEPA filters of the sterilizing flow path between the blower and the sterilizing gas inlet of the shroud. A sterilizing gas source in fluid communication with the blower supplies a sterilizing gas to the sterilization system, the sterilizing gas including a sterilizing agent such as nitrogen dioxide, chlorine dioxide, vaporized hydrogen peroxide, or the like.
Preferably, sterilization of the fill assembly and its shield is accomplished by combining humidified air at a relative humidity of about 50% to about 75% with nitrogen dioxide to provide a sterilizing gas containing about 10 to about 20 milligrams of nitrogen dioxide per liter of sterilizing gas, and contacting the fill assembly shield with the sterilizing gas at a temperature in the range of about 18 ℃ to about 30 ℃ for a period of at least 20 minutes. The remaining nitrogen dioxide is thereafter removed by purging the fill assembly with air at a temperature of at least 50 ℃ (about 122 ° f.) for at least 20 minutes, preferably about 30 to about 45 minutes, depending on the shroud space and fill assembly geometry.
Drawings
Fig. 1 is a schematic flow diagram showing the present blow/fill/seal machine sterilization system.
Detailed Description
The blow/fill/seal process is a specialized aseptic liquid packaging process that involves a specific container manufacturing technique in which the container is formed, filled and sealed in a continuous process from a thermoplastic material without manual intervention. The filling and sealing of the container takes place in a sterile, closed space within a blow/fill/seal machine. Typical schematic fill assemblies are shown in U.S. patent No.4,671,762 to Weiler et al and U.S. patent No.4,997,014 to Weiler et al, and are incorporated herein by reference in their entirety. The blow/fill/seal manufacturing technique provides an automated aseptic packaging process under controlled conditions through the following three steps: sterilization of the container, aseptic filling and sealing of the container.
First, a thermoplastic resin such as polypropylene, polyethylene, or the like is extruded into a tubular shape (a semi-finished product), which finally becomes a final container. After the desired length of the semifinished product has been extruded between the open mould parts, the mould parts are closed and the semifinished product sections are cut from the extruded semifinished product. The top of the semi-finished product segment is fixed in position and is open, and the bottom of the semi-finished product is tightly clamped by the closed mold parts. The semi-finished product sections and the mould are then transferred to a filling area where a filling assembly is located, which comprises one or more blowing and filling nozzles.
The blow and fill nozzle is then lowered into the parison segment until a seal is formed between the parison segment and the mold neck. The sterilized, filtered compressed air is introduced into the semi-finished product section, which is expanded relative to the mold cavity and forms the container body. After the blowing cycle is completed, sterile air is bled from the container body and the sterile liquid product is fed into the container through the filling nozzle. At the completion of the filling cycle, the filling nozzle is retracted and the separate sealing mold closes the top of the semi-finished section and seals the formed filled container.
The filling assembly of the blow/fill/seal machine must be sterilized from time to ensure sterile filling conditions. Heretofore, the use of sanitization processes for the shield and the use of internal steam sterilization for the product path has affected the sterilization process. Figure 1 shows an improved dry sanitizing system for a hood and a fill assembly wrapped by the hood that can be utilized at relatively low temperatures to achieve up to 10 deg.f with a sanitizing gas containing nitrogen dioxide and similar sanitizing agents -6The sterilization assurance level of (2).
Referring to fig. 1, a
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In order to perform effective sterilization, the sterilizing gas must have a predetermined Relative Humidity (RH) in the range of about 50% RH to about 75% RH. The necessary humidity is provided by
The air combined with a sterilizing agent, such as nitrogen dioxide, from
After the sterilization cycle is completed, purge air is directed to the system via
The purge air exits the sterilization system from the
Provision is made for using a sterilizing gas by combining humidified air having a relative humidity of about 50% to about 75% with a sterilizing agent, such as nitrogen dioxide from a suitable source, such as
During the sterilization cycle, the sterilizing gas contacts the fill assembly at a temperature in the range of about 18 ℃ to about 30 ℃ for at least 20 minutes, preferably 20 to about 30 minutes at ambient temperature.
The foregoing discussion and examples are intended to be illustrative, and not limiting. Other variations and rearrangements of parts within the spirit and scope of the invention are possible and will readily be apparent to those skilled in the art.
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