CN104434517A - Double-layer aseptic packaging, packaging method and sterility testing method for large-capacity injection - Google Patents
Double-layer aseptic packaging, packaging method and sterility testing method for large-capacity injection Download PDFInfo
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- 238000004806 packaging method and process Methods 0.000 title claims abstract description 149
- 238000002347 injection Methods 0.000 title claims abstract description 34
- 239000007924 injection Substances 0.000 title claims abstract description 34
- 238000000034 method Methods 0.000 title claims abstract description 31
- 238000009455 aseptic packaging Methods 0.000 title claims abstract description 24
- 238000013190 sterility testing Methods 0.000 title claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000003814 drug Substances 0.000 claims abstract description 16
- 238000004659 sterilization and disinfection Methods 0.000 claims description 21
- 239000007788 liquid Substances 0.000 claims description 12
- 238000007789 sealing Methods 0.000 claims description 11
- 230000001954 sterilising effect Effects 0.000 claims description 11
- 239000008215 water for injection Substances 0.000 claims description 10
- 238000011049 filling Methods 0.000 claims description 6
- 239000008213 purified water Substances 0.000 claims description 6
- 230000002439 hemostatic effect Effects 0.000 claims description 5
- 241000894006 Bacteria Species 0.000 claims description 3
- 229920002799 BoPET Polymers 0.000 claims description 3
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 239000004816 latex Substances 0.000 claims description 3
- 229920000126 latex Polymers 0.000 claims description 3
- -1 polypropylene Polymers 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 238000004500 asepsis Methods 0.000 claims description 2
- 239000002874 hemostatic agent Substances 0.000 claims 1
- 230000036512 infertility Effects 0.000 abstract description 16
- 239000000243 solution Substances 0.000 abstract description 12
- 238000001514 detection method Methods 0.000 abstract description 10
- 238000004519 manufacturing process Methods 0.000 abstract description 9
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- 238000003860 storage Methods 0.000 abstract description 7
- 229940079593 drug Drugs 0.000 abstract description 4
- 238000002360 preparation method Methods 0.000 abstract description 4
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- 238000001704 evaporation Methods 0.000 abstract 1
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- 238000007689 inspection Methods 0.000 description 6
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- 238000012360 testing method Methods 0.000 description 4
- 238000001125 extrusion Methods 0.000 description 3
- 238000001802 infusion Methods 0.000 description 3
- 238000012946 outsourcing Methods 0.000 description 3
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- 239000008280 blood Substances 0.000 description 2
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- 238000009489 vacuum treatment Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000012864 cross contamination Methods 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
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Abstract
本发明涉及大容量注射剂生产领域，提供了一种大容量注射剂的双层无菌包装、包装方法及无菌检测方法。其中包装包括内包装袋，和包裹在内包装袋外侧的外包装袋；对所述内包装袋和外包装袋之间进行抽真空处理，得到外包装袋几乎贴合在所述内包装袋上；所述内、外包装袋之间无菌。本发明增强了包装袋的机械性能和水汽阻隔性能，解决了运输或储存过程中，包装渗漏或者水汽蒸发导致的产品污染和用药安全隐患问题。除此之外，对抽真空后的到的包装袋进行灭菌处理，在产品内包装袋内的药液无菌的同时，也保证了内包装袋和外包装袋之间也无菌。由此，产品在进入临床配剂与使用等无菌要求较高的环境时，只需脱去外包装袋即可，无需再经医护人员逐个消毒。The invention relates to the field of large-capacity injection production, and provides double-layer aseptic packaging, a packaging method and a sterility detection method for large-volume injections. Wherein the packaging includes an inner packaging bag, and an outer packaging bag wrapped outside the inner packaging bag; vacuumizing is carried out between the inner packaging bag and the outer packaging bag, so that the outer packaging bag is almost attached to the inner packaging bag ; Aseptic between the inner and outer packaging bags. The invention enhances the mechanical performance and water vapor barrier performance of the packaging bag, and solves the problems of product pollution and drug safety hazards caused by packaging leakage or water vapor evaporation during transportation or storage. In addition, the packaging bag after vacuuming is sterilized. While the medicinal solution in the product inner packaging bag is sterile, it also ensures that the space between the inner packaging bag and the outer packaging bag is also sterile. As a result, when the product enters an environment with high aseptic requirements such as clinical preparation and use, it only needs to take off the outer packaging bag, and there is no need to be sterilized by medical staff one by one.
Description
技术领域technical field
本发明涉及大容量注射剂生产领域，尤其涉及一种大容量注射剂的双层无菌包装、包装方法及无菌检测方法。The invention relates to the field of production of large-capacity injections, in particular to a double-layer aseptic packaging of large-volume injections, a packaging method and a sterility detection method.
背景技术Background technique
在大容量注射剂生产领域，经过吹塑、热严密封口等工艺制造而成的多层共挤膜软袋和直立式软袋等塑料包装形式，由于存在不用回气管和不产生回血，且可减少临床交叉污染等优势，被大量使用。但是有利有弊，为了保障不需要用回气管和不产生回血，上述形式的包装均比较薄、软，由此不仅导致其机械冲击性能力差，易出现渗漏；而且使得水汽透性大，产品在储存期间药的浓度升高。更值得警惕的是，上述形式的包装若出现微渗漏，则很难被检测出，于是将引发更严重的用药安全隐患问题。In the field of large-capacity injection production, plastic packaging forms such as multi-layer co-extruded film soft bags and stand-up soft bags manufactured through blow molding and heat-tight sealing processes can reduce air return pipes and produce no blood return. Advantages such as clinical cross-contamination are widely used. However, there are advantages and disadvantages. In order to ensure that there is no need to use a return air tube and no return of blood, the above-mentioned packaging is relatively thin and soft, which not only leads to poor mechanical impact performance and is prone to leakage; it also makes the water vapor permeability large. The concentration of the drug increases during storage of the product. What is more worthy of vigilance is that if micro-leakage occurs in the above-mentioned packaging, it will be difficult to be detected, which will lead to more serious hidden dangers of medication safety.
进一步地，现有多层共挤膜软袋和直立式软袋等形式的包装，其无菌保证水平差，在临床配剂和输液等无菌要求较高的环节使用前，须经医护人员逐袋进行局部或者全面消毒。此消毒过程不仅耗费医护人员的时间，给其带来极大的麻烦，而且可能会存在消毒不到位的问题。Furthermore, the existing multi-layer co-extrusion film soft bags and stand-up soft bags have poor sterility assurance levels, and must be approved by medical staff before use in clinical dispensing and infusion, etc. Carry out partial or comprehensive disinfection bag by bag. This disinfection process not only consumes the time of medical staff and brings them great trouble, but also may have the problem of insufficient disinfection.
发明内容Contents of the invention
(一)要解决的技术问题(1) Technical problems to be solved
本发明要解决的技术问题就是如何提供一种大容量注射剂的包装形式，解决现有大容量注射剂生产领域的塑料包装存在的问题。The technical problem to be solved by the present invention is how to provide a packaging form of large-capacity injections, so as to solve the problems existing in the plastic packaging in the field of production of large-volume injections.
(二)技术方案(2) Technical solution
为了解决上述技术问题，本发明提供了一种大容量注射剂的双层无菌包装，其特征在于，包括内包装袋，和包裹在所述内包装袋外侧的外包装袋；In order to solve the above technical problems, the present invention provides a double-layer aseptic packaging for large-capacity injections, which is characterized in that it includes an inner packaging bag and an outer packaging bag wrapped outside the inner packaging bag;
所述内包装袋和所述外包装袋之间进行抽真空处理，得到外包装袋几乎无缝贴合在所述内包装袋上；vacuumize between the inner packaging bag and the outer packaging bag, so that the outer packaging bag is almost seamlessly attached to the inner packaging bag;
所述内包装与所述外包装袋之间无菌。There is asepsis between the inner packaging and the outer packaging bag.
优选地，在所述内包装袋和所述外包装袋之间有少量的注射用水或纯化水。Preferably, there is a small amount of water for injection or purified water between the inner packaging bag and the outer packaging bag.
优选地，所述注射用水或纯化水的用量为0.01ml-5mlPreferably, the dosage of said water for injection or purified water is 0.01ml-5ml
优选地，所述内包装袋为多层共挤膜软袋、直立式软袋、或聚丙烯瓶。Preferably, the inner packaging bag is a multi-layer co-extruded film soft bag, a stand-up soft bag, or a polypropylene bottle.
优选地，所述外包装为PET膜袋或CPP膜袋。Preferably, the outer packaging is a PET film bag or a CPP film bag.
本发明还提供一种应用大容量注射剂的包装方法，包含以下步骤：The present invention also provides a packaging method using a large-capacity injection, comprising the following steps:
步骤一：将药液灌装入内包装袋，并完成封口；Step 1: Fill the liquid medicine into the inner packaging bag and complete the sealing;
步骤二：将经灌装封口后的内包装袋，装入外包装袋中，抽真空后将外包装袋封口，然后送灭菌；Step 2: Put the filled and sealed inner packaging bag into the outer packaging bag, seal the outer packaging bag after vacuuming, and then send it for sterilization;
步骤三：进行产品、内包装袋、外包装袋一体灭菌。Step 3: Sterilize the product, inner packaging bag and outer packaging bag together.
优选地，在将所述经灌装封口后的内包装袋装入外包装袋中之后，进行抽真空之前，向内包装袋和外包装袋加入注射用水。Preferably, after putting the filled and sealed inner packaging bag into the outer packaging bag and before vacuumizing, add water for injection into the inner packaging bag and the outer packaging bag.
本发明还提供一种针对大容量注射剂的双层无菌包装进行无菌检测的方法，其特征在于，包含以下步骤：The present invention also provides a method for aseptic detection of double-layer aseptic packaging for large-capacity injections, which is characterized in that it comprises the following steps:
步骤一：对所述大容量注射剂的双层无菌包装的无菌培养基注入部位进行擦拭消毒；Step 1: Wipe and disinfect the injection site of the sterile medium in the double-layer aseptic packaging of the large-capacity injection;
步骤二：在止血钳的两夹头上分别套上一只消毒后的适宜乳胶管后待用；Step 2: Put a suitable sterilized latex tube on the two chucks of the hemostatic forceps and set aside for use;
步骤三：在消毒部位，用无菌剪刀剪开一个的小口；Step 3: At the disinfection site, use sterile scissors to cut a small opening;
步骤四：将集菌过滤器的针头小心插入内包装袋与外包装袋之间，用准备好的止血钳两夹头夹住针管和小口进行密封；Step 4: Carefully insert the needle of the bacteria-collecting filter between the inner packaging bag and the outer packaging bag, and use the prepared hemostatic forceps to clamp the needle tube and the small opening to seal;
步骤五：开启集菌仪将适宜的无菌培养基注入内包装袋与外包装袋之间；Step 5: Turn on the bacteria collector and inject suitable sterile medium between the inner packaging bag and the outer packaging bag;
步骤六：拔出集菌过滤器的针头，用封口机将小口严密封口；Step 6: Pull out the needle of the bacteria-collecting filter, and seal the small opening tightly with a sealing machine;
步骤七：将封口后的包装移至规定的恒温培养室培养。Step 7: Move the sealed package to a specified constant temperature culture room for cultivation.
优选地，所述小口的尺寸为0.5-3mm。Preferably, the size of the small opening is 0.5-3mm.
(三)有益效果(3) Beneficial effects
本发明的一种大容量注射剂的双层无菌包装，在内包装袋外侧包裹一层具有优良的机械冲击性、水气阻隔性、耐低温性和化学稳定性的外包装袋，从而增强产品在生产、装卸、储运及使用各环节的抗外部机械冲击性和挤压能力；与此同时，提高产品水汽阻隔性能。在内包装袋和外包装袋之间进行真空吸塑后，一旦内包装袋渗漏，内包装袋和外包装袋间真空度下降甚至丧失，就会出现人眼易识别的胀袋。基于上述原理，本发明的技术方案提高了储运环节产品渗漏检出的几率，可以有效防止已经渗漏产品污染其它产品，提高输液和用药安全。除此以外，对抽真空后得到的包装袋进行灭菌处理，在产品内包装袋内的药液无菌的同时，也保证了内包装袋和外包装袋之间也无菌。由此，产品在进入临床配剂与使用等无菌要求较高的环境时，只需脱去外包装袋即可，无需再经医护人员逐个消毒。In the double-layer aseptic packaging of a large-capacity injection of the present invention, an outer packaging bag with excellent mechanical impact, water vapor barrier, low temperature resistance and chemical stability is wrapped outside the inner packaging bag, thereby enhancing the product External mechanical impact resistance and extrusion capacity in production, loading and unloading, storage, transportation and use; at the same time, improve the water vapor barrier performance of the product. After the vacuum blister is carried out between the inner packaging bag and the outer packaging bag, once the inner packaging bag leaks, the vacuum degree between the inner packaging bag and the outer packaging bag drops or even loses, and a bulging bag that is easily recognized by the human eye will appear. Based on the above principles, the technical solution of the present invention increases the probability of product leakage detection in the storage and transportation link, can effectively prevent the leaked product from contaminating other products, and improve the safety of infusion and medication. In addition, the packaging bag obtained after vacuuming is sterilized to ensure the sterility between the inner packaging bag and the outer packaging bag while the medicinal solution in the inner packaging bag of the product is sterile. As a result, when the product enters an environment with high aseptic requirements such as clinical preparation and use, it only needs to take off the outer packaging bag, and there is no need to be sterilized by medical staff one by one.
本发明的一种大容量注射剂的包装方法，突破传统“灌装——灭菌——套外包装袋”的工艺限制，打破传统外包装袋仅起一般防尘作用的思想束缚，采用抽真空技术，使外包装袋成为包装袋本身一部分，增强包装袋的机械性能；进一步的，将包装过程改为“灌装——套外包装袋——真空处理——灭菌”，使产品的在保证内包装内部药液无菌的同时，内外包装之间也无菌；在进入临床配剂与使用等无菌要求较高的环境时，脱去外层包装即可，无需再经医护人员逐个消毒，从而提高了产品无菌保证水平、减少污染机会。The packaging method of a large-capacity injection of the present invention breaks through the traditional process limitation of "filling-sterilization-covering the outer packaging bag", breaks the ideological shackles of the traditional outer packaging bag only for general dustproof function, and adopts vacuum pumping technology, making the outer packaging bag a part of the packaging bag itself, and enhancing the mechanical properties of the packaging bag; further, changing the packaging process to "filling-outer packaging bag-vacuum treatment-sterilization" to make the product While ensuring the sterility of the inner medicine liquid in the inner packaging, the inner and outer packaging are also sterile; when entering an environment with high aseptic requirements such as clinical formulation and use, the outer packaging can be removed, and there is no need to go through medical staff one by one. Disinfection, thereby improving the level of product sterility assurance and reducing the chance of contamination.
本发明的一种大容量注射剂的双层无菌包装的无菌检测方法，采用直接将无菌培养基注入内外袋之间培养的方法进行无菌检查，排除了外环境对无菌检测的干扰。The sterility detection method of the double-layer aseptic packaging of large-capacity injections of the present invention adopts the method of directly injecting the sterile medium into the inner and outer bags to cultivate the sterility inspection, and eliminates the interference of the external environment on the sterility detection .
具体实施方式Detailed ways
下面对本发明的实施方式作进一步详细描述。以下实施例用于说明本发明，但不能用来限制本发明的范围。Embodiments of the present invention will be further described in detail below. The following examples are used to illustrate the present invention, but should not be used to limit the scope of the present invention.
实施例一Embodiment one
本实施例提供一种大容量注射剂的双层无菌包装，在内包装袋之外侧包裹一层具有优良的机械冲击性、水气阻隔性、耐低温性和化学稳定性的外包装袋，所述外包装袋可以优先但不局限于采用高阻隔塑料包装袋。所述内包装袋和所述外包装袋进行抽真空处理，得到外包装袋无缝贴合在所述内包装袋上，从而使得外包装袋也成为包装袋本身一部分，增强产品在生产、装卸、储运及使用各环节的抗外部机械冲击性和挤压能力，而不仅仅起到防尘的作用。This embodiment provides a double-layer aseptic packaging of a large-capacity injection, and an outer packaging bag with excellent mechanical shock resistance, moisture barrier property, low temperature resistance and chemical stability is wrapped outside the inner packaging bag. The above-mentioned outer packaging bags can be preferentially but not limited to high-barrier plastic packaging bags. The inner packaging bag and the outer packaging bag are subjected to vacuum treatment, so that the outer packaging bag is seamlessly attached to the inner packaging bag, so that the outer packaging bag also becomes a part of the packaging bag itself, and the process of product production, loading and unloading is enhanced. , storage, transportation and use of the external mechanical impact resistance and extrusion capacity, not just play a role in dust.
本方案中，内包装袋可以使用现有技术中的任意一项大容量注射剂包装技术，但是优选为现在市场上比较成熟和完善的多层共挤膜软袋、直立式软袋或聚丙烯瓶。外包装袋为了满足抗压、抗冲击、阻隔水气等特点，优选为PET膜袋或CPP膜袋或其他具有较高水气阻隔性能材料制成的膜袋。In this solution, the inner packaging bag can use any large-capacity injection packaging technology in the prior art, but it is preferably a mature and perfect multi-layer co-extruded film soft bag, stand-up soft bag or polypropylene bottle in the market . In order to meet the characteristics of compression resistance, impact resistance, and water vapor barrier, the outer packaging bag is preferably a PET film bag or a CPP film bag or a film bag made of other materials with high water vapor barrier properties.
本方案中，优选在所述内包装袋和所述外包装袋之间加入注射用水。从而在后期灭菌时实现湿热灭菌，提高灭菌效果。In this solution, it is preferable to add water for injection between the inner packaging bag and the outer packaging bag. In this way, moist heat sterilization can be realized in the later stage of sterilization, and the sterilization effect can be improved.
本方案中，对所述大容量注射剂的双层无菌包装进行产品、内、外包装袋一体灭菌，实现塑料包装的容量注射剂双层包装之间无菌的包装形式。在进入医院临床配剂、输液及手术室等无菌要求较高的环节时，只需脱去外层包装，无需再经医护人员逐个产品进行局部或全面消毒，即可获得更好的无菌保证。从而提高了产品无菌保证水平。In this solution, the product, inner and outer packaging bags are sterilized as a whole for the double-layer aseptic packaging of the large-capacity injection, so as to realize the aseptic packaging form between the double-layer packaging of the plastic-packed injection. When entering the links with high aseptic requirements such as clinical dispensing, infusion and operating room in the hospital, you only need to take off the outer packaging, and you don’t need to be partially or completely disinfected by medical staff one by one to obtain better sterility. ensure. Thereby improving the level of product sterility assurance.
实施例二Embodiment two
本实施例提供一种采用实施例一所述的双层无菌包装进行包装的方法。典型的药液生产到运输过程依次包括：配制——过滤——灌装——灭菌——灯检——外包袋——装箱——入库——检测——放行。由此可知，从药液生产完到药液进入市场流通中，包装工艺只是整个过程的一部分，但是却与其他的工艺都息息相关，因此本方案结合所述药液的“配制到放行”整个过程对包装方法进行阐述。This embodiment provides a packaging method using the double-layer aseptic packaging described in Embodiment 1. The typical liquid medicine production to transportation process includes: preparation—filtration—filling—sterilization—light inspection—outsourcing bag—boxing—storage—testing—release. It can be seen from this that the packaging process is only a part of the whole process from the production of the liquid medicine to the circulation of the liquid medicine in the market, but it is closely related to other processes. Therefore, this scheme combines the whole process of "preparation to release" of the liquid medicine Describe the packaging method.
本方案中，从药液生产到运输的过程依次包括：配制——过滤——灌装——外包袋——真空处理——灭菌——灯检——装箱——入库——检测——放行，具体地工艺条件如下：In this plan, the process from liquid medicine production to transportation includes: preparation—filtration—filling—outsourcing bag—vacuum treatment—sterilization—light inspection—packing—storage—inspection —— Release, the specific process conditions are as follows:
配制：在C级环境下完成，并将检测合格后的药液泵入过滤系统；Preparation: Completed in a C-level environment, and pump the qualified liquid medicine into the filtration system;
过滤：药液经过密封的管道进入过滤系统，依次完成粗滤——保护性滤——除菌过滤，然后直接供灌装；Filtration: The medicinal liquid enters the filtration system through the sealed pipeline, completes coarse filtration-protective filtration-sterilization filtration in sequence, and then directly supplies for filling;
灌装：在C环境下的局部A级环境内，将药液灌装入在C级环境下制成的洁净内包装袋中，并完成封口；Filling: In the local A-level environment under the C environment, fill the liquid medicine into the clean inner packaging bag made under the C-level environment, and complete the sealing;
外包袋：经灌装封口后的内包装袋，出灌装后直接装入具有优良的耐机械冲击性、水气阻隔性、耐低温性、化学稳定性的外包装袋中；Outer packaging bag: the inner packaging bag after filling and sealing is directly packed into the outer packaging bag with excellent mechanical shock resistance, moisture barrier property, low temperature resistance and chemical stability after filling;
真空处理：对内包装袋和外包装袋之间进行抽真空，然后外包装袋封口后送灭菌；Vacuum treatment: vacuumize the space between the inner packaging bag and the outer packaging bag, then seal the outer packaging bag and send it for sterilization;
灭菌：按照产品注册工艺要求，一般为115℃环境下，进行30分钟以上蒸汽水浴灭菌后，送入灯检；Sterilization: According to the product registration process requirements, generally at 115°C, after sterilizing in a steam water bath for more than 30 minutes, send it to the lamp inspection;
灯检、装箱、入库：逐袋检查外观与可见异物，合格的按上市规格装箱后入库；Light inspection, boxing, and storage: check the appearance and visible foreign matter bag by bag, and pack the qualified ones according to the listing specifications before putting them into storage;
检测、放行：出厂放行前，除了按照《中国药典》标准进行检验外，还须按照本发明提供的检测方法，进行内、外包装袋之间的无菌检测。Detection and release: Before release from the factory, in addition to the inspection according to the "Chinese Pharmacopoeia" standard, the sterility test between the inner and outer packaging bags must also be carried out according to the detection method provided by the present invention.
显而易见地，本方案中，先对灌装封口后的内包装袋套外包装袋，然后对内包装袋和外包装袋之间抽真空，最后进行产品、内包装袋、外包装袋一体灭菌。采用与以上步骤，在实现内袋内药品无菌的同时，保证内包装袋与外包装袋之间无菌。Obviously, in this solution, first cover the inner packaging bag after filling and sealing with the outer packaging bag, then vacuumize the space between the inner packaging bag and the outer packaging bag, and finally sterilize the product, the inner packaging bag, and the outer packaging bag . By adopting the above steps, while realizing the sterility of the medicine in the inner bag, the sterility between the inner packaging bag and the outer packaging bag is ensured.
需要注意的是，本方案中“配置——过滤”和“灯检——装箱——入库——检测——放行”这些处理都和传统技术中处理方式和原理一样，出现在本实施中仅仅是为了便于理解“一种双层无菌包装进行包装的方法”的前因后果，而不应当视为对本方案的限制。另外本方案中“灌装——外包袋——真空处理——灭菌”的工艺条件也只是本方案的优选而非必要条件。It should be noted that the processing methods and principles of "configuration-filtering" and "light inspection-packing-storage-inspection-release" in this solution are the same as those in the traditional technology, and appear in this implementation The above is only for the convenience of understanding the ins and outs of "a double-layer aseptic packaging method for packaging", and should not be regarded as a limitation of this scheme. In addition, the process conditions of "filling-outsourcing bag-vacuum treatment-sterilization" in this scheme are only the preferred but not necessary conditions of this scheme.
实施例三Embodiment Three
本实施例提供一种大容量注射剂的双层无菌包装的无菌检测方法，包含以下步骤：This embodiment provides a method for aseptic detection of double-layer aseptic packaging of large-capacity injections, comprising the following steps:
步骤一：将药液灌装入内包装袋，并完成封口；Step 1: Fill the liquid medicine into the inner packaging bag and complete the sealing;
步骤二：将经灌装封口后的内包装袋，装入外包装袋中，抽真空后将外包装袋封口，然后送灭菌；Step 2: Put the filled and sealed inner packaging bag into the outer packaging bag, seal the outer packaging bag after vacuuming, and then send it for sterilization;
步骤三：进行产品、内包装袋、外包装袋一体灭菌。Step 3: Sterilize the product, inner packaging bag and outer packaging bag together.
本方案中，在将所述经灌装封口后的内包装袋装入外包装袋中之后，进行抽真空之前，向内包装袋和外包装袋加入注射用水或纯化水。注射用水或纯化用水当然要适量，例如0.01ml到5ml之间一般是可以的。加入注射用水的目的是为了进行湿热灭菌，以提高灭菌效果。In this solution, after the filled and sealed inner packaging bag is loaded into the outer packaging bag and before vacuuming, water for injection or purified water is added to the inner packaging bag and the outer packaging bag. Of course, water for injection or purified water should be used in an appropriate amount, for example, between 0.01ml and 5ml is generally acceptable. The purpose of adding water for injection is to carry out moist heat sterilization to improve the sterilization effect.
本发明还提供一种针对大容量注射剂的双层无菌包装进行无菌检测的方法，其特征在于，包含以下步骤：The present invention also provides a method for aseptic detection of double-layer aseptic packaging for large-capacity injections, which is characterized in that it comprises the following steps:
步骤一：对所述大容量注射剂的双层无菌包装的无菌培养基注入部位进行擦拭消毒；Step 1: Wipe and disinfect the injection site of the sterile medium in the double-layer aseptic packaging of the large-capacity injection;
步骤二：在止血钳的两夹头上分别套上一只消毒后的适宜乳胶管后待用；Step 2: Put a suitable sterilized latex tube on the two chucks of the hemostatic forceps and set aside for use;
步骤三：在消毒部位，用无菌剪刀剪开1mm的小口；Step 3: Cut a small opening of 1 mm with sterile scissors at the disinfection site;
步骤四：将集菌过滤器的针头小心插入内包装袋与外包装袋之间，用准备好的止血钳两夹头夹住针管和剪开的小口进行密封；Step 4: Carefully insert the needle of the bacteria-collecting filter between the inner packaging bag and the outer packaging bag, and use the prepared two clamps of the hemostatic forceps to clamp the needle tube and the cut opening to seal;
步骤五：开启集菌仪将适宜的无菌培养基注入内包装袋与外包装袋之间；Step 5: Turn on the bacteria collector and inject suitable sterile medium between the inner packaging bag and the outer packaging bag;
步骤六：拔出集菌过滤器的针头，用封口机将1mm的小口严密封口；Step 6: Pull out the needle of the bacteria-collecting filter, and seal the 1mm small opening tightly with a sealing machine;
步骤七：将封口后的包装移至规定的恒温培养室培养。Step 7: Move the sealed package to a specified constant temperature culture room for cultivation.
本方案采用直接将无菌培养基注入内外袋之间培养的方法进行无菌检查，排除了外环境对无菌检测的干扰。This program adopts the method of directly injecting the sterile medium into the inner and outer bags to cultivate the sterility test, which eliminates the interference of the external environment on the sterility test.
本实施例中消毒部位的开口并不一定要是1mm，可以是一定范围内的任意值，这里的范围也没有特殊限定，优选为0.5-3mm。In this embodiment, the opening of the disinfection site does not have to be 1 mm, but can be any value within a certain range, and the range here is not particularly limited, and is preferably 0.5-3 mm.
以上实施方式仅用于说明本发明，而非对本发明的限制。尽管参照实施例对本发明进行了详细说明，本领域的普通技术人员应当理解，对本发明的技术方案进行各种组合、修改或者等同替换，都不脱离本发明技术方案的精神和范围，均应涵盖在本发明的权利要求范围当中。The above embodiments are only used to illustrate the present invention, but not to limit the present invention. Although the present invention has been described in detail with reference to the embodiments, those skilled in the art should understand that various combinations, modifications or equivalent replacements of the technical solutions of the present invention do not depart from the spirit and scope of the technical solutions of the present invention, and all should cover Within the scope of the claims of the present invention.
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