CN104434517A - Double-layer aseptic package, packaging method and sterility test method for large volume injections - Google Patents
Double-layer aseptic package, packaging method and sterility test method for large volume injections Download PDFInfo
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- CN104434517A CN104434517A CN201410531725.3A CN201410531725A CN104434517A CN 104434517 A CN104434517 A CN 104434517A CN 201410531725 A CN201410531725 A CN 201410531725A CN 104434517 A CN104434517 A CN 104434517A
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Abstract
The invention relates to the field of production of large volume injections, and provides a double-layer aseptic package, packaging method and sterility test method for large volume injections. The package comprises an inner packaging bag and an outer packaging bag wrapping the inner packaging bag. The space between the inner packaging bag and the outer packaging bag is vacuumized, so that the outer packaging bag is nearly attached to the inner packaging bag, and the space between the inner packaging bag and the outer packaging bag is aseptic. The mechanical performance and moisture blocking performance of the packaging bags are enhanced, and the problems of product pollution and medical potential safety hazard caused when packages leak or moisture evaporates in the transportation or storage process are solved. Besides, the vacuumized packaging bags are subjected to sterilization, liquid medicine in the inner packaging bag of the package is aseptic, and meanwhile the space between the inner packaging bag and the outer packaging bag is also aseptic. Thus, when the package is applied to the environment like clinical dispensing having high aseptic requirements, it is only required that the outer packaging bag is taken off, and medical staff do not need to disinfect packages one by one.
Description
Technical field
The present invention relates to bulk capacity injection production field, particularly relate to a kind of double-layer sterile packaging of bulk capacity injection, packing method and sterile detection method.
Background technology
At bulk capacity injection production field, through plastics package forms such as the multi-layer co-extruded film soft bag of the manufacture technics such as blowing, the tight sealing of heat and upright flexible bags, owing to existing without muffler and not producing blood back, and can the advantages such as clinical cross-contamination be reduced, be widely used.But both advantageous and disadvantageous, do not need with muffler to ensure and do not produce blood back, the packaging of above-mentioned form is all thinner, soft, not only causes its mechanical impact property's ability thus, easily occurs seepage; And making steam permeability large, the concentration of product medicine between the storage life raises.More vigilance should be maintained to the fact, if Micro blazed-grating appears in the packaging of above-mentioned form, be then difficult to be detected, so will more serious drug safety potential problem be caused.
Further, the packaging of the forms such as existing multi-layer co-extruded film soft bag and upright flexible bag, its sterility assurance level is poor, before the link that the sterility requirements such as clinical ingredients and transfusion are higher uses, must carry out local or pasteurised completely through medical personnel by bag.This disinfecting process not only expends the time of medical personnel, brings great trouble to it, and may there is sterilization problem not in place.
Summary of the invention
(1) technical problem that will solve
The technical problem to be solved in the present invention is exactly the packaged form how providing a kind of bulk capacity injection, solves the plastics package Problems existing of existing bulk capacity injection production field.
(2) technical scheme
In order to solve the problems of the technologies described above, the invention provides a kind of double-layer sterile packaging of bulk capacity injection, it is characterized in that, comprise packing inside bag, and be wrapped in the outer packaging bag outside described packing inside bag;
Carry out evacuation process between described packing inside bag and described outer packaging bag, obtain outer packaging bag almost seamless applying on described packing inside bag;
Aseptic between described inner packing and described outer packaging bag.
Preferably, between described packing inside bag and described outer packaging bag, a small amount of water for injection or purified water is had.
Preferably, the consumption of described water for injection or purified water is 0.01ml-5ml
Preferably, described packing inside bag is multi-layer co-extruded film soft bag, upright flexible bag or polypropylene vial.
Preferably, described outer package is PET film bag or CPP film bag.
The present invention also provides a kind of packing method applying bulk capacity injection, comprises following steps:
Step one: medicine liquid irrigation is loaded packing inside bag, and complete sealing;
Step 2: by the packing inside bag after filling and sealing, loads in outer packaging bag, is sealed by outer packaging bag, then send sterilizing after evacuation;
Step 3: carry out product, packing inside bag, the sterilizing of outer packaging bag one.
Preferably, after loading in outer packaging bag by described packing inside bag after filling and sealing, before carrying out evacuation, water for injection is added to packing inside bag and outer packaging bag.
The present invention also provides a kind of double-layer sterile for bulk capacity injection to pack the method for carrying out Sterility testing, it is characterized in that, comprises following steps:
Step one: cleaning disinfection is carried out to the aseptic culture medium injection position that the double-layer sterile of described bulk capacity injection is packed;
Step 2: stand-by after the suitable latex tubing on overlapping respectively on two chucks of mosquito forceps after a sterilization;
Step 3: at sterilization position, cut off the osculum of by sterile scissors;
Step 4: carefully inserted between packing inside bag and outer packaging bag by the syringe needle of bacteria gathering filter, seals by ready mosquito forceps two chuck grip needle cannula and osculum;
Step 5: open germ collector and suitable aseptic culture medium is injected between packing inside bag and outer packaging bag;
Step 6: the syringe needle extracting bacteria gathering filter, tightly seals osculum with sealing machine;
Step 7: the constant temperature culture room packaging after sealing being moved to regulation is cultivated.
Preferably, described osculum is of a size of 0.5-3mm.
(3) beneficial effect
The double-layer sterile packaging of a kind of bulk capacity injection of the present invention, outside packing inside bag, wrap up the outer packaging bag that one deck has excellent mechanical impact property, aqueous vapor barrier, lower temperature resistance and chemical stability, thus strengthen product producing, handling, accumulating and use anti-exterior mechanical impact and the extrusion capability of each link; Meanwhile, product water vapour locking separating performance is improved.Carry out vacuum forming between packing inside bag and outer packaging bag after, once packing inside bag seepage, between packing inside bag and outer packaging bag, vacuum decline is even lost, and just there will be the swollen bag that human eye is easy to identify.Based on above-mentioned principle, technical scheme of the present invention improves the probability that accumulating link product seepage detects, and effectively can prevent seepage contamination of products other products, improves transfusion and drug safety.In addition, sterilization treatment is carried out to the packaging bag obtained after evacuation, while the medicinal liquid in product packing inside bag is aseptic, also ensure that between packing inside bag and outer packaging bag also aseptic.Thus, product, when entering the higher environment of the sterility requirements such as clinical ingredients and use, only need slough outer packaging bag, without the need to sterilizing one by one through medical personnel again.
The packing method of a kind of bulk capacity injection of the present invention, break through the technique restriction of tradition " fill---sterilizing---cover outer packaging bag ", the outer packaging bag that breaks traditions only plays the thought binding of general dustproof effect, adopt vacuum pumping technology, make outer packaging bag become a packaging bag part itself, strengthen the mechanical performance of packaging bag; Further, packaging process is changed into " fill---cover outer packaging bag---application of vacuum---sterilizing ", make product while the inner medicinal liquid of guarantee inner packing is aseptic, also aseptic between exterior and interior packing; When entering the higher environment of the sterility requirements such as clinical ingredients and use, sloughing outer packaging, without the need to sterilizing one by one through medical personnel again, thus improve product sterility assurance level, decreasing pollution chance.
The sterile detection method of the double-layer sterile packaging of a kind of bulk capacity injection of the present invention, adopts the method for cultivating between outer bag in directly being injected by aseptic culture medium to carry out sterility test, eliminates the interference of external environment to Sterility testing.
Detailed description of the invention
Below embodiments of the present invention are described in further detail.Following examples for illustration of the present invention, but can not be used for limiting the scope of the invention.
Embodiment one
The present embodiment provides a kind of double-layer sterile of bulk capacity injection to pack, have the outer packaging bag of excellent mechanical impact property, aqueous vapor barrier, lower temperature resistance and chemical stability at the outside of packing inside bag parcel one deck, described outer packaging bag can preferentially but be not limited to employing high-barrier plastic packaging bag.Described packing inside bag and described outer packaging bag carry out evacuation process, obtain outer packaging bag seamless applying on described packing inside bag, thus make outer packaging bag also become a packaging bag part itself, strengthen product in production, handling, accumulating and the anti-exterior mechanical impact and the extrusion capability that use each link, and not only play dust-proof effect.
In this programme, packing inside bag can use any one bulk capacity injection packing technique of the prior art, but is preferably existing commercially comparative maturity and perfect multi-layer co-extruded film soft bag, upright flexible bag or polypropylene vial.Outer packaging bag, in order to meet the features such as resistance to compression, shock resistance, obstruct aqueous vapor, is preferably PET film bag or CPP film bag or other have the film bag that higher aqueous vapor barrier property material makes.
In this programme, preferably between described packing inside bag and described outer packaging bag, add water for injection.Thus realize moist heat sterilization when later stage sterilizing, improve sterilization effect.
In this programme, product, the sterilizing of inside and outside packaging bag one are carried out to the double-layer sterile packaging of described bulk capacity injection, realizes packaged form aseptic between plastics packed volume injection agent double casing.When entering the higher link of the sterility requirements such as hospital clinical ingredients, transfusion and operating room, only need slough outer packaging, without the need to again through medical personnel one by one product carry out local or pasteurised completely, better Sterility Assurance can be obtained.Thus improve product sterility assurance level.
Embodiment two
The present embodiment provides a kind of and adopts the double-layer sterile described in embodiment one to pack the method for carrying out packing.Typical medicinal liquid is produced transportation and comprised successively: preparation---filters---fill---sterilizing---lamp inspection---outer bag---vanning---warehouse-in---detection---clearance.It can thus be appreciated that, having produced medicinal liquid from medicinal liquid comes into the market circulation, technology of the package is a part for whole process, but but all closely bound up with other technique, and therefore this programme is set forth packing method in conjunction with " being formulated into clearance " whole process of described medicinal liquid.
In this programme, the process of producing transport from medicinal liquid comprises successively: preparation---filter---fill---outer bag---application of vacuum---sterilizing---lamp inspection---vanning---warehouse-in---detection---is let pass, and process conditions are as follows particularly:
Preparation: complete under C level environment, and the medicinal liquid after qualified for detection is pumped into filtration system;
Filter: medicinal liquid through sealing pipeline enter filtration system, complete coarse filtration successively---protectiveness filter---aseptic filtration, then directly supplies fill;
Fill: in the local A level environment under C environment, in the clean packing inside bag made under medicine liquid irrigation being enclosed in C level environment, and complete sealing;
Outer bag: the packing inside bag after filling and sealing, directly loads after going out fill and has in the outer packaging bag of excellent mechanical resistant impact, aqueous vapor barrier, lower temperature resistance, chemical stability;
Application of vacuum: carry out evacuation between packing inside bag and outer packaging bag, then send sterilizing after outer packaging bag sealing;
Sterilizing: according to equipment registration technological requirement, under being generally 115 DEG C of environment, after carrying out more than 30 minutes steam water-bath sterilizations, sends into lamp inspection;
Lamp inspection, vanning, warehouse-in: check outward appearance and visible foreign matters by bag, qualified presses the rear warehouse-in of listing specification vanning;
Detect, let pass: dispatch from the factory before letting pass, except testing according to " Chinese Pharmacopoeia " standard, also according to detection method provided by the invention, the Sterility testing between inside and outside packaging bag must be carried out.
Apparently, in this programme, first to the packing inside bag cover outer packaging bag after filling and sealing, then to evacuation between packing inside bag and outer packaging bag, finally carry out product, packing inside bag, the sterilizing of outer packaging bag one.Adopt and above step, while realizing medicine in inner bag and be aseptic, ensure between packing inside bag and outer packaging bag aseptic.
It should be noted that, in this programme, " configuration---filter " and " lamp inspection---vanning---warehouse-in---detection---clearance " these process are all the same with principle with processing mode in conventional art, appear in this enforcement the cause and effect being only used to be convenient to understand " a kind of double-layer sterile packaging carries out the method for packing ", and should not be considered as the restriction to this programme.In addition in this programme the process conditions of " fill---outer bag---application of vacuum---sterilizing " also just this programme preferably but not essential condition.
Embodiment three
The sterile detection method that the present embodiment provides a kind of double-layer sterile of bulk capacity injection to pack, comprises following steps:
Step one: medicine liquid irrigation is loaded packing inside bag, and complete sealing;
Step 2: by the packing inside bag after filling and sealing, loads in outer packaging bag, is sealed by outer packaging bag, then send sterilizing after evacuation;
Step 3: carry out product, packing inside bag, the sterilizing of outer packaging bag one.
In this programme, after loading in outer packaging bag by described packing inside bag after filling and sealing, before carrying out evacuation, add water for injection or purified water to packing inside bag and outer packaging bag.Water for injection or purification use water want appropriate certainly, such as, be generally fine between 0.01ml to 5ml.The object adding water for injection is to carry out moist heat sterilization, to improve sterilization effect.
The present invention also provides a kind of double-layer sterile for bulk capacity injection to pack the method for carrying out Sterility testing, it is characterized in that, comprises following steps:
Step one: cleaning disinfection is carried out to the aseptic culture medium injection position that the double-layer sterile of described bulk capacity injection is packed;
Step 2: stand-by after the suitable latex tubing on overlapping respectively on two chucks of mosquito forceps after a sterilization;
Step 3: at sterilization position, cut off the osculum of 1mm by sterile scissors;
Step 4: carefully inserted between packing inside bag and outer packaging bag by the syringe needle of bacteria gathering filter, seals by ready mosquito forceps two chuck grip needle cannula and the osculum cut off;
Step 5: open germ collector and suitable aseptic culture medium is injected between packing inside bag and outer packaging bag;
Step 6: the syringe needle extracting bacteria gathering filter, tightly seals with the osculum of sealing machine by 1mm;
Step 7: the constant temperature culture room packaging after sealing being moved to regulation is cultivated.
The method of cultivating between outer bag in this programme adopts and directly injected by aseptic culture medium carries out sterility test, eliminates the interference of external environment to Sterility testing.
If sterilize in the present embodiment, the opening at position might not 1mm, and can be the arbitrary value in certain limit, scope here be also not particularly limited, and is preferably 0.5-3mm.
Above embodiment is only for illustration of the present invention, but not limitation of the present invention.Although with reference to embodiment to invention has been detailed description, those of ordinary skill in the art is to be understood that, various combination, amendment or equivalent replacement are carried out to technical scheme of the present invention, do not depart from the spirit and scope of technical solution of the present invention, all should be encompassed in the middle of right of the present invention.
Claims (9)
1. the double-layer sterile packaging of a bulk capacity injection, is characterized in that, comprise packing inside bag, and be wrapped in the outer packaging bag outside described packing inside bag;
Evacuation process is carried out between described packing inside bag and described outer packaging bag;
Aseptic between described inner packing and described outer packaging bag.
2. the double-layer sterile packaging of bulk capacity injection according to claim 1, is characterized in that between described packing inside bag and described outer packaging bag, have water for injection or purified water.
3. the double-layer sterile packaging of bulk capacity injection according to claim 2, it is characterized in that, the consumption of described water for injection or purified water is 0.01ml-5ml.
4. the double-layer sterile packaging of bulk capacity injection according to claim 1, it is characterized in that, described packing inside bag is multi-layer co-extruded film soft bag, upright flexible bag or polypropylene vial.
5. the double-layer sterile packaging of bulk capacity injection according to claim 1, it is characterized in that, described outer package is PET film bag or CPP film bag.
6. a packing method for bulk capacity injection, is characterized in that, uses the double-layer sterile of the bulk capacity injection described in any one in claim 1 to 5 to pack, comprises following steps:
Step one: medicine liquid irrigation is loaded packing inside bag, and complete sealing;
Step 2: by the packing inside bag after filling and sealing, loads in outer packaging bag, is sealed by outer packaging bag, then send sterilizing after evacuation;
Step 3: carry out product, packing inside bag, the sterilizing of outer packaging bag one.
7. method according to claim 6, is characterized in that, after loading in outer packaging bag by described packing inside bag after filling and sealing, before carrying out evacuation, adds water for injection to packing inside bag and outer packaging bag.
8. the double-layer sterile packaging of bulk capacity injection as claimed in any of claims 1 to 7 carries out the method for Sterility testing, it is characterized in that, comprises following steps:
Step one: cleaning disinfection is carried out to the aseptic culture medium injection position that the double-layer sterile of described bulk capacity injection is packed;
Step 2: stand-by after the suitable latex tubing after two chucks of mosquito forceps overlap a sterilization respectively;
Step 3: at sterilization position, cut off an osculum by sterile scissors;
Step 4: carefully inserted between packing inside bag and outer packaging bag by the syringe needle of bacteria gathering filter, seals by ready mosquito forceps two chuck grip needle cannula and osculum;
Step 5: open germ collector and suitable aseptic culture medium is injected between packing inside bag and outer packaging bag;
Step 6: the syringe needle extracting bacteria gathering filter, tightly seals osculum with sealing machine;
Step 7: the constant temperature culture room packaging after sealing being moved to regulation is cultivated.
9. method according to claim 8, is characterized in that, described osculum is of a size of 0.5-3mm.
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| CN201410531725.3A CN104434517A (en) | 2014-10-10 | 2014-10-10 | Double-layer aseptic package, packaging method and sterility test method for large volume injections |
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| CN201410531725.3A CN104434517A (en) | 2014-10-10 | 2014-10-10 | Double-layer aseptic package, packaging method and sterility test method for large volume injections |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104800076A (en) * | 2015-04-24 | 2015-07-29 | 安徽双鹤药业有限责任公司 | Novel outer bag for infusing liquid medicine |
| CN111392138A (en) * | 2020-03-31 | 2020-07-10 | 连云港佑源医药设备制造有限公司 | Sterilization packaging method for plastic packaging food |
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| CN202052023U (en) * | 2011-02-24 | 2011-11-30 | 四川沱牌药业有限责任公司 | Positive pressure leak detection high-capacity soft bag infusion |
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| CN201020020Y (en) * | 2007-04-29 | 2008-02-13 | 山东新华鲁抗医药经贸有限公司 | Double-bag vacuum-packing disposable transfusion soft bag |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104800076A (en) * | 2015-04-24 | 2015-07-29 | 安徽双鹤药业有限责任公司 | Novel outer bag for infusing liquid medicine |
| CN111392138A (en) * | 2020-03-31 | 2020-07-10 | 连云港佑源医药设备制造有限公司 | Sterilization packaging method for plastic packaging food |
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Application publication date: 20150325 |