CN208516310U - The system that the sterile material of aseptic packaging is transferred to gnotobasis from ambient non-sterile - Google Patents

Abstract

The utility model discloses the systems that a kind of sterile material of aseptic packaging is transferred to gnotobasis from ambient non-sterile, and the system comprises RABs and the isolator adjacent with RABs；The laminar flow hood of the RABs provides A grades of one-way flows, and the front end of the RABs is equipped with a material pass-through box, and there is a waste discharge mouth in the side of the RABs, and there are a rat hole in the RABs and the isolator junction；The laminar flow hood of the isolator provides A grades of one-way flows.The system of the utility model is suitable for carry out the sterile transfer of the material of moist heat sterilization；It can carry out continuous sterile transfer；The sterile transfer of single is time-consuming short.

Description

The system that the sterile material of aseptic packaging is transferred to gnotobasis from ambient non-sterile

Technical field

The utility model relates to sterile transfer techniques fields, specifically a kind of to be applied to the row such as pharmacy, biology, food The sterile material of the aseptic packaging of industry is transferred to the system and method for gnotobasis from ambient non-sterile.

Background technique

Currently, the sterile transfer techniques that domestic pharmacy and biological industry use mainly include RTP (Rapid Transfer Ports) fast transfer technology and VHP purification techniques.There are some for fast transfer technology by RTP (Rapid Transfer Ports) Defect: 1) it can not be suitable for do not can be carried out the sterile transfer of the material of moist heat sterilization；2) time-consuming for single sterilizing；3) for some It needs to do the product being thoroughly dried after sterilization, it is difficult to which guarantee is accomplished to be completely dried；4) can not carry out continuous material without Bacterium transfer.One VHP chamber is connected by VHP purification techniques with sterile production region, and the material of aseptic packaging is placed in VHP chamber, After the completion of purification, the two is communicated, and is transferred the material into sterile production region.Defect existing for such method is as follows: 1) one The VHP period takes a long time；2) VHP chamber involves great expense；3) material has hydrogen peroxide infiltration and remaining risk.

Utility model content

In place of solving above-mentioned the deficiencies in the prior art, the purpose of this utility model is to provide a kind of aseptic packagings Material is transferred to the system and method for gnotobasis from ambient non-sterile, to realize continuous sterile transfer.

One side according to the present utility model, the utility model provide the sterile material of aseptic packaging a kind of from non-sterile The system that environment is transferred to gnotobasis, the system comprises RABs and the isolator adjacent with RABs；The laminar flow of the RABs Cover provides A grades of one-way flows, and the front end of the RABs is equipped with a material pass-through box, and there is a waste discharge in the side of the RABs Mouthful, there are a rat hole in the RABs and the isolator junction；The laminar flow hood of the isolator provides A grades of one-way flows.

In the technical solution of system described in the utility model, it is preferable that the pressure in the isolator is greater than described Pressure in RABs, and pressure difference is not less than 17.5Pa.

In the technical solution of system described in the utility model, it is preferable that the pressure in the isolator is opened in rat hole When greater than the pressure in the RABs, and pressure difference is not less than 17.5Pa.

In the technical solution of system described in the utility model, it is preferable that the isolator is VHP purification before work Isolator, so that the inside of the isolator is in gnotobasis.

In the technical solution of system described in the utility model, it is preferable that the clean area that the RABs and isolator are placed Rank is not less than C grades.Here, the C grades of clean areas for referring to the lower operating procedure of significance level in aseptic medicine production process.Specifically Standard is as follows: suspended particles maximum allowable number/cubic meter: static conditions: >=0.5 μm, 352000；>=5 μm, 2900；It is dynamic State condition: >=0.5 μm, 3520000；>=5 μm, 29000." pharmaceutical production quality management practices (2010 is derived from above Revision) " aseptic medicine annex.

In the technical solution of system described in the utility model, it is preferable that described the system also includes being separately positioned on A wind speed measurement in RABs and the isolator is popped one's head in.

Another aspect according to the present utility model, the utility model provide it is a kind of using the system by aseptic packaging Sterile material is transferred to the sterile transfer method of gnotobasis from ambient non-sterile, and the sterile transfer method includes following step It is rapid: 1) to be transmitted to the sterile material with one layer of aseptic packaging in the RABs by the material pass-through box of the front end of RABs； 2) sterile material with one layer of aseptic packaging is passed to the designated position in the RABs；3) there is one layer of aseptic packaging Sterile material carries out self-cleaning under A grades of one-way flows；4) after the completion of self-cleaning, the outer of side adjacent with rat hole is opened in fixed outer packing The opening of packaging, 5) sterile material in bag is automatically transferred in the isolator；And 6) discarded housing material is led to The waste discharge oral instructions for crossing the side RABs are handed to except the RABs.

In the technical solution of sterile transfer method described in the utility model, it is preferable that before self-cleaning, the aseptic packaging Outer surface can be carried out disinfection using disinfectant.

In the technical solution of sterile transfer method described in the utility model, it is preferable that the aseptic packaging without fungus Material has at least one layer of sterile outer packing.

In the technical solution of sterile transfer method described in the utility model, self-cleaning, the list are carried out under A grades of one-way flows It is the one-way flow of 0.45m/s ± 20% vertically downward to the speed of stream.And the speed of the one-way flow is always by wind in oRABs Speed probe 207 is monitored.Once equipment is alarmed immediately it was found that speed exceeds the range of 0.45m/s ± 20%.

In addition, when the designated position is less than 10cm apart from rat hole II 211, the outer packing of fixed sterile material.

The utility model has the advantages that the sterile transfer for 1) being suitable for carry out the material of moist heat sterilization； 2) continuous sterile transfer can be carried out；3) the sterile transfer of single is time-consuming short.

Detailed description of the invention

Fig. 1 shows the systems that the sterile material of one layer of aseptic packaging is transferred to gnotobasis from ambient non-sterile；

Fig. 2 indicates the system that the sterile material of three layers of aseptic packaging is transferred to gnotobasis from ambient non-sterile.

Description of symbols:

101-RABs, 102- wind speed measurement probe, the front end 103-RABs material pass-through box, 104- waste discharge mouth, The sterile material of mono- layer of 105- packaging, 106-A grades of one-way flows, 107- isolator, 108- wind speed measurement probe, 109- rat hole, 110-A grades of one-way flows, tri- layers of 201- packaging sterile materials, 202-oRABs, 203- material pass-through box, two layers of 204- packaging Sterile material, 205- rat hole I, 206-oRABs waste discharge mouth, wind speed probe in 207-oRABs, A grades in 208-oRABs One-way flow, the sterile material of mono- layer of 209-cRABs, 210- packaging, 211- rat hole II, wind speed probe in 212-cRABs, 213- CRABs waste discharge mouth, A grades of one-way flows in 214-cRABs, 215- isolator, wind speed probe in 216- isolator, 217- A grades of one-way flows in isolator.

Specific embodiment

The utility model is further described in detail by following embodiment and its attached drawing, but is not limited only to following reality Apply the process parameters range in example and embodiment.

Referring to Figure 1, Fig. 1 shows be from what ambient non-sterile was transferred to gnotobasis by the material of one layer of aseptic packaging System.As shown in Figure 1, the system comprises RABs101 and the isolator 107 adjacent with RABs101；The laminar flow of the RABs101 Cover provides A grades of one-way flows 106, and the front end of the RABs101 is equipped with a material pass-through box 103, and the side of the RABs101 has There are a rat hole 109 in one waste discharge mouth 104, the RABs101 and 107 junction of isolator；The isolator 107 Laminar flow hood provide A grades of one-way flows 110.Preferably, one is respectively arranged in the RABs101 and the isolator 107 Wind speed measurement probe 102 and 108.

It is greater than the pressure in the RABs101 in the pressure in the isolator 107, and pressure difference is not less than 17.5Pa, and And when rat hole 109 is opened, still it is able to satisfy.Preferably, the isolator 107 first carries out VHP purification before work, so that institute The inside for stating isolator 107 is in gnotobasis.The clean area rank that wherein RABS and isolator are placed is not less than C grades.

Fig. 2 is referred to again, and the material of three layers of aseptic packaging is by Fig. 2 expression from what ambient non-sterile was transferred to gnotobasis System.As shown in Fig. 2, unpacking the sterile material 201 packed with three layers to after there is two layers of sterile outer packing, oRABs is opened Front end material pass-through box 203, is transferred in oRABs 202 by operator, and operator will have two layers by oRABs gloves The sterile material 204 of packaging is placed in designated position.Self-cleaning is carried out under good A grades of one-way flow 208, the one-way flow is Speed is that the speed of 0.45m/s ± 20% one-way flow vertically downward and one-way flow is carried out by wind speed probe 207 in oRABs always Monitoring, once discovery speed exceeds the range of 0.45m/s ± 20%, equipment is alarmed immediately.Clean-down capability is monitored, when reaching self-cleaning Between after, in oRABs 202 automatically unpacking equipment cut have two layers packaging sterile material 204 outer packaging, cRABs There is a mechanical arm to grab the sterile material 210 only with one layer of packaging in cRABs 209 by rat hole I 205 in 209. Operator is transmitted the packaging waste in oRABs 202 from the side oRABs waste discharge mouth 206 by oRABs gloves 202 oRABs out.After the sterile material 210 packed with one layer enters cRABs 209, it is transmitted to by automatic transmission rail Designated position.The designated position is less than 10cm, the outer packing of fixed sterile material apart from rat hole II 211.It is single at good A grades Self-cleaning is carried out to stream 214 is lower, and the speed of the one-way flow is 0.45m/s ± 20% one-way flow vertically downward and one-way flow Speed is monitored by wind speed probe 212 in cRABs always, once discovery speed exceeds the range of 0.45m/s ± 20%, equipment It alarms immediately.Clean-down capability is monitored, after reaching clean-down capability, at this point, there have an automatic equipment of unpacking to automatically open to be adjacent with rat hole The opening of the outer packing of side, and strutted the opening using vacuum chuck.There is a mechanical arm to pass through rat hole in isolator 215 II 211 grab sterile material in isolator, for use.The isolator has used VHP cleaned in advance, is in sterile shape State possesses the A grade one-way flow 217 of 0.45m/s ± 20% vertically downward in the isolator.The one-way flow speed always by every It is monitored from wind speed probe 216 in device, once discovery speed exceeds the range of 0.45m/s ± 20%, equipment is alarmed immediately.It passes After the completion of passing, the waste in cRABs 209 is passed through the side cRABs waste discharge mouth by cRABs gloves by operator 213 pass out cRABs 209.The technology 1 of the utility model) be suitable for can not carry out moist heat sterilization material sterile biography It passs；The sterile transfer that not can be carried out the material of moist heat sterilization may be implemented in VHP purification techniques and the art of this patent, and RTP is quick Transfer techniques can not be realized；2) continuous sterile transfer can be carried out；Only continuous sterile transfer may be implemented in the art of this patent, RTP fast transfer technology and VHP purification techniques can only realize transfer in batches.

In particular, the use of the method measurement single transfer time-consuming of the utility model being about 7min, the sterile transfer of single is time-consuming It is short.And the sterilizing transfer of RTP fast transfer technology single batch is about 3 hours time-consuming, the purification transfer of VHP purification techniques single batch is time-consuming About 45min.

Only the utility model preferred embodiment is described above, but is not to be construed as the limit to claim System.The utility model is not only limited to above embodiments, and specific structure is allowed to vary.It is all in the utility model independent right It is required that protection scope in made various change it is within the protection scope of the present utility model.

Claims (6)

1. a kind of system that the sterile material of aseptic packaging is transferred to gnotobasis from ambient non-sterile, which is characterized in that described System includes RABs and the isolator adjacent with RABs；The laminar flow hood of the RABs provides A grades of one-way flows, the front end of the RABs Equipped with a material pass-through box, there is a waste discharge mouth in the side of the RABs, and the RABs has with the isolator junction One rat hole；The laminar flow hood of the isolator provides A grades of one-way flows.

2. system according to claim 1, which is characterized in that the pressure in the isolator is greater than the pressure in the RABs Power, and pressure difference is not less than 17.5Pa.

3. system according to claim 2, which is characterized in that the pressure in the isolator is greater than institute when rat hole is opened The pressure in RABs is stated, and pressure difference is not less than 17.5Pa.

4. system according to claim 1, which is characterized in that the isolator is the isolator of VHP purification before work, So that the inside of the isolator is in gnotobasis.

5. system according to claim 1, which is characterized in that the RABs and the clean area rank that isolator is placed be not low In C grades.

6. any system according to claim 1~5, which is characterized in that further include being separately positioned on the RABs and institute State the wind speed measurement probe in isolator.