Calibrating device of medicinal vacuum freeze dryer
Technical Field
The utility model relates to the technical field of equipment calibration, in particular to a calibration device of a medicinal vacuum freeze dryer.
Background
The vacuum freeze-drying technology is a method for removing water and preserving the original form of a substance by utilizing the sublimation principle to freeze the water-containing substance below the eutectic point temperature in advance under a high vacuum state based on the tri-state change of water so as to enable the water to be changed into a solid state, and then sublimating the water in the solid state into a gas state under a low temperature and vacuum environment.
The freeze-drying is completed in vacuum and low temperature state, so that it is not easy to produce oxidation and thermal denaturation, and can maximally retain the physicochemical property and biological property of freeze-dried product, and the solid ice crystal can be sublimated into porous spongy structure formed after water vapor, so that it possesses excellent quick-solubility and rehydration property, can quickly absorb water and dissolve and restore its original property, at the same time possesses the characteristics of thorough dehydration, low water content and light weight, and can be stored for a long time under the condition of normal temp., and can be stored for a long time, and because the vacuum freeze-drying has the incomparable advantages of other drying methods, so that its application in biological products and medicinal chemical products of vaccine, diagnosis preparation, serum product, antibiotic, vitamin, enzyme preparation and blood product, etc. is increasingly extensive.
However, in the process of freeze-drying the medicines, the temperature and the vacuum degree are required to be precisely controlled, and the plate layer temperature control performance and the vacuum parameter of the freeze dryer directly influence the molding of the freeze-drying process of the products and the moisture content of the medicines. At present, some requirements of domestic enterprises for referencing GMP or industry standard standards of freeze-drying machines are adopted, the automatic verification method of manufacturers is adopted, measuring devices for verification are not uniform, and a comprehensive, specific and effective calibration method for equipment performance is lacked, most enterprises only verify temperature parameters of the freeze-drying machines, vacuum parameters cannot be verified or equipment vacuum meters need to be disassembled to be sent to a measuring department for calibration, and a temperature and pressure multi-parameter integrated calibration device is lacked, so that the comprehensive evaluation of the performance of the freeze-drying machines by product production cannot be met.
Disclosure of utility model
The utility model discloses a calibrating device of a medicinal vacuum freeze dryer, and aims to solve the technical problems in the prior art.
The utility model adopts the following technical scheme:
A calibrating device of a medicinal vacuum freeze dryer is connected with a computer and comprises a main body unit, a long rod vertically and fixedly connected with the bottom plane of the main body unit, and a temperature probe and a pressure sensor which are respectively connected with the main body unit through flexible wires;
the main body unit comprises a shell and an electronic unit positioned in the inner cavity of the shell;
The top wall of the shell is provided with a plurality of upper through holes, the pressure sensor is fixedly attached to the bottoms of the upper through holes, and the outer edges of the pressure sensor comprise the outer edges of all the upper through holes; the temperature probe comprises an inner cavity end part fixedly arranged on the long rod.
In some embodiments, the shell made of PEEK material comprises an upper shell and a lower shell which are detachably and fixedly connected into a whole, the top wall of the upper shell is provided with an upper through hole, the center of the bottom plane of the lower shell is provided with a lower through hole, and the lower through hole is communicated with the inner cavity of the long rod, and the center line of the lower through hole coincides with the center line of the long rod.
In some embodiments, the bottom plane of the lower shell is also fixedly connected with supporting units, and the supporting units are uniformly distributed on the periphery of the long rod at equal intervals.
In some embodiments, the support unit comprises a plurality of support plates, which are arranged symmetrically in a lateral and longitudinal direction at least about the center line of the long rod.
In some embodiments, the stainless steel long rod is a straight rod with uniform thickness, the upper end of the long rod is communicated with the lower through hole, the lower end of the long rod is a blind hole, the temperature probe is fixedly connected in the blind hole, and the diameter D of the long rod is smaller than 5mm.
In some embodiments, the temperature probe is of a fully-encapsulated design, and comprises a metal outer layer and a temperature sensing element positioned in an inner cavity of the metal outer layer, wherein the temperature sensing element is tightly attached to the metal outer layer, comprises a platinum resistor, and is connected with the flexible lead.
In some embodiments, the flexible wire is an insulated thermocouple wire, the outer layer is a glass fiber braid, and the length of the flexible wire connected with the temperature probe is matched with the length of the long rod.
In some embodiments, the electronic unit comprises a circuit board and a battery module fixedly arranged at the upper end of the circuit board, wherein the circuit board is fixedly connected with a singlechip for controlling acquisition temperature and pressure, a memory for storing data information, a wireless communication module in communication connection with a computer and a Hall module for wirelessly connecting the calibration device with the computer through a special interface.
In some embodiments, the device further comprises an interface, a platform for placing the calibration device is arranged on the interface, and an activator is arranged in the interface, so that after the hall module is activated and opened by the activator, the computer controls the calibration device to sample or reads the pressure information and the temperature information stored in the memory.
In some embodiments, the total height H of the calibration device should be such that H.ltoreq.100 mm.
The beneficial effects are that:
The utility model discloses a calibrating device of a medicinal vacuum freeze dryer, which has the following advantages compared with the prior art:
A calibrating device of a medicinal vacuum freeze dryer is characterized in that temperature and vacuum degree are detected simultaneously through the integrated multi-parameter detection of a plate layer of the medicinal vacuum freeze dryer, detection efficiency and measurement accuracy are effectively improved, the total height of the calibrating device, namely a main body unit and the total length of a long rod are not more than 100mm, the long rod is a straight rod and the diameter of the long rod is smaller than 5mm, the long rod can be inserted into liquid medicine of a penicillin bottle and then placed into the plate layer, pressure and temperature can be measured simultaneously through only one calibrating device placed in one plate layer of the medicinal vacuum freeze dryer, a plurality of upper through holes are formed in the top wall of a shell, a pressure sensor is fixedly attached to the bottoms of the plurality of upper through holes, the outer edge of the pressure sensor comprises the outer edges of the plurality of upper through holes, the vacuum degree is accurately measured, the temperature sensor is located at the blind hole end of the lower end of the long rod and is fixedly attached to the blind hole, the temperature probe is accurately measured in the penicillin bottle, a supporting unit is fixedly connected to the bottom plane of a lower shell, the supporting unit comprises a plurality of supporting plates, the supporting plates are at least one side-to-side communication module, and the wireless communication device can be placed on a wireless communication device through a plurality of wireless communication module, and a wireless communication device is arranged on the side-to the wireless communication device, and the wireless communication device can be used for calibrating the medical vacuum freeze dryer.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the drawings required for the description of the embodiments are briefly described below, which form a part of the present utility model, and the exemplary embodiments of the present utility model and the description thereof illustrate the present utility model and do not constitute undue limitations of the present utility model, in which:
FIG. 1 is a schematic structural diagram of a calibration device for a vacuum freeze dryer for pharmaceutical use according to an embodiment of the present utility model;
FIG. 2 is a view in the direction A of FIG. 1;
FIG. 3 is a view in the B direction of FIG. 1;
Fig. 4 is a schematic structural diagram of a technical scheme when a long rod of the calibrating device is inserted into a penicillin bottle;
FIG. 5 is a schematic diagram of an electronic unit;
Fig. 6 is a schematic structural diagram of a technical solution when the calibration device is placed on the interface.
In the figure:
The main body unit 1, the housing 11, the upper housing 111, the upper through hole 1111, the mounting hole 1112, the lower housing 112, the inner chamber 113, the upper chamber 1131, the lower chamber 1132, the lower through hole 1133, the electronic unit 12, the battery module 121, the circuit board 122, the singlechip 1221, the wireless communication module 1222, the hall module 1223, the memory 1224, the pressure sensor 2, the temperature probe 3, the metal outer layer 31, the temperature sensing element 32, the supporting unit 4, the supporting plate 41, the long rod 5, the inner cavity 51, the flexible wire 6, the computer 7, the interface 8, the platform 81, the activator 82, the penicillin bottle 9 and the liquid medicine 91.
Detailed Description
In order to make the objects, technical solutions and advantages of the present utility model more apparent, the technical solutions of the present utility model will be clearly and completely described below with reference to specific embodiments of the present utility model and corresponding drawings, and in the description of the present utility model, it should be noted that the term "comprising" mentioned in the specification and claims is an open term, so should be construed as "including but not limited to", and "several" means more than 2.
In the description of the present utility model, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present utility model and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present utility model.
It is apparent that the described embodiments are only some embodiments of the present utility model, not all embodiments, and that all other embodiments obtained by persons of ordinary skill in the art without making creative efforts based on the embodiments in the present utility model are within the protection scope of the present utility model.
As shown in fig. 1-6, the technical scheme disclosed by the utility model is as follows:
The calibrating device of the medical vacuum freeze dryer is connected with a computer 7 and comprises a main body unit 1, a long rod 5 vertically and fixedly connected with the bottom plane of the main body unit 1, a temperature probe 3 and a pressure sensor 2 which are respectively connected with the main body unit 1 through flexible wires 6;
The main body unit 1 comprises a shell 11 and an electronic unit 12 positioned in the inner cavity of the shell;
the top wall of the shell 11 is provided with a plurality of upper through holes 1111, the pressure sensor 2 is fixedly attached to the bottoms of the plurality of upper through holes 1111, the outer edge of the pressure sensor 2 comprises the outer edges of all the plurality of upper through holes 1111, and the temperature probe 3 comprises an inner cavity 51 fixedly arranged at the end part of the long rod 5.
As shown in fig. 1 to 6, a preferred embodiment of the present utility model:
A calibrating device of a medicinal vacuum freeze dryer is connected with a computer 7 and comprises a main body unit 1, a long rod 5 vertically and fixedly connected with the bottom plane of the main body unit 1, a temperature probe 3 and a pressure sensor 2 which are respectively connected with the main body unit 1 through flexible wires 6.
The main body unit 1 includes a housing 11 and an electronic unit 12 located in an inner chamber 113 of the housing 11.
The shell 11 comprises an upper shell 111 and a lower shell 112 which are detachably and fixedly connected into a whole, a plurality of upper through holes 1111 are formed in the top wall of the upper shell 111, the upper through holes 1111 are 3 in the embodiment, a lower through hole 1133 is formed in the center of the bottom plane of the lower shell 112, the lower through hole 1133 is located in the center of the bottom plane, the long rod 5 is fixedly connected with the bottom plane of the lower shell 112 through adhesive, the long rod 5 is vertically and fixedly connected with the bottom plane of the lower shell 112, and the center line of the long rod 5 coincides with the center line of the lower through hole 1133.
The inner chamber 113 includes an upper chamber 1131 and a lower chamber 1132, and the upper through hole 1111, the lower through hole 1133, and the upper chamber 1131 and the lower chamber 1132 are communicated.
The upper shell 111 and the lower shell 112 are made of PEEK, which is not easy to conduct heat and is firm, and wireless communication can be emitted.
The upper through holes 1111 have ventilation effect, the specific number and size of the upper through holes 1111 should meet the preset requirement, in this embodiment, 3 upper through holes 1111 are selected, the pressure sensor 2 is set to one, and is attached and fixed to the bottom of the 3 upper through holes 1111, and encapsulated in the upper chamber 1131, and the outer edge of the pressure sensor 2 includes all the outer edges of the upper through holes 1111, as shown in fig. 3.
The pressure sensor 2 is connected with the electronic unit 12 through the flexible lead 6, the pressure sensor 2 adopts a piezoresistive pressure sensor, and the air pressure can be accurately measured through ventilation of the closely attached 3 upper through holes 1111.
The long rod 5 is made of stainless steel, is of an armored design, is firm and inflexible, the long rod 5 is made of a straight rod with uniform thickness, the whole long rod is made of stainless steel, the long rod 5 is provided with an inner cavity 51, the upper end of the inner cavity 51 is communicated with the lower through hole 1133, the lower end of the long rod 5 is provided with a blind hole, the temperature probe 3 is fixedly attached to the tail end of the blind hole, the temperature probe 3 is of a full-package design, the temperature probe comprises a metal outer layer 31 and a temperature sensing element 32 located in the inner cavity of the metal outer layer 31, the temperature sensing element 32 is tightly attached to the metal outer layer 31, and the temperature sensing element 32 comprises a PT1000 temperature sensor and is connected with the flexible lead 6.
The flexible wire 6 is an insulated thermocouple wire, the outer layer is a glass fiber woven layer, and the length of the flexible wire 6 connected with the temperature sensor is matched with the length of the long rod 5.
The diameter D of the long rod 5 is smaller than 5mm, the long rod is matched with the bottle mouth of the penicillin bottle 9, the long rod can be conveniently inserted, the length of the long rod 5 can be set according to preset requirements, and the temperature measurement in the liquid medicine 91 at the lower end of the penicillin bottle 9 can be achieved.
The bottom plane of the lower shell 112 is also fixedly connected with supporting units 4, and the supporting units 4 are uniformly distributed on the periphery of the long rod 5 at equal intervals, and the mode of adhesive fixation is adopted in the example.
The supporting unit 4 includes a plurality of backup pads 41, the backup pad 41 all perpendicular solid dress in on the basal plane of lower casing 112, the quantity of backup pad 41 can be selected as required, in this embodiment, selects 4 backup pads 41, regard as the center line of stock 5 two by two symmetry along cross axle, vertical axis symmetrical arrangement, the size of backup pad 41 should satisfy the requirement of predetermineeing, namely satisfies when supporting unit 4 supports and places on the bottle lid of xiLin bottle 9, main part unit 1 is steady placed state just stock 5 is perpendicular hanging all the time in xiLin bottle 9, makes the accurate temperature measurement of temperature probe 3.
The electronic unit 12 comprises a circuit board 122 and a battery module 121 fixedly arranged at the upper end of the circuit board 122, wherein a singlechip 1221 for controlling acquisition temperature and pressure, a memory 1224 for storing data information, a wireless communication module 1222 in communication connection with a computer 7, and a Hall module 1223 in wireless connection with the calibration device and the computer 7 through a special interface 8 are fixedly connected to the lower end of the circuit board 122, and the singlechip 1221 further comprises a MAC timer module and an RF transceiver.
In this embodiment, the battery module 121 is a 1632 button battery, and is placed in the battery compartment, so that the height of the main body unit 1 is reduced.
The total height H of the calibrating device is not more than 10cm, the diameter of the long rod is smaller than 5mm, the whole calibrating device is of a small design, can be placed in penicillin bottles of almost all sizes, is suitable for the plate layer spacing of most medical vacuum freeze dryers on the market, can be conveniently carried, and can automatically replace batteries.
The hall module 1223 connects the main body unit 1 with the computer 6 wirelessly through a special interface 8, a platform 81 for placing the main body unit 1 is provided on the interface 8, an activator 82 is provided inside the interface, the activator 82 activates the hall module 1223, that is, the interface 8 is connected with the computer 7 by software, and establishes communication with the computer 7 through a wireless communication module 1222, and the computer 7 reads the pressure information stored in the memory 1224 and the temperature information of the temperature probe 3.
The method comprises the steps of controlling one or more offline calibration devices through software, setting sampling frequency to be 10Hz/2min, storing data offline by the calibration device, transmitting the data to a software end real-time data display interface in real time, reading all data in the calibration device through software after calibration is finished, automatically drawing a curve and generating all original data, deriving the original data into excel original data, processing and calculating through a computer, reducing errors of manual calculation, and improving calibration efficiency.
The embodiments of the present utility model have been described above with reference to the accompanying drawings, but the present utility model is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present utility model and the scope of the claims, which are to be protected by the present utility model.