Medicine standard substance packaging and transporting method

Abstract

The invention discloses a medicine standard substance packaging and transporting method, and relates to the technical field of medicine standard substance packaging and transporting, and the technical scheme is characterized by comprising the following nine steps: freezing an ice raft; fully blowing the bubble cap; the standard substance is buckled into the special box; examining and screening the foam box; marking the temperature of a standard substance; stacking the ice rows; filling a filler; sealing the foam box; and loading into a special box and delivering and shipping. By researching the key points and key points of all links of standard substance packaging and transporting, a set of standard substance packaging and transporting procedure method is created, the effects of shock resistance, breakage resistance and optimal temperature control are achieved, and the quality and efficiency of standard substance supply work are effectively guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical standard substance transportation, and more specifically, to a pharmaceutical standard substance packaging and transportation method. Background Art

[0002] National pharmaceutical standard substances (hereinafter referred to as standard substances) refer to substances used for physical, chemical and biological tests of drugs in national statutory drug standards, with definite characteristics or values, and used for calibrating equipment, evaluating measurement methods, assigning values ​​to test drugs or identifying them. It is an indispensable tool for controlling drug quality and plays an important role as a "measuring weight" in standard inspection. The outer packaging materials of national pharmaceutical standard substances mainly include vials and ampoules, which have a certain risk of breakage; they are usually divided into three storage temperatures: room temperature, refrigeration, and freezing; one of the main functions of the China Food and Drug Inspection Institute (hereinafter referred to as the China Inspection Institute) is to organize and carry out the planning, planning, research, preparation, calibration, distribution and management of national standard substances. Except for a very small number of special standard substances, all standard substances are supplied from the headquarters of the China Inspection Institute to the user units by express mail.

[0003] Currently, about 20,000 units of users order national pharmaceutical reference materials each year, and by 2023, the China National Institute for Inspection and Quarantine will send about 110,000 packages. Due to the wide variety of reference materials, the transportation temperature requirements vary to a certain extent, the mail transportation time guarantee scheme is insufficient, and the reference materials have a certain risk of damage during transportation. There are also very few cases where the contents of the foam box do not match the express delivery order.

[0004] Therefore, the present invention aims to provide a method for packaging and transporting pharmaceutical standard substances to solve the above-mentioned problems. Summary of the invention

[0005] The purpose of the present invention is to provide a method for packaging and transporting pharmaceutical standard substances. By studying the key points and critical points of each link in the packaging and transportation of standard substances, the present invention has created a set of packaging and transportation process methods for standard substances, achieving the effect of shockproof and anti-crushing and optimal temperature control. According to the temperature requirements of the mailed product and the temperature and area of ​​the mailing destination, the evaluation and recommendation of the reference information system, and combined with the short-term stability result data of the standard substance, the optimal combination of coolant, insulation equipment, and transportation method is determined, which can effectively ensure the temperature control of the standard substance during transportation, and achieve the standard substance mailing product without damage and the best transportation time.

[0006] The above technical objectives of the present invention are achieved through the following technical solutions: A method for packaging and transporting pharmaceutical standard substances, comprising the following steps:

[0007] S1. Preliminary preparation: Freezing ice blocks, requiring the biological ice blocks to be pre-frozen for a certain period of time, so that the refrigerant solidifies and releases slowly until it meets the expected requirements; blowing up the bubble cover, inflating, ensuring that the pillars of the bubble cover are full and have an anti-shattering effect; sealing the bubble cover to ensure that the seal is complete and leak-free, and the wrapping is strong; if there is leakage, replace the bubble cover; if there is no leakage, execute step S2;

[0008] S2. Generate and print the express delivery note: select the corresponding transportation method and refrigerant according to the storage temperature of the standard material, transportation conditions and other factors, check that the order number in the express delivery note is clearly printed, and execute step S3;

[0009] S3, standard materials are put into special boxes: according to the specifications, quantity, texture and other factors of the product, they are put into suitable special boxes to ensure the fitting effect; the special boxes and the order are put into the standard material customized bag together, and step S4 is executed;

[0010] S4, sorting to ensure the "three consistency" of key information: sort the express order and the corresponding standard material customized bag according to the order number information, and ensure that the order numbers of the "three items" of the order, standard material and express order are consistent. If the order number information of the three items matches, execute step S5;

[0011] S5. Review and select foam boxes and mark the temperature of standard substances: Packaging personnel select large or small foam boxes of appropriate size according to the total number of ordered products, and carefully check their integrity. There must be no sand holes or holes to support temperature control. After that, mark the standard substance temperature and order number information on the foam box cover to guide the selection of the quantity of ice pack coolant. When multiple packages from the same user are involved, check that the order numbers are consistent and the order is clearly recorded. Finally, check that the order numbers of the order, standard substance and express order in the custom bag are consistent. After confirming that they are consistent, put the custom bag into the filled bubble cover and seal it. Finally, fold the corner of the express order and stick it on the foam box cover.

[0012] S6. Stacking ice blocks: Based on the results of the third-party temperature control test report, and taking the regional location, seasonal temperature and marked temperature of the standard material as reference, select the corresponding number of ice blocks for refrigerant storage and stack them around the bubble cover to meet the transportation conditions corresponding to the standard material;

[0013] S7. Filling: It is easy to get bumped during transportation. In order to further ensure the integrity of the standard materials, fillers should be placed after the ice blocks are stacked to fix the shape and prevent shock and breakage.

[0014] S8, Sealed foam box: Use multiple layers of tape to wrap to ensure the airtightness of the box to ensure the combined temperature control effect of the ice pack foam box;

[0015] S9. Pack into a special box and deliver it for mailing: Check that the marking information on the foam box and the express delivery slip is consistent, put the sealed foam box into a suitable special box for standard substances, paste the express delivery slip, count the handover quantity together with the postal personnel, confirm the transportation method and calculate the cost, keep delivery records, and implement closed-loop management.

[0016] The present invention is further configured as follows: in step S1, the ice blocks are frozen to a set temperature 3 days in advance.

[0017] The present invention is further configured as follows: in step S6, the method of selecting a corresponding amount of ice pack coolant is as follows:

[0018] When the reference material is transported to the southern region in summer and the transportation conditions are refrigerated, it is necessary to use a combination of 12 biological ice blocks and a large foam box, and choose air transportation to deliver it within 48 hours;

[0019] When the standard material is transported at room temperature, except for transportation to the southern region in summer, it should be delivered by land transportation within 72 hours; when the standard material is transported to the southern region in summer and the transportation condition is room temperature, it is necessary to use a combination of 1-6 pieces of appropriate biological ice blocks and foam boxes, and choose land transportation to deliver it within 72 hours;

[0020] When the transportation conditions are refrigerated or frozen, when transporting to various regions across the country in summer, a combination of 8-12 biological ice blocks and foam boxes must be used, and air transportation must be chosen to deliver within 48 hours; when transporting to the entire country in spring and autumn and to southern regions in winter, a combination of 1-6 biological ice blocks and foam boxes must be used, and land transportation must be chosen to deliver within 72 hours; when transporting to northern regions in winter, land transportation must be chosen to deliver within 72 hours.

[0021] In summary, the present invention has the following beneficial effects:

[0022] 1. Support high-quality development of the industry. This invention creates a packaging and transportation process method for standard substances, which achieves the effect of shockproof and anti-breakage and optimal temperature control, ensuring the quality and efficiency of standard substance supply. In the past three years, a total of about 300,000 pieces of standard substances have been supplied and distributed, effectively supporting the production inspection, market supervision, innovative research and other related work of drugs, and contributing to the high-quality development of the pharmaceutical industry.

[0023] 2. The practical effect is remarkable, and there is no abnormal situation feedback. The present invention determines the optimal combination of coolant, insulation equipment, and transportation method based on the temperature requirements of the mailed products and the temperature and area of ​​the mailing destination, and in combination with the short-term stability result data of the standard substance. It can effectively ensure the temperature control of the standard substance during transportation, and achieve the standard substance mailing products without damage and the optimal transportation time. Over the years, customers have not reported any abnormal situation.

[0024] 3. Improve work efficiency and shorten the overall supply cycle. The present invention has created a set of packaging and transportation process methods for standard substances. By solidifying the implementation steps and detailed operations and undergoing repeated training, the work is ensured to be orderly and the packaging work efficiency is greatly improved. At the same time, by restricting the mail transportation time limit, the air transportation time limit is controlled within 48 hours and the land transportation time limit is controlled within 72 hours. While ensuring product quality, the working time limit is also shortened, and the overall supply cycle is shortened by nearly 50%. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic flow chart of a method for packaging and transporting a pharmaceutical standard substance in an embodiment of the present invention;

[0026] Figure 2 Schematic diagram of the appearance of the test sample and the position of the temperature sensor in the embodiment of the present invention. DETAILED DESCRIPTION

[0027] The following is combined with Figure 1-2 The present invention is described in further detail.

[0028] Embodiment: A method for packaging and transporting pharmaceutical standard substances, comprising the following steps:

[0029] S1. Preliminary preparation. Freezing ice blocks requires pre-freezing of biological ice blocks for a certain period of time to achieve the effect of solidification and slow release of the refrigerant until it meets the expected requirements; blowing up the bubble cover and inflating it to ensure that the pillars of the bubble cover are full and have an anti-shattering effect; sealing the bubble cover to ensure that the seal is complete and leak-free and has strong wrapping; if there is a leak, replace the bubble cover; if there is no leak, execute step S2.

[0030] S2. Generate and print the express delivery note. According to the storage temperature of the standard material, transportation conditions and other factors, select the corresponding transportation method and refrigerant, check that the order number in the express delivery note is clearly printed, and execute step S3.

[0031] S3, standard materials are put into special boxes. According to the specifications, quantity, texture and other factors of the product, they are put into suitable special boxes to ensure the fitting effect; the special boxes and the order are put into the standard material customized bag together, and step S4 is executed.

[0032] S4. Sorting to ensure the consistency of the three key information. Sorting the express order and the corresponding standard material customized bag according to the order number information to ensure that the order number of the order, standard material and express order is consistent. If the order number information of the three items matches, then execute step S5.

[0033] S5. Review and screen the foam boxes and mark the temperature of the standard substances. The packaging staff selects large or small foam boxes of appropriate size according to the total number of ordered products, and carefully checks their integrity. There must be no sand holes or holes to support temperature control. After that, mark the standard substance temperature and order number information on the foam box cover to guide the selection of the quantity of ice pack coolant, etc. When multiple packages from the same user are involved, check that the order numbers are consistent and the order is clearly recorded in sequence. Finally, check that the order numbers of the order, standard substance and express order in the custom bag are consistent. After confirming that they are consistent, put the custom bag into the filled bubble cover and seal it. Finally, fold the corner of the express order and stick it on the foam box cover.

[0034] In this embodiment, the ice blocks are placed in a foam box and stacked around the bubble pad; the packing personnel will select the corresponding number of ice blocks and transportation methods according to the size of the foam box, seasonal characteristics and the regional distribution of the customer's receiving address, as shown in Table 1, and the specific provinces corresponding to the season division are shown in Table 2:

[0035] Table 1 Storage temperature and recommended ice block dosage

[0036]

[0037] Table 2 Season and region division

[0038]

[0039] In this embodiment, it is preferred that the standard substances are transported by air because there is no land transportation condition in Tibet; the Beijing-Tianjin-Hebei region does not send air transportation due to regional characteristics, so all of them are transported by land; when transported to Hainan, refrigerated and frozen standard substances are transported by air regardless of the season.

[0040] The temperature control combination of ice blocks and foam boxes has been verified by CNAS reports and results show that the temperature can be controlled below refrigeration conditions within 48 hours.

[0041] S6. Stacking ice blocks. Based on the results of the third-party temperature control test report, and taking the regional location, seasonal temperature and marked temperature of the standard material as reference, select the corresponding number of ice blocks and coolant storage agents, and stack them around the bubble cover to meet the transportation conditions corresponding to the standard material.

[0042] S7. Filling. It is easy to get bumped during transportation. In order to further ensure the integrity of the standard material, fillers need to be filled after the ice blocks are stacked to fix the shape and prevent shock and breakage.

[0043] S8. Seal the foam box. Wrap it with multiple layers of tape to ensure that the box is airtight to ensure the combined temperature control effect of the ice pack and foam box.

[0044] S9. Pack into a special box and deliver it to the mail. Check that the marking information on the foam box and the express delivery slip is consistent, pack the sealed foam box into a suitable special box for standard materials, paste the express delivery slip, count the handover quantity together with the mailing personnel, confirm the transportation method and calculate the cost, keep a good record of the delivery, and achieve closed-loop management.

[0045] In this embodiment, the transportation method of the standard substance is affected by the temperature and region of the receiving area, and can be air transportation or land transportation.

[0046] When choosing a packaging method, you need to consider the following four points:

[0047] 1. Temperature control.

[0048] 2. Anti-breakage method.

[0049] 3. Selection of coolant and container materials.

[0050] 4. Specific packaging steps.

[0051] In order to achieve the best effect of shockproof, anti-shattering and temperature control, we conducted 17 groups of experiments. By comparing the results of multiple groups of experiments, we obtained the optimal solutions for the material and quantity of the coolant, the thickness of the foam box and the packaging process.

[0052] The following are the details of the experiment:

[0053] Firstly, the test environment is room temperature (i.e. 27-29.6℃). According to BG / T4857.2-2005 "Basic Tests for Packaging and Transport Packages Part 2: Temperature and Humidity Conditioning Treatment", 12 0-degree 300g ice blocks are placed in the foam box during the test (the ice blocks have been frozen in a -40℃ freezer for 48 hours). A foam box of 40.5*29.5*47cm and 5cm wall thickness is selected.

[0054] During the test, place the foam boxes on the shelves in the test box at the required spacing to ensure good air circulation in the test box. Place ice blocks in the foam boxes and place a temperature sensor in each box. The sensor is located at the bottom of the foam box. Open the test box according to the set experimental program, observe and record the temperature of the temperature sensor, and close the test box after the program is completed. Place the test sample as follows: Figure 2 shown.

[0055] The temperature records are shown in Table 3:

[0056] Table 3 Test sample temperature record

[0057] Test time, h 0 1 2 3 4 5 6 7 8 9 Temperature, °C 32 -33.5 -32.3 -29.6 -28.2 -26.6 -23.8 -19.8 -17.1 -16.1 Test time, h -15.7 -13.5 -11.3 -9.2 -8.1 -7.3 -5.9 -4.3 -3.7 -2.4 Temperature, °C 10 11 12 13 14 15 16 17 18 19 Test time, h -1.6 -1.5 -1.2 -0.9 -0.9 -0.8 -0.7 -0.6 -0.6 -0.5 Temperature, °C 20 21 22 23 24 25 26 27 28 29 Test time, h 30 31 32 33 34 35 36 37 38 39 Temperature, °C -0.5 -0.4 -0.4 -0.4 -0.3 -0.2 -0.1 -0.1 -0.1 0.0 Test time, h 40 41 42 43 44 45 46 47 48 / Temperature, °C 0.0 0.0 0.0 0.0 1.1 2.1 2.5 2.9 3.1 /

[0058] Through the above experiment, 12 ice blocks were stacked in a foam box (specification 40.5*29.5*47cm, wall thickness 5cm). Under the external temperature condition of 32°C, the temperature inside the foam box could reach the refrigerated storage condition requirements within 48 hours.

[0059] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

Claims

1. A method for packaging and transporting pharmaceutical standard substances, characterized by: The following steps are involved: S1. Preliminary preparation: Freezing ice blocks, requiring the biological ice blocks to be pre-frozen for a certain period of time, so that the refrigerant solidifies and releases slowly until it meets the expected requirements; blowing up the bubble cover, inflating, ensuring that the pillars of the bubble cover are full and have an anti-shattering effect; sealing the bubble cover to ensure that the seal is complete and leak-free, and the wrapping is strong; if there is leakage, replace the bubble cover; if there is no leakage, execute step S2; S2. Generate and print the express delivery note: select the corresponding transportation method and refrigerant according to the storage temperature of the standard material, transportation conditions and other factors, check that the order number in the express delivery note is clearly printed, and execute step S3; S3, standard materials are put into special boxes: according to the specifications, quantity, texture and other factors of the product, they are put into suitable special boxes to ensure the fitting effect; the special boxes and the order are put into the standard material customized bag together, and step S4 is executed; S4, sorting to ensure the "three consistent" key information: sort the express order and the corresponding standard material customized bag according to the order number information, and ensure that the order numbers of the "three items" of the order, standard material and express order are consistent. If the order number information of the three items matches, execute step S5; S5. Review and select foam boxes and mark the temperature of standard substances: Packaging personnel select large or small foam boxes of appropriate size according to the total number of ordered products, and carefully check their integrity. There must be no sand holes or holes to support temperature control. After that, mark the standard substance temperature and order number information on the foam box cover to guide the selection of the quantity of ice pack coolant. When multiple packages from the same user are involved, check that the order numbers are consistent and the order is clearly recorded. Finally, check that the order numbers of the order, standard substance and express order in the custom bag are consistent. After confirming that they are consistent, put the custom bag into the filled bubble cover and seal it. Finally, fold the corner of the express order and stick it on the foam box cover. S6. Stacking ice blocks: Based on the results of the third-party temperature control test report, and taking the regional location, seasonal temperature and marked temperature of the standard material as reference, select the corresponding number of ice blocks for refrigerant storage and stack them around the bubble cover to meet the transportation conditions corresponding to the standard material; S7. Filling: It is easy to get bumped during transportation. In order to further ensure the integrity of the standard materials, fillers should be placed after the ice blocks are stacked to fix the shape and prevent shock and breakage. S8, Sealed foam box: Use multiple layers of tape to wrap to ensure the airtightness of the box to ensure the combined temperature control effect of the ice pack foam box; S9. Pack into a special box and deliver it for mailing: Check that the marking information on the foam box and the express delivery slip is consistent, put the sealed foam box into a suitable special box for standard substances, paste the express delivery slip, count the handover quantity together with the postal personnel, confirm the transportation method and calculate the cost, keep delivery records, and implement closed-loop management.

2. A method for packaging and transporting pharmaceutical standard substances according to claim 1, characterized in that: In step S1, the ice blocks are frozen to a set temperature 3 days in advance.

3. A method for packaging and transporting pharmaceutical standard substances according to claim 1, characterized in that: In step S6, the method of selecting a corresponding amount of ice pack coolant is as follows, taking the regional location of the destination, seasonal temperature and the marked temperature of the standard substance as reference: Standard materials are transported in refrigerated or frozen conditions: when transported to the whole country in summer, a combination of 8-12 biological ice blocks and foam boxes should be used, and air transportation should be selected to deliver the materials within 48 hours; when transported to the whole country in spring and autumn or to the southern region in winter, a combination of 1-6 biological ice blocks and foam boxes should be used, and land transportation should be selected to deliver the materials within 72 hours; when transported to the northern region in winter, land transportation should be selected to deliver the materials within 72 hours; Standard materials are transported at room temperature. When transported to southern regions in summer, a combination of 1 to 6 bio-ice blocks and foam boxes is required, and land transportation is selected to deliver the materials within 72 hours. In addition, land transportation should be selected and delivered within 72 hours.

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