CN102323128A - Production process for solution reference material - Google Patents
Production process for solution reference material Download PDFInfo
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- CN102323128A CN102323128A CN201110226205A CN201110226205A CN102323128A CN 102323128 A CN102323128 A CN 102323128A CN 201110226205 A CN201110226205 A CN 201110226205A CN 201110226205 A CN201110226205 A CN 201110226205A CN 102323128 A CN102323128 A CN 102323128A
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- standard substance
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Abstract
The invention discloses a production process for a solution reference material. The process comprises the following steps of: performing six-effect distillation on purified water to obtain water for injection; washing an ampoule by using the water for injection in a ten-thousand-grade purification region, and sterilizing and drying the washed ampoule; and filling the solution reference material into the ampoule in a hundred-grade purification region with temperature of 16-24 DEG C and humidity of 45%-65%, and sealing. By utilizing the process, the preparation and use of the water for injection, selection for a package container, filling and sealing processes for the solution reference materials and the like during preparation of the reference material are realized, therefore, the quality of the reference material product is guaranteed; and technical parameters, such as preparation, uniformity inspection, stability inspection, estimation for certainty and total uncertainty of a fixed value and a standard value, package, preservation and the like, of the reference material are in accordance with the specifications so as to reach desired indexes.
Description
Technical field
The present invention relates to the development field of food composition analysis, environmental chemical analysis and drug ingredient analytical standard material, be specifically related to a kind of production technology of solution standard substance.
Background technology
(Reference Material is to have one or more enough all even fine characteristic values of having confirmed RM) to standard substance, in order to the calibration measurement device, estimates measuring method or gives the material or the material of material assignment.Because of it has the measurement standard of accurate value, obtained using widely in chemical measurement, bio-measurement, engineering survey and physical measurement field.In process of production; Processing from the trial-production of the evaluation of the control of the check of the raw material of industry, technological process, product quality, new product to the three wastes and utilization etc. all need various its results' of corresponding standard material guarantee reliability; Make production run be in good quality control state, improve the quality of products effectively.In addition, standard substance guarantees to formulate at product aspect checking and the enforcement, aspect the quality control and evaluation of the examination and test of products and certification authority, is all bringing into play important effect aspect the approval work of use chamber.
The system of the development of China's standard substance at present implements according to country " primary standard material technical manual " (JIG 1006-1994); This standard is applicable to the development of chemical constitution, physicochemical characteristics and engineering characteristic primary standard material, and has proposed the confirming and the technical parameters such as estimation, packing and storage of overall uncertainty of preparation, uniformity testing, stability test, definite value, standard value of standard substance.But this standard does not propose particular provisions to the preparation technology of solution standard substance, and the preparation technology of solution standard substance is the critical control link that guarantees the standard substance product quality, for reaching expection technical parameter index important influence.
Summary of the invention
To the defective that exists in the prior art, the object of the present invention is to provide a kind of production technology of solution standard substance, guaranteed the standard substance product quality, make each technical parameter of standard substance up to specification.
For realizing above-mentioned purpose, the technical scheme that the present invention adopts is following:
A kind of production technology of solution standard substance may further comprise the steps:
(1) purified water is carried out six effect distillations and obtain water for injection;
(2) in ten thousand grades of purifying areas, use water for injection to clean ampoule, and the ampoule after will washing carry out the sterilizing-drying processing;
(3) in hundred grades of Clean rooms, the solution standard substance is filled in the ampoule, and seals; Wherein, the temperature of hundred grades of Clean rooms is 16 ℃～24 ℃, and humidity is 45%～65%.
Further, the production technology of aforesaid solution standard substance, in the step (1), 65 ℃ of insulations of said water for injection are deposited, and face the time spent to return to room temperature; In the step (2), all through ISO9001 quality system certification and the authentication of ISO14001 environmental system, the ampoule of use all meets state quality standard in the ampoule manufacturer that is selected for use.。
Effect of the present invention is: the production technology of solution standard substance of the present invention; Solved standard substance prepare preparation and use, the packing container of water for injection in the process selection, solution standard substance wash, irritate, seal technical matterss such as technology; Guaranteed the standard substance product quality; Make standard substance preparation, uniformity testing, stability test, definite value, standard value confirm and the technical parameters such as estimation, packing and storage of overall uncertainty up to specification, reach expectation index.
Description of drawings
Fig. 1 is the process flow diagram of the production technology of a kind of solution standard substance of the present invention.
Embodiment
Below in conjunction with Figure of description and embodiment the present invention is done further detailed description.
Fig. 1 shows the process flow diagram into the production technology of a kind of solution standard substance of the present invention, by finding out that this method may further comprise the steps among the figure:
Step S11: preparation water for injection;
Water is the key factor that guarantees end product quality in the standard substance preparation, and the pure water of prepared in laboratory can not solve the needs of this technology because water production rate is few.Therefore, process water seems even more important in the production run.
Process using L-2000 type water making device according to the invention.Purified water obtains water for injection after imitating distillation through six, and this injection electrical conductivity of water reaches 0.01mS/m, and chemical purity has reached (GB/T6682-2008) one-level water index of national standard " assay laboratory's water specification and test method " up to 99.999%; This water for injection concentrates 30 times of inspection pyrogens negative (pyrogen is that (pyrogen) refers to the pyrogenic substance that can cause the rising of homeothermal animal abnormal body temperature by microorganisms); Viable count＜1/L.Adopt the water production rate of this method can satisfy the needs of whole technological processs fully, water for injection adopts stainless steel cask to deposit, and 65 ℃ of insulations face the time spent to return to room temperature.
Step S12: with ampoule clean, sterilization and dried;
Use the water for injection described in the step S11 to clean ampoule, guarantee the high cleanliness of ampoule bottle, inclusion-free, no thermal source, no bacterium are guaranteed the quality and the stability thereof of solution standard substance.And its difficult quality of the pure water of prepared in laboratory reaches above standard.After washing ampoule is used after the oven dry of sterilizing-drying cabinet.All through ISO9001 quality system certification and the authentication of ISO14001 environmental system, the ampoule of use meets state quality standard in the ampoule manufacturer of process using according to the invention.
Step S13: can solution standard substance.
The can of solution standard substance and seal in hundred grades of clean rooms and carry out, the temperature of hundred grades of clean rooms is 16 ℃～24 ℃, humidity is 45%～65%.Be difficult to accomplish this technology in the laboratory operation condition.
Below in conjunction with specific embodiment the present invention is carried out further detailed explanation.
Embodiment
Present embodiment is that example comes that the present invention will be described to be that the melamine solution standard substance of 1.00mg/mL is filled in the glass ampule of 5mL with the concentration for preparing.
At first purified water is carried out six and imitates the water for injection that distillation obtains, in ten thousand grades of purifying areas, use then water for injection glass cleaning ampoule, and will wash after ampoule carry out that sterilizing-drying handles; Be 16 ℃～24 ℃ in temperature at last, humidity is in hundred grades of Clean rooms of 45%～65% the melamine solution standard substance for preparing to be filled in the ampoule.
When carrying out the production of standard substance through production technology of the present invention, operating personnel change one's clothes, change footwear by purifying requirement when operating, and regularly cleaning is obeyed.Whenever during naked manual manipulation, sterilized once at a distance from 30 minutes.Though use this technology standard substance to carry out online production; Guaranteed the standard substance product quality; Make the technical parameter such as preparation, uniformity testing, stability test, definite value, Uncertainty of Certified Value, packing of standard substance up to specification, reach expectation index.
Obviously, those skilled in the art can carry out various changes and modification to the present invention and not break away from the spirit and scope of the present invention.Like this, belong within the scope of claim of the present invention and equivalent technology thereof if of the present invention these are revised with modification, then the present invention also is intended to comprise these changes and modification interior.
Claims (3)
1. the production technology of a solution standard substance may further comprise the steps:
(1) purified water is carried out six effect distillations and obtain water for injection;
(2) in ten thousand grades of purifying areas, use water for injection to clean ampoule, and the ampoule after will washing carry out the sterilizing-drying processing;
(3) in hundred grades of Clean rooms, the solution standard substance is filled in the ampoule, and seals; Wherein, the temperature of hundred grades of Clean rooms is 16 ℃～24 ℃, and humidity is 45%～65%.
2. the production technology of solution standard substance as claimed in claim 1 is characterized in that: in the step (1), said water for injection adopts 65 ℃ of insulations of stainless steel cask to deposit, and faces the time spent to return to room temperature.
3. the production technology of solution standard substance as claimed in claim 1; It is characterized in that: in the step (2); All through ISO9001 quality system certification and the authentication of ISO14001 environmental system, the ampoule of use all meets state quality standard in the ampoule manufacturer that is selected for use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110226205A CN102323128A (en) | 2011-08-08 | 2011-08-08 | Production process for solution reference material |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110226205A CN102323128A (en) | 2011-08-08 | 2011-08-08 | Production process for solution reference material |
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| CN102323128A true CN102323128A (en) | 2012-01-18 |
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| CN201110226205A Pending CN102323128A (en) | 2011-08-08 | 2011-08-08 | Production process for solution reference material |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102879488A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Preparation method for benzene and benzene series mixed solution reference substance used for cigarette paper analysis |
| CN102879503A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Method for preparing standard substance for detecting residual amount of acetic esters in paper for cigarettes |
| CN102879578A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Method for preparing standard substance for detecting residual amount of ketones in paper for cigarettes |
| CN102879579A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Preparation method of standard substance used for detecting residual quantity of alcohol in cigarette paper |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1201906A (en) * | 1997-06-11 | 1998-12-16 | 于荣云 | Preparation of standard sulfide |
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2011
- 2011-08-08 CN CN201110226205A patent/CN102323128A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1201906A (en) * | 1997-06-11 | 1998-12-16 | 于荣云 | Preparation of standard sulfide |
Non-Patent Citations (3)
| Title |
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| 李永安: "《药品包装实用手册》", 31 December 2003, article "《药品包装实用手册》" * |
| 柴玉生 等: "建立药品标准物质分包装工作原则", 《中国药事》, vol. 21, no. 9, 20 September 2007 (2007-09-20) * |
| 肖丽华 等: "浅谈生化药品检定用标准物质管理", 《中国药事》, vol. 23, no. 8, 31 August 2009 (2009-08-31) * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102879488A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Preparation method for benzene and benzene series mixed solution reference substance used for cigarette paper analysis |
| CN102879503A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Method for preparing standard substance for detecting residual amount of acetic esters in paper for cigarettes |
| CN102879578A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Method for preparing standard substance for detecting residual amount of ketones in paper for cigarettes |
| CN102879579A (en) * | 2012-09-18 | 2013-01-16 | 中国烟草总公司郑州烟草研究院 | Preparation method of standard substance used for detecting residual quantity of alcohol in cigarette paper |
| CN102879578B (en) * | 2012-09-18 | 2015-07-08 | 中国烟草总公司郑州烟草研究院 | Method for preparing standard substance for detecting residual amount of ketones in paper for cigarettes |
| CN102879579B (en) * | 2012-09-18 | 2015-07-08 | 中国烟草总公司郑州烟草研究院 | Preparation method of standard substance used for detecting residual quantity of alcohol in cigarette paper |
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Application publication date: 20120118 |