ASTM E1094-2004 Standard Specification for Pharmaceutical Glass Graduates《制药用玻璃量杯标准规范》.pdf

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1、Designation: E 1094 04Standard Specification forPharmaceutical Glass Graduates1This standard is issued under the fixed designation E 1094; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in paren

2、theses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification covers glass graduates suitable forlaboratory, ph

3、armaceutical, and other uses, in both conical andcylindrical shapes.2. Referenced Documents2.1 ASTM Standards:2E 438 Specification for Glasses in Laboratory ApparatusE 671 Specification for Maximum Permissible Thermal Re-sidual Stress in Annealed Glass Laboratory ApparatusE 694 Specification for Lab

4、oratory Glass Volumetric Appa-ratusE 920 Specification for Commercially Packaged LaboratoryApparatusE 921 Specification for Export Packaged Laboratory Appa-ratusE 1133 Practice for Performance Testing of Packaged Labo-ratory Apparatus for United States Government Procure-mentsE 1157 Specification fo

5、r the Sampling and Testing of Reus-able Laboratory Glassware2.2 Other Document:NIST Handbook 44, Section 4.44 Graduates33. Classification3.1 Graduates shall be in the following types and sizes:3.1.1 Type 1Graduated in metric scale only.3.1.1.1 Sizes5, 10, 25, 50, 100, 250, 500, and 1000 mL.3.1.2 Typ

6、e 2Graduated in both metric and inch-poundscales.3.1.2.1 Sizes5 mL and 60 minims, 10 mL and 120minims, 15 mL and 4 fluid drams, 25 mL and 8 fluid drams, 50mL and 2 fluid oz, 100 mL and 4 fluid oz, 250 mL and 8 fluidoz, 500 mL and 16 fluid oz, and 1000 mL and 32 fluid oz.NOTE 1The term millilitre (mL

7、) is commonly used as a special namefor the cubic centimetre (cm3) in accordance with the International Systemof Units (SI). (The inch-pound fluid ounce is equivalent to 29.5735 mL,hence, the fluid dram is equivalent to 3.6967 mL and the minim isequivalent to 0.0616 mL).4. Material and Annealing4.1

8、Graduates shall be made of borosilicate glass conform-ing to the requirements of Type 1, Class A of SpecificationE 438.4.2 Maximum residual thermal stress shall be such as toconform to Specification E 671.5. Design5.1 StyleGraduates having a capacity of more than 15 mL(4 fluid drams) may be either c

9、onical or cylindrical. Thosehaving a capacity of 15 mL or less shall be cylindrical.5.2 DimensionsThe inside measurement from the bottomof the graduate to the top capacity graduation shall be not lessthan five times the inside diameter on a cylindrical graduateand two times on a conical graduate. Th

10、e inside measurementfrom the bottom of the graduate to the point representing onefourth of the capacity shall not be less than the inside diameterat that point.5.3 Pour-Out SpoutAll graduates shall have a pour-outspout that ensures delivery of an unbroken stream of liquidwithout wetting the outside

11、wall of the graduate.5.4 BaseThe base shall be perpendicular to the verticalaxis of the graduate. The base shall be large enough so that theempty graduate will stand on a surface 15 from the horizontal.6. Graduations6.1 Each graduate shall have clear graduation markingsperpendicular to the vertical

12、axis of the graduate and parallel toeach other. They shall conform to the requirements of Speci-fication E 694.6.1.1 No graduation line shall extend less than one fourththe circumference of the graduate. Graduates shall have aninitial interval that is not subdivided, equal to not less than onefifth

13、and not more than one fourth of the capacity of the1This specification is under the jurisdiction of ASTM Committee E41 onLaboratory Apparatus and is the direct responsibility of Subcommittee E41.01 onApparatus.Current edition approved May 1, 2004. Published May 2004. Originallyapproved in 1991. Last

14、 previous edition approved in 2003 as E 1094 98(2003).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandardsvolume information, refer to the standards Document Summary page onthe ASTM website.3Availab

15、le from National Institute of Standards and Technology (NIST),Gaithersburg, MD 20899.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.graduate. Except for this interval, the values of all graduatedintervals shall be the same. Each mai

16、n graduation line shall bemarked to indicate its value; intermediate lines shall not bemarked. Numerals shall be uniformly positioned, either di-rectly upon or immediately above the graduation line to whichthey refer. Numerals shall be set in from the ends of the linesa sufficient distance to permit

17、 the line ends to be used inmaking a meniscus setting.6.1.2 Type 1 graduates shall have main graduation lines thatencircle the graduate at least 90 %. Intermediate lines shallextend at least 50 % of the circumference of the graduate.6.1.3 Type 2 graduates (double scale) shall have a clearspace betwe

18、en the ends of the main graduation lines of the twoscales. This space shall be approximately 90 % removed fromthe pour-out spout of the graduate and shall comply to therequirements of Table 1.6.2 Graduation Marking Details:6.2.1 Capacities, graduation ranges, values of graduatedintervals, and number

19、ed graduations applicable to single-scalegraduates and to appropriate portions of double-scale gradu-ates, are shown in Table 2.6.2.2 Permanency of MarkingsGraduation markings shallbe permanent and legible. They shall be applied by etching andfilling with a permanent pigment, by firing a ceramic ena

20、melinto the glass without etching, or by applying a stain and firinginto the glass without etching.6.3 Tolerances shall be as shown in Table 3 and in accor-dance with Table 3 of Section 4.44 of NIST Handbook 44.Pharmaceutical graduates are calibrated “to deliver” and at20C. The tolerance applicable

21、at a specific graduation line isdetermined by the inside diameter of the graduate at the pointin question.7. Markings7.1 Each graduate shall be permanently marked with thename or trademark, or both, of the manufacturer; the letters“TD” or “EX,” or both; the calibration temperature, 20C; andthe units

22、 of capacity, such as mL for Type 1 graduates, and mLand minims, fluid drams or fluid oz, for Type 2 graduates.8. SamplingFor sampling and testing, refer to Specification E 1157.9. PackagingSelect from Specifications E 920, E 921, and E 1133.10. Keywords10.1 glass; graduate; pharmaceuticalTABLE 1 Sp

23、ace Between Ends at Main Graduations onDouble-Scale GraduatesInside Diameter atGraduation LineSpace Between EndsLess than 40 mm 3 to 6 mm40 to 80 mm 6 to 13 mmOver 80 mm 10 to 16 mmTABLE 2 Graduation Line DetailsDouble-Scale GraduatesCapacityLeast GraduationLineSubdivisionNumbers atEach Even5 mL 1.0

24、 mL 0.5 mL 1 mL10 mL 2.0 mL 1.0 mL 2 mL25 mL 5.0 mL 5.0 mL 5 mL50 mL 10.0 mL 5.0 mL 10 mL100 mL 20.0 mL 10.0 mL 20 mL250 mL 50.0 mL 25.0 mL 50 mL500 mL 100.0 mL 25.0 mL 50 mL1000 mL 200.0 mL 50.0 mL 100 mL60 minims 15.0 minims 5.0 minims 10 minimsA120 minims 30.0 minims 10.0 minims 20 minimsB4 fluid

25、 drams 1.0 fluid drams 0.5 fluid drams 1 fluid dram8 fluid drams 2.0 fluid drams 1.0 fluid drams 2 fluid drams2 fluid oz 0.5 fluid oz 0.25 fluid oz 0.5 fluid oz4 fluid oz 1.0 fluid oz 0.5 fluid oz 1 fluid oz8 fluid oz 2.0 fluid oz 0.5 fluid oz 1 fluid oz16 fluid oz 4.0 fluid oz 1.0 fluid oz 2 fluid

26、oz32 fluid oz 8.0 fluid oz 2.0 fluid oz 4 fluid ozAAlso at the first 15-minim graduation.BAlso at the first 30-minim graduation.TABLE 3 Maintenance and Acceptance Tolerances, in Excessand in Deficiency, for GraduatesInside Diameter of GraduateFromTo But NotIncludingTolerance FromTo But NotIncludingT

27、olerancemillimetres milliliters in. minims0 16 0.1 0916 216 21 0.29161316 321 26 0.41316 1116 626 31 0.6 1116 1516 1031 36 0.8 1516 1916 1536 41 1.1 1916 11316 2041 46 1.4 11316 2116 3046 51 1.8 2116 2516 4051 56 2.2 2516 2916 5056 61 2.8 2916 21316 6561 66 3.4 21316 3116 8066 71 4.1 3116 3516 9571

28、76 4.8 3516 3916 11076 81 5.6 3916 31316 13081 86 6.4 3316 4116 15086 91 7.291 96 8.196 101 9.0E1094042ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that d

29、etermination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved

30、 or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel

31、that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).E1094043