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1、USSR STATE STANDARD SOLID CULTURE MEDIA (FOR VETERINARY PURPOSES) GENERAL SPECIFICATIONS GOST 29112-91 Official Edition THE USSR COMMITTEE FOR STANDARDIZATION AND METROLOGY Moscow Copyright Gosudarstvennye Standarty State Standard GOST (Russian) Provided by IHS under license with GOST ion/Inv?Licens
2、ee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or networking permitted without license from IHS -,-,- UDC 576.8:006.354Group P35 USSR STATE STANDARD SOLID CULTURE MEDIA (FOR VETERINARY PURPOSES) General specifications OKP (All-Union Product Classi
3、fication Code ) 93 88 80 GOST 29112-91 Date of Introduction 01.10.92 This Standard applies to dense culture media - meat infusion agar (MPA), Hottingers agar, liver agar, Saburos agar and wort agar - designed for cultivation of micro organisms. The terms of this Standard are obligatory. 1. TECHNICAL
4、 REQUIREMENTS 1.1. Characteristics 1.1.1. The solid culture media shall be produced in accordance with the requirements of this Standard and with adherence to GOST 10444.1 or production instructions (or schedules) approved in accordance with the established procedure. 1.1.2. The physical, chemical,
5、biochemical and biologic indicators of the solid culture media shall meet the requirements and standards specified in table 1. Official Edition Standards Publishing House, 1992 This Standard may not be reproduced, in full or in part, reprinted or distributed without permission of Gosstandart of Russ
6、ia Copyright Gosudarstvennye Standarty State Standard GOST (Russian) Provided by IHS under license with GOST ion/Inv?Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or networking permitted without license from IHS -,-,- p. 2 GOST 2911291 Tabl
7、e 1 Requirements and standards Indicators MPA Hottingers agar Liver agar Saburos agar Wort agar AppearanceAt 20 C it is a gel without exogenous inclusions Color, in %, no less than6040104040 Transparence, in %, no less than5050405040 Gel strength, in g, no less than200200110110200 Mass fraction of a
8、mine nitrogen, in %, no less than Mass fraction of polypeptides, in %, no less than 0.06 1.4 0.12 1.2 0.06 1.2 1.0 Mass fraction of carbohydrates, in %, no less than6.0 Hydrogen ions concentration (?)7.2 to 7.67.2 to 7.67.2 to 7.46.4 to 7.06.4 to 7.0 Mass fraction of chlorides, as converted to chlor
9、ine ions, in %0.8 0.1 pNa0.82 to 0.98 SterilityShall be sterile Ability to support the growth of test-strains of micro organisms, in optical density units, no less than: for “Lossmans” Staphylococcus aureus:0.50.80.3. or Strain 675 Escherichia coli:0.40.60.5 or Strain 1911 Corynebacterium diphtheroi
10、des:0.40.70.3 for Strain 1a 8516 Shigella flexneri:0.20.40.2 Note: During checks of sodium chloride content in solid culture media, only one indicator - either mass fraction of chlorides, or pNa - shall be determined. 1.2. Packing 1.2.1. Solid culture media shall be packaged is sterile conditions in
11、 2.5 dm3 glass bottles complying with GOST 10782; 100, 200 and 500 cm3 vials complying with TU (Specifications) 10-09-202 or in large-bottomed flat flasks with wide mouth (so-called “biologic mattresses”), with filling of two thirds of the volume of each flask. 1.2.2. The bottles shall be closed wit
12、h sterile rubber plugs, wrapped from above with parchment paper complying with GOST 1341 and tied. The vials shall be closed with rubber plugs complying with TU 38-106-293 and rolled around with sealing aluminum caps complying with OST (Industry Standard) 64-009. Copyright Gosudarstvennye Standarty
13、State Standard GOST (Russian) Provided by IHS under license with GOST ion/Inv?Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or networking permitted without license from IHS -,-,- GOST 2911291 p. 3 1.2.3. The glass bottles containing the med
14、ium shall be packed in expanded polystyrene containers complying with TU 10-09-30; the vials shall be wrapped with alignin complying with GOST 12923 or, in a cool season, with cotton wool or other heat-insulating material and packed in board containers of no more than 20 kg gross weight complying wi
15、th GOST 13357, which ensure the immobility and integrity of vials. 1.2.4. The label indicating the name of the manufacturer, name of the preparation, quantity of the preparation present in the container, the batch number, the control number, the date of packing, the shelf life, as well as the number
16、 and surname of the packer, shall be inserted in each container. 1.3. Marking 1.3.1. Paper labels shall be glued to bottles and vials indicating the following: name and trade mark of the manufacturer; name of the preparation; quantity of the preparation present in the bottle (or vial); sterility of
17、the preparation; batch number; control number; date of manufacture; shelf life; conditions of storage; number of this Standard. 1.3.2. Transport marking complying with GOST 14192 shall be applied to each cargo position (that is, container) with the use of “Fragile”, “Avoid heating” and “Avoid freezi
18、ng” handling instructions, as well as the “Biologic preparations” warning inscription. the marking characterizing the packed product shall contain the following data: name and trade mark of the manufacturer;. name of the preparation and its quantity present in the container; the batch number; date o
19、f manufacture; shelf life; conditions of storage; gross weight. Simultaneous application of the transport marking and the marking characterizing the packed product on one side of the transport container is not allowed. 2. ACCEPTANCE 2.1. The solid culture media shall be accepted in batches. A defini
20、te quantity of a solid culture medium being produced during one process cycle, simultaneously packed and supplied with one quality certificate with indicated control number shall be considered as a batch. Copyright Gosudarstvennye Standarty State Standard GOST (Russian) Provided by IHS under license
21、 with GOST ion/Inv?Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or networking permitted without license from IHS -,-,- p. 4 GOST 2911291 2.2. Each batch of culture media shall be checked at the manufacturing plant by the OTK (Quality Depar
22、tment) (or OBK (Biologic Quality Department) of the manufacturing plant. 2.3. For quality control of the medium, the aggregate sample shall be collected from different places of the batch, the amount of which (n) shall be found using the formula: n = N4 . 0, where N is the number of packages present
23、 in the batch. 2.4. Quality control of the medium at the customers request shall be carried out by the specialized laboratory of the All-Russian State Scientific Testing Institute of Veterinary Preparations. 2.5. Testing against the “Ability to support the growth of test-strains of micro organisms”
24、indicator of culture media being produced in less than 50 dm3 volumes shall be carried out on every fifth batch. 2.6. If test results are unsatisfactory even against one of the indicators, a re-test shall be carried out on the twofold quantity of the medium. The results of the re-testing shall be as
25、signed to the entire batch. 3. TEST METHODS 3.1. Sampling In case of testing of bottled media, individual samples shall be collected with a glass tube from the upper, middle and lower parts of each unit of the aggregate sample (that is, from each bottle belonging to the aggregate sample) in sterile
26、conditions. The medium shall be melted in a water bath prior to sampling. The 1200 cm3 common sample shall be divided into two equal parts. One part shall be used for quality control, and the other part shall be stored at the manufacturing plant for the shelf life period to be used in disputable cas
27、es. In case of testing of media, which have been packaged in vials, 6 to 10 vials shall be sampled from each unit of the aggregate sample. One part of vials (3 to 5 in number) shall be used for quality control, and the other part shall be stored at the manufacturing plant for the shelf life period.
28、3.2. Evaluation of appearance of the media Appearance of the media shall be evaluated visually in conditions of light transmission. 3.3. Evaluation of color and transparence of the media 3.3.1. Instrumentation and materials Water bath. Conic flasks complying with GOST 25336. Glass laboratory cooler
29、complying with GOST 25336. Cotton-gauze plugs with paper caps. Heating element (burner or electric heater). Photoelectric colorimeter. Distilled water complying with GOST 6709. 3.3.2. Carrying out of the test Solid culture media shall be melted in a water bath, in a flask equipped with a reverse coo
30、ler or in a vial closed with cotton-gauze plug and parchment cap. Copyright Gosudarstvennye Standarty State Standard GOST (Russian) Provided by IHS under license with GOST ion/Inv?Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or networking
31、permitted without license from IHS -,-,- GOST 2911291 p. 5 Melted solid culture medium shall be poured in a cuvet of photoelectric colorimeter with 5 mm working length and left for 10 to 15 minutes until congelation has occurred. Color and transparence shall be evaluated on a photoelectric colorimet
32、er with dark blue (400 to 440 nm) and yellow-orange (580 to 600 nm wavelengths) light filters respectively, with using of water as an optical control. 3.4. Determination of gel strength 3.4.1. Instrumentation and materials Technical balance. The Valents instrument. 30 cm3 metal or thick-walled glass
33、 cups (24 mm in height and 40 mm in diameter). Flat-bottomed vessel (crystallizer). Glass laboratory thermometer. Glass laboratory beakers and flasks complying with GOST 25336. Quartz sand. 3.4.2. Carrying out of the tests 200 cm3 of solid culture medium, which has been melted in accordance with cla
34、use 3.3.2, shall be poured in five 30 cm3 cups. The cups containing hot culture medium shall be placed in a horizontally positioned flat-bottomed vessel filled with water having 20 C temperature to the level higher than the level of solution present in the cups. The cups containing the culture mediu
35、m shall be incubated for 1 hour at 20 C; this temperature shall be maintained by adding, while mixing, cold or warm water. Further procedure of gel strength determination shall comply with GOST 26185. 3.5. Determination of amine nitrogen 3.5.1. Instrumentation, materials and reagents pH-meter, ? ion
36、ometer or other instrument designed for the same purpose. ? balance or other balance of the same accuracy class. Laboratory beakers and flasks complying with GOST 25336. Pipettes and burettes complying with GOST 20292. Technical formalin complying with GOST 1625. 1 % alcoholic solution of phenolphth
37、alein. Sodium hydroxide complying with GOST 4328: solution with concentration of NaOH c (1 NaOH) of 0.1 mol/dm3. Sulfuric acid complying with GOST 4204: solution with concentration of H2SO4 c (1/2 H2SO4) of 0.1 mol/dm3. Distilled water complying with GOST 6709. 3.5.2. Preparation for the test Prepar
38、ation of formolite mixture: 1 cm3 of 1 % solution of phenolphthalein shall be added to 50 cm3 of the filtered formalin, and the color of the mixture shall be brought to rose-pink by adding of sodium hydroxide solution with concentration of NaOH c (1 NaOH) of 0.1 mol/dm3. Solid culture medium, which
39、has been melted in accordance with clause 3.3.2, shall be cooled to 40 to 50 ?, and a 10 g sample of it shall be obtained with the use of a technical balance with a margin of error of 0.01 g and transferred in a 100 to 200 cm3 glass vessel. Distilled water having 40 to 50 C temperature shall be adde
40、d until the weight of the medium being diluted has reached 50 g and mixed. Copyright Gosudarstvennye Standarty State Standard GOST (Russian) Provided by IHS under license with GOST ion/Inv?Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or ne
41、tworking permitted without license from IHS -,-,- p. 6 GOST 2911291 10 cm3 of the medium, which has been diluted, shall be transferred in a wide low beaker designed for pH measurements, and distilled water shall be added to ensure appropriate immersion of electrodes in the solution. The pH value of
42、the solution shall be brought to 7.0 by adding of several drops of sulfuric acid or sodium hydroxide. 2 cm3 of the formolite mixture shall be added, which shall result in changing of pH level due to formation of free carboxyl groups; these groups shall be titrated with sodium hydroxide solution with
43、 concentration of NaOH c (1 NaOH) of 0.1 mol/dm3. Titration shall be carried out until the pH value of 8.5 has been reached. 3.5.3. Processing of the results The content of amine nitrogen in a solid culture medium (X), as a percentage, shall be found using the formula: 2 1 51000014 . 0 V KV X =, whe
44、re V1 is the volume of sodium hydroxide solution being used for titration of the sample being tested, in cm3; K is the correction coefficient being applied to the titer of sodium hydroxide solution with concentration of NaOH c (1 NaOH) of 0.1 mol/dm3; 5 is the dilution ratio; V2 is the volume of the
45、 medium, which has been diluted, being used for analysis, in cm3; 0.0014 is the quantity of nitrogen corresponding to 1 cm3 of sodium hydroxide solution with concentration of NaOH c (1 NaOH) of 0.1 mol/dm3; 100 is the conversion to 100 cm3 of the medium. 3.6. Determination of content of polypeptides
46、 3.6.1. Instrumentation, materials and reagents Photoelectric colorimeter or spectrophotometer. Centrifuge test tubes. Pipettes complying with GOST 20292. Type ? desktop centrifuge. Sodium hydroxide complying with GOST 4328: 10 % solution. Cupric sulfate complying with GOST 4165: 2 % solution. Disti
47、lled water complying with GOST 6709. 3.6.2. Preparation for the test 3.6.2.1. Plotting of the calibration curve For plotting of the calibration curve, the concentration of polypeptides, as a percentage, shall be plotted on the abscissa, and the optical density of the solution, corresponding to the d
48、ata presented in table 2, shall be plotted on the ordinate. Copyright Gosudarstvennye Standarty State Standard GOST (Russian) Provided by IHS under license with GOST ion/Inv?Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 04/02/2008 20:32:40 MDTNo reproduction or networking permitted without license from IHS -,-,- GOST 2911291 p. 7 Table 2 Concentration of polypeptides, in %Optical density 0.10.14 0.20.26 0.30.37 0.40.49 3.6.3. Carrying out of the test Five cubic centimeters of the solut