Some standard content:
62--5
Ministry of Chemical Industry of the People's Republic of China
HG 4-559-79
Published by Technical Standards Press:
(Beijing Fuwai Sanli Liquor Co., Ltd.)
Technical Standards Press Printed by the Beijing Publishing House of Xinhua Bookstore
Published by Xinhua Bookstores in various places
Format 850×11681/92
Series 1/4
Price 7,000
First printing in February 1880Www.bzxZ.net
First edition in February 1980
Print run 13,000
Price 0.04
Book number: 15169 -2-8346
4-55419
Ministry of Chemical Industry of the People's Republic of China
HG 4-559-79
Replaces HG4-53-67
No. 45
This standard applies to rubber bottle stoppers for packaging antibiotic powders (hereinafter referred to as stoppers)
I. Structure, specifications
1. Regulations.
1. The structure, specifications, dimensions and tolerances shall comply with the following figure and Table 1. Its structure is shown in Figures A, B, and
It is made of high-quality rubber.
Ministry of Chemical Industry of the People's Republic of China
"Shijiazhuang Chemical Industry Bureau
As shown.
May 1, 1979
Shijiazhuang No. 1 Rubber Factory and other units
6 Yellow
Jing type
HG 4—559--79
Unit,
.- 0. 10
-2. The eccentricity between the upper cover and the plug is not allowed to be greater than 0.3mm. ,2. Technical requirements
, the color of the rubber plug shall be determined by the user and the manufacturer through negotiation. The physical and mechanical properties of the rubber plug material shall comply with the provisions of Table 2. Elongation, kg/cm
Tear-off elongation, %
Permanent change of salt breaking, %
Degree (A)
Not less than
Not less than
Not greater than
Aging coefficient (70±2*×72 hours) Not less than 60% of the rubber plug shall not fall off after three needle punctures. pH value of the rubber plug The ratio of the ... The puncture ring and the part in contact with the powder are not allowed to have stains and impurities. (3) The edge of the rubber plug cover is not allowed to have a rubber defect with a depth of more than 0.3 mm and a convexity of less than 0.3 mm due to punching. (4) The rubber wall surface is not allowed to have a rubber defect or crack with an area greater than 1 mm and a depth of 0.3 mm. The defective part should be smooth. The puncture ring is not allowed to have a rubber defect or crack. (5) The rubber plug surface is not allowed to have obvious fading marks caused by molding. (6) The color of the same rubber should be uniform. The actual sample of the appearance of the rubber plug shall be determined by the user and the manufacturer. When the formula and production process of the rubber plug are changed, relevant tests shall be carried out, and the quality level shall not be lower than the standard. III. Acceptance rules 13. The rubber plug shall be inspected by the technical inspection department of the manufacturer. 【Manufacturing】"It should be ensured that the products leaving the factory meet the requirements specified in this standard, and each batch of products should be accompanied by a quality certificate. 14. Users have the right to inspect product quality according to the provisions of this standard. The rubber plugs shall be in batches of no more than 20-30 kg (the output of a small output shall be in batches of one week). 16. The appearance quality of the plugs shall be 100% inspected, and the number of random inspections of each batch of appearance shall be 0.1% during acceptance. The number of unqualified appearance after random inspection shall not exceed 2% of the number of single inspections. %, otherwise take another double release sample for re-testing. If the re-testing still exceeds 2%, the batch of products will not be accepted and will be returned to the manufacturer for re-inspection. 17. The main dimensions of rubber plugs should be inspected regularly, not less than once a month. 18. Take a certain amount of samples from each batch of rubber plugs and test them according to the provisions of Articles 5, 6, 8 and 10 of this standard.
The rubber plugs should be inspected once a week, and the adaptability and smoothness tests should be conducted monthly. 19. The free sulfur content of rubber plugs should be checked regularly, not less than once a month.
20. The physical and mechanical properties of rubber plugs should be checked regularly, not less than twice a month. 6 萍4
HG 4—559--79
21. If the product's energy or physical and mechanical properties are unqualified, a double test ladder should be taken from the batch of products or rubber materials to retest the unqualified items. If they are still unqualified after retesting, the batch of products or rubber materials shall be unqualified. If the regular inspection items are unqualified, the batch should be inspected again until the items are qualified and stable.
IV. Test method
22. Use a vernier caliper with an accuracy of 0.05 mm to check the main dimensions of the rubber plug, and check the appearance quality of the product by daily measurement.
23. Test method for physical and mechanical properties of rubber plugs and rubber materials: (1) Breaking strength, elongation at break and permanent deformation at break tests shall be carried out in accordance with GB 528-76.
(2) Hardness (Shore A type) shall be carried out in accordance with GHS91-76. (3) Aging test shall be carried out in accordance with GHS91-76. 4-845-76. 24. Needle puncture test method: (1) Sample treatment: Take a certain amount of rubber and put it into a container, add a suitable amount of 2% sodium carbonate solution, make the sample completely submerged, boil for 30 minutes, add water appropriately during the boiling process to replenish the evaporated water. Wash with water to remove the alkali, use steam to wash the neutral type, dry it, and prepare for winter test (2) Needle test: a. The needle used for the needle puncture test is a 6 1/2 stainless steel needle with a needle bevel of 14 ±9. The surface should be smooth,
, and free of hair and roughness after processing. The degree of
5. For the medicine bottle used in the acupuncture test, first wash it with fresh steamed water, and then inject about half of the volume of filtered distilled water for use.
℃, take ten treated rubber stoppers, plug them into the bottle filled with distilled water, and then use the specified needle cover on a 5 ml syringe, pierce the needle in the acupuncture tube to the water surface, and inject distilled water! After piercing, take a specific E
head, place the bottle under a black background and fluorescent light, and observe whether there is rubber skin leakage in the bottle with normal force (other suspended matter is not counted). The above operation is repeated twice, and a total of 3 needles are pierced. 25. Determination of pH value:
Take 10 grams of treated rubber stoppers, put them in a 200℃ boiling water, and add 100 ml of distilled water. Cover with fur and heat to boil for 20 minutes. Add water to make up for the evaporated water. Let it cool and measure the pH with a pH meter.
26. Determination of free vegetables,
HG 4—559—79
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Take an appropriate amount of treated glue, cut it into 1 mm* size particles, accurately weigh about 2 grams of the sample, add 100 ml of 5% newly prepared sodium sulfite solution to 500 ml of conical flask, cover the bottle mouth with a glass funnel, heat and boil for 90 minutes, remove it, rinse the funnel with a small amount of water, add 100 ml of 5% calcium oxide solution, filter it into a 500 ml tight-mouth conical flask after cooling slightly, and wash it 8 to 10 times with 100 ml of water, add 5 ml of 40% formaldehyde and 10 ml of glacial acetic acid to the filtrate, shake it vigorously, cool it in cold water to below 15 degrees, add 5 ml of starch indicator solution, and titrate it with 0.025N iodine standard solution until it just turns light blue. Perform a blank test under the same conditions.
Free sulfur content is temporarily calculated using the following formula:
5% --V*0. 026. 100
Wherein:
Amount of white iodine standard solution used in titration,
ml,
Amount of iodine standard solution used in titration sample,
ml,
Concentration of monoiodine standard solution,
Weight of sample, g,
0.03206—1 ml of 1N iodine standard solution is equivalent to the number of grams of sulfur. 27. Determination of chemical impurities;
(1) Preparation of acetic acid leaching solution for rubber plugs:
Take 10 grams of the treated rubber plugs and put them into a 150-liter beaker, such as 100 ml of 2% ethanol, and soak them for 24 hours to obtain the rubber plug acid wet solution for use. (2) Determination of heavy metals:
Take 10 ml of the dense acetic acid solution and put it into a 50 ml colorimetric tube. Add 10 ml of freshly prepared saturated hydrogen sulfide aqueous solution. No color should be observed after 10 minutes (the whitening test is 10 ml of 2% acetic acid plus 10 ml of freshly prepared saturated hydrogen sulfide aqueous solution). If corrosion is observed, the test should be repeated. The method is changed to add 0.5 g of ascorbic acid to the test and blank test before adding the hydrogen sulfide solution. After the solution is dissolved, add the hydrogen sulfide aqueous solution. No color should be observed. This test is qualified only after the zinc is qualified. ( 9) Determination of zinc salt:
, add 1 ml of zinc standard solution (0.1 mg/L) to one tube, add 4 ml of distilled water, add 5 ml of acetic acid extract to the other tube, and then add 1 ml of 1:1 salt solution to each tube. 10 liters of 10% ammonium hydroxide solution, 0.1 liter of 20% sodium sulfite solution, shake well and let stand for 5 minutes, add 0.5 ml of 0.5% potassium ferrous ferrate solution, add water to 25 ml, shake and let stand for 10 minutes. Turbidimetric, the sample tube shall not be deeper than the standard tube. 28. Heat resistance test method:
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