Some standard content:
YY0249
—1996
This standard is equivalent to the British standard BS2006--84 "Aluminum Hose". According to the packaging requirements of drugs, this standard adds six technical indicators: chemical stability of inner coating, printing quality, tail coating uniformity, tube cap matching, bacterial inspection and abnormal toxicity. In addition, this standard is mainly different from BS2006 in the following ways:
a) This standard does not specify the length of the tube body, and the dimensional tolerance of the thin top thickness is stricter than BS2006; b) The inner coating continuity index is higher than BS2006; c) The air pressure in the test method of sealing is increased from 0.02MPa to 0.2MPa. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the Shandong Drug Packaging Materials and Container Product Quality Inspection Center of the State Drug Administration. The drafting units of this standard: Shanghai Industrial Mali Art Materials Co., Ltd., Shanghai Xinya Pharmaceutical Company Jinshan Branch, and Shanghai Drug Administration Drug Testing Institute.
The main drafters of this standard are Wang Yuren, Lv Ronghua and Zhu Wuhua. 222
Pharmaceutical Industry Standard of the People's Republic of China
Aluminum tube for medicinal ointment
Aluminum tube for medicinal ointmentYY0249---1996
This standard specifies the product classification, technical requirements, test methods, inspection rules and marking, packaging, transportation and storage of aluminum tubes for medicinal ointment. This standard applies to aluminum tubes for ointments. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB191-90 Pictorial signs for packaging, storage and transportation
GB2828--87 Count sampling procedures and sampling tables for batch inspection (applicable to inspection of continuous batches) GB2829-87 Count sampling procedures and sampling tables for periodic inspection (applicable to inspection of stability of production process) Corrugated cardboard boxes
GB6543--86
Part II 3 Product classification of Pharmacopoeia of the People's Republic of China 1995 edition
The aluminum tube for medicinal ointment (hereinafter referred to as aluminum tube) consists of an aluminum tube body (as shown in Figure 1) and a plastic tube cap. d—diameter, di—outer diameter, dz—inner diameter, s—thin top thickness, ssi—wall thickness; S2—shoulder thickness, h—length, h—tube mouth length; —pitch; α—shoulder angle Figure 1 Diagram of the main parts of the aluminum tube
Approved by the State Medical Administration on December 30, 1996 and implemented on July 1, 1997
4 Technical requirements
4.1 Materials
YY0249-1996
4.1.1 The material of the aluminum tube should be pure aluminum with an aluminum content of not less than 99.7%. 4.1.2 The inner coating material should meet the requirements of medicinal ointment. 4.2 The specifications of the aluminum tube are divided according to the outer diameter of the tube body, and the dimensions of each specification of aluminum tube should comply with the provisions of Table 1. Table 1 Specifications and dimensions
13.5±0.1
10.09±0.02/0.40±0.10
M7X1.254.5±0.3
0.10±0,02
5.5±0.20.50.5
M9×1.255.5±0.35.7±0.21.0+0.5t0.50.14±0.04|| tt||+0.020.50±0.15
0.12±0.02
0.55±0.15
0.13±0.02
0.60±0.15
±1.00.15±0.050.14
0.15±0.030.70±0.20
1) The nominal size of the tube length shall be agreed upon by the supplier and the buyer. 4.3 Continuity of inner coating
Test according to 5.2, and the current displayed shall not be greater than 40mA. 4.4 Chemical stability of inner coating
Gently wipe the inner surface with cotton wool dipped in acetone, and the inner coating shall not fall off. 4.5 Flexibility and adhesion of coating
After the tube body is squeezed and stretched, the inner and outer coatings should be free of cracks and falling off. 4.6 Toughness
Tested according to 5.5, it should meet the requirements of Table 2. 4.7 Sealing
After applying pressure inward from the open end of the aluminum tube tail, there should be no leakage. mm
4.8 Printing quality
4.8.1 The printed content should be clear and complete, and the position should be correct. The printed surface should be flat and smooth, and meet the requirements of the buyer and the relevant printing of medicines. 224
1) There is an additional bottom plate (see Figure 5).
YY0249--1996
Table 2 Toughness test limit
Not greater than the following values
4.8.2 The printed surface should have sufficient curing strength. Use cotton wool dipped in ethanol to gently wipe the printed surface of the aluminum tube, and there should be no discoloration. 4.9 Cleanliness
4.9.1 The aluminum tube should be clean, and there should be no processing residues and other foreign matter in the tube. 4.9.2 After the tube cap and the nozzle thread are screwed together, no metal debris should be generated. 4.10 Tail coating uniformity
The surface of the aluminum tube tail coating should be even and free of sag. 4.11 Tube cap matching
The tube cap and the nozzle thread of the aluminum tube should match appropriately. 4.12 Bacteria inspection
Inspect according to 5.11. Bacteria and molds shall not exceed 5/mL each, and Staphylococcus aureus and Pseudomonas aeruginosa shall not be detected. 4.13 Abnormal toxicity
The aluminum tube should have no abnormal toxicity.
5 Test method
5.1 Dimensions
The thickness of the aluminum cover thin top (s) is measured with a dial indicator with an accuracy of 0.01mm, the shoulder thickness (s2) is measured with a pointed dry ruler with an accuracy of 0.01mm, the wall thickness (s) is measured with a micrometer with an accuracy of 0.01mm, and the other dimensions are measured with a vernier caliper with an accuracy of 0.02mm. 5.2 Internal coating continuity test
5.2.1 Principle
The internal coating continuity test of the aluminum tube uses the instrument shown in Figure 2, and the measurement circuit is shown in Figure 3. The coated aluminum tube is filled with a test solution containing copper sulfate, a sliding electrode is immersed in the test solution, and the aluminum tube itself is in contact with a base electrode with a V-shaped groove, and then a DC voltage of 5V±0.5V is applied between the sliding electrode and the aluminum tube. The current flowing is proportional to the surface area of the aluminum tube not covered by the internal coating. If the coating is not continuous, copper deposition may occur. 225
YY 0249-1996
1---Ammeter (2.5 level); 2-Power on indicator light (red); 3-Fuse (60 mA); 4-On/off and range selection switch; 5-Swing electrode: 6-Sliding electrode: 7-V-groove base electrode 8-Power cord; 9-Check button: 10-Test button; 11-Fuse (500 mA): 12-Instrument adjustment screw Figure 2 Internal coating continuity test instrument
5.2.2 Test solution preparation
Copper sulfate crystals (CuSO.·5HO), 10 g; Glacial acetic acid (CH,COOH), 0. 5 mL;
Sodium dioctanoate sulfonate (CoHa?NaO,S), 0.05 g; Add distilled water to 1000 mL.
5.2.3 Instrument calibration before use
Turn on the power supply, and the red indicator light on the panel will light up. Press the calibration button to calibrate the circuit: Press the calibration button continuously, and at the same time, set the range selector switch to 5, 50 or 500mA, respectively, and adjust the instrument so that the pointer deflection is within 10% of 1.8, 18 or 180mA, respectively. Release the calibration button, and the instrument calibration is completed.
5.2.4 Test steps
To protect the instrument and avoid overload, set the range selector switch to 500mA when starting to read. Put a cap on the aluminum tube to be tested, and inject the test liquid into the aluminum tube to 10mm away from the mouth end. Install the nozzle and shoulder of the aluminum tube into the V-groove of the base electrode, and slide the 226
YY0249--1996
sliding electrode downward into the aluminum tube. Adjust the height of the sliding cone to keep the aluminum tube coaxial with the swing electrode. Press the test button and determine the appropriate test range as quickly as possible, and read the data after 5 seconds. The same test solution cannot be used more than eight times. Transformer
Output voltage
3A fuse
Three-position range
Selection switch
5.3 Internal coating chemical stability test
Test button
Verification button
+Sliding electrode
550500
Figure 3 Measurement circuit
Cut the aluminum tube body longitudinally and level it. Use cotton wool dipped in acetone to gently wipe the internal coating 30 times to observe whether the coating falls off on the cotton wool.
5.4 Coating flexibility and adhesion test
5.4.1. Put the aluminum tube to be tested on the rod shown in Figure 4, so that the tail of the tube is put on the step corresponding to the specifications of the aluminum tube, and let it extend from the nozzle. The aluminum tube should be in a vertical state with the base throughout the test. 5.4.2. Put the top pressure plate on the extended rod and let it rest lightly on the top of the nozzle. Apply uniform pressure on the pressure plate and quickly squeeze the aluminum tube downward. The aluminum tube should present an evenly folded "accordion-like" appearance. 5.4.3. Remove the pressed aluminum tube from the rod, stretch it as close to the original length as possible, cut it open longitudinally, and observe whether there are cracks and peeling on the surface of the inner and outer coatings.
5.5 Toughness test
YY 0249---1996
Figure 4 Test device for flexibility and adhesion of inner coating For the toughness test of aluminum tube, use the device shown in Figure 5. Place the aluminum tube to be tested in the positioning groove (if the diameter of the aluminum tube is less than 16mm, place it on the additional bottom plate, as shown in Figure 5), make the tail end of the aluminum tube contact the stopper, release the gate, let the gate fall onto the tube body, and read the scale number on the ruler at the top of the gate.
5.6 Sealing test
For the sealing test of aluminum tube, use a special testing machine (pressure gauge with accuracy of 2.5 grade), pour the aluminum tube with the tube cap installed into a water cup at room temperature, immerse it until the tail end of the tube is about 10mm from the water surface, then use a conical filler to apply 0.2MPa of air pressure to the open end of the tail of the aluminum tube to be tested, and observe whether bubbles appear in the aluminum tube immersed in water within 5s. 5.7 Printing quality
5.7.1 Appearance: Visual inspection.
5.7.2 Curing strength: Use cotton wool dipped in 50% (V/V) ethanol to gently wipe the printed surface 30 times, and observe whether there is any color or ink falling off on the cotton wool.
5.8 Cleanliness
5.8.1 Tube body: Visual inspection.
5.8.2 Screw the cap and nozzle together: Screw the cap and nozzle up and down repeatedly 10 times. Under the condition of double magnification, observe whether there are any metal debris bitten or transferred into the cap.
5.9 End coating uniformity
Visual inspection.
5.10 Cap fit
Screw the cap and nozzle of the aluminum tube to be tested up and down twice to check whether the tightness of the fit is appropriate. 228
5.11 Bacteria inspection
Acute angle blunt
But not round
YY 0249--1996
About 100
1 Gate plate, 2-Slidable gate plate (70.0g ± 1g), 3-Gate plate slideway, 4-Stopper 5-Location groove 6-Additional bottom plate: Cancer meter ruler (the reading is 0 when the gate plate contacts the fire surface) Figure 5 Toughness test device
5.11.1 Extraction solution preparation
Take 5 aluminum tubes for test, and pour sterile physiological saline into each aluminum tube according to the provisions of Table 3. After shaking for 5 minutes, combine the extract solution for use. 5.11.2 Check according to the provisions of Part II of the 1995 edition of the Pharmacopoeia of the People's Republic of China. Table 3 Preparation of test solution for bacterial test
Tube length, mm
Normal saline amount, niL
5.12 Abnormal toxicity
5.12.1 Preparation of extract: Same as 5.11.1, YY0249
Table 3 (end)
Tube length, mm
5.12.2 Administration route: Oral administration, the dosage is 0.5mL per mouse. Normal saline amount, mL
5.12.3 Inspection methods and result judgment shall be carried out in accordance with the provisions of Part II of the 1995 edition of the Pharmacopoeia of the People's Republic of China. 6 Inspection rules
6.1 Each batch of products shall be shipped after passing the inspection. 6.2 Factory inspection
6.2.1 Factory inspection shall be carried out in accordance with the provisions of GB2828, and the test grouping, inspection items, inspection level (IL), and qualified quality level (AQL) shall be as specified in Table 4.
Note: The sampling plan for factory inspection can also be agreed upon by the supplier and the buyer, but it shall not be lower than the requirements of this standard. Table 4 Factory inspection rules
Test grouping
6.3 Type inspection
Inspection items
Cap fit
Tail coating uniformity
Printing quality
Inner coating continuity
Inner coating chemical stability
Sealing
Cleanliness
Coating flexibility and adhesion
6.3.1 Type inspection should be carried out in the following situations: a) When new products are put into production;
Test method
b) When there are major changes in materials and processes that may affect product performance; 230
Inspection level
Qualified quality level
YY0249-1996
c) During normal production, it should be carried out once a year or according to the cycle agreed upon by the supply and demand parties. 6.3.2 Type inspection shall be carried out in accordance with the provisions of GB2829, with the discrimination level (DL) being I. The non-conforming classification, test grouping, inspection items and non-conforming quality level (RQL) shall be as specified in Table 5.
Table 5 Type inspection rules
Unqualified categories
Marking, packaging, transportation, storage
7.1 Marking
Test group
Inspection items
Cap fit
Tail coating uniformity
Printing quality
Inner coating continuity
Inner coating chemical stability
Sealing
Cleanliness
Coating flexibility and adhesion
Abnormal toxicity
Test method
Unqualified quality level
The aluminum tube packaging should have the product name, enterprise name, enterprise address, standard number, enterprise license number, specification, production batch number (or manufacturing date) and signs such as "Handle with care", "Do not tumble", and "Afraid of moisture". The signs should comply with the provisions of GB191. 7.2 Packaging
Each aluminum tube is separated by a clean partition in the small packaging box. The structure of the small packaging box should be reasonable, strong and reliable to prevent the aluminum tube from deforming. Small packaging should be completed in a 100,000-level clean room. The corrugated paper box used for the outer packaging should comply with the provisions of GB6543. The package should be accompanied by a certificate of conformity. 7.3 Transportation
During transportation, it should be protected from rain and handled with care. 7.4 Storage
Packaged aluminum tubes should be stored in a clean, ventilated, dry warehouse without corrosive gases and with a relative humidity not exceeding 80%. The stacking should not be too high during storage to prevent the packaging from being crushed. The bottom layer should be placed on clean wooden boards or gold plates to avoid moisture. The shelf life of aluminum tubes is one year provided that they meet the transportation and storage requirements. 2313-gate slideway, 4-stopper 5-positioning groove 6-additional bottom plate: cancer meter scale (the reading is 0 when the gate contacts the firewood surface) Figure 5 Toughness test device
5.11.1 Preparation of extract
Take 5 aluminum tubes for test, and pour sterile physiological saline into each aluminum tube according to the provisions of Table 3. After shaking for 5 minutes, combine the extracts for use. 5.11.2 Check according to the provisions of Part II of the 1995 edition of the Pharmacopoeia of the People's Republic of China. Table 3 Preparation of test solution for bacterial test
Tube length, mm
Normal saline amount, niL
5.12 Abnormal toxicity
5.12.1 Preparation of extract: Same as 5.11.1, YY0249
Table 3 (end)
Tube length, mm
5.12.2 Administration route: Oral administration, the dosage is 0.5mL per mouse. Normal saline amount, mL
5.12.3 Inspection methods and result judgment shall be carried out in accordance with the provisions of Part II of the 1995 edition of the Pharmacopoeia of the People's Republic of China. 6 Inspection rules
6.1 Each batch of products shall be shipped after passing the inspection. 6.2 Factory inspection
6.2.1 Factory inspection shall be carried out in accordance with the provisions of GB2828, and the test grouping, inspection items, inspection level (IL), and qualified quality level (AQL) shall be as specified in Table 4.
Note: The sampling plan for factory inspection can also be agreed upon by the supplier and the buyer, but it shall not be lower than the requirements of this standard. Table 4 Factory inspection rules
Test grouping
6.3 Type inspection
Inspection items
Cap fit
Tail coating uniformity
Printing quality
Inner coating continuity
Inner coating chemical stability
Sealing
Cleanliness
Coating flexibility and adhesion
6.3.1 Type inspection should be carried out in the following situations: a) When new products are put into production;bzxZ.net
Test method
b) When there are major changes in materials and processes that may affect product performance; 230
Inspection level
Qualified quality level
YY0249-1996
c) During normal production, it should be carried out once a year or according to the cycle agreed upon by the supply and demand parties. 6.3.2 Type inspection shall be carried out in accordance with the provisions of GB2829, with the discrimination level (DL) being I. The non-conforming classification, test grouping, inspection items and non-conforming quality level (RQL) shall be as specified in Table 5.
Table 5 Type inspection rules
Unqualified categories
Marking, packaging, transportation, storage
7.1 Marking
Test group
Inspection items
Cap fit
Tail coating uniformity
Printing quality
Inner coating continuity
Inner coating chemical stability
Sealing
Cleanliness
Coating flexibility and adhesion
Abnormal toxicity
Test method
Unqualified quality level
The aluminum tube packaging should have the product name, enterprise name, enterprise address, standard number, enterprise license number, specification, production batch number (or manufacturing date) and signs such as "Handle with care", "Do not tumble", and "Afraid of moisture". The signs should comply with the provisions of GB191. 7.2 Packaging
Each aluminum tube is separated by a clean partition in the small packaging box. The structure of the small packaging box should be reasonable, strong and reliable to prevent the aluminum tube from deforming. Small packaging should be completed in a 100,000-level clean room. The corrugated paper box used for the outer packaging should comply with the provisions of GB6543. The package should be accompanied by a certificate of conformity. 7.3 Transportation
During transportation, it should be protected from rain and handled with care. 7.4 Storage
Packaged aluminum tubes should be stored in a clean, ventilated, dry warehouse without corrosive gases and with a relative humidity not exceeding 80%. The stacking should not be too high during storage to prevent the packaging from being crushed. The bottom layer should be placed on clean wooden boards or gold plates to avoid moisture. The shelf life of aluminum tubes is one year provided that they meet the transportation and storage requirements. 2313-gate slideway, 4-stopper 5-positioning groove 6-additional bottom plate: cancer meter scale (the reading is 0 when the gate contacts the firewood surface) Figure 5 Toughness test device
5.11.1 Preparation of extract
Take 5 aluminum tubes for test, and pour sterile physiological saline into each aluminum tube according to the provisions of Table 3. After shaking for 5 minutes, combine the extracts for use. 5.11.2 Check according to the provisions of Part II of the 1995 edition of the Pharmacopoeia of the People's Republic of China. Table 3 Preparation of test solution for bacterial test
Tube length, mm
Normal saline amount, niL
5.12 Abnormal toxicity
5.12.1 Preparation of extract: Same as 5.11.1, YY0249
Table 3 (end)
Tube length, mm
5.12.2 Administration route: Oral administration, the dosage is 0.5mL per mouse. Normal saline amount, mL
5.12.3 Inspection methods and result judgment shall be carried out in accordance with the provisions of Part II of the 1995 edition of the Pharmacopoeia of the People's Republic of China. 6 Inspection rules
6.1 Each batch of products shall be shipped after passing the inspection. 6.2 Factory inspection
6.2.1 Factory inspection shall be carried out in accordance with the provisions of GB2828, and the test grouping, inspection items, inspection level (IL), and qualified quality level (AQL) shall be as specified in Table 4.
Note: The sampling plan for factory inspection can also be agreed upon by the supplier and the buyer, but it shall not be lower than the requirements of this standard. Table 4 Factory inspection rules
Test grouping
6.3 Type inspection
Inspection items
Cap fit
Tail coating uniformity
Printing quality
Inner coating continuity
Inner coating chemical stability
Sealing
Cleanliness
Coating flexibility and adhesion
6.3.1 Type inspection should be carried out in the following situations: a) When new products are put into production;
Test method
b) When there are major changes in materials and processes that may affect product performance; 230
Inspection level
Qualified quality level
YY0249-1996
c) During normal production, it should be carried out once a year or according to the cycle agreed upon by the supply and demand parties. 6.3.2 Type inspection shall be carried out in accordance with the provisions of GB2829, with the discrimination level (DL) being I. The non-conforming classification, test grouping, inspection items and non-conforming quality level (RQL) shall be as specified in Table 5.
Table 5 Type inspection rules
Unqualified categories
Marking, packaging, transportation, storage
7.1 Marking
Test group
Inspection items
Cap fit
Tail coating uniformity
Printing quality
Inner coating continuity
Inner coating chemical stability
Sealing
Cleanliness
Coating flexibility and adhesion
Abnormal toxicity
Test method
Unqualified quality level
The aluminum tube packaging should have the product name, enterprise name, enterprise address, standard number, enterprise license number, specification, production batch number (or manufacturing date) and signs such as "Handle with care", "Do not tumble", and "Afraid of moisture". The signs should comply with the provisions of GB191. 7.2 Packaging
Each aluminum tube is separated by a clean partition in the small packaging box. The structure of the small packaging box should be reasonable, strong and reliable to prevent the aluminum tube from deforming. Small packaging should be completed in a 100,000-level clean room. The corrugated paper box used for the outer packaging should comply with the provisions of GB6543. The package should be accompanied by a certificate of conformity. 7.3 Transportation
During transportation, it should be protected from rain and handled with care. 7.4 Storage
Packaged aluminum tubes should be stored in a clean, ventilated, dry warehouse without corrosive gases and with a relative humidity not exceeding 80%. The stacking should not be too high during storage to prevent the packaging from being crushed. The bottom layer should be placed on clean wooden boards or gold plates to avoid moisture. The shelf life of aluminum tubes is one year provided that they meet the transportation and storage requirements. 231
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