This standard specifies the classification and marking, requirements, test methods and inspection rules of eye drop linkage lines. JB 20003.1-2004 Eye drops linkage line JB20003.1-2004 standard download and decompression password: www.bzxz.net

ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20003.1---2004
Production line for eye drops
Published on February 5, 2004
Implemented on June 1, 2004
Published by the National Development and Reform Commission
Foreword
1
Scope||tt| |2 Normative references..
3 Classification and marking
4
S
Requirements
Test methods
Inspection rules
6
Table of contents
JB20003.1—2004
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5
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6
JB20003.1-2004
Foreword
This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The drafting unit of this standard: Beijing Aerospace Wanda High-Tech Development Center. The main drafters of this standard: Wang Jinyan, Feng Ruixin, Shuai Jingzhou. 1 Scope
Eye drop assembly line
This standard specifies the classification and marking, requirements, test methods and inspection rules for eye drop assembly lines. This standard applies to eye drop plastic bottle assembly lines (hereinafter referred to as assembly lines). 2 Normative references
JB20003.1—2004
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version shall apply to this standard. GB/T191 Pictorial signs for packaging, storage and transportation
GB5226.1--2002 Safety of machinery - Mechanical and electrical equipment - Part 1: General technical requirements GB/T6388 Shipping and receiving signs for transport packaging
CB/T9969.1 General principles for instructions for use of industrial products Method for random sampling using random number pseudocodes GB/T 10111
GB/T13306 Signs
GB/T13384
GB/T16769
General technical requirements for packaging of electromechanical products
Method for measuring the sound pressure level of noise from metal cutting machine tools Eye drop linkage line
Cleaning machine
JB 20003.2
JB20003.3 Eye drops linkage line tunnel drying machineJB20003.4 Eye drops linkage line filling, plugging and capping machineJB20003.5 Eye drops linkage line labeling machine
YY/T0216—1995 Pharmaceutical machinery product model compilation method Good manufacturing practice for pharmaceuticals (1998 revised edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Committee 3 Classification and labeling
3.1 Type
The linkage line consists of four machines: cleaning machine, tunnel drying machine, filling, plugging and capping machine, and labeling machine, and is equipped with a connection mechanism between single machines. 3.2 Model
The model of the linkage line should comply with the provisions of YY/T0216-1995. 5
JB20003.1—2004
3.3 Marking Examples
4 Requirements
4.1 General
D
DL
Each unit of the linkage line shall comply with the following corresponding standards: a) The cleaning machine shall comply with the provisions of JB20003.2: Main parameters (applicable filling specifications, mL) Main parameters (production capacity, pieces/min) Product type and characteristics Collection code (L-linked production line) Product function code (D-eye drop machine) Applicable filling volume specification is 7mL
Production capacity is 80 pieces/min
Eye drop linked production line
Tunnel drying machine shall comply with the provisions of JB20003.3: b)
Filling, plugging and capping machine shall comply with the provisions of JB20003.4; c
d) Labeling machine shall comply with the provisions of JB20003.5. 4.2 Appearance requirements
Linked production line shall comply with the requirements of each single machine.
4.3 Structural requirements
4.3.1 Linked production line shall comply with the requirements of each single machine. 4.3.2 The conveying device of linked production line shall not pass through clean areas of different levels. 4.4 Performance requirements
During the operation of linked production line, the connection of each single machine shall be harmoniously matched, stable and reliable, and the monitoring system shall be coordinated and accurate: there shall be automatic adjustment and control device for lack of bottles and accumulated bottles.
4.4.1 No-load performance:
The linkage line is flexible, stable and unobstructed when running without load, and there is no abnormality in the electrical control system. 4.4.2 Load matching performance:
When the linkage line is running under load, the conveying device should ensure that the bottles are in place, the connection of each unit should be matched, stable and reliable, the monitoring system should be coordinated accurately, and there should be automatic adjustment and control devices for missing bottles and accumulated bottles. 4.4.3 Product qualification rate:
The qualification rate of linkage line products should be greater than or equal to 95%. 4.4.4 Noise:
The sound pressure level of the noise of the linkage line under load operation is not greater than 80dB(A). 6
4.5 Electrical safety performance requirements
The linkage line should meet the electrical safety performance requirements of each unit. 5 Test methods
5.1 Appearance inspection
Inspect the appearance quality of each unit.
5.2 Structural inspection
5.2.1 Inspect the structural quality of each unit. 5.2.2 Visually inspect the area where the linkage line conveyor passes. 5.3 Performance test
5.3.1 No-load test:
JB20003.1—2004
Each single machine linkage should be operated for no less than 1 hour to confirm the matching and reliability of the machine speed and the coordination accuracy of the monitoring system. 5.3.2 Load test:bZxz.net
The linkage line shall be subjected to load test after the no-load test is passed. During the test, the slow speed operation state shall be gradually adjusted to the rated speed operation state. The operation time shall be no less than 10 minutes. During the operation, the matching of the unit shall be tested. Visually observe that there is no bottle falling from the washing machine into the dryer; and the bottle entering the sealing machine from the dryer is unobstructed. During linkage, the bottle inlet of the filling and sealing machine is artificially blocked, and the dryer shall be able to stop automatically. 5.3.3 Product qualification rate test:
The linkage line simulates the normal production process, randomly selects 600 bottles, inspects the product quality and calculates the product qualification rate according to formula (1):
Product qualification rate:
5.3.4 Noise test:
Number of bottles qualified in the test
×100%
Total number of bottles tested
The linkage line is tested at the highest production speed and under load operation conditions using a sound level meter in accordance with the provisions of GB/T16769. 5.4 Electrical system inspection
Inspect the electrical safety performance of each single machine. 6 Inspection rules
6.1 Inspection classification
The inspection of the linkage line is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Each linkage line shall be inspected and qualified by the inspection department of the manufacturing unit before it can be shipped out of the factory, and a product certificate shall be attached when it leaves the factory. 6.2.2 The factory inspection shall be carried out according to the items in Table 1. Table 1 Factory inspection items for linkage lines
Item category
General items
Main items
Main inspection items
4.2,4.3.1
4.3.2, 4.4, 4.5
. (1)
JB20003.1—2004
6.2.3 During the factory inspection of each linkage line, if any defective product is found, it shall be returned for repair. If it is still defective after repair, it shall be judged as a defective product and shall not be allowed to leave the factory.
6.3 Type inspection
6.3.1 Type inspection should be carried out in any of the following circumstances: a) When the product is trial-formulated or transferred to another factory for production; b) When the product structure, material, or process has undergone major changes; e) When the product is resumed after being discontinued for 2 years; When the national quality supervision agency proposes a requirement for type inspection; d)
e) When a pharmaceutical manufacturer conducts equipment certification. 6.3.2 Type inspection items:
Type inspection shall be carried out in accordance with all technical requirements of this standard for comprehensive quality assessment and review. 6.3.3 Sampling rules:
The sample for type inspection shall be selected from the products that have passed the factory inspection, and one linkage line shall be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
When all inspection results in the type inspection meet the requirements of this standard, the type inspection is judged to be qualified. If any unqualified items are found in the electrical safety performance during the inspection, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to detect unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified. 8
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