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JB | 01Implementation
National Development and Reform Commission Release
ICS11.120.30
C92
JBbzxZ.net
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20005.1—2004
Replacing YY0235.1-1995
Glass infusion bottle washing machine
Glassinfusionbottlewashingmachine2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission
Release
Foreword
Scope·
2 Normative Reference Documents
3 Classification and Labeling·
4 Requirements·
5 Test methods
6 Inspection rules
7 Marking, instructions for use, packaging and storage Appendix A (informative appendix)
Item
Type inspection Test Record Sheet
Times
JB 20005.12004
JB20005.1-2004
Foreword
This standard is based on the "Good Manufacturing Practice for Pharmaceuticals" and CB /T1.1-2000.GB/T1.2--2002 Standardization Work Guidelines requirements, revision of YY0235.1-1995 "Glass Infusion Bottle Roller Cleaning Machine". This standard will be implemented as YY0235.1-1995 from the date of implementation. Compared with YY0235.1-1995, the main changes in this standard are as follows: a) Clauses 3.1, 3.3, 4.2, 4.9.2.4.11, 4.12, and 5.4 in YY0235.1-1995 have been deleted. b) Revised the following clauses in YY0235.1--1995 and changed the standard name to "Glass Infusion Bottle Cleaning Machine". It has a wide range of applications; one by one, according to the four steps of verification in the "Good Manufacturing Practice for Drugs", the original standard The terms in the "Requirements" section have been rearranged. The contents of "requirements" are classified and put forward in the order of verification; - The operability of the test method is enhanced. The test method corresponds to the content of the requirements chapter; a pair of inspection rules terms and content are revised; - the importance of electrical quality requirements is emphasized, revised according to CB5226.1-2002; - the machine load operation noise is reduced to 80dB ( A). c) The main clauses added to this standard:
appearance quality requirements (see 4.3);
- structural requirements (see 4.4):
- working condition requirements (see 4.5.1~ 4.5.34.5.5); - Requirements for control functions, display functions, interlock functions, and protection functions (see 4.6.5~4.6.8); - Quality requirements for cleaning bottles (see 4.7.4.3 and 4.7.4.4): - Clauses corresponding to the requirements have been added to the test method (see Chapter 5); - The inspection of working conditions has been clarified (see 6.1.2); - Informative Appendix A "Type Inspection Test Record Form" has been added. This The standard is proposed by the 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 is: Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd. The main drafters of this standard are: Sun Jinlian, Zhou Jie, Wang Yuanping, and Huang Yun. The previous versions of the standards replaced by the standard are: CB11753.11989, YY0235.1-1995. 1 Scope
Glass infusion bottle cleaning machine
JB 20005.1-2004
This standard stipulates This standard applies to glass infusion bottle cleaning machines (hereinafter referred to as cleaning machines). 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigendum content) or revised editions are included. None of them apply to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For undated reference documents, the latest versions are applicable to this standard. Illustrated mark
CB2639 glass infusion bottle
GB5226.1-2002 Mechanical Safety Machinery and Electrical Equipment Part 1: General Technical Conditions CB/T6388 Transport Packaging Receipt and Delivery Mark
Industrial Products General instructions for use
GB/T 9969.1
GB/T10111 Random sampling method using random numbers GB/T13306 Labeling
CB/T13384 General technical conditions for mechanical and electrical product packaging Metal cutting Method for measuring sound pressure level of machine tool noise GB/T 16769
YY/T0216 Method for preparation of pharmaceutical machinery product models Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Commission Good Manufacturing Practice for Drugs (1998 revised edition) National Drug Supervision and Administration Bureau 3 Classification and Labeling
3.1 Classification
Cleaning machines are classified into three types: brush type, ultrasonic type, and pressure water flushing type. Brush type cleaning machines are represented by OS, ultrasonic. Type cleaning machines are represented by QC, and pressure water washing machines are represented by QY. 3.2 Model
3.2.1 The model of the cleaning machine should comply with the regulations of YY/T0216. 3.2.2 Model marking:
JB20005.1—2004
3.2.3 Marking example:
Improved design sequence number (A, B, C-)
Specifications Code: Glass bottle specifications (mL)
Type and characteristics code: Qing (Q) washing machine [Brush (S) washing, ultra (C) sonic washing, pressure (Y) force washing) ||tt| |Product function code: Infusion Machinery
S0S100/500 type: represents a brush-type cleaning machine for glass infusion bottles of 100mL~500mL. 4 Requirements
4.1 General
The cleaning machine should comply with the requirements of this standard and the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition) on the manufacturing of pharmaceutical equipment. 4.2 Material requirements
4.2.1 Parts in direct contact with water and gas should be austenitic stainless steel. Stainless steel should have corresponding material certificates. 4.2.2 Other materials should be non-toxic, corrosion-resistant, rust-free, and free of particle precipitation. 4.3 Appearance requirements
4.3.1 The outer surface of the cleaning machine should not have bulges, depressions, roughness or other damage. The appearance of the whole machine should be clean and tidy, and the paint layer should be evenly glossy. 4.3.2 The edges of the exposed joint surfaces of the parts should be neat and even, and there should be no obvious misalignment. There should be no obvious gaps between the door, cover and joint surfaces.
4.4 Structural Requirements
4.4.1 Pipe welding uses argon arc welding, and pipeline connections use quick-open sanitary joints that are easy to clean. 4.4.2 The cleaning station should be equipped with a transparent cover. 4.4.3 The cleaning machine should have an interface for discharging water and steam. The cleaning station should have water collection. 4.4.4 The lower part of the bottle conveyor used by the cleaning machine should have a movable water tray. 4.4.5 There should be isolation devices between different cleaning fluids. 4.4.6 There should be temperature and pressure detection and control devices for the cleaning fluid before it is used. 4.4.7 Pipelines and water collection tanks should have a certain slope and drain ports to drain away the remaining water. 4.4.8 The working surface of the cleaning machine should have certain vertical height and horizontal adjustment devices. 4.4.9 The bottle outlet of the cleaning machine should have a sealing plate connected to the partition wall. 4.5 Working conditions
4.5.1 A recovery device for cleaning fluid recycling should be configured. 4.5.2 Water and steam systems should have filtering devices. The filtration precision is: fresh water for injection is 0.2m; recycled water for injection is 0.45um; compressed air is 0.2um. The upper and lower parts of the filter should be equipped with exhaust and discharge ports. 4.5.3 Flushing fluid pressure and temperature requirements:
a) Flushing fluid pressure: greater than or equal to 0.2MPa; 6
b) Compressed air pressure: greater than or equal to 0.3MPa; alkali temperature: 30 ℃~40℃
c)
d) Hot water temperature: 40℃~50℃;
e) Purified water temperature: 70℃~80℃
f ) Water for injection temperature: 70℃~80℃.
4.5.4 Packaging material requirements: Glass infusion bottles should comply with CB2639 requirements. JB20005.1—2004
4.5.5 Environmental requirements: The bottle outlet of the fine cleaning device should be connected to the bottle feeding and conveying machine of the bottle loading machine under the 100-level laminar flow hood. 4.6 Functional requirements
The flushing liquid should fill the inner wall of the bottle.
4.6.1
4.6.2 The remaining water in the bottle should be eliminated.
4.6.3 The cleaning machine should be able to meet the production speed requirements and have stepless speed regulation within the specified range. 4.6.4 The cleaning machine should be able to clean 100mL, 250mL, 500mL and other glass infusion bottles. Replacing specifications and accessories should be simple, reliable, and quick to replace.
4.6.5 Control functions: control the detection of incoming bottle shortages and incoming bottle counting; control the prevention of accumulation of outgoing bottles; control the operation and cleaning time of the cleaning process: control the temperature and pressure of the cleaning fluid; control the production speed; Control cleaning procedures. 4.6.6 Display function: display the production speed and total output; display the temperature and pressure of the flushing fluid before the point of use. 4.6.7 Interlock function: When the cleaning fluid pressure does not reach the set value, it should automatically stop; when the cleaning fluid temperature does not reach the set value, it should automatically stop; when the incoming bottles are missing or the outgoing bottles are accumulated, the machine should automatically stop. 4.6.8 Protection function: When the outer cover of the cleaning station is opened, the machine should stop working. 4.7 Performance requirements
4.7.1 There shall be no leakage in the piping system, no oil leakage from the reducer oil tank, and the temperature rise shall not exceed 35°C. There is no abnormal noise in the whole machine and the machinery is running normally.
4.7.2 The conveying device should ensure that the bottles enter the bottle washing station accurately, and the movements of each process are sensitive and accurate. 4.7.3 The noise level during load operation shall not exceed 80dB(A). 4.7.4 Quality requirements for cleaned glass infusion bottles: 4.7.4.1 The surface of the cleaned bottle must be free of stains, flow marks and dull thin layers. 4.7.4.2 After loading the water for injection, check that there should be no foreign matter and less than or equal to 3 white spots. 4.7.4.3 The microbial removal effect on the inner surface of the bottle should be less than 50CFU/bottle. Note: The meaning of CFU is: a bacterial colony formed by one or more bacteria after bacterial culture. It is referred to as CFU for short and is usually expressed by number. 4.7.4.4 The chemical and particle residue removal effect on the inner surface of the bottle should reach: a) pH measurement: pH value 5.0~7.0;
b) Conductivity measurement: less than 2.0uS/cm; c) Particle measurement: There are less than 25 particles larger than 10μm/mL, and less than 3 particles larger than 25pm/mL. 4.7.5 Electrical system quality requirements:
4.7.5.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 4.7.5.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.1-2002. 4.7.5.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. JB 20005.1—2004
4.7.5.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1—2002. 4.7.5.5 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
Visual inspection requirements of 4.2, 4.3.1, 4.3.2, 4.4,1~4.4.9. 5.2 Inspection of cleaning machine documentation and working conditions 5.2.1 Inspection of documentation:
Visually inspect the cleaning machine instruction manual, product certificate, material certificate, instrument calibration certificate, etc. 5.2.2 Working condition test:
a) After the cleaning machine is installed successfully, visually check whether it is equipped with a recovery device for recycling the cleaning fluid. b) Whether the water and steam supply system is equipped with filters that meet the requirements. c) Use a grade 2 industrial thermometer to measure the temperature of the cleaning fluid: Use a grade 2.5 pressure gauge to detect the pressure of the cleaning fluid. 5.2.3 Packaging material confirmation:
Glass infusion bottles are inspected according to the regulations of CB2639. 5.3 Cleaning machine function test
5.3.1 At the test site, visually inspect the flushing fluid to fill the inner wall of the bottle. 5.3.2 At the test site, the cleaned bottles were detected. No water droplets could be seen by visual inspection. The bottles were inverted for 1 minute and no water flowed out. 5.3.3 Production speed test:
Adjust the speed of the cleaning machine to the designed maximum speed, replace the cleaning fluid with drinking water, put it into the bottle, simulate the positive belt production program and run for 30 minutes, then count with a tachometer or stopwatch 5 minutes. Then adjust the transmission device within the specified range, and measure the speed adjustment range by testing the production speed.
5.3.4 Replacement of accessories and bottle specification test: Replace accessories of corresponding specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the production speed test method.
5.3.5 Control function test:
Before the cleaning machine leaves the factory, cold water and hot water are used as cleaning fluids to simulate normal production procedures for testing. 5.3.6 At the test site, visually inspect the display function. 5.3.7 Chain function test:
a) Adjust the cleaning fluid pressure to lower than the set value, and observe that the machine should stop automatically: b) Adjust the cleaning fluid temperature above or below the set value, and observe that the machine should stop. Automatic shutdown; c) Remove the bottles in front of the entrance of the bottle inlet star wheel, and the observation machine will automatically stop; d) If there are too many bottles piled up at the bottle outlet, the observation machine will automatically stop. 5.3.8 Protection function test:
When the cleaning machine is working, open the cleaning station cover and observe that the machine should stop working. 5.4 Cleaning machine performance inspection
5.4.1 No-load test:
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JB20005.1—2004
Start the cleaning machine with no load, and run the speed from low to high 2h, place a secondary industrial thermometer on the top of the reducer oil tank shell for 10 minutes to measure the temperature rise of the oil tank; visually check that there is no leakage in the pipeline system, no oil leakage from the reducer, and no abnormal noise. 5.4.2 Load test:
After the cleaning machine passes the air cutting test, the load test will be performed. The manufacturer uses the highest production speed during the test, uses drinking water instead of cleaning fluid, injects it into bottles, and simulates normal production procedures for 30 minutes. Check that the bottle delivery is in place and the process movements are sensitive and accurate. 5.4.3 Noise test:
When the cleaning machine is working, test the machine noise according to the regulations of GB/T16769. 5.4.4 Glass infusion bottle cleanliness test:
5.4.4.1 Bottle surface quality inspection: Visually inspect the surface quality of the bottle after cleaning. 5.4.4.2 Foreign matter and white spot inspection: Under the laminar flow hood at the actual production site, randomly and continuously sample 15 bottles, fill them with water for injection to the standard volume, seal them with sterile rubber stoppers, hold the neck of the glass infusion bottle, and hold it upright or upside down. , head-up three-step rotation visual inspection. 5.4.4.3 Microbial removal effect test: At the actual production site, under the laminar flow hood, randomly sample, once every 2 minutes, and take 10% of the output per minute each time, for a total of five times, seal with a sterile rubber stopper before sending away the microorganisms The laboratory conducts microbial content testing. The test method is: use 50ml/bottle of water for injection to oscillate and rinse the entire inner surface of the bottle, filter the eluent through a 0.22m sterile filter membrane, culture and count. 5.4.4.4 Determination of chemical and particle residues on the inner surface of bottles: At the actual production site, under laminar flow rate, 40 to 50 bottles are randomly selected, sealed with rubber stoppers rinsed with 0.22m filtered water for injection, and sent for inspection room inspection. a) pH value measurement: Take out 10 bottles from the sample, rinse the inner surface of the bottles with 50mL/bottle of fresh water for injection, then put the pH test paper into the cleaning solution, take out the pH test paper and compare it with the pH value color guide; b) Conductivity measurement: Take out 20 bottles from the sample, rinse the inner surface of the bottles with 50 mL/bottle of fresh water for injection, and then use a conductivity meter to measure the conductivity of the rinsed water for injection, which should be less than 2.0 μS/cm; Note: Conductivity The rate is the reciprocal of the electric function rate. Analytical methods such as polymer chromatography and atomic absorption spectrometry are usually used to determine the content of various anions and cations in water.
c) Particle determination: Take out 20 bottles from the sample, pour 20 mL of 0.22mum filtered 0.9% NaCI solution under the laminar flow hood and rinse the inner surfaces of the bottles. Use a particle counter to determine the number of particles larger than 10gm and 25m. Note: The quality of water for injection used for cleaning and inspection should comply with the provisions of the Pharmacopoeia of the People's Republic of China (2000 edition). 5.4.5 Quality inspection of electrical system:
5.4.5.1 Continuity of protective grounding circuit and insulation resistance of electrical system The withstand voltage test shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 in CB5226.1-2002.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be in accordance with GB5226.1--2002. 8.2 and inspection specified in Chapter 14
6 Inspection rules
6.1 General inspection rules
6.1.1. Each cleaning machine must pass the inspection by the inspection department of the manufacturing unit in accordance with this standard before leaving the factory. The manufacturer will issue a product certificate after the product passes the inspection items after installation. 6.1.2 The inspection of documentation and working conditions of the cleaning machine (i.e. installation confirmation test) is only carried out during type inspection. 6.2 Inspection classification
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