Some standard content:
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JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20032—2004
Pharmaceutical vacuum freezing dryer
-05 Release
2004-06-01 Implementation
National Development and Reform Commission Release
Foreword
1 Scope
2 Normative Reference Documents|| tt||3 Classification and marking
4 Requirements.
5 Test methods...·
6 Inspection rules·
Logo, instructions for use, packaging, transportation and storage purposes
Times
JB20032-2004
10
JB20032—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Pharmaceuticals" Requirements and GB/T1.1-2000 "Standardization Work Guidelines Part 1: Standard Structure and Writing Rules", CB/T1.2-2002 "Standardization Work Guidelines Part 2: Contents of Normative Technical Elements in Standards" "Determination Method" compiled.
This standard applies to medicinal vacuum freeze dryers and steam sterilization vacuum freeze dryers used in the production of biological products and pharmaceuticals. This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Shanghai Far East Pharmaceutical Machinery Factory. The main drafters of this standard: Lin Xiaohua, Zhang Jinmei, and Shi Weiqin. 4
1 Scope
Pharmaceutical vacuum freeze dryer
JB200322004
This standard specifies the classification of medicinal vacuum freeze dryers and steam sterilization vacuum freeze dryers and markings, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation, and storage. This standard applies to medicinal vacuum freeze dryers (hereinafter referred to as freeze dryers) and medicinal steam sterilization vacuum freeze dryers (hereinafter referred to as steam sterilization freeze dryers).
2 Normative reference documents
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. Version. For undated referenced documents, the latest version shall apply to this standard. GB150—1998 Steel Pressure Vessels
GB/T191 Packaging, Storage and Transportation Pictorial Marks
GB5226.1-2002 Mechanical Safety Machinery and Electrical Equipment Part 1: General Technical Conditions GB/T9969.1 Industrial Products General instructions for use of crystals Method of random sampling using random numbers GB/T 10111
GB/T13306 Labeling
General technical conditions for packaging of mechanical and electrical products
GB/T13384||tt| |GB/T16769
Measurement method of noise sound pressure level of metal cutting machine tools YY/T0216 Pharmaceutical machinery product model compilation method Pressure vessel safety technical supervision regulations (1999 edition) National Bureau of Quality and Technical Supervision 3 Classification and labeling||tt| |3.1 Type
Lyophilizer can be divided into two types: vacuum freezing and steam sterilization vacuum freezing. 3.2 Type
The whole machine control is human-machine interface control.
3.3 Model
3.3.1 The model of the freeze dryer should comply with the regulations of YY/T0216. 3.3.2 Model mark:
5
JB20032—2004
GZL
3.3.3 Marking example:
Improved design sequence number (A, B , C)
Shelf area, m
Structural feature code (Y - hydraulic, Z - steam sterilization) Type code (Z - vacuum: L - frozen)
Product function code: Drying equipment
GZLY10A
The 1st improved design
Shelf area is 10m
Hydraulic (if it is not hydraulic, it does not need to be marked)
Vacuum freeze dryer
GZLY
3.4 ??Basic parameters
Each freeze dryer should have the following basic parameters: a) Shelf area, m;
b) Shelf Plate temperature, ℃;
c) Ultimate vacuum degree in drying oven, Pa;
d) Working temperature of water vapor condenser, ℃: Z10A
The 1st improved design|| tt||One pick-off plate area is 10m
Yan steam sterilization
Hydraulic
Vacuum freeze dryer
e) Water capture capacity of water vaporizer: ≥10kg/ m2; working pressure of steam sterilization: 0.11MPa~0.125MPa; working temperature of f
steam sterilization: 121℃~123℃. g | |tt | Regulation. 4.2 Material requirements
4.2.1 All parts in the freeze dryer and the steam sterilization freeze dryer that come into contact with the product should be made of austenitic stainless steel. 4.2.2 The door sealing strip of the drying oven should be made of non-toxic and odorless silicone rubber. 6
4.3 Structural requirements inside the drying box
JB20032—2004
4.3.1 The structure inside the drying box should be designed as an arc transition, and the inner surfaces must be polished and the surface roughness The Re value should be less than or equal to 0.8jm | adjust. 4.3.4 The temperature difference between removing the board and each board layer should not be greater than ±1°C. 4.4 Performance requirements
4.4.1 Cooling rate of the drying oven: The time for the temperature of the bundle board to drop from 20℃±2℃ to -40℃ should not be more than 2h. 4.4.2 Cooling rate of water vapor condenser: from the ambient temperature of 20℃±2℃, the time for water cooling to -50℃ and air cooling to -45℃ should not be more than 1 hour.
4.5 The monitoring system for water, electricity, temperature, and vacuum in the freezing machine should be able to alarm promptly and accurately, and have automatic display or recording functions. 4.6 The drying box and water vapor condenser should be equipped with sight glasses. 4.7 The water capturing capacity of the water vapor anti-condensation device should be greater than or equal to 10kg/m. 4.8 Vacuum performance of drying oven and water vapor condenser 4.8.1 The ultimate vacuum degree of drying oven and water vapor condenser should be less than or equal to 2.7Pa. 4.8.2 The vacuum leakage rate of the drying box should not be greater than 0.025Pa*㎡/s4.9 Steam sterilization freeze dryer
4.9.1 The door of the drying box should have a safety interlocking device. 4.9.2 The pressure test of the drying oven and water vapor condenser should comply with the provisions of 3.8.1 in GB1501998. 4.10 There should be no abnormal noise during the operation of the freeze-drying machine, and its noise value should not be greater than the sound pressure level 80dB (A). 4.11 Electrical safety performance requirements
4.11.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 of CB5226.1-2002. 4.11.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in CB5226.1-2002. The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.11.3
4.11.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 4.11.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.1-2002. 4.11.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 4.11.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 4.11.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of CB5226.12002. 4.12 Appearance quality requirements
4.12.1. The overall shape of the freeze dryer should be beautiful and elegant, with a compact structure, reasonable layout, and easy maintenance. Accessories should be coordinated with the machine.
4.12.2 The electrical box and electrical components are reasonably arranged on the box surface and easy to operate; the control buttons should be sensitive, accurate and reliable, and the indicator lights and displays should be clear and eye-catching.
4.12.3 The layout of electrical, hydraulic, vacuum refrigeration and piping systems should be tight, reasonable and neatly arranged. 5 Test methods
5.1 According to the requirements of CB150 and "Pressure Vessel Safety Technical Supervision Regulations" (1999 edition), inspect the drying box and 7
JB20032-2004||tt of the steam sterilization freeze-drying machine ||Design and manufacture of water vapor condensers.
5.2 Materials
Materials used in freeze dryers and steam sterilization freeze dryers must provide material certificates. 5.3 Structural requirements test inside the box
5.3.1 Use a comparison sample to test the surface roughness in the drying box. 5.3.2 Use a knife edge ruler or a square ruler to place it on the flat surface of the shelf, and use a feeler gauge to check the flatness of the shelf. 5.3.3 Automatic plugging test:
According to the operation method specified in the instruction manual, start the uncovering plate to perform plugging, and visually observe the automatic plugging process. Adjust the pressure knob and visually adjust the pressure value to the set value.
5.3.4 Uniformity test of board removal temperature:
When the temperature of the base board reaches -40℃, after holding it constant for 15 minutes, take any two-layer base board and use a non-contact tester with an accuracy of less than 0.3℃ The temperature measuring instrument should be measured at any five points within 100mm of the surrounding shelf. The temperature error should not be greater than ±1°C. 5.4 Performance requirements
5.4.1 Drying oven refrigeration rate test:
Turn on the water valve, turn on the power switch, and press the refrigeration button for cooling. Start timing when the deboarding temperature reaches 20°C, and the time when it drops to -40°C should not be more than 2 hours.
5.4.2 Water vapor condenser refrigeration rate test; when the drying box shelf temperature reaches -40°C, place the selector switch to the water vapor condenser position to cool the water vapor condenser, and the water cooling will drop to - The time for cooling from 50℃ to -45℃ should not exceed 1 hour. 5.5 Fault alarm test
5.5.1 Water and electricity alarm test:
When the water and power supply are cut off, the console should display corresponding alarms. 5.5.2 Temperature alarm test:
Preselect a temperature value on the temperature controller. When the temperature in the drying box exceeds the preselected value, there should be an alarm display and the heating will stop. 5.5.3 Vacuum alarm test:
Preselect a pressure value on the vacuum controller. When the pressure in the drying oven exceeds the preselected value, a report should be displayed and heating will stop. 5.6 Visual observation automatic display or recording function. 5.7 Visually observe the peepholes of the drying box and water vapor condenser. 5.8 Test of the water vapor condenser’s water capture capacity
Put the water that is equal to the water capture capacity of the freeze dryer and the same as the room temperature into a special stainless steel plate so that the amount of water in each stainless steel plate is equal, and put it into the drying box Shelves are refrigerated. When the temperature of the drying oven reaches -40°C, the water vapor condenser is refrigerated. When the temperature reaches -50°C, the vacuum pump is started to sublimate the product. The water holding capacity should be in accordance with 4.7. 5.9 Vacuum degree performance testbZxz.net
5.9.1 Under the dry conditions of the dry explosion box and water vapor condenser, open all pipes of the drying box, water vapor condenser and vacuum pump, start the vacuum pump to evacuate the drying box and water vapor condenser for 45 minutes The vacuum degree should comply with the requirements of 4.8.1. 5.9.2 When the pressure in the dry coal box reaches 5Pa, turn off the vacuum pump and maintain the pressure for 30 minutes. Record the value on the vacuum meter and calculate the vacuum leakage rate according to formula (1). 8
Where:
30×60×Vs≤0.025Paml/s
Vacuum leakage rate=
X-5
The vacuum pressure in the drying oven after 30 minutes, Pa; V - the net volume in the drying oven, m. 5.10 Yanqi Auto Sterilization Test
JB20032—2004
(1)
5.10.1 Place the biological indicator made from thermophilic Bacillus spores on each layer of the drying box At the designated position on the plate, when the temperature rises to 121°C and the pressure reaches 0.11MPa, keep it for 30 minutes. Take out the biological indicator and place it directly at 56°C ~ 60°C for 24h~48h. Then take it out and judge the sterilization effect based on the color reaction. After culture, if it remains purple, it means the sterilization has passed; if it turns yellow, it means the sterilization has failed.
5.10.2 During steam sterilization, when the pressure in the drying box is higher than the atmospheric pressure, the drying box door should be safe and reliable. 5.10.3 Pressure test:
The pressure test of the drying oven and water vapor condenser should be carried out according to the method specified in 10.9.4 of GB150--1998. 5.11 Noise test
Use a sound level meter to test the noise of the freeze-drying machine according to the test method of CB/T16769. 5.12 Electrical safety performance test
5.12.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1-2002 respectively. 5.12.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.1-2002 respectively. stipulations. 5.13 Appearance quality
Visually inspect the appearance quality of electrical boxes, drying boxes, and piping systems. 6 Inspection Rules
6.1 Each freeze-drying machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. 6.2 Freeze dryers are subject to factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory products must be inspected one by one according to the provisions of Table 1, and qualified products will be issued with product certificates and quality certificates. Table 1 Factory inspection items
Item category
First number performance
Main performance
Inspection items
4.1,4.2,4.3.2,4.5,4.6 ,4.10,4.11.4,4.11.5,4.11.6,4.11.7,4.11.8,4.124.4.1,4.4.2,4.8.1,4.11.1,4.11.2,4.11.36.2.1.2 Lyophilized If any unqualified product is found during the machine inspection, it should be allowed to be returned for repair and re-inspection. If the product is still unqualified, the product will be judged to be unqualified.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when the following circumstances occur:5 Fault alarm test
5.5.1 Water and electricity alarm test:
When the water and power supply are cut off, the console should display corresponding alarms. 5.5.2 Temperature alarm test:
Preselect a temperature value on the temperature controller. When the temperature in the drying box exceeds the preselected value, there should be an alarm display and the heating will stop. 5.5.3 Vacuum alarm test:
Preselect a pressure value on the vacuum controller. When the pressure in the drying oven exceeds the preselected value, a report should be displayed and heating will stop. 5.6 Visual observation automatic display or recording function. 5.7 Visually observe the peepholes of the drying box and water vapor condenser. 5.8 Test of the water vapor condenser’s water capture capacity
Put the water that is equal to the water capture capacity of the freeze dryer and the same as the room temperature into a special stainless steel plate so that the amount of water in each stainless steel plate is equal, and put it into the drying box Shelves are refrigerated. When the temperature of the drying oven reaches -40°C, the water vapor condenser is refrigerated. When the temperature reaches -50°C, the vacuum pump is started to sublimate the product. The water holding capacity should be in accordance with 4.7. 5.9 Vacuum degree performance test
5.9.1 Under the dry conditions of the dry explosion box and water vapor condenser, open all pipes of the drying box, water vapor condenser and vacuum pump, start the vacuum pump to evacuate the drying box and water vapor condenser for 45 minutes The vacuum degree should comply with the requirements of 4.8.1. 5.9.2 When the pressure in the dry coal box reaches 5Pa, turn off the vacuum pump and maintain the pressure for 30 minutes. Record the value on the vacuum meter and calculate the vacuum leakage rate according to formula (1). 8
Where:
30×60×Vs≤0.025Paml/s
Vacuum leakage rate=
X-5
The vacuum pressure in the drying oven after 30 minutes, Pa; V - the net volume in the drying oven, m. 5.10 Yanqi Auto Sterilization Test
JB20032—2004
(1)
5.10.1 Place the biological indicator made from thermophilic Bacillus spores on each layer of the drying box At the designated position on the plate, when the temperature rises to 121°C and the pressure reaches 0.11MPa, keep it for 30 minutes. Take out the biological indicator and place it directly at 56°C~60°C for 24h~48h. Then take it out and judge the sterilization effect based on the color reaction. After culture, if it remains purple, it means the sterilization has passed; if it turns yellow, it means the sterilization has failed.
5.10.2 During steam sterilization, when the pressure in the drying oven is higher than the atmospheric pressure, the drying oven door should be safe and reliable. 5.10.3 Pressure test:
The pressure test of the drying oven and water vapor condenser should be carried out according to the method specified in 10.9.4 of GB150--1998. 5.11 Noise test
Use a sound level meter to test the noise of the freeze-drying machine according to the test method of CB/T16769. 5.12 Electrical safety performance test
5.12.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1-2002 respectively. 5.12.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.1-2002 respectively. stipulations. 5.13 Appearance quality
Visually inspect the appearance quality of electrical boxes, drying boxes, and piping systems. 6 Inspection Rules
6.1 Each freeze-drying machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. 6.2 Freeze dryers are subject to factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory products must be inspected one by one according to the provisions of Table 1, and qualified products will be issued with product certificates and quality certificates. Table 1 Factory inspection items
Item category
First number performance
Main performance
Inspection items
4.1,4.2,4.3.2,4.5,4.6 ,4.10,4.11.4,4.11.5,4.11.6,4.11.7,4.11.8,4.124.4.1,4.4.2,4.8.1,4.11.1,4.11.2,4.11.36.2.1.2 Lyophilized If any unqualified product is found during the machine inspection, it should be allowed to be returned for repair and re-inspection. If the product is still unqualified, the product will be judged to be unqualified.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when the following circumstances occur:5 Fault alarm test
5.5.1 Water and electricity alarm test:
When the water and power supply are cut off, the console should display corresponding alarms. 5.5.2 Temperature alarm test:
Preselect a temperature value on the temperature controller. When the temperature in the drying box exceeds the preselected value, there should be an alarm display and the heating will stop. 5.5.3 Vacuum alarm test:
Preselect a pressure value on the vacuum controller. When the pressure in the drying oven exceeds the preselected value, a report should be displayed and heating will stop. 5.6 Visual observation automatic display or recording function. 5.7 Visually observe the peepholes of the drying box and water vapor condenser. 5.8 Test of the water vapor condenser’s water capture capacity
Put the water that is equal to the water capture capacity of the freeze dryer and the same as the room temperature into a special stainless steel plate so that the amount of water in each stainless steel plate is equal, and put it into the drying box Shelves are refrigerated. When the temperature of the drying oven reaches -40°C, the water vapor condenser is refrigerated. When the temperature reaches -50°C, the vacuum pump is started to sublimate the product. The water holding capacity should be in accordance with 4.7. 5.9 Vacuum degree performance test
5.9.1 Under the dry conditions of the dry explosion box and water vapor condenser, open all pipes of the drying box, water vapor condenser and vacuum pump, start the vacuum pump to evacuate the drying box and water vapor condenser for 45 minutes The vacuum degree should comply with the requirements of 4.8.1. 5.9.2 When the pressure in the dry coal box reaches 5Pa, turn off the vacuum pump and maintain the pressure for 30 minutes. Record the value on the vacuum meter and calculate the vacuum leakage rate according to formula (1). 8
Where:
30×60×Vs≤0.025Paml/s
Vacuum leakage rate=
X-5
The vacuum pressure in the drying oven after 30 minutes, Pa; V - the net volume in the drying oven, m. 5.10 Yanqi Auto Sterilization Test
JB20032—2004
(1)
5.10.1 Place the biological indicator made from thermophilic Bacillus spores on each layer of the drying box At the designated position on the plate, when the temperature rises to 121°C and the pressure reaches 0.11MPa, keep it for 30 minutes. Take out the biological indicator and place it directly at 56°C ~ 60°C for 24h~48h. Then take it out and judge the sterilization effect based on the color reaction. After culture, if it remains purple, it means the sterilization has passed; if it turns yellow, it means the sterilization has failed.
5.10.2 During steam sterilization, when the pressure in the drying box is higher than the atmospheric pressure, the drying box door should be safe and reliable. 5.10.3 Pressure test:
The pressure test of the drying oven and water vapor condenser should be carried out according to the method specified in 10.9.4 of GB150--1998. 5.11 Noise test
Use a sound level meter to test the noise of the freeze-drying machine according to the test method of CB/T16769. 5.12 Electrical safety performance test
5.12.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1-2002 respectively. 5.12.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.1-2002 respectively. stipulations. 5.13 Appearance quality
Visually inspect the appearance quality of electrical boxes, drying boxes, and piping systems. 6 Inspection Rules
6.1 Each freeze-drying machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. 6.2 Freeze dryers are subject to factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory products must be inspected one by one according to the provisions of Table 1, and qualified products will be issued with product certificates and quality certificates. Table 1 Factory inspection items
Item category
First number performance
Main performance
Inspection items
4.1,4.2,4.3.2,4.5,4.6 ,4.10,4.11.4,4.11.5,4.11.6,4.11.7,4.11.8,4.124.4.1,4.4.2,4.8.1,4.11.1,4.11.2,4.11.36.2.1.2 Lyophilized If any unqualified product is found during the machine inspection, it should be allowed to be returned for repair and re-inspection. If the product is still unqualified, the product will be judged to be unqualified.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when the following circumstances occur:2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when the following circumstances occur:2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when the following circumstances occur:
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