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Aseptic PET bottles cold-filling line

Basic Information

Standard ID: GB/T 24571-2009

Standard Name:Aseptic PET bottles cold-filling line

Chinese Name: PET瓶无菌冷灌装生产线

Standard category:National Standard (GB)

state:in force

Date of Release2009-10-30

Date of Implementation:2010-03-01

standard classification number

Standard ICS number:Packaging and transportation of goods>>55.200 Packaging machinery

Standard Classification Number:General>>Marking, packaging, transportation, storage>>A84 packaging tools

associated standards

Publication information

publishing house:China Standards Press

ISBN:155066·1-39236

Publication date:2010-03-01

other information

Release date:2009-10-30

drafter:Huang Dongning, Shi Zhongwei, He Deping, Lu Peizhong, Huang Weidi, etc.

Drafting unit:Nanjing Lehui Light Industrial Equipment Manufacturing Co., Ltd., Hangzhou Zhongya Machinery Co., Ltd., etc.

Focal point unit:National Packaging Machinery Standardization Technical Committee (SAC/TC 436)

Proposing unit:National Packaging Machinery Standardization Technical Committee (SAC/TC436)

Publishing department:General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China

competent authority:National Standardization Administration

Introduction to standards:

GB/T 24571-2009 PET Bottle Aseptic Cold Filling Production Line GB/T24571-2009 Standard Download Decompression Password: www.bzxz.net
This standard specifies the terms and definitions, models, types, equipment composition, basic parameters, aseptic line working conditions, requirements, test methods, inspection rules, marking, packaging, transportation and storage requirements of PET bottle aseptic cold filling production line. This standard is applicable to the filling production equipment of PET and other plastic bottles for liquid food under aseptic conditions, and is used in food and other industries.
This standard is proposed and managed by the National Packaging Machinery Standardization Technical Committee (SAC/TC436). The
responsible drafting units of this standard are: Nanjing Lehui Light Industry Equipment Manufacturing Co., Ltd., Hangzhou Zhongya Machinery Co., Ltd., Jiangsu Newamstar Liquid Packaging Engineering Technology Research Center Co., Ltd., Langfang Baiguan Packaging Machinery Co., Ltd., Jianji Group Foshan Jianbang Machinery Co., Ltd., and Machinery Industry Packaging Machinery Product Quality Supervision and Inspection Center.
The main drafters of this standard are: Huang Dongning, Shi Zhongwei, He Deping, Lu Peizhong, Huang Weidi, Chen Xiaoping, Ji Yonglin, Zhang Guohong, Zhang Tiejun, Li Feng, Cai Linchang, Chen Runjie.

The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, 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 all undated referenced documents, the latest versions are applicable to this standard.
GB/T191 Pictorial signs for packaging, storage and transportation (GB/T191-2008, ISO780:1997, MOD)
GB2894 Safety signs and guidelines for their use
GB/T4789.2 Microbiological examination of food hygiene - Determination of total colony count
GB/T4789.15 Microbiological examination of food hygiene - Count of molds and yeasts
GB/T4789.26 Microbiological examination of food hygiene - Test for commercial sterility of canned food
GB/T5048 Moisture-proof packaging
GB5226.1-2002 Safety of machinery - Electrical equipment of machinery - Part 1: General technical requirements (IEC602041:2000, IDT)
GB5749 Hygienic standard for drinking water
GB/T7311 Classification and model compilation method of packaging machinery
GB9969 General principles for industrial product instruction manuals
GB12695 Good manufacturing practice for beverage enterprises
GB/T13306 Signs
GB/T13384 General technical conditions for packaging of electromechanical products
GB16179 Guidelines for the use of safety signs
GB/T16273.1 Graphic symbols for equipment Part 1: General symbols (GB/T16273.1-2008, ISO7000:2004, NEQ)
GB/T16292 Test method for suspended particles in clean rooms (areas) for pharmaceutical industry
GB/T16293 Test method for floating bacteria in clean rooms (areas) for pharmaceutical industry
GB/T16294 Test method for sedimentation bacteria in clean rooms (areas) of pharmaceutical industry
GB16798 Food machinery safety and sanitation
GB/T17876 Plastic anti-theft bottle caps for packaging containers
GB/T18883-2002 Indoor air quality standard
GB19891 Mechanical safety Hygienic requirements for mechanical design (GB19891-2005, ISO14159:2002, MOD)
JB/T7232 Simple method for determination of sound power level of packaging machinery noise
JB7233 Safety requirements for packaging machinery
QB1868 Polyethylene terephthalate (PET) carbonated beverage bottles
JJF1070 Rules for metrological inspection of net content of quantitatively packaged goods
Technical Specifications for Disinfection (2002 Edition) issued by the Ministry of Health of the People's Republic of China

Some standard content:

ICS55.200
National Standard of the People's Republic of China
GB/T 24571--2009
Aseptic PFT hotiles cold-filling line2009-10-30Release
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
2010-03-01Implementation
People's Republic of China
National Standard
Aseptic PFT hotiles cold-filling line
GR/T245712005
Published and distributed by China Standard Publishing House
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Format 88C×12301/16 Printing sheet 1 Word count 24 characters First edition in November 2009 First printing in November 2009x
Book number: 1:5066·135236
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Report telephone: (010)68533533
http://foodmate.netForeword
This standard is proposed and managed by the National Packaging Machinery Standard Promotion Technical Committee (SAC/TC436). GB/T 24571—2009
The responsible drafting organizations of this standard are: Nanjing Lehui Light Industry Equipment Manufacturing Co., Ltd., Hangzhou Zhongya Machinery Co., Ltd., Jiangsu Xinmeijin Liquid Packaging Engineering Technology Research Center Co., Ltd., Langfang Baiguan Packaging Machinery Co., Ltd., Jianji Group Foshan Jianbang Machinery Co., Ltd., and Machinery Industry Packaging Machinery Product Quality Supervision and Inspection Center. The main drafters of this standard are: Huang Dongning, Shi Zhongwei, He Deping, Lu Pei, Huang Weidi, Chen Xiaoping, Ji Yonglin, Zhang Guohong, Zhang Tiejun, Li Feng, Cai Linchang, and Chen Runjie.
http://
1 Scope
PET Bottle Aseptic Cold Filling Production Line
CB/T 24571—2009
This standard specifies the terms and definitions, models, types, equipment composition, basic parameters, working conditions, requirements, test methods, inspection rules, marking, packaging, transportation and storage requirements of PET bottle aseptic cold filling production line (hereinafter referred to as "light sterilization line"). This standard is applicable to the filling production equipment of plastic bottles such as PFT for liquid food under aseptic conditions, and is used in food and other industries. 2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties who reach an agreement based on this standard are encouraged to study whether the latest version of this document can be used. For undated referenced documents, the latest version shall apply to this standard. GB/T191 Pictorial marking for packaging, storage and transportation (GB/T191-2008, IS0780:1997, MOID) GB2894 Safety signs and guidelines for their use
G13/T4789.2 Microbiological examination of food hygiene - Determination of total colony count
GB/T4789.15 Microbiological examination of food hygiene - Count of bacteria and yeast GB/T4789.26 Microbiological examination of food hygiene - Examination of commercial sterility of food
G3/T5018 Moisture-proof packaging
GB5226.1—2002 Mechanical safety Mechanical electrical equipment Part 1: General technical conditions (1ECG0204-1: 2000, II)T) GB5749 Drinking water Weihua standard promotion
G13/T7311 Packaging machinery classification and model compilation method GB9969 Industrial product instructions 5 General principles
GB12695 Good manufacturing practice for beverage enterprises
G13/T13306 Signs
GB/T13381 General technical conditions for packaging of electromechanical products GB 16179
Guidelines for the use of safety signs
(H13/T16273.1 Graphic symbols for equipment Part 1: General symbols (GB/T16273.1—2008.IS0) 7000: 2004, NEQ
GB/T 16292
Test method for suspended particles in clean air (area) of pharmaceutical industry HI3/T16293
Test method for floating bacteria in clean room (area) of pharmaceutical industry GB/T16294Test method for settling bacteria in clean room (area) of pharmaceutical industry GB16798Safety and sanitation of food machinery
GB/T17876Plastic anti-theft bottle caps for packaging containers GB/T18883—2002Air quality standard GB19891Machinery safetySanitary requirements for machinery design (GB198912005, IS OI4159:2002.MOI)) J13/T7232 Simple method for determination of noise level of packaging machinery JB7233 Safety requirements for packaging machinery QB1868 Polyethylene terephthalate (PFT) carbonated beverage bottles JJF1070 Rules for metrological inspection of net content of quantitatively packaged goods Technical specification for disinfection of the Ministry of Health of the People's Republic of China (2002 edition) GB/T24571-2009 3 Terms and definitions The following terms and definitions apply to this standard. 3.1 Commercial sterilization The packaged liquid food does not contain pathogenic bacteria or microorganisms that can proliferate at room temperature. 3.2 Aseptic cold-filling Aseptic cold-filling is to fill and seal the sterilized liquid food in a sterilized container under normal temperature and aseptic conditions, so that the food can be transported and stored at room temperature within the shelf life. Cleaning in place means to use a cleaning liquid of a certain temperature and concentration to strongly act on the surface to be cleaned under closed conditions, so that the surface in contact with food is cleaned without dismantling the equipment or components. It is also called cleaning in place, abbreviated as "cleaning in place". Sterilization in place means to use a cleaning liquid of a certain temperature and concentration to strongly act on the surface to be cleaned under closed conditions, so that the surface in contact with food is cleaned without dismantling the equipment or components. Sterilization medium of a certain temperature and expansion, or using steam hot water or superheated water to strongly act on the surface of the tea to meet the sterilization requirements, referred to as SIP"3.5
Equipment surface cleaning
leaningoutsideprocess,cop
Cleaning of the inner surface of the space, referred to as COPR
Equipment surface sterilization outsideprocessSop sterilization of the surface of the equipment inside the space, referred to as SOPS
itrature heat treated.UHT
Ultra-high temperature instantaneous sterilization
The product is heated to 120℃-150℃ in a closed system and then quickly cooled to the palm temperature for a sterilization process, referred to as \UHT\
Aerobic bacilli count is the total number of colonies contained in 1 μL (g) of the sample after being cultured under the following conditions (such as culture composition, culture temperature and time, pH, oxygen demand, etc.). According to the national standard method, that is, under aerobic conditions, cultured at 37℃ for 48h, the total number of mesophilic aerobic colonies that can grow on ordinary nutrient agar plates is expressed in "CFU/nL ()\3.9
Class 100 clean room (area) class100cleanro0m (area) is a room or area that is required to be environmentally controlled for dust particles and microbial pollution according to regulations. Its equipment, structure and use have the function of reducing the entry, generation and stagnation of pollution sources in the area. The cleanliness level of the clean room (area) meets the requirements of Class 100 clean room (area) specified in the relevant standards,
Aseptic period
The longest interval time for periodic CIP/SIP cleaning and sterilization to ensure aseptic production status. 3.11
Sterilization efficiencySEThe logarithm of the total number of microorganisms before and after sterilization of materials and equipment. The sterilization efficiency is calculated using the following formula. 2
Food||||Total number of microorganisms before sterilization
SE=log
Total number of microorganisms after sterilization
Low acid liquid foodlowacidliguidfoodLiquid food with a balanced pH value greater than 4.6 after sterilization, except for alcoholic beverages3.13
Acid liquid foodLiquid food with a balanced pH value less than or equal to 4.6 after sterilization. 3.14
Coniamination ratio of productThe ratio of the number of microbial proliferation bottles in a sample inspection batch of a product to the total number of bottles produced. 3.15
Microbe
GB/T 24571—2009
-·A general term for microorganisms with a body size less than 0.mm, simple structure, invisible or unclear to the naked eye, mainly including prokaryotes (bacteria, nematodes, etc.): eukaryotes (fungi such as fungi, mosses, protozoa such as amoeba, microalgae such as Chlamydomonas), non-bacteria (pathogens and viruses), etc.:
Net content nelquantity
The amount of the product after removing the packaging and other accompanying materials Note: Regardless of the packaging materials of the product or any other materials packaged with the product, the net content should not be recorded as the net content. 4 Model, type, equipment composition, basic parameters and wireless working conditions 4.1 Model
The model of the sterile line shall be compiled in accordance with the provisions of G13/T7311. GWI-LI
Improved design sequence code. Indicated by English letters A, B, C... in sequence. The first designed product has no sequence code. Derived sequence code: Indicated by Roman numerals 『, 『, 』, ..... Number of capping (hot-press capping) heads, in pieces. Number of filling valves, in pieces.
Structural type code: Rotary type is indicated by "X", linear type is indicated by \7". PET bottle aseptic cold filling production line
Example 1: GWJX32-12 represents a rotary PFT bottle cold filling production line, with 32 valves, 12 capping heads, and the first design. Example: GWJ-Z8-8 represents a linear PET bottle aseptic cold filling production line, with 8 capping heads and 12 capping heads. 8, first design.
4.2 Aseptic lines are divided into three types according to the following situations 4.2.1 According to the bottle supply method, they are divided into: inline type and non-inline type. 4.2.2 According to the filling structure type, they are divided into: rotary type and linear type. 4.3 Equipment composition
4.3.1 Aseptic lines should be composed of the following main units and systems: a)
Material sterilization system;
Bottle sterilizer:
btt
GB/T 24571—2009
Cap sterilizing machine;
Aseptic bottle washing, filling, capping (hot pressing and sealing) unit: capping (capping) system;
Automatic CIP, SIP system:
Disinfectant liquid configuration and recovery system,
Aseptic water preparation system;
100-class clean room (area) air purification system:
Steam purification system;
Sterile compressed air or light bacteria nitrogen system
Exhaust gas treatment system. ||t The aseptic line can be equipped with the following auxiliary equipment:
Light sterilization tank system:
Blowing machine or bottle unscrambler
Bottle storage warehouse:
Bottle conveying system;
Bottle cap lifting machine
White dynamic COP
Wrapping (sleeving) labeling machine)
system;
Cartoning machine cover
Core packaging machine;
Carton conveying system
Palletizer;
Inkjet printer
Other auxiliary
Basic Parameters
Basic parameters of aseptic line should include:
Filling capacity
Number of filling valves
Quantity:
Capping (heat pressing and sealing)
Production capacity: bottle
Power.kw;
Rated voltage and frequency: V,
The production efficiency of aseptic line should not be less than 85% of the rated production capacity. 4.5 Working conditions of aseptic line
Sterile water, electricity, gas (including sterile and aseptic) steam (not less than 0.6MIP a), compressed air (not less than 0.6MIa), chain disinfectant 4.5.1
and other process conditions and parameters shall meet the requirements of each unit in the sterile line. 4.5.2 The air compressor and its storage tank shall be separated from the sterile line. 4.5.3 The water used for production shall meet the requirements of GB5749 4.5.4 The deviation between the power supply voltage and the rated voltage shall not exceed +5% and -10% 4.5.5 The working environment of the sterile bottle flushing, filling, capping (or counteracting) unit shall be in a clean workshop of 100,000 grade. 4.5.6
According to the nature of the filling material and the shelf life, determine the anoxic and light-proof conditions of the bottle and the cap. 5 Requirements
5. The sterile line shall meet the requirements of this standard and be manufactured according to the drawings and technical documents approved by the prescribed procedures. 4
http://foodmate.netCB/T24571--2009
5.2 Each unit of the sterile line should run smoothly, with reliable working performance, and the moving parts should move flexibly, coordinately and accurately, without blocking, abnormal heating, vibration and abnormal sound.
5.3 Each circuit control system of the sterile line should meet the requirements of GB5226.1, be safe and reliable, and move accurately. Each electrical connector should be firmly connected and numbered; the operating button should be flexible and have an emergency stop button; the indicator light display should be normal. 5.4 The conveyor belt should be stable and reliable, and the bottle stopper should be flexible and reliable. 5.5 The steam, compressed air, lubrication system, conveying pipeline, etc. in the sterile line should be unobstructed, flexible to control, and leak-free, and should comply with the relevant national and industry standards.
5.6 The sterile line should be equipped with an automatic interlocking protection system for the sterile production environment. When the sterile production environment is damaged, the system should immediately alarm: automatically enter the relevant processing flow according to the degree of damage for the operator to confirm. 5.7 The cleanliness of the bottle washing, filling, and capping areas should comply with the standards of the 100-level clean area (room) specified in GB/T1622, GB/T16293. GB/T16294. The air flow should flow from the high-level area to the adjacent low-level area. The high-level area should maintain a positive pressure of 10Pa~15Pa relative to the low-level area, and the positive pressure measurement should be continuous and visible. 5.8 After the clean area (room) space and central equipment surfaces are cleaned and sterilized by COP/SOP, all the impact points should be tested and there should be no colony growth. The sterilization efficiency of the disinfectant (SF7) 5.9 The sterilization efficiency of the physical sterilization equipment matched with the aseptic line for low-acid liquid food is not less than that for ten-acid liquid food. 5.10 Carry out microbial verification test on the empty bottle caps, empty bottles with caps, and sterile water after sterilization. The results should show no difference, bacteria and yeast growth: Use the corresponding culture medium for filling test. In the sterilization state, the peracetic acid or peroxide in the empty bottle after normal filling and sterilization is not more than 10,000 parts per million. The residual oxygen concentration should not be less than 0.5mg/1ol
Aseptic line
The concentration of peracetic acid or peroxide gas should not be greater than ing/L.
When filling acid
foods, the aseptic cycle should not be less than 48h. When filling low-acid liquid foods, the aseptic cycle should not be less than 16h. The filling machine accuracy should comply with the requirements of Table 1. The actual content should comply with the requirements of JIF1070, and the filling accuracy
Content/mL (g)
5.15 Appearance and sealing quality of the package.
5.15.1 The appearance quality of the package should meet the following requirements: Filling accuracy/%
The surface of the package should be smooth and free of deformation, concave filtering, mislabeling and wire drawing at the bottle mouth support ring. 5. 15. 1. 1
There shall be no drooping lid, broken lid or missing lid at the sealing part of the package. 5. 15. 1.2
5.15.1.3 The production date, production batch number and other coding positions of the package shall be correct and consistent, and the coding shall be clear and firm. 5.15.2 The opening torque of the bottle cap shall be within the range of 0.6N·m~2.8Nm, and the qualified rate shall not be less than 19.8% (hot press capping shall not be subject to this test).
5.15.3 After the sealing test, there shall be no leakage at the sealing part of the package. 5.16 The appearance and seal pass rate of the package shall not be less than 99.5%. 5.17 The microbiological indicators of the package shall comply with the requirements of commercial sterilization and the hygiene standards of relevant products. 5.18 When the sterile line is operating normally, the noise sound pressure level shall not be greater than 80dB(A). 5.19
The insulation resistance measured when a voltage of 500V is applied between the power circuit conductor and the protective grounding circuit shall not be less than 1M. 5.20
Electrical equipment shall have a reliable grounding device and an obvious grounding mark. The grounding resistance shall comply with the requirements of 19.2 in GB5226.12002.
bt
GB/T24571-2009
All circuit conductors and protective grounding circuits of electrical equipment shall be subjected to a withstand voltage test of at least 1 hour. 5.22 The safety and expansion protection of sterile lines shall comply with the following provisions: a) The safety protection of each unit of the sterile line shall comply with the provisions of JB7233: h)
Each unit of the sterile line shall have clear and obvious signs of operation, lubrication, safety protection and warning, etc. All signs shall comply with GB 2894, GB16179 and GB/T 16273.1; The sterile line should be equipped with interlock protection. When the packaging bottle is stuck, the material is missing or the operation is wrong, an alarm should be sounded and the machine should be stopped. When opening the protective device of the sterile line may cause danger, the device should be interlocked with the transmission mechanism; the steam system and the compressed air system should have safety devices, the steam system pipeline should have moisturizing measures, and the pipelines that are not convenient for insulation should have obvious high-temperature signs. The markings should comply with the provisions of GB2894; the sterile line should have anti-loosening devices for parts that are easy to fall off, and the exposed rotating gears, pulleys, sprockets, etc. should have protective devices. The reciprocating motion of the machine should have extreme position protection devices: when the sterile line uses volatile chrysanthemum-killing liquid, the storage box or the non-foaming box should be closed and have safety protection devices; g) When the height of the overhead passage for operators connecting the various parts of the sterile line exceeds 1.5m, there should be guardrails on both sides, and the height of the guardrails should not be less than 1.05 m.
5.23 The appearance quality of the sterile line shall comply with the following provisions: 5.23.1 The paint and plastic spraying layer on the surface shall be smooth and even in color, without obvious dirt, flow marks, bubbles and other defects. 5.23.2 The parts on the surface shall have even color, without bubbles, delamination, rust and other defects. 5.24 The materials and parts of the sterile line shall comply with the following provisions: 5.24.1 The materials and sanitary equipment structure of each unit of the sterile line and its safety, cleanability, disassembly and other requirements shall comply with the provisions of G1316798.
5.24.2 The surface of the equipment that contacts the packaging container and the filling material shall be smooth, flat, easy to clean or disinfect, corrosion-resistant, and shall not react chemically with the filling material.
5.24.3 The surfaces of containers, pipes, valves, etc. that are in contact with filling materials or need to be cleaned by CIP should be polished, without dead angles, welds should be polished, and there should be no gaps for material storage. The material contact area of ​​the sterile line should not be contaminated by materials. The surface roughness Ra value of narrow vessels and valves should not exceed 1.6m. The roughness Ra value of non-product contact surface parts in the clean area (room) should not exceed 3.2pI. 5.24.4 Lubricating oils used in clean areas should have protective devices and comply with relevant standards for food-grade lubricating oils. 5.24.5 Purchased valves, pipe fittings, and detection components that are in contact with filling materials, sterile water, and sterile gas should be sterile or have a structure without cleaning dead angles.
5.24.6 Rubber parts and sealing materials that are in contact with (may be) disinfectants or cleaning fluids and other chemical and corrosive media in the sterile line should be of oxidative corrosion type, such as fluororubber, silicone rubber, ethylene propylene rubber, etc. 5.24.7 The raw materials and purchased supporting parts used in the sterile line should have the quality certificate of the manufacturer15. If there is no quality certificate, it should be accepted according to the product and relevant standards before it can be put into use. 5.24.8 The mechanical design and sanitation safety of the sterile line should comply with the requirements of GR19891. 6 Test method
6, 1 Test conditions
6.1.1 The test environment temperature should be 15℃-~27℃, and the relative humidity should not be greater than 50%. The factory building and facilities should comply with the requirements of GB12695.
6.1.2 The PET bottles used in the test towels should comply with the relevant provisions of Q31868, the plastic anti-theft bottle caps should comply with the relevant provisions of GB/T17876, and other bottles and caps should comply with the provisions of relevant national and industry standards. 6.1.3 The original chrysanthemum drop count of the bottle and cap shall not exceed 5CFU/bottle (cap). 6.1.4 The filling material shall use a liquid medium (juice, etc.) that complies with the relevant national and industry standards. 6.1.5 The cleanliness of the clean area (room) shall be tested according to the methods specified in GB/T16292, GB/T16293 and GB/T16294 and shall meet the requirements of 6.2~6.10 after the cleanliness of the area meets the requirements. 6.2 Idle operation test GB/T24571—2009 After each aseptic line is assembled, an empty operation test shall be carried out. The continuous empty operation time shall not be less than 24 hours. Check the machine performance and it shall meet the requirements of 5.2~5.1.
6.3 Production efficiency test
After the whole production line runs normally, at the finished product outlet, collect the number of finished products filled for 2 hours continuously, and calculate the production line efficiency according to formula (1), which should meet the requirements of g) in 1.4:
7-Production line efficiency, %
F-Production capacity, single channel is pushed per hour (bottles/h); T---effective time, unit is hour (h); M
The number of finished products within 2 hours, unit is bottle. t 1)
The effective time (T) is: the total time of the test time 2 minus the total time of the planned downtime of any single machine not caused by the equipment itself during the test time (2),
Where:
Current time (2):
, unit is hour (h)
The sum of all downtimes not caused by equipment failure itself, unit is hour (). 6.4 Check the air, pipe and lubrication system tightness. Check whether there is steam leakage and dripping on the air, which should comply with the provisions of 5.5. 6.4.2 Apply saturated water or washing water to the seal of the pneumatic component seal to observe whether there is leakage, which should comply with the provisions of 5.5. 6.4.3 Gently wipe the seal of the lubrication system with degreased cotton and observe whether there is any stain on the absorbent cotton. It should comply with the provisions of 5.5. Gently wipe the seal of the pipeline with degreased cotton. 6.4.4 6.5 Microbiological verification 6.5.1 Colony test on the surface of the clean room and its equipment 6.5.1.1 Clean room space Observe whether there is any object on the absorbent cotton. It should comply with the provisions of 5.5. Colony test: first put the plate with culture medium (sterilized) into the clean area (room) (its cleanliness has reached 100% standard): after COP/SOP cleaning and sterilization, open the plate at the set key point for no more than 10 minutes, then make the filling machine operate normally, maintain the air flow in the clean area (room), and conduct dynamic test. After 30 minutes, cover it and then put it in the incubator for cultivation. Test it according to the provisions of GB/T 4789.2. Observe its results. It should meet the requirements of 5.8. Patch test: place 10 to 30 steel plates with bacteria (specified species and quantity) in the designated area of ​​the clean room, and take them out after COP/SOP cleaning and sterilization. Test it according to the provisions of GR/T4789.2. Observe its results. Its sterilization efficiency should meet the requirements of 5.8.
6.5.1.2 Equipment surface: Carry out a smear test on the surface of the clean room equipment. Use a sterile cotton swab to take samples from designated locations (generally arranged on equipment surfaces that are difficult to clean, and locations with extremely high sterility requirements, such as near the filling head). Test according to the provisions of T in GB/T4789.2 and observe the results. They should meet the requirements of 5 and 8. 6.5.2 Original colony test of empty bottles and caps
6.5.2.1 Original colony test of empty bottles
Randomly select 100 empty bottles before TE (when the number of filling valves is less than 100, take 100 empty bottles; when the number of filling valves is greater than or equal to 100, the number of samples taken should not be less than the number of discharge valves). Rinse each empty bottle with 200mL of sterile saline, take 100mL of water sample for total bacterial count test, and the remaining 100mL of water sample for mold and yeast test. Use the membrane filtration method: use a filter with a pore size of no more than 0.5m sterile membrane with a diameter of about 501nm is used for suction filtration. After filtration, the membrane is replaced in a container with culture medium (if a dense membrane filter is used, the culture medium is added to the corresponding container). According to the specified test in GB/T4789.2.GB/T4789.15, observe the results, which should meet the requirements of 6.1. 3. Requirements of the bottle caps,
6.5.2.2 Original colony test of bottle caps
Randomly select [000] caps before sterilization (when the number of filling valves is less than 100, take 100 caps; when the number of filling valves is greater than or equal to 100, the sample number should not be less than the number of filling valves), 10 as a group, and place them in 10 sterile wide-mouth empty bottles in the shade-free area (). After adding 200mL of sterile physiological saline, quickly seal the bottles, rinse the caps in the bottles thoroughly, and use membrane filtration to perform microbial verification test on the rinse fluid. The inspection method is the same as 6.5.2.1. It should meet the requirements of 6.1.3. 6.5.3 Microbiological verification test for empty bottles and caps after sterilization Randomly select 100 empty bottles and caps after sterilization (when the number of filling valves is less than 100, take 100 empty bottles and caps; when the number of filling valves is greater than or equal to [00, the sampling number should not be less than the filling number], and use membrane filtration method for microbiological verification test. The inspection method is the same as 6.5.2 and should meet the requirements of 5.10.
6.5.4 Microbiological verification test for empty bottles after capping (sealing) After the aseptic line is running stably, randomly select 100 empty bottles after sterilization and filling (when the number of filling valves is less than 100, take 100 empty bottles; when the number of filling valves is greater than or equal to 100, the sampling number should not be less than the filling number ), use membrane filtration method for microbial validation test, the inspection method is the same as 6.5.2.1, and should meet the requirements of 5.10. 6.5.5 Sterile water test
After disinfection and sterilization according to the CIP.SIP and COP.SOP procedures set by the sterile line, take 8 sterile water restored by the system for testing. The sampling method is shown in Table 2.
Table 2 Sterile water sampling location and number
Bottle rinsing water
Bottle mouth rinsing water
cr cleaning water
Bottle rinser
Bottle rinser outlet
Bottle rinser table
Pangye rinsing water
CIP cleaning water
CIP cleaning water
Filling machine table| |tt||Exit of the screw machine
The unit is
Use membrane filtration method to conduct sterile water microbial verification test, the inspection method is the same as 6.5.2.1. It should meet the requirements of 5.10, 6.5.6 Culture medium filling test
According to the production capacity of the equipment, use Lireler-Grain culture medium test regardless of pH value (pH value of low acid liquid food is 6.5~6.8. pH value of acidic liquid food is 4.3~~4.6). Fill the culture medium production station according to the normal production process. The filling is divided into 3 batches. The extraction time of each batch is not less than 24 hours. Each time, 10009 bottles are filled. According to GB/T4789.2, GB/T4789.15 Observe the results of the test and they shall meet the requirements of 5.10. 6.6 Determination of residual peracetic acid or hydrogen peroxide in the bottle after sterilization After the aseptic line is running stably, randomly select 3K empty bottles (K is the number of bottle rinsers, 3 bottles are taken for each bottle rinser) that have been sterilized and disinfected and then directly capped (sealed) and measure them according to the determination method of peroxide residue in the "Technical Specifications for Disinfection". It shall meet the requirements of 5.11. 6.7 Determination of peracetic acid or hydrogen peroxide concentration in the operating area After the aseptic line is running normally, take samples at 1.2m away from the aseptic rinsing, filling, and capping (sealing) units and 1.6m above the unit. Measure according to the method specified in Appendix C of GB/T[8883-2002. It shall meet the requirements of 5.12. 6. 8 Filling accuracy test
Use a calibration scale with a maximum allowable error less than or equal to one third of the allowable deviation of the net content of the package being tested to weigh the net content of the contents in accordance with the provisions of Table 3. The difference between the actual measured net content of the contents and the marked net content shall comply with the provisions of 5.14: 8
http://foodmate.nBatch of packages N
11--50
51--99
1o0--5co
51--3 200
More than 3200
Number of samples
Jiang 1: The confidence level of this sampling plan is 99.5% Table 3 Sampling plan for counting test
Correction value of average actual content (A·S)
Correction factor
Deviation of actual content from standard
GB/T 24571—2009
A single piece is allowed to exceed the number of pieces with
precision of packing by 1 time less than or
equal to 2 times
A single piece is allowed to exceed the number of pieces with
precision of packing by 2 times
Jiang 2: When an inspection lot consists of 10 pieces or less, only the actual content of each single piece of certified packaged commodity shall be inspected and evaluated, and the average safe content shall not be calculated. The average actual content shall be calculated according to formula (3)
(3)
Where:
Average actual content of sampled packages: Actual measured net content of contents:
-number of sampled packages.
The average actual content meets the requirements of formula (4): n(Q.-a.)
Where:
Q---net content;
Correction factor = ts>
S Actual content deviation S = Www.bzxZ.net
Note: The average actual content of the sample shall be greater than or equal to the net content of the label minus the average actual content of the sample, so the correction value S. 6.9 Package appearance and seal pass rate test 6.9.1 Package appearance quality
The test is carried out after the sterile line is running normally. Under the condition of rated speed operation, sample bottles are taken in two batches: 100 bottles are taken from the continuous axis each time, a total of 210 bottles, and the time interval between the two times is not less than 10 minutes. The appearance quality of the sample bottles tested daily shall meet the requirements of 5.15.1, and the number of unqualified products a shall be counted.
6.9.2 Cap opening torque test
Randomly select 100 sample bottles with qualified appearance quality, and use a torque meter with a dynamic accuracy of 1% to test the opening torque. It should comply with the provisions of 5.15.2. Count the number of unqualified products4.
6.9.3 Sealing air tightness test
Take the remaining sample bottles with qualified appearance quality, immerse them upright in a water towel of (50+2)℃ for 10min, and the bottle is qualified if there is no bubble overflowing; or apply a pressure of 200N to the side of the bottle and keep it for 10s. The sample bottle is qualified if there is no leakage at the mouth, and count the number of unqualified productsas9
http:The sampling method is shown in Table 2.
Table 2 Sampling positions and numbers of sterile water
Bottle rinsing water
Bottle mouth rinsing water
CR cleaning water
Bottle rinser
Bottle rinser outlet
Bottle rinser table
Pan leaf rinsing water
CIP cleaning water
CIP cleaning water
Filling machine table
Twist machine outlet
Unit is
The membrane filtration method is used for sterile water microbiological verification test. The inspection method is the same as 6.5.2.1. It should meet the requirements of 5.10. 6.5.6 Culture medium filling test
According to the production capacity of the equipment, use Lireler-Grain culture medium regardless of pH value for testing (pH value of low acid liquid food is 6.5~6.8. pH value of acidic liquid food is 4.3~~4.6). Fill the culture medium production station according to the normal production process. The filling is divided into 3 batches. The extraction time of each batch is not less than 24 hours. Each batch is filled with 10009 bottles. Test according to the provisions of GB/T4789.2 and GB/T4789.15. Observe the results. They should meet the requirements of 5.10. 6.6 Determination of peracetic acid or hydrogen peroxide residue in the bottle after sterilization After the aseptic line is running stably, randomly select 3K empty bottles that have been sterilized and disinfected and filled and directly capped (sealed) (K is the number of bottle heads, and 3 bottles are taken for each bottle head). Determine according to the determination method of hydrogen peroxide residue in the "Disinfection Technical Specifications". It should meet the requirements of 5.11. 6.7 Determination of peracetic acid or hydrogen peroxide concentration in the operating area After the aseptic line is operating normally, samples shall be taken at a distance of 1.2m from the aseptic rinsing, filling and capping (sealing) units and 1.6m above the unit. The concentration shall be measured according to the method specified in Appendix C of GB/T[8883-2002 and shall comply with the provisions of 5.12. 6.8 Filling accuracy test
Use a calibration scale with a maximum permissible error less than or equal to one third of the permissible deviation of the net content of the package being tested to weigh the net content of the contents in accordance with the provisions of Table 3. The difference between the measured net content of the contents and the marked net content shall comply with the provisions of 5.14: 8
http://foodmate.nBatch of packages N
11--50
51--99
1o0--5co
51--3 200
More than 3200
Number of samples
Jiang 1: The confidence level of this sampling plan is 99.5% Table 3 Sampling plan for counting test
Correction value of average actual content (A·S)
Correction factor
Deviation of actual content from standard
GB/T 24571—2009
A single piece is allowed to exceed the number of pieces with
precision of packing by 1 time less than or
equal to 2 times
A single piece is allowed to exceed the number of pieces with
precision of packing by 2 times
Jiang 2: When an inspection lot consists of 10 pieces or less, only the actual content of each single piece of certified packaged commodity shall be inspected and evaluated, and the average safe content shall not be calculated. The average actual content shall be calculated according to formula (3)
(3)
Where:
Average actual content of sampled packages: Actual measured net content of contents:
-number of sampled packages.
The average actual content meets the requirements of formula (4): n(Q.-a.)
Where:
Q---net content;
Correction factor = ts>
S Actual content deviation S =
Note: The average actual content of the sample shall be greater than or equal to the net content of the label minus the average actual content of the sample, so the correction value S. 6.9 Package appearance and seal pass rate test 6.9.1 Package appearance quality
The test is carried out after the sterile line is running normally. Under the condition of rated speed operation, sample bottles are taken in two batches: 100 bottles are taken from the continuous axis each time, a total of 210 bottles, and the time interval between the two times is not less than 10 minutes. The appearance quality of the sample bottles tested daily shall meet the requirements of 5.15.1, and the number of unqualified products a shall be counted.
6.9.2 Cap opening torque test
Randomly select 100 sample bottles with qualified appearance quality, and use a torque meter with a dynamic accuracy of 1% to test the opening torque. It should comply with the provisions of 5.15.2. Count the number of unqualified products4.
6.9.3 Sealing air tightness test
Take the remaining sample bottles with qualified appearance quality, immerse them upright in a water towel of (50+2)℃ for 10min, and the bottle is qualified if there is no bubble overflowing; or apply a pressure of 200N to the side of the bottle and keep it for 10s. The sample bottle is qualified if there is no leakage at the mouth, and count the number of unqualified productsas9
http:The sampling method is shown in Table 2.
Table 2 Sampling positions and numbers of sterile water
Bottle rinsing water
Bottle mouth rinsing water
CR cleaning water
Bottle rinser
Bottle rinser outlet
Bottle rinser table
Pan leaf rinsing water
CIP cleaning water
CIP cleaning water
Filling machine table
Twist machine outlet
Unit is
The membrane filtration method is used for sterile water microbiological verification test. The inspection method is the same as 6.5.2.1. It should meet the requirements of 5.10. 6.5.6 Culture medium filling test
According to the production capacity of the equipment, use Lireler-Grain culture medium regardless of pH value for testing (pH value of low acid liquid food is 6.5~6.8. pH value of acidic liquid food is 4.3~~4.6). Fill the culture medium production station according to the normal production process. The filling is divided into 3 batches. The extraction time of each batch is not less than 24 hours. Each batch is filled with 10009 bottles. Test according to the provisions of GB/T4789.2 and GB/T4789.15. Observe the results. They should meet the requirements of 5.10. 6.6 Determination of peracetic acid or hydrogen peroxide residue in the bottle after sterilization After the aseptic line is running stably, randomly select 3K empty bottles that have been sterilized and disinfected and filled and directly capped (sealed) (K is the number of bottle heads, and 3 bottles are taken for each bottle head). Determine according to the determination method of hydrogen peroxide residue in the "Disinfection Technical Specifications". It should meet the requirements of 5.11. 6.7 Determination of peracetic acid or hydrogen peroxide concentration in the operating area After the aseptic line is operating normally, samples shall be taken at a distance of 1.2m from the aseptic rinsing, filling and capping (sealing) units and 1.6m above the unit. The concentration shall be measured according to the method specified in Appendix C of GB/T[8883-2002 and shall comply with the provisions of 5.12. 6.8 Filling accuracy test
Use a calibration scale with a maximum permissible error less than or equal to one third of the permissible deviation of the net content of the package being tested to weigh the net content of the contents in accordance with the provisions of Table 3. The difference between the measured net content of the contents and the marked net content shall comply with the provisions of 5.14: 8
http://foodmate.nBatch of packages N
11--50
51--99
1o0--5co
51--3 200
More than 3200
Number of samples
Jiang 1: The confidence level of this sampling plan is 99.5% Table 3 Sampling plan for counting test
Correction value of average actual content (A·S)
Correction factor
Deviation of actual content from standard
GB/T 24571—2009
A single piece is allowed to exceed the number of pieces with
precision of packing by 1 time less than or
equal to 2 times
A single piece is allowed to exceed the number of pieces with
precision of packing by 2 times
Jiang 2: When an inspection lot consists of 10 pieces or less, only the actual content of each single piece of certified packaged commodity shall be inspected and evaluated, and the average safe content shall not be calculated. The average actual content shall be calculated according to formula (3)
(3)
Where:
Average actual content of sampled packages: Actual measured net content of contents:
-number of sampled packages.
The average actual content meets the requirements of formula (4): n(Q.-a.)
Where:
Q---net content;
Correction factor = ts>
S Actual content deviation S =
Note: The average actual content of the sample shall be greater than or equal to the net content of the label minus the average actual content of the sample, so the correction value S. 6.9 Package appearance and seal pass rate test 6.9.1 Package appearance quality
The test is carried out after the sterile line is running normally. Under the condition of rated speed operation, sample bottles are taken in two batches: 100 bottles are taken from the continuous axis each time, a total of 210 bottles, and the time interval between the two times is not less than 10 minutes. The appearance quality of the sample bottles tested daily shall meet the requirements of 5.15.1, and the number of unqualified products a shall be counted.
6.9.2 Cap opening torque test
Randomly select 100 sample bottles with qualified appearance quality, and use a torque meter with a dynamic accuracy of 1% to test the opening torque. It should comply with the provisions of 5.15.2. Count the number of unqualified products4.
6.9.3 Sealing air tightness test
Take the remaining sample bottles with qualified appearance quality, immerse them upright in a water towel of (50+2)℃ for 10min, and the bottle is qualified if there is no bubble overflowing; or apply a pressure of 200N to the side of the bottle and keep it for 10s. The sample bottle is qualified if there is no leakage at the mouth, and count the number of unqualified productsas9
http:3 Sealing airtightness test
Take the remaining sample bottles with qualified appearance quality, immerse them upright in a water towel at (50+2)℃ for 10 minutes, and the bottle is qualified if there is no bubble overflowing; or apply 200N pressure to the side of the bottle and keep it for 10 seconds. The sample bottle is qualified if there is no leakage at the mouth, and the number of unqualified products is countedas9
http:3 Sealing airtightness test
Take the remaining sample bottles with qualified appearance quality, immerse them upright in a water towel at (50+2)℃ for 10 minutes, and the bottle is qualified if there is no bubble overflowing; or apply 200N pressure to the side of the bottle and keep it for 10 seconds. The sample bottle is qualified if there is no leakage at the mouth, and the number of unqualified products is countedas9
http:
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