GB/T 44997-2024General technical requirements for linear aseptic filling capping machine (English PDF)

1 Scope

This document defines the terms and definitions of the linear aseptic filling capping machine, specifies the model designation, the types, the basic parameters and working conditions, the technical requirements, the inspection rules and the nameplate, packing, transport and storage, and describes the corresponding test methods.

This document applies to the design, manufacture, inspection and application of linear aseptic filling capping machines, hereinafter called aseptic filling machines, for low-acid liquid products and acid liquid products in the beverage, dairy, pharmaceutical, health product and similar industries.

3 Terms and definitions

3.1 aseptic filling. The process of filling and sealing sterilized liquid product and packaging material in an aseptic environment. [SOURCE: GB/T 41124-2021, 3.2, modified]

3.2 linear aseptic filling capping machine. Equipment that uses dry hydrogen peroxide sterilization and, running in multiple lanes in an intermittent or continuous straight line, carries out aseptic filling and screw capping or lid film heat sealing on plastic bottles of polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP) and similar materials.

3.3 low acid liquid. A liquid product with an equilibrium pH after sterilization greater than 4.6. [SOURCE: GB/T 19063-2009, 3.8, modified]

3.4 acid liquid. A liquid product with an equilibrium pH after sterilization less than or equal to 4.6. [SOURCE: GB/T 19063-2009, 3.9, modified]

3.5 screw capping. The process of sealing by tightening a cap onto the thread of a plastic bottle.

3.6 lid film hot sealing. The process of sealing a plastic bottle with a lid film by applying heat and pressure.

3.7 cleaning out of place; COP. The cleaning of the surfaces of the equipment inside the aseptic space.

3.8 sterilization out of place; SOP. The sterilization of the surfaces of the equipment inside the aseptic space.

3.9 cleaning in place; CIP. A method in which, without dismantling the equipment or its components and under closed conditions, cleaning solution at a certain temperature and concentration acts forcefully on the surfaces to be cleaned, so that the surfaces in contact with the product are cleaned. Note: cleaning in place is also called on-site cleaning.

3.10 sterilization in place; SIP. A method in which, without dismantling the equipment or its components and under closed conditions, a sterilizing medium at a certain temperature and concentration, or steam, hot water or superheated water, sterilizes the surfaces in contact with the product so that the intended sterilization requirement is met.

3.11 sterilization efficiency; SE. The logarithm of the ratio of the total number of microorganisms on a given object before and after sterilization. [SOURCE: GB/T 24571-2009, 3.11, modified]

3.12 commercial sterilization. The condition in which the packaged liquid product contains no pathogenic bacteria and no microorganisms capable of multiplying at normal temperature. [SOURCE: GB/T 19063-2009, 3.7]

3.13 aseptic period. The longest interval between the periodic CIP and SIP cleaning and sterilization cycles carried out to keep production in an aseptic state. [SOURCE: GB/T 24571-2009, 3.10]

3.14 product contamination rate. The ratio of the number of bottles in which microorganisms have multiplied to the total number of bottles sampled in one sampling inspection batch of product. [SOURCE: GB/T 24571-2009, 3.14, modified]

3.15 finished product. The product formed after filling and screw capping or lid film heat sealing. [SOURCE: GB/T 33467-2016, 3.6, modified]

3.16 filling accuracy. The quantified indicator of the departure of the net content of filled product in the finished bottle from the standard value. [SOURCE: GB/T 33467-2016, 3.11, modified]

3.17 production capacity. The number of finished products produced per unit of time when the aseptic filling machine is running steadily. [SOURCE: GB/T 38463-2020, 3.16, modified]

3.18 production efficiency. The percentage that the number of finished products produced within the effective time when the aseptic filling machine is running steadily represents of the product of the rated production capacity of the equipment and the effective time. [SOURCE: GB/T 38463-2020, 3.17, modified]

3.19 bottle damaged rate. The percentage that the number of bottles lost when the aseptic filling machine is running steadily represents of the total number of conforming bottles fed in. [SOURCE: GB/T 33467-2016, 3.12, modified]

3.20 cap (film) damaged rate. The percentage that the number of caps or films lost when the aseptic filling machine is running steadily represents of the total number of conforming caps or films fed in. [SOURCE: GB/T 38463-2020, 3.14, modified]

4 Model designation, types, basic parameters and working conditions

4.1 Model designation. The model designation of the aseptic filling machine shall be drawn up in accordance with GB/T 7311. Example: DGWJ40/20N designates a linear aseptic filling capping machine with 40 filling valves and 20 capping heads, of the first design.

4.2.1 The types of aseptic filling machine are: a) by mode of running, intermittent and continuous; b) by mode of bottle feed, single row and multiple row; c) by number of filling operations, single filling and multiple filling; d) by bottle mouth size, one bottle mouth and two bottle mouths; e) by mode of sealing, screw capping and lid film heat sealing.

4.2.2 The basic composition of the aseptic filling machine is: a) bottle sterilizing and drying system; b) cap or film sterilizing and drying system; c) liquid filling system; d) sterile air back pressure system; e) screw capping or lid film heat sealing system; f) cap sorting and feeding system; g) bottle infeed and outfeed system; h) bottle mould plate gripping and conveying system; i) automatic CIP and SIP system; j) hydrogen peroxide vaporizing system; k) automatic COP and SOP system; l) class N5 clean air purification system; m) compressed air sterile system and steam sterile system; n) waste gas collection system.

4.2.3 The following systems may be fitted as options to the aseptic filling machine: a) pulp filling system; b) nitrogen purge system; c) liquid nitrogen dosing system; d) cap changeover system.

4.3 Basic parameters. The names and units of the basic parameters of the aseptic filling machine are: a) rated production capacity, in bottles per hour; b) filling volume, in millilitres, litres or grams; c) number of filling valves; d) number of capping or lid film heat sealing heads; e) rated voltage, in volts; f) frequency, in hertz; g) total power, in kilowatts; h) reference overall dimensions, length by width by height in millimetres; i) reference mass, in kilograms.

4.4.1 The working ambient temperature range shall be 15 degrees Celsius to 35 degrees Celsius, with a fluctuation range of plus or minus 3 degrees Celsius; the relative humidity shall not be greater than 70 % and the altitude shall not be greater than 1 000 m.

4.4.2 The filling room shall at least meet the requirements for a class N8 cleanroom given in 3.0.1 of GB 50073-2013.

4.4.3 The deviation of the supply voltage from the rated voltage shall conform to 4.2 of GB/T 12325-2008.

4.4.4 The water used in production shall conform to GB 5749 and the source pressure shall be greater than 0.3 MPa.

4.4.5 The pressure of the compressed air supply shall be 0.6 MPa to 0.8 MPa; the quality of the compressed air shall conform to GB/T 13277.1-2023, with a particle class not lower than class 4, a humidity and liquid water class not lower than class 4, and a total oil content class not lower than class 2.

4.4.6 The air compressor and its receiver shall be separated from the room in which the aseptic filling machine works.

4.4.7 The steam shall be clean and the steam pressure shall not be less than 0.5 MPa.

4.4.8 The plastic bottles shall conform to the relevant national standards.

4.4.9 Plastic tamper-evident caps shall conform to GB/T 17876-2010.

4.4.10 The oxygen transmission of the cap or film shall conform to GB/T 28118.

4.4.11 The initial total plate count of the bottles shall not be greater than 10 CFU per 10 bottles, and that of a single bottle shall not be greater than 5 CFU; the initial total plate count of the caps or films shall not be greater than 10 CFU per 10 items.

4.4.12 The liquid product supplied to the aseptic filling machine shall be commercially sterile.

4.4.13 The hydrogen peroxide used for dry sterilization shall conform to the relevant national standards.

4.4.14 The product piping and fittings connecting to the upstream processing equipment shall be of S31603 stainless steel or of stainless steel of similar properties.

5 Technical requirements

5.1.1 The aseptic filling machine shall be manufactured according to drawings and technical documents approved by the prescribed procedure.

5.1.2 The total volume of the aseptic chamber of the aseptic filling machine shall not be greater than 5 cubic metres.

5.1.3 The aseptic filling machine shall meet the requirements for CIP, SIP, COP and SOP cleaning and sterilization, and the total cleaning and sterilization time for a single filling shall not be greater than 4.5 h.

5.1.4 The aseptic filling machine shall run smoothly; the moving parts shall act sensitively, in coordination and accurately, without jamming and without abnormal noise.

5.1.5 The pneumatic system, water system, steam system, lubrication system and product conveying system of the aseptic filling machine shall run freely, with accurate and responsive control and without leakage or blockage.

5.1.6 The filling system shall ensure that no filling takes place when no bottle is present.

5.1.7 When bottles, caps, film or other packaging material run short on a running aseptic filling machine, the machine shall give an alarm; when the product runs short, a cap jams or another abnormality occurs, the machine shall stop working and give an alarm.

5.1.8 After filling by the aseptic filling machine there shall be no liquid residue on the bottle mouth.

5.2.1 Requirements for microbiology and for the aseptic environment: a) the air cleanliness of the cleanroom shall conform to class N5 as given in 3.0.1 of GB 50073-2013; b) the equipment surfaces in the cleanroom shall be clean after COP; c) after the cleanroom space and its equipment surfaces have been cleaned and sterilized by COP and SOP, swab testing and settle plate testing of the internal surfaces of the cleanroom of the aseptic filling machine shall detect no microorganisms; d) after the cleanroom space and its equipment surfaces have been cleaned and sterilized by COP and SOP, the sterilization efficiency SE obtained by coupon testing shall be greater than or equal to 5; e) for microbiological testing of the inner surfaces of sterilized bottles and of caps or films, the sterilization efficiency SE shall be greater than or equal to 5; f) for microbiological testing of the bottle mouth and the outer surfaces of caps or films after sterilization, the sterilization efficiency SE shall be greater than or equal to 4; g) when acid liquid product is filled, the aseptic period shall not be less than 48 h; when low-acid liquid product is filled, the aseptic period shall not be less than 24 h; h) in a filling test using LG culture medium, the product contamination rate shall not be greater than one in ten thousand; i) under normal production conditions, the total residual hydrogen peroxide inside the sterilized empty bottle and inside the cap or film shall not be greater than 0.5 mg/L; j) the mass concentration of hydrogen peroxide in the operating area of the aseptic filling machine shall not be greater than 2 mg/L.

5.2.2 The aseptic filling machine shall meet its rated production capacity, and in continuous production the production efficiency shall not be less than 90 %.

5.2.3 The appearance quality of the finished product shall conform to the following: a) the surface shall be smooth, without deformation, denting or noticeable scratches; b) after screw capping there shall be no high caps, crooked caps, broken caps or missing caps, and no noticeable scratches on the cap surface; after lid film heat sealing the sealed area shall be uniform, without scorching, missing caps or noticeably crooked caps.

5.2.4 The filling accuracy of the aseptic filling machine shall conform to Table 1, which gives the tolerance as a formula in the declared net content Qn, in millilitres or grams, over three bands: 100 up to but not including 230, 230 up to but not including 550, and 550 up to but not including 1 250. For product without pulp the tolerance is plus or minus the quantity in brackets [1.0 + 0.005 (Qn - 100)] in the first band, [1.65 + 0.005 (Qn - 230)] in the second and [3.25 + 0.005 (Qn - 550)] in the third. For product containing pulp whose largest diagonal is less than 5 mm the same three expressions apply with the leading constants 4.5, 5.15 and 6.75 respectively.

5.2.5 The cap opening torque shall conform to GB/T 17876-2010; the difference in cap opening torque between the capping heads, and the variation of each head itself, shall not be greater than plus or minus 0.4 N times m.

5.2.6 Finished products that have been screw capped or lid film heat sealed shall show no leakage at the seal in the air tightness test.

5.2.7 The qualified finished product rate shall not be less than 99.5 %.

5.2.8 The bottle loss rate shall not be greater than 0.1 %.

5.2.9 The cap or film loss rate shall not be greater than 0.2 %.

5.2.10 When the aseptic filling machine is running with no load, the sound pressure level of the noise shall not be greater than 80 dB(A).

5.3.1 The electrical control system of the aseptic filling machine shall conform to GB/T 5226.1-2019; control shall be safe and reliable and shall act accurately; the wiring of each electrical device shall be securely connected and numbered; the operating buttons shall be responsive and an emergency stop button shall be provided; the indicator lamps shall display normally.

5.3.2 The aseptic filling machine shall be fitted with an automatic interlock protection system for the aseptic production environment; when that environment is compromised, the system shall give an immediate alarm and shall automatically enter the appropriate handling procedure according to the extent of the loss, for confirmation by the operator.

5.3.3 The insulation resistance measured between the power circuit conductors and the protective bonding circuit with 500 V DC applied shall not be less than 1 megohm.

5.3.4 All exposed conductive parts of the aseptic filling machine shall be connected to the protective bonding circuit as required by 8.2 of GB/T 5226.1-2019. The connection between the earthing terminal or earthing contact and the earthed metal part shall have a low resistance, not greater than 0.1 ohm.

5.3.5 The power circuit conductors and the protective bonding circuit of the electrical equipment shall withstand a dielectric voltage test lasting at least 1 s.

5.3.6 The degree of protection of the electrical cabinet shall not be lower than IP54 as given in GB/T 4208-2017, and that of the electrical components in the product contact area and the splash area shall not be lower than IP67 as given in GB/T 4208-2017.

5.3.7 To ensure the safety of persons and of production, control units involving safety shall use a safety circuit. In principle the safety control circuit shall use a safety voltage not greater than 36 V.

5.3.8 The electrical equipment shall have a reliable earthing device with a clear earthing mark.

5.4.1 The safety protection of the aseptic filling machine shall conform to JB 7233.

5.4.2 The safety design of the aseptic filling machine shall conform to GB/T 15706.

5.4.3 The aseptic filling machine shall carry clear and conspicuous markings for operation, lubrication, high temperature and protection against chemical injury, and the safety signs shall conform to GB 2894.

5.4.4 The main pipework of the steam system and of the sterilizing and drying systems shall be insulated; pipework that cannot conveniently be insulated shall carry conspicuous high-temperature warning signs conforming to GB 2894.

5.4.5 The aseptic filling machine shall give an audible and visual warning signal when it starts.

5.4.6 The parts, bolts, nuts and other fasteners on the aseptic filling machine shall be fixed reliably and prevented from loosening, and shall not fall off through vibration.

5.4.7 Where the gears, belts, chains, friction wheels and other moving parts of the aseptic filling machine are exposed, guards shall be fitted. Reciprocating movements of the machinery shall have limiting devices at their end positions.

5.4.8 Where the aseptic filling machine presents a potential hazard of drawing in, trapping, crushing, pinching or burning, or where injury to persons could otherwise be caused, fixed or movable guards shall be fitted, designed in accordance with GB/T 8196 and with safety distances conforming to GB/T 23821.

5.4.9 An emergency stop device shall be provided at the operator control position and at the other positions determined by risk assessment, designed in accordance with GB/T 16754; the emergency stop device shall be designed to be easily reached and shall not itself create a hazard for the operator when actuated.

5.4.10 The design of the fixed means of access to the aseptic filling machine, such as stairs, stepladders, guard rails, working platforms and walkways, shall conform to GB/T 17888.1 to GB/T 17888.3.

5.4.11 Rubber and plastic parts bonded to surfaces in contact with the filled product, such as sealing rings and sight glass frames that have to be held in place, shall be bonded continuously so that they do not come away during normal working operations such as cleaning, heating and pressurizing.

5.4.12 Where there is a risk during production and maintenance of leakage of the chemical media used for cleaning and sterilization, the equipment shall be fitted with the corresponding safety measures and interlocks, so that it locks itself out safely or reminds the operator to take protective measures.

5.4.13 The safety performance of the pneumatic system shall conform to GB/T 7932.

5.5.1 The hygiene of the mechanical design of the aseptic filling machine shall conform to GB/T 19891.

5.5.2 The raw materials and bought-in components used in the aseptic filling machine shall have a certificate of quality conformity from the manufacturer; where there is no such certificate, they may only be put into use after being accepted as conforming to the relevant product standard.

5.5.3 The equipment surfaces in contact with the packaging container and the filled product shall be smooth and flat, easy to clean or sterilize, and corrosion resistant.

5.5.4 Vessels, pipework, valves and similar items in contact with the product or requiring CIP, SIP, COP or SOP cleaning or sterilization may be pickled or ground and polished so that the internal surfaces are smooth and free from crevices where product can lodge. The product contact areas shall not contaminate the product. The surface roughness Ra of the vessels and valves in contact with the product shall not be greater than 0.8 micrometres, and the roughness Ra of the non-product-contact surfaces of parts within the filling and capping area shall not be greater than 1.6 micrometres.

5.5.5 Bought-in valves, fittings and sensing elements in contact with the filled product or with sterile air shall be of aseptic design or of a construction with no dead spaces for cleaning.

5.5.6 Rubber items in the aseptic filling machine that are, or may be, in contact with readily oxidizing or corrosive media such as sterilizing or cleaning solutions shall be of oxidation and corrosion resistant material, such as fluororubber, silicone rubber or ethylene-propylene rubber.

5.5.7 Reciprocating mechanisms passing between the cleanroom and the non-clean area shall have a barrier that separates them, so that the aseptic environment is maintained.

5.5.8 The lubricating oil used in the cleanroom shall conform to GB 15179.

5.6.1 The appearance quality of the aseptic filling machine after machining and assembly shall conform to GB/T 14253.

5.6.2 The painted and plastic-coated surfaces of the aseptic filling machine shall be flat and smooth, without noticeable defects such as scratches, soiling or corrosion.

5.6.3 The instructions for use of the aseptic filling machine shall be drawn up in accordance with GB/T 9969, and shall state the oil change interval of the lubrication system.

6 Test methods

6.1 Test conditions. The test conditions shall conform to 4.4.

6.2.1.1 Every aseptic filling machine shall be given a no-load running test after assembly; the continuous running time shall not be less than 8 h and the running condition of the machine shall be checked.

6.2.1.2 While the aseptic filling machine is running with no load, the aseptic door of the cleanroom is opened and the automatic interlock protection system of the aseptic production environment is checked.

6.2.2.1 A high-foaming detergent solution is applied to the seals of the pneumatic components and to the line connections, and these are observed for leakage.

6.2.2.2 The seals and line connections of the water system and the steam system are checked for leakage and dripping.

6.2.2.3 Degreased cotton is wiped lightly around the seals and line connections of the lubrication system and observed for traces of oil.

6.2.2.4 The product conveying pipework is closed off and pressurized to 0.25 MPa to 0.30 MPa and the pressure is held for 12 h, and it is observed whether the pressure drop is greater than 0.01 MPa.

6.3.1 Cleanroom air cleanliness test. In production mode, a particle counter is used and the measurement is made by the method specified in GB/T 16292.

6.3.2 Colouring test of the COP cleaning effect on the equipment surfaces in the cleanroom. A spray bottle is used to spray the prepared colouring solution over the internal space of the cleanroom of the aseptic filling machine, covering all the key surfaces, such as those of the bottle sterilizing, drying, filling, capping and transfer mechanisms. After spraying, the machine is left to stand for 0.5 h to 1.0 h, COP cleaning is then carried out, and the cleaning effect is assessed by eye, with photographs taken before and after cleaning, to see whether any colouring remains; at positions that are difficult to observe, a swab may be used to assess the cleaning effect. The recommended method of preparing the colouring solution is given in Table A.1 of Annex A.

6.3.3 Cleanroom swab test. After the aseptic filling machine has been automatically cleaned and sterilized by COP and SOP, sterile swabs are used to take samples at designated positions, generally chosen among the equipment surfaces that are difficult to clean and the parts with the highest aseptic requirements, such as near the filling heads and the capping heads. The total plate count is determined in accordance with GB 4789.2 and the mould and yeast count in accordance with GB 4789.15.

6.3.4 Cleanroom settle plate test. Plates already charged with culture medium, and sterilized, are placed in the cleanroom, whose cleanliness has already reached class N5; after automatic COP and SOP cleaning and sterilization, settle plate sampling is carried out in accordance with GB/T 16294.

6.3.5 Cleanroom sterilization efficiency test (coupon test). Twenty to forty steel coupons carrying the indicator organism are placed in the designated area of the cleanroom, the surface roughness of the coupons matching that of the area in which they are placed. After COP and SOP cleaning and sterilization the coupons are removed and placed in a vessel containing neutralizer and eluent and thoroughly eluted, then membrane filtered and cultured; counting is carried out in accordance with GB 4789.2 and the sterilization efficiency is calculated. The recommended indicator organism for the test is Bacillus atrophaeus ATCC 9372, at a population of the order of ten to the fifth to ten to the seventh.

6.3.6 Sterilization efficiency test of the inner surfaces of bottles and of caps or films. After the inner surfaces of the bottles and of the caps or films have been inoculated, sterilization is carried out at the rated production speed and with the set process parameters; the items are then placed in a vessel containing neutralizer and eluent and thoroughly eluted, membrane filtered and cultured; counting is carried out in accordance with GB 4789.2 and the sterilization efficiency is calculated. The recommended indicator organism is Bacillus atrophaeus ATCC 9372, at a population of the order of ten to the fifth to ten to the seventh. The number of inoculated samples taken for the inner surfaces of the bottles and of the caps or films shall be not less than five times the index step, and the total number sampled shall in each case be not less than 50.

6.3.7 Sterilization efficiency test of the bottle mouth and of the outer surfaces of caps or films. The procedure is as in 6.3.6, with the recommended indicator organism Bacillus atrophaeus ATCC 9372 at a population of the order of ten to the fourth to ten to the sixth; the number of inoculated samples taken shall be not less than five times the index step and the total number sampled shall in each case be not less than 50.

6.3.8 Media fill test. A filling test is carried out with LG culture medium and the product contamination rate is checked. Before filling, the LG medium shall have been made commercially sterile by ultra-high-temperature short-time sterilization, with SE greater than or equal to 9. The bottles used for the test shall be transparent. The method of preparing the LG medium, for 10 000 L, is given in Table A.2. According to the pH of the product the aseptic filling machine fills, LG media of different pH are used for the test, pH 4.3 to 4.6 for acid liquid products and pH 6.5 to 6.8 for low-acid liquid products. The medium is filled at the rated production speed and with the set process, and the filling batches and sample numbers are determined by the aseptic period. a) For acid liquid products, where the aseptic period is not less than 48 h: after normal COP, CIP, SOP and SIP the machine fills bottles half full with medium, not less than half the declared net content. The initial filling shall be not less than 3 000 bottles, of which 3 000 are sampled; at 24 h not less than 3 000 bottles are filled, of which 3 000 are sampled; at 48 h not less than 4 000 bottles are filled, of which 4 000 are sampled. After each sampling the samples are incubated at 30 degrees Celsius to 35 degrees Celsius; after 3 d they are inverted, and on the 7th day and the 14th day all the samples are examined by eye. Where there is swelling of the bottle, turbidity, flocculation or another abnormality, the sample is judged to be contaminated, apart from samples abnormal because of poor packaging, and the product contamination rate is calculated. b) For low-acid liquid products, where the aseptic period is not less than 24 h: the same procedure is followed, with the initial filling of not less than 3 000 bottles, not less than 3 000 bottles at 12 h and not less than 4 000 bottles at 24 h, all of them sampled, and with the same incubation and examination.

6.3.9 Determination of hydrogen peroxide residue inside the bottle. With the aseptic filling machine running steadily, empty bottles that have been sterilized and then capped or lid film sealed without being filled are taken, the number taken being not less than the number of bottles in one index step. In an environment free from chemical interference the sample bottle is filled with purified water to the declared net content, the water is poured out of the sample bottle within 1 min, and the determination is carried out in accordance with GB 5009.226.

6.3.10 Determination of the hydrogen peroxide concentration in the operating area. With the aseptic filling machine running steadily, samples are taken at 1.2 m from the equipment and at 1.6 m above the top of the equipment, and the determination is carried out in accordance with GBZ/T 300.48.

6.3.11 Production capacity test. With the aseptic filling machine running steadily, it is run continuously for 10 min and the total number of finished products completed is counted; this is done twice and the production capacity is calculated by Formula (1), where V is the production capacity in bottles per hour, M1 is the total number of finished products completed, in bottles, and T1 is the actual running time, in hours.

6.3.12 Production efficiency test. With the aseptic filling machine running steadily, the number of finished products filled over a continuous 2 h is recorded and the production efficiency is calculated by Formula (2), where the efficiency is M2 divided by the product of F and T2, M2 being the number of finished products filled in the continuous 2 h, in bottles, F the rated production capacity in bottles per hour and T2 the effective time in hours. The effective time T2 is the 2 h of test time less the sum of all the stoppage times within the test period that were not caused by a fault of the aseptic filling machine itself, as given by Formula (3).

6.3.13.1 Appearance quality check. With the aseptic filling machine running steadily, 800 bottles of samples are taken in four lots, 200 bottles taken consecutively each time; the appearance quality of the samples is checked by eye and the number of non-conforming samples is counted as a1.

6.3.13.2 Filling accuracy test. Samples that have passed the appearance quality check are used for the filling accuracy test. The checkweigher is chosen so that its maximum permissible error is not greater than one third of the permitted deviation of the net content of the finished product being tested; the checkweigher weighs the net content of the finished products, the difference between the measured net content and the declared net content is calculated and the number of non-conforming samples is counted as a2.

6.3.13.3 Screw cap seal air tightness test. Samples that have passed both the appearance quality check and the filling accuracy test are subjected to the screw cap seal air tightness test by the method of 6.4.1 of GB/T 17876-2010, and the number of non-conforming samples is counted as a3.

6.3.13.4 Cap opening torque test. Samples that have passed the appearance quality check, the filling accuracy test and the screw cap seal air tightness test are tested for cap opening torque with a torque meter of 1 % dynamic accuracy, and the number of non-conforming samples is counted as a4.

6.3.13.5 Lid film heat seal air tightness test. Lid film heat sealed samples that have passed both the appearance quality check and the filling accuracy test are placed in a seal tester and evacuated so that the negative pressure inside the vessel reaches 0.05 MPa to 0.06 MPa, held for 30 s and observed for leakage; the number of non-conforming samples is counted as a5.

6.3.13.6 Calculation of the qualified finished product rate. For screw capped samples the qualified finished product rate is calculated by Formula (4), from 800 less the sum of a1, a2, a3 and a4 over 800; for lid film heat sealed samples it is calculated by Formula (5), from 800 less the sum of a1, a2 and a5 over 800.

6.3.14 Bottle loss rate test. With the aseptic filling machine running steadily, which may be done at the same time as the test of 6.3.12, the total number of conforming bottles fed in and the number of bottles lost over a continuous 2 h are recorded, bottles lost because of their own poor quality not being counted, and the bottle loss rate is calculated by Formula (6).

6.3.15 Cap or film loss rate test. With the aseptic filling machine running steadily, which may be done at the same time as the test of 6.3.12, the total number of conforming caps or films fed in and the number lost over a continuous 2 h are recorded, items lost because of their own poor quality not being counted, and the cap or film loss rate is calculated by Formula (7).

6.3.16 Noise test. With the aseptic filling machine running continuously under no load, the measurement is made by the method specified in JB/T 7232.

6.4.1 The insulation resistance is measured with an insulation resistance tester in accordance with 18.3 of GB/T 5226.1-2019.

6.4.2 The earthing arrangement is checked: with the electrical equipment disconnected from the supply, a constant current taken from a source of no-load voltage not exceeding 12 V, AC or DC, and equal to 1.5 times the rated current or to 25 A, whichever is the greater, is passed in turn between the earthing terminal and each accessible metal part; the voltage drop is measured and the resistance calculated from the current and the voltage drop.

6.4.3 A dielectric voltage test is carried out with a withstand voltage tester in accordance with 18.4 of GB/T 5226.1-2019, the maximum test voltage being twice the rated supply voltage or 1 000 V, whichever is the greater.

6.4.4 The degree of protection of the electrical cabinet is determined by the method given in GB/T 4208-2017.

6.5 Mechanical safety checks. The guarding and the design of the aseptic filling machine are checked against JB 7233 and GB/T 15706; the markings and signs at each position are checked; the anti-loosening measures on the fasteners of the moving parts and the limiting devices of the reciprocating mechanisms are checked; the guards, the interlocking protective devices at each position and the operating devices are checked; with the machine running normally a guard is opened and it is observed whether the machine gives an alarm and stops working; the other mechanical safety requirements are checked by eye.

6.6 Checking of material quality and design. The hygiene of the mechanical design is checked against GB/T 19891; the certificates of quality conformity of the raw materials and bought-in components, or their acceptance against the relevant standards, are checked; the structural design of the equipment surfaces is checked by eye for flatness and for crevices where product can lodge; the barrier separating the reciprocating mechanisms passing between the cleanroom and the non-clean area is checked by eye; the lubricating oil used in the cleanroom is checked against GB 15179.

6.7 Checking of appearance quality and instructions for use. The appearance quality of the aseptic filling machine and its instructions for use are checked by eye.

7 Inspection rules

7.1 Classification of inspection. Inspection of the aseptic filling machine is divided into delivery inspection and type inspection; the inspection items, requirements and test methods are given in Table 2. Table 2 lists twenty-eight inspection items, running from the no-load running test through the microbiological and sterilization efficiency tests, the media fill and hydrogen peroxide determinations, the output, efficiency, appearance, accuracy, tightness, torque and loss rate tests, to the noise, electrical safety, mechanical safety, material and documentation checks, and marks each as compulsory or not for type inspection and for delivery inspection; the columns of the table are detached from one another in the scan and the marks cannot be assigned to individual items with certainty, so the assignments are not reproduced here.

7.2 Delivery inspection. Every aseptic filling machine shall be given a delivery inspection and may only leave the works after passing it.

7.3.1 Type inspection shall be carried out in any of the following cases: transfer of production of a product to another works, or trial manufacture and type approval of a new product; a substantial difference in material, structure or process after series production has begun that may affect the performance of the aseptic filling machine; after a certain accumulated output during normal production, or a periodic inspection; resumption of production after a long stoppage; a substantial difference between the result of a delivery inspection and that of the previous type inspection; a requirement for type inspection raised by the national market supervision authority.

7.3.2 The type inspection items are given in Table 2. The type inspection is passed when all its items conform. If in the type inspection any one of the continuity of the protective bonding circuit, the insulation resistance, the dielectric voltage test or the aseptic validation fails, the type inspection is judged to have failed. Where other items fail, the aseptic filling machine may be rectified and the failed items re-inspected after rectification; if items still fail after re-inspection, the machine is judged to have failed the type inspection.

8 Nameplate, packing, transport and storage

8.1 Nameplate. A nameplate shall be fixed in a conspicuous position on the aseptic filling machine; the dimensions and technical requirements of the nameplate shall conform to GB/T 13306. The nameplate shall show at least the following: the product model; the product name; the product standard, that is the number of this document; the main technical parameters of the product; the date of manufacture and the works serial number; the name of the manufacturer.

8.2.1 The transport packing of the aseptic filling machine shall conform to GB/T 13384.

8.2.2 Before packing, any water remaining in the pipework shall be drained and the exposed machined surfaces shall be given rust protection.

8.2.3 The packing case shall be strong and reliable and suited to the demands of transport and handling.

8.2.4 The packing case shall have reliable protection against rain and damp.

8.2.5 The special tools and wearing parts supplied with the machine shall be packed separately and fixed within the packing case.

8.2.6 The technical documents shall be properly packed and placed inside the packing case and shall comprise: the product certificate of conformity; the instructions for use of the product; the packing list.

8.2.7 The outer surface of the packing case shall be marked clearly with the dispatch and transport handling marks, in accordance with the relevant provisions of GB/T 191.

8.3.1 The aseptic filling machine shall be handled with care during transport and shall not be inverted or knocked.

8.3.2 The aseptic filling machine shall be stored in a dry, ventilated place free from corrosive agents.