Procedures & Guidelines A practical approach to Aseptic Performance FSQ-588014-0101 Table of contents Introduction Checklists 2.1 Introduction to the Checklist 2.2 Guideline to the checklist 2.2.1 Milk Reception 2.2.1.1 2.2.1.2 2.2.1.3 2.2.1.4 2.2.1.5 2.2.2 2.2.3 2.2.4 Raw milk temperature Microbiological raw milk quality Bacterial Spore Count Acidity Alcohol stability Raw Material Pre-processing UHT-processing 2.2.4.1 2.2.4.2 2.2.4.3 2.2.5 2.2.6 Pre-sterilising Production CIP Aseptic product transfer and storage 10 Filling and packaging 11 2.2.6.1 2.2.6.2 2.2.6.3 2.2.6.4 2.2.6.5 2.2.6.6 2.2.6.7 2.2.6.8 2.2.6.9 2.2.6.10 2.2.7 2.2.8 2.2.9 Filling room 11 Raw material (Packaging material) 12 Hydrogen peroxide 12 Pre-sterilising 13 Production 13 Package integrity 13 Samples for laboratory control 14 CIP (Cleaning In Place) 14 COP (Cleaning Out of Place) 15 External cleaning 15 Downstream packaging 15 Finished product storage 15 Laboratory 15 2.2.9.1 2.2.9.2 Records and documentation 16 Consumer complaints 17 2.3 Checklist (could be customised for application) 18 2.3.1 Reception 18 2.3.2 Pre-processing 18 2.3.3 UHT-processing 18 2.3.4 Aseptic product transfer 19 2.3.5 Aseptic storage 19 2.3.6 Filling and Packaging 19 2.3.7 Downstream packaging 20 2.3.8 Finished product storage 20 2.3.9 Laboratory 20 2.3.9.1 2.3.9.2 2.4 Records and documentation 20 Consumer complaints 21 Summary of findings 21 FSQ-588014-0101 Table of contents 2.5 Actions required 21 References 22 FSQ-588014-0101 Procedures & Guidelines A practical approach to Aseptic Performance Introduction This document is intended to serve as a practical approach to assure the Aseptic performance in a production line The scope of the document is related to the verification of several factors contributing to the output of the Aseptic performance according to predefined specifications Available literature has been consulted In addition mainly many years of practical field experience from FiSQA network members has gone into this study (4, 5) As a preventive action this Guideline could be used as a checklist for QA and Internal revision The document is supplied as a guideline only, not as a guarantee in itself The document is not intended to be prescriptive nor does the document claim to be complete It presumes that all relevant equipment operating manuals, recommended maintenance schedules, as well as generally accepted good manufacturing practices etc are followed Whenever there is an unsterility situation a systematic troubleshooting approach is preferred The FiSQA experience can be of help during the performance of systematic troubleshooting If the intention is to identify improvement possibilities the FiSQA Plant Quality Review (PQR) can be used, as it is an independent evaluation of the manufacturing capability for all type of food products The PQR covers every aspect from raw materials to packages on the shop shelf, which has an impact on the finished product quality The structure to identify possibilities for improvements goes from a General overview via Comprehensive investigation to the Implementation plan The Aseptic Performance of a Production line for Commercially Sterile Products depends on several factors Factor Possible effect Quality of raw material (content of bacterial spores) Process-survivors causing unsterility If applicable mixing and re-hydration Process survivors causing unsterility during the Pre-process steps (content of bacterial spores) Heat-treatment in UHT-Process equipment Insufficient UHT-treatment (time / temp Ratio) Quality of raw material (content of bacterial spores) Environmental contamination Insufficient Packaging material sterilisation Heat / chemical-treatment of packaging Insufficient Packaging material sterilisation material in Aseptic Filling machine (Time, temp, conc.) Status of all equipment in the production- Re-infection line (leakage, damage, faulty-non aseptic, maintenance) CIP-result (remaining soil) Insufficient pre-sterilisation Pre-sterilisation of UHT-Process Filling equipment (time/ temp Ratio) and Insufficient pre-sterilisation FSQ-588014-0101 Procedures & Guidelines A practical approach to Aseptic Performance Note: All documents mentioned in this guideline can be downloaded from the FiSQA homepage on Orbis, or ordered from FiSQA directly Checklists 2.1 Introduction to the Checklist It is a common situation that major problems or visible damage is causing unsterilities To prevent an unsterility situation, a checklist with checkpoints might be a help to avoid the problem The customers engineer, a Tetra Pak service engineer or a FiSQA person could use the checklist Knowledge is needed to understand an aseptic production line, components name, function and position The following guidelines will serve as a help to inspect a production line in a systematic way 2.2 Guideline to the checklist 2.2.1 2.2.1.1 Milk Reception Raw milk temperature What is the temperature during reception of milk? The temperature of the raw milk after milking, transportation and storage is of utmost importance for the microbiological quality of the raw milk The temperature has direct impact on the ‘Standard Plate Count’ of the raw milk and influence the amount of bacterial spores The European Union e.g is laying down the following rules: “If the milk is not collected within two hours of milking, it must be cooled to a temperature of 8°C or lower in the case of daily collection or 6°C or lower if collection is not daily While the milk is being transported to the treatment and/or processing establishment its temperature must not exceed 10°C.” The optimum temperature to keep the microbiological raw milk quality under control is 4°C 2.2.1.2 Microbiological raw milk quality The microbiological quality of the raw milk has an important impact on the protein stability (sedimentation) and organoleptic changes during storage time It can have an effect on the free amino-N content as a result of proteolysis by extremely heat resistant enzymes, often produced by psychrotrophic bacteria (1) Furthermore it influences the spore count in the raw milk, which is critical for the aseptic performance The European Union e.g specifies the microbiological raw milk quality as follows: * Raw cow's milk intended for the production of heat-treated drinking milk, fermented milk, junket, jellied or flavoured milk and cream must meet the following standards: FSQ-588014-0101 Procedures & Guidelines A practical approach to Aseptic Performance Plate count 30°C (per ml) 100 000 cfu Somatic cell count (per ml) 400 000 (Further details can be found in the ‘Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products’) Whereas the USA FDA regulation says: * Standards for Grade “A” raw milk and milk products for Pasteurization, Ultrapasteurization or Aseptic processing: Individual producer milk not to exceed 100 000 cfu/ml (32°C) prior to commingling with other producer milk Commingled milk not to exceed 300 000 cfu/ml (32°C) as prior to pasteurization Somatic cell count (per ml) in milk from individual producer not to exceed 750 000 / ml (Further details can be found U.S Food and Drug Administration Centre for Food Safety & Applied Nutrition Grade "A" Pasteurized Milk Ordinance 2001 Revision May 15, 2002) * In countries where the regulations from the European Union or the FDA are not applicable, national rules have to be followed If no national rules apply the European Union or FDA standards respectively could be considered as a guideline 2.2.1.3 Bacterial Spore Count The amount of bacterial spores is critical for the Aseptic performance Following guideline could be given for raw-milk if an AQL* of 1/1000 defective packages in the end product is aimed for, in 1000 ml packages The figures given in the table below can only be seen as a very rough indication of what should be recommended in terms of spore load based on a log reduction during processing: Guide for Thermoresistant Spore count in UHT processing* (Sample taken from balance tank of sterilizer) Type Goal Action Processability limit Total amount of Spores 110 °C Note that a steam barrier should not be too hot Exceeding 125°C will give unnecessary wearing of seals, and might create product scaling Steam barriers are normally situated at tank-valve cluster, agitator and end-valve-cluster Some products require that an agitator is used, depending on viscosity, separation etc If no such products are produced, the agitator should be removed and the hole sealed with a blinder to avoid unnecessary risk of infection FSQ-588014-0101 10 Procedures & Guidelines A practical approach to Aseptic Performance Check that the Aseptic valves are in good condition Is regularly service and maintenance done? Check that the pre-sterilisation is carried out properly Commonly, Aseptic tanks and product-lines are pre-sterilised together by means of steam 30 minutes at >125 °C is required Temperature guards should be placed in critical positions like valve-cluster, sterile air filter and end-valve-cluster What happens if the temperature falls below the lower limit during pre-sterilising? The timer should restart from when the right temperature is obtained Check the overpressure in the tank during pre-sterilisation, cooling and production A minimum of 0,5 bar should always be kept Is there a guard for low-pressure? Check the CIP-result by opening the tank and inspect the inside with help of a torch (Agitator, top, bottom and the sprayball) At the same time look for rust or cracks If necessary, climb inside the tank Open a valve in the valve-cluster, check for residues 2.2.6 2.2.6.1 Filling and packaging Filling room The requirements of a filling-room could be referred to “Guideline for the Hygienic Production of Liquid Food, Part 1; FiSQA” In general, the filling-room should be separated from the rest of production Doors should be kept closed and there should be an overpressure of filtered air in the room This implies especially for open filling systems as TBA/3, Tetra Fino, A1/P1 and Classic Placing air settle plates in different parts of the room could check the air quality in the room Prepare PCA plates, Yeast and Moulds Leave the plates open for 15 minutes in the room Incubate the plates accordingly and evaluate the result One reference is maximum 40 cfu/ 100 cm2 , total count However the usage of an air-sampling device is recommended due to a much higher accuracy Unfortunately there are no recommendations regarding acceptable limits of air bioburden in production rooms of aseptic food plants According to data from tests the air microbial load in production rooms of UHT - (aseptic) dairy plants within the range of 500-1000 cfu/m3 is regarded as OK (measured with an air sampling device) This data must be lower, if it comes to non-aseptic machines filling pasteurised products Radmore and Lück (1984) proposed the following: Total count: Good = < 200/m3; Poor => 2000 /m3 Yeasts and mould count: Good = < 100/m3; Poor => 1000/m3 These proposals have been made for production rooms of cheese, milk powder, butter and condensed milk Proposals regarding production of UHT milk, pasteurised milk and juices are not available (3) FSQ-588014-0101 11 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.6.2 Raw material (Packaging material) Packaging material arrives to the customer on pallets, wrapped in plastic film It should be stored like this, inside, in a dry and normally tempered place When intermediately stored, before production, it is important that dust or water does not contaminate the Packaging material, i.e keep plastic wrapping until use Partially used reels have to be re-wrapped in plastic, marked and stored in a suitable place To be used as soon as possible Check if actual storage-places are suitable Check if dirty Packaging material exists in storage or intermediate storage Note that the longitudinal strip and Pulltab strip also are parts of raw material for packaging Check if system for first in first out is used (FIFO) The operator must clean and disinfect hands before splice of reels or strip Low hygiene will result in re-infection 2.2.6.3 Hydrogen peroxide Check the concentration of Hydrogen Peroxide It should be between 30-50 % Do the operators have proper equipment (aerometer and plastic cylinder for density check)? Are they following the Operator Manual (OM)? Is the Hydrogen Peroxide quality according to the Tetra Pak specification (Technical Bulletin No: 1:3/96 issue 4) For open filling systems as TBA/3, A1 and Tetra Classic machines, especially with lowacid products, it is recommended to check the Hydrogen Peroxide consumption/hour and compare it with OM-specifications ml PSM (wetting agent)/ 1000 ml Peroxide has to be pre-mixed for these machines K-material type of Packaging material is not recommended for machines with open baths, due to uneven wetting of Hydrogen peroxide to the K-material (hydrophobic) Notice the influence of temperature and humidity High temp / Dry air, needs an increased peroxide consumption Low temp / Humid air, increases peroxide residues in ready packages= need to decrease consumption Example of consumption in a TBA/3 -1000 ml: TBA/3-1000 PEROXIDE CONSUMPTION Consumption 25°C Consumption 35°C Consumption 45°C Relative Humiditiy % 20 30 40 50 60 70 80 Consumption ml/hour Consumption ml/hour Consumption ml/hour 240 - 280 230 - 270 225 - 255 215 - 240 205 - 230 195 - 220 280 - 335 270 - 320 255 - 305 240 - 290 230 - 275 220 - 255 335 - 405 320 - 385 305 - 360 290 - 340 275 - 320 255 - 295 FSQ-588014-0101 12 Procedures & Guidelines A practical approach to Aseptic Performance Peroxide residues in ready packages are measured by peroxide sticks (in product), or by Colometric glass tubes (in water test) The sample equipment could be ordered from Tetra Pak Parts: Peroxide sticks, Tetra Pak order number 90298-30 Colometric test kit (The blue box), TP order number 90298-31 2.2.6.4 Pre-sterilising Pre-sterilising is system specific Function and design differs between machine systems Parameters might vary and should be confirmed in with the OM Use when applicable, e.g.: Check that steps of drying and spraying are working At spraying, condense of Hydrogen peroxide should appear on the inside of the window in the Aseptic chamber No alarm regarding peroxide should appear during pre-sterilisation Check temperatures at sterilisation The Superheater temperature should be between 360400°C, and the temperature after the pre-heating step behind the heat exchanger 280°C The steam barrier for the C-valve should be 130 °C Also check that guards are set to correct minimum temperature according to OM 2.2.6.5 Production Production is system specific Function and design differs between machine systems Parameters might vary and should be confirmed in with the OM Use when applicable, e.g.: Check the temperature of the peroxide bath Lower limit is 68 °C (not by systems with open bath) The steam barrier for the C-valve should be higher 130°C A steam barrier temperature higher than 130°C leads to unnecessary wear of gaskets and scaling of product during production, which than can lead to cleaning problems and consequently to unsterilities Also check that guards are set to correct minimum temperature according to OM 2.2.6.6 Package integrity It is common that Package integrity is a reason for unsterility The operator should check package integrity frequently, recommended at least every 30 minutes (not applicable for high capacity systems like TBA/22 or A3-Speed, please consult the OM book) Check that the operators carry out the control according to the OM Results from the control should be documented in a production protocol Deviations in the quality of package integrity should be rectified immediately in terms of corrective actions (Further information regarding Package Integrity control could be found in the FiSQA Guidelines for the Evaluation of a Batch of TBA Packages or the BoC – Book of Competence about Package Integrity) FSQ-588014-0101 13 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.6.7 Samples for laboratory control Sampling can be done in two different ways: Random sampling Aimed sampling For random sampling the number of packages, which should be drawn at regular interval should be ideally reflect the number of jaws from the respective filling machine For example every 30 minutes packages on a TBA/21-1000B and/or every 60 minutes 10 packages on a TBA/22-200S These samples should be marked with the time for traceability purposes The laboratory then carries out microbiological, sensory and chemical analyses of the samples Note: The number of random samples taken, has to be decided by the management of the customer and should depend on the defect level the customer wants to detect Tetra Pak can give statistical guidance (See “Guideline for Microbiological Evaluation of Commercially Sterile Products”, FiSQA) The goal of random sampling is to detect sporadic unsterility and to gather statistics over the total defect rate Aimed sampling focuses on areas of increased microbiological risk These situations arise whenever production conditions are changed, for example: • Starting production • Short Stop / Normal Stop • Changing packaging material • Changing the longitudinal strip • Changing Innerpatch of PullTap • Changing the product, new batch • If applicable, changing from steriliser to sterile tank and vice versa • End of production • Etc It is recommended to draw between and 30 packages at aimed sampling The higher number at start and end of production, the lower number at other events mentioned above These samples should be marked with respective event The laboratory then carries out microbiological, sensory and chemical analyses of the samples The goal of aimed sampling is to quantify the contribution of certain risk areas to the total defect rate, and to identify areas for improvements The Technical Service Product ‘Quality Performance Analysis’ including the software tool ‘Incubation Result File’ (IRF) could be used for systematic monitoring and documentation of incubation results 2.2.6.8 CIP (Cleaning In Place) CIP is system specific The CIP-result is critical Check the result after CIP Look for residues in critical parts of the AFM, i.e valves A-B-C, and the upper filling-pipe (see TEM for Cleaning of TBA filling machines) FSQ-588014-0101 14 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.6.9 COP (Cleaning Out of Place) COP is system specific Check that the lower filling-pipe is clean, and that it is kept in a disinfectant solution between productions (preferably in a disinfection based on peracetic acid, like e.g Oxonia) Weigh (check reference weight stamped on the float) or shake the float and check that there is no liquid in it 2.2.6.10 External cleaning External cleaning is system specific Check that the upper filling-pipe, LS-element, LScounter pressure roller and air-nozzle are clean There should not be any burnt deposits Rollers should rotate freely Check that all SA-roller surfaces are clean and undamaged, and that the rollers rotate freely Check that the strainer of the air-knife is clean Check that the inductors are clean Check that the splicing table is clean and disinfected daily Check that the jaw system and final folder are clean New machine systems with spray nozzles need foam agent (see OM) to clean properly 2.2.7 Downstream packaging Check that Conveyor, Accumulator, Straw-applicator, Re-Cap, Tray-packer, Shrink or Palletiser are not damaging the packages Note that an Accumulator might make the traceability in a troubleshooting case difficult, when packages are stored there at different times of a production run FIFO (first in, first out) is only applied in the latest edition of accumulators like Tetra Helix) The cleanliness of downstream equipment is important for mechanical function, and to avoid reinfection 2.2.8 Finished product storage Check the pallets and packages in the final storage Blowers, leakage, product on the floor or water dripping from the ceiling are critical A “Positive release” system should be in place, were products are released to the market only after laboratory authorization Proper storage handling should have a documented control system, where defectives are examined and classified The Technical Service Product ‘Quality Performance Analysis’ including the software tool ‘Incubation Result File’ (IRF) could be used for systematic monitoring and documentation of Storage Control results 2.2.9 Laboratory It is important that laboratory analyses give proper result, i.e a pH-meter has to be calibrated regularly, and the pre-incubation of packages and incubation of petri dishes has to be done at right time/temperature The right Agar should be used It is recommended to calibrate the pH-meter with calibration buffers of pH 7,00 and pH 4,00 every day FSQ-588014-0101 15 Procedures & Guidelines A practical approach to Aseptic Performance PCA (Total Plate Count Agar) or TGA (Tryptone Glucose Agar) should be used for Lowacid products, and OSA (Orange Serum Agar) for High-Acid products It is also good to remember that the OSA should, if possible, be pH adjusted to the same pH as the product to be analysed Note that the pH is sometimes different in the agar compared with the product This might affect the growth Pre-incubation and incubation of aseptically packaged product, for Quality Control purposes, are recommended as following: Product type Low-acid (>pH 4,6) High acid ([...]... butter and condensed milk Proposals regarding production of UHT milk, pasteurised milk and juices are not available (3) FSQ-588014-0101 11 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.6.2 Raw material (Packaging material) Packaging material arrives to the customer on pallets, wrapped in plastic film It should be stored like this, inside, in a dry and normally tempered place... intermediately stored, before production, it is important that dust or water does not contaminate the Packaging material, i.e keep plastic wrapping until use Partially used reels have to be re-wrapped in plastic, marked and stored in a suitable place To be used as soon as possible Check if actual storage-places are suitable Check if dirty Packaging material exists in storage or intermediate storage Note that... spray nozzles need foam agent (see OM) to clean properly 2.2.7 Downstream packaging Check that Conveyor, Accumulator, Straw-applicator, Re-Cap, Tray-packer, Shrink or Palletiser are not damaging the packages Note that an Accumulator might make the traceability in a troubleshooting case difficult, when packages are stored there at different times of a production run FIFO (first in, first out) is only applied... laboratory analyses give proper result, i.e a pH-meter has to be calibrated regularly, and the pre-incubation of packages and incubation of petri dishes has to be done at right time/temperature The right Agar should be used It is recommended to calibrate the pH-meter with calibration buffers of pH 7,00 and pH 4,00 every day FSQ-588014-0101 15 Procedures & Guidelines A practical approach to Aseptic Performance. .. for laboratory CIP COP External cleaning Scheduled service Within specifications Remarks and recommendations: FSQ-588014-0101 19 Procedures & Guidelines A practical approach to Aseptic Performance 2.3.7 Downstream packaging Type of control Conveyor status, mechanical Cleanliness, cleaning schedule Defective packages Date OK, sign Date OK, sign Date OK, sign Date OK, sign Remarks and recommendations:... (compare with stated AQL *) • Used in a continuous improvement process It is imperative that the documents are structured to aid traceability in case of nonconformity situation Are records kept properly for different areas? Are records reviewed by the QA? FSQ-588014-0101 16 Procedures & Guidelines A practical approach to Aseptic Performance *AQL - Acceptance Quality Level has to be established for all pertinent.. .Procedures & Guidelines A practical approach to Aseptic Performance Check that the Aseptic valves are in good condition Is regularly service and maintenance done? Check that the pre-sterilisation is carried out properly Commonly, Aseptic tanks and product-lines are pre-sterilised together by means of steam 30 minutes at >125 °C is required Temperature guards should be placed in critical positions... market only after laboratory authorization Proper storage handling should have a documented control system, where defectives are examined and classified The Technical Service Product ‘Quality Performance Analysis’ including the software tool ‘Incubation Result File’ (IRF) could be used for systematic monitoring and documentation of Storage Control results 2.2.9 Laboratory It is important that laboratory... roller and air-nozzle are clean There should not be any burnt deposits Rollers should rotate freely Check that all SA-roller surfaces are clean and undamaged, and that the rollers rotate freely Check that the strainer of the air-knife is clean Check that the inductors are clean Check that the splicing table is clean and disinfected daily Check that the jaw system and final folder are clean New machine... documentation Type of control Records for different areas Scheduled review of records AQL- evaluation of level QA feedback to production Remarks and recommendations: FSQ-588014-0101 20 Procedures & Guidelines A practical approach to Aseptic Performance 2.3.9.2 Consumer complaints Type of control Claim control, documentation Defective packages, classification QA feedback to production Date OK, sign Date