Tài liệu Procedures & guidelines_a practical approach to aseptic performance

Procedures & Guidelines A practical approach to Aseptic Performance FSQ-588014-0101 Table of contents 1. Introduction ....................................................................................... 4 2. Checklists.......................................................................................... 5 2.1. Introduction to the Checklist .......................................................................... 5 2.2. Guideline to the checklist................................................................................ 5 2.2.1. Milk Reception.............................................................................................. 5 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 ..................................................................................................................... 5 Microbiological raw milk quality.................................................................................................... 5 Bacterial Spore Count ..................................................................................................................... 6 Acidity............................................................................................................................................. 6 Alcohol stability .............................................................................................................................. 7 Raw Material ................................................................................................ 7 Pre-processing ............................................................................................. 8 UHT-processing ........................................................................................... 8 2.2.4.1. 2.2.4.2. 2.2.4.3. 2.2.5. 2.2.6. Pre-sterilising .................................................................................................................................. 8 Production ....................................................................................................................................... 9 CIP................................................................................................................................................... 9 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 2 Table of contents 2.5. 3. Actions required ............................................................................................ 21 References....................................................................................... 22 FSQ-588014-0101 3 Procedures & Guidelines A practical approach to Aseptic Performance 1. 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 4 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. 2. 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 5 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 9 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 <100 1000 10 000 (Mesophilic spore count) Thermoresistant spores <10 100 1000 (Thermophilic spore count) * Reference Material: “A practical approach to the detection and enumeration of spore forming bacteria”. 2.2.1.4. Acidity Acidity (pH or equivalent) should be measured. A normal value in cow milk might be pH 6,6-6,7. If pH is lower than normal one can suspect sour milk or milk from sick cows (high microbiological load). If pH is higher than normal one can suspect that some chemicals are added to the milk in order to increase alkalinity (quality is base for payment to the farmer). Note that pH varies in milk from different animals and in different countries. The pH relates to sedimentation during storage. Even a small deviation from the normal pH increases precipitate of a protein/fat mixture. A “sandy” flavour defect results. It has been suggested that the drop in pH in the raw milk should not exceed ~0,02 units. (2) FSQ-588014-0101 6 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.1.5. Alcohol stability Alcohol stability will impact running times in the Pasteurizer and in the Sterilizer. The product scaling will increase and possibly give a non-satisfying CIP-result. A suitable method for checking alcohol stability in milk is to take equal volumes of milk and ethylalcohol and mix them. Typically concentrations of 68, 72, 74 and 80 % alcohol are used. Apply 2 ml milk and 2 ml alcohol on a Petri-dish or a test-tube and swirl it. If coagulated/ flocculated = positive test. IDF recommends a minimum alcohol number of 72, whereas Tetra Pak suggests 74. (2) Alcohol test is not used for high acid products. Is the raw product within the company specifications/ AQL? (AQL= Acceptable Quality Level) 2.2.2. Raw Material What type of raw materials are used and what about the microbiological quality? Apart from the raw milk other raw materials like water, sugar, milk powder, chocolate powder, emulsifier, stabilizer, juice concentrates and different flavor ingredients, etc. are having significance for a wide range of aseptically filled products. For the aseptic performance the microbiological quality of the raw material is of importance. A high microbiological load in the raw materials can add up during the different pre-process steps, like mixing and blending, to a level where the microbiological safety is no longer ensured during the process steps. Special attention should be paid to the load of sporeforming units since the microbiological result obtained from a given UHT treatment is determined by the spore count (2). Guide for Microbiological count in some of the common raw materials. The figures are based on practical experience and applied by many food producers in the world (5). The figures given in the table below can only be seen as a very rough indication of what should be recommended in terms of microbiological load, as this figures are very much depending on the type of product produced and the quality demand of each individual food producer. Product Type Total Count Mesophilic Spore count Thermophilic Yeast Mould Powder ingredients, e.g. milk or cocoa powder < 5000 < 100 < 10 n.a. n.a. Juice Concentrate < 1000 n.a. n.a. < 100 < 10 Crystalline Sugar < 50 < 10 < 10 < 10 Water* < 100** Spore count (All values are expressed as cfu/g or cfu/ml, respectively) *Furthermore water should be free of pathogenic microorganism. This is fulfilled if in 100 ml no Escherichia coli and no Coliforms can be detected. **At an incubation temperature of 20°C and 36°C respectively. FSQ-588014-0101 7 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.3. Pre-processing If powders are not dissolved properly into water or milk, particles might not be sterilised in the UHT-process. When producing chocolate milk, it is common to mix a slurry of chocolate powder, sugar water and milk. This slurry is heat treated at approx. 80 to 95°C for 10 to 30 minutes, to reduce the microbiological load from the chocolate powder. (See “Procedures for Production of UHT Chocolate Milk Beverage”; FiSQA) In general, it is recommended to have a certain soaking/maturation time for formulated products before UHT-treatment, usually between 8-12 hours at 4-6 °C. The intermediate product is filtered afterwards by a double filter of 180 to 200 mesh (75 micron). An intermediate storage before UHT-process is critical in terms of temperature and time. Sampling for chemical and microbiological analyses should be done prior to UHTprocessing. The product has to be within specifications to continue further processing. Note: The water quality (not only microbiological but also chemical quality) is of utmost importance when recombining milk, or mixing beverages. Check for records from water analyse, which should be done regularly. The quality should fulfil local regulations. If this is not done an analyse should be carried out. Note: When mixing high acid products it is of utmost importance to reach proper pH value in the product prior to the heat treatment. The temperature of the treatment is chosen after the acidity in the product, e.g. juice with a pH of 3,5 is usually pasteurised between 90 and 95° for 20-30 seconds whilst a juice with a pH of 4,5 (e.g. tomato juice) needs around 122 °C for 20-30 seconds to eliminate microorganisms able to multiply in such product. The pH value in beverages is commonly adjusted by adding Citric acid. Is the pre-processing within the company specifications? 2.2.4. 2.2.4.1. UHT-processing Pre-sterilising Check the function of pre-sterilising. Critical points are time and temperature. Where the temperature-guard is placed is crucial. It should be placed on the return-line from the Aseptic Filling Machine (AFM), or return-line from Aseptic tank (Supposedly the coldest places in the pre-sterilisation circuit) Commonly, pre-sterilising for Low-acid application is carried out for 30 minutes at minimum 130 °C. (90-120 °C for High-acid application) Check the settings for the timer and temperature-guard in the PLC-registers. What happens if the temperature falls below the setting in pre-sterilising? The timer should restart from 0 when correct temperature is obtained. Is the pre-sterilisation within specifications? FSQ-588014-0101 8 Procedures & Guidelines A practical approach to Aseptic Performance 2.2.4.2. Production During production the time/ temperature-ratio is critical. Check the volume of the holding-cell, versus used capacity (flow). Use following equation to calculate the holding-time; Length (meter) * Volume (l)/ meter Flow (liter/hour) =Seconds HC 3 600(seconds/ hour) Following table show volume in pipes (SMS); Diameter(mm-outer) 25 38 51 63,5 76 102 Liter/ meter 0,39 0,99 1,84 2,92 4,24 7,77 The table can be used as a help to calculate holding-times as well as velocity in CIP. Note that as a result of product scaling inside the holding tube, the velocity will change resulting in shorter holding time. Maximum running time should be determined accordingly. (See “Guidelines for assessing the appropriate cleaning interval for TTASteriliser”, FiSQA) Commonly, UHT-treatment* of Low-acid products is carried out between 135 and 150°C for 1 to 6 seconds (Plain, white milk*), and of High-acid products between 85 and 95°C for 20-30 seconds. Other temperature programs might be used depending on products and process equipment. Viscosity, particles and pH are parameters influencing the choice of temperature program. A temperature-guard should be placed in the end of the holdingcell, guarding that the sterilising temperature never falls below lower limit (Tetra Pak standard 133 / 91°C for low / high acid, respectively). Check automatic recorder paper. Is the temperature deviating during production? Is the production within specifications? *According to EU legislation Council Directive 92/46/EEC: UHT milk must have been obtained by applying to the raw milk a continuous flow of heat entailing the application of a high temperature for a short time (not less than +135°C for not less than a second). 2.2.4.3. CIP The CIP-result is critical. Check the heat-exchanger after CIP. Look for residues in those parts of the heat exchanger, were it is the warmest during production (e.g. holding tube). FSQ-588014-0101 9 Procedures & Guidelines A practical approach to Aseptic Performance Parameters that serve for an effective CIP are; Parameter Flow Time Temperature Concentration Tetra Pak recommendations TTA-Flex 1,5 meter/ second 50 min. Alkali / 30 min. Acid Productin temperature for alkali (e.g. 138°C) and 105°C for acid (holding cell) 2 % alkali / 1 % acid If the CIP-result is not satisfactory (present residues), improvements have to be done to the CIP-parameters. (See “Guidelines for assessing the appropriate cleaning interval for TTA-Steriliser”, FiSQA) 2.2.5. Aseptic product transfer and storage The denomination “Aseptic product transfer” of a plant means the part of the plant downstream (after) the holding-cell, all the way to the last filling-machine and further a few meters. It is likely that re-infection takes place in this part, if something is malfunctioning. Start at the holding-cell, and then follow the entire “Aseptic product transfer”. Look for leaks, suspicious welds (quality), rolled connections, gauges, unions, valves, steam traps, backpressure valves, dead ends etc. A dead end should be no longer then 1,5 times the pipe diameter. Each and every component in the aseptic product transfer of a plant is adding a potential risk to aseptic performance. If aseptic tanks are part of the aseptic product transfer, they are usually pre-sterilised by steam. Piping must be properly designed, avoiding “ups and downs” that could collect condensate. Measure the temperature of such places with a surface thermometer during pre-sterilisation (>125 °C should be reached in each part). Open the system, in some critical places (e.g. end-valve-cluster), after CIP to check the CIP-result. Check if regularly service and maintenance is done of the aseptic product transfer. The denomination “Aseptic storage” means Aseptic tank systems, which serves as a buffer to obtain a more flexible production. Critical points are sterile air filters, steam barriers, aseptic valves, agitator, presterilisation, over-pressure and CIP-result. Check the sterile air filters. Are they clean (visual and smell), dry, any visible damage? What is the interval for replacement? Check the temperature of the steam barriers during production. Normally, a steam barrier should keep >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 0 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. 3 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: 1. Random sampling 2. 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 2 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 4 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 ( - Xem thêm -