Human Milk is not simply a food but a complex infant support system Medicare Colgate Ltd Post Cross Business Park Cullompton, Devon, EX15 2BB, England Tel: +44 (0) 1884 266 666 Fax: +44 (0) 1884 266 333 www.sterifeed.com E-mail: [email protected] Dear Reader, We have collated this document to help you with your decision making process when purchasing an infant feed pasteurizer. As pasteurization equipment does not come under the FDA umbrella therefore it is vital that your Bio Medical Engineering and Infection Control Departments vet all equipment prior to purchasing. The enclosed information is based on published medical science papers. We have highlighted the three most important features to consider when pasteurizing: Rapid refrigerated cooling with a final milk temperature of 39.2F to ensure the milk is at a safe temperature to put directly into the fridge or freezer and to limit the regrowth of bacteria – National Institute of clinical excellence – UK government - Human Milk Banking guidelines Fully submerging bottles during the heating process to ensure the entire bottle is treated – Human Milk Banking Association of North America guidelines – HMBANA Electronic data verification of the milk temperature to ensure proof of treatment - Human Milk Banking Association of North America guidelines – HMBANA - USA Safe Pasteurization of Mother’s Milk and Special Diets Contents Introduction Why Sterifeed Pasteurizers How to Choose a Safe Pasteurizer HMBANA Guidelines – Submerging bottles HMBANA Guidelines – Data logging of the Milk Refrigerated Cooling graph Comparison tap water cooling versus refrigerated cooling Infant Feed Pasteurization – Line Paper Three Levels of Safety - Pasteurization Treatment Procedure for the New Millennium Scientific Report: Affect of Water Level when Pasteurizing Human Milk Defrost Program/Bottle Warming Program Data Logging System Pasteurization Cycle Summary Data Logger Cycle Profiles Pasteurizer Position Testing Pasteurizer Basket Options Pasteurizer Certification Standards HMBANA Pasteurizer Installations Product Leaflets Pasteurizers Leaflet S90ECO Pasteurizer Leaflet S180ECO Pasteurizer Leaflet T30 PP Storage Bottle & Tamper Evident Bottles Leaflet Printer Leaflet Medicare Colgate Ltd Post Cross Business Park Cullompton, Devon, EX15 2BB, England Tel: +44 (0) 1884 266 666 Fax: +44 (0) 1884 266 333 www.sterifeed.com E-mail: [email protected] Why Sterifeed Pasteurizers ● More than 250 units operating world-wide in over 30 different countries. Half of current HMBANA milk banks use Sterifeed pasteurizers ● Continuous development since 1977. Sterifeed Pasteurizers use the Holder Method based on Prof. David J. Baum’s and Co-workers at John Radcliffe’s Hospital invention of the pasteurizer. ● We pride ourselves on our pasteurizers accuracy, safety and company customer service and after sales support ● The Baum or Holder method that the Sterifeed pasteurizers are based upon is controlled heating followed by controlled cooling. Milk temperature pasteurization at 63ºc / 145.4ºF for 30 minutes followed directly by rapid refrigerated cooling to less than 4ºc / 39.2ºF as required by all European Guidelines. Rapid refrigerated cooling reduces the window of opportunity for re-growth of bacteria not destroyed by the pasteurization process. ● Through the use of the Sterifeed ICS Induction Heat Sealer, the whole bottle can be submerged on the heating cycle as per HMBANA and all major Human Milk Banking Guidelines. ● Sterifeed pasteurizers monitor Milk Temperature by means of a control bottle probe. It is the actual milk temperature that is the vital reading on the verification of treatment data, not the bath temperature. ● Visual monitoring window - every stage of the pasteurization cycle can be observed. ● Temperature can only be adjusted with approval of Infection control, and by strict Milk Banking protocol. ● Easy to use computerized data logging system for verification of treatment. Complete proof of treatment and data re-call for the entire heating and cooling cycle should verification be required. Paper records take up space and are difficult to retrieve. ● On Site training and commissioning 12 months on site parts and labor warranty. Local distributor for servicing and maintenance. ● Stainless steel construction no rivets, no dirt or water traps. ● CE marking, being the manufacturer’s declaration that the product meets the requirements of the applicable EC directives and is a worldwide recognized standard ● Energy efficient hot fill, ready to use in approximately ten minutes. ● Uses low cost Sterifeed clear bottles available direct from Sterifeed or from your local distributor. ● Preferred and approved by Bio Medical Engineering & Infection control Departments. There are several safety issues when choosing a pasteurizer Do not take a risk - unless you have extensive Medical Physics experience, consult your Medical Physics and Infection Control team. The Safety Issues! PASTEURIZER WATER LEVELS – Sterifeed pasteurizers have adjustable water levels Bottles should be fully submerged during the heating process and not submerged during the rapid cooling process. (Unless Sterifeed foil safety seal bottles are used) HMBANA GUIDELINES 2.a (please see following pages for guideline reference extract) The reason why the bottle is required to be submerged is to ensure the entire bottle is treated; there is a risk that milk droplets adhere to the cap or neck of the bottle as such the entire bottle is required to be treated. NB some pasteurizers on the market do not submerge and therefore don’t treat the entire bottle ELECTRONICALLY RECORDING THE MILK TEMPERATURE - Sterifeed pasteurizers have a bottle probe and data logger. It is vital that the Milk temperature as well as the bath temperature is recorded. HMBANA GUIDELINES 2.f (please see following pages for guideline reference extract) The water bath temperature does not indicate what the actual milk temperature is, especially during the cooling process. Proof of treatment for both heating and cooling of the milk is essential this must be carried out via the use of a control bottle with a probe and data logger. A data verification system for easy data storage and recall on your PC is vital for your proof of treatment and professionalism of your milk bank. NB some pasteurizers on the market do not have a control bottle and do not record the key milk temperature RAPID REFRIGERATED COOLING IS ESSENTAIL – Sterifeed pasteurizers have a refrigeration unit to enable rapid controlled cooling. All Milk Banking Guidelines recommend rapid cooling of the milk straight after pasteurization. HMBANA GUIDELINES 3.a (please see following pages for guideline reference extract) Sterifeed pasteurizers via the use of a refrigeration unit rapidly cool the milk from 63ºC to 25 ºC (145.4 ºF to 77ºF) in less than 10 minutes. With a final temperature of 4 ºC (39 ºF) Rapid refrigerated cooling is vital as it limits the re-growth of bacteria in the milk. NB some pasteurizers on the market do not have a refrigeration unit and therefore without this cannot meet the rapid cooling requirements 2. Heat Processing a. Aliquots of milk are processed by completely submerging the containers in a well-agitated or shaking water bath preheated to a minimum of 62.5°C / 144.5°F 2. Heat Processing b. A control bottle containing the same amount of milk or water as the most filled container of milk in the batch is fitted with a calibrated thermometer to register milk temperature during heat processing. The control bottle follows the same process as the rest of the batch at all times. f. Milk temperature and bath temperature are monitored and recorded. Comparison between Sterifeed pasteurizers and tap water cooled pasteurizers / water baths Feature " STERIFEED" Refrigerated water cooled "Bench Top / Water bath" Tap water cooled Milk Treatment method precise for heating Yes Yes Milk Treatment method precise for cooling Meets - Baum / Holder Method – The scientific method of automatic heating followed by refrigerated cooling in one chamber Yes No Yes No Method practice proven for more than 35 years Yes No Method "Peer reviewed" in two major studies Yes No Method used in 250 Milk Banks using Sterifeed in 35 different countries Yes No Verifiable milk temperature for entire cycle heating & cooling Yes No Easy access of computerized proof of treatment data Yes No Rapid cooling milk temperature to 77 °F in less than 10 min Yes No Final milk temperature in the same bath of 39.2 °F Yes No Meets all World Milk Banking guidelines Yes No Computerized Data Logging for proof of treatment Yes No Bottles submerged during heating to give 100% treatment of contents Yes No Cooling water recycled for minimum waste Yes No Measure milk temperature not water bath temperature Milk Temperature controlled by Pasteurizer to ensure no overheating of the milk Yes No Yes No Minimum incoming cold water temperature required (57°F) No Yes High water consumed through running water for cooling No Yes Infant Feed Pasteurisation A fully referenced evidence based guide to the "practice proven" method for the Thermal Treatment of Human Milk By David J. Colgate S.J.Line Mphil FIBMS CBIOL MIBIOL Managing risk in feed preparation In the late 1970's, faced with a growing range of formulae feeds the goal was to establish an infection control procedure that renders safe donated Human Milk, at the same time preserving the majority of the immune and nutritional factors. This paper describes a precise method of treatment that can be repeated at any location. Risks must be minimised The established Pasteurisation method raises the temperature of milk in a closed bottle to 62.5°C¹, holding for 30 minutes, then immediately cooled rapidly to > 4°C², within the Pasteurisation Cycle. Rapid cooling is described as cooling from 62.5 °C to 25 °C 4 in less than 10 minutes giving a cooling rate of 3.75 °C per minute 6. If cooling is slow any surviving bacteria will multiply, therefore the time milk is held between 45oC and 15oC must be minimised. To achieve rapid cooling a refrigeration plant is essential to remove excess heat. The use of a cold water supply as a cooling medium is inadequate for two reasons. Firstly the water is discarded after each flush, therefore an environmentally unfriendly process. In addition the temperature of the supply water will vary depending on the time of year and the proximity of the cold water pipe to warm situations. An air space of about 2 cm should be left below the mouth of each bottle to allow for expansion during heating and subsequent freezing 6. Bottles must be submerged during the heating cycle 3 , mandatory in USA 7, to ensure that all surfaces of the bottle and lid as well as the milk are heat-treated 10. Bottles should not be submerged during the cooling cycle 5 (unless foil sealed bottles are used) as a low pressure will be produced in the bottle head space which could cause cooling water to be drawn into the bottle contaminating the milk. Comment The method was developed by the late Professor J David Baum and his co workers at the John Radcliff Hospital, Oxford in 1977 ¹. Dr J. David Baum personally gave his paper to The American Academy of Paediatrics at their Annual Conference in New York in 1982. A comprehensive comparative study at Sorrento Maternity Hospital Birmingham in 1992 ² became the basis of the first Guideline Published in 1994 by The Royal College of Paediatrics and Child Health 5. Almost all studies relating to various aspects of donated Human Milk, particularly if they relate to the elimination of the H.I.V. will have used the above method of treatment. Users of other treatment methods cannot draw comfort from these studies. Precise Equipment The first patented prototype of an Automatic Pasteuriser with controlled refrigerated cooling was built in 1977 by the Medical Physics department of John Radcliff Hospital, Oxford ¹. The patent was licensed to Vickers Medical Ltd. who built the first 20 bottle production model under the "OXFORD" brand (discontinued in 1982). In 1978 Colgate Medical Ltd developed in conjunction with Kings College University Hospital 3, London a semi automatic Pasteuriser based on standard water baths with dip cooled refrigeration. The Public Health Laboratory was also consulted and their studies found that milk drops in the cap did not receive the same treatment unless the bottle was submerged during the heating cycle 3 7. To precisely achieve the above method a fully automatic Pasteuriser with 42 bottles was designed by David Colgate in 1980, marketed under the brand "Axicare" and the development was chosen in 1983 for display by The British Technology Group for the opening of their new Headquarters by HRH the Prince of Wales. This model of Pasteuriser built by Scott Weston Ltd was used for the studies by Sorrento Birmingham in 1992.² This treatment method is now specified in all other European guidelines. This is apart from Austria and Italy who specify the final cooling temperature to be 4°C to reduce even further the window of opportunity for Bacteria re-growth 7 9. In Sweden compliance with the protocol is mandatory 8. Technological advances enabled Medicare Colgate Ltd to introduce a compact version with many additional safety features marketed under the brand "STERIFEED". Namely all water traps were removed including the secondary cooling tank thus avoiding the need for a sterilisation cycle. Verification of Treatment As with sterilisation equipment, a record of independent verification of satisfactory treatment of the milk (not the water bath) for the complete cycle (heating & cooling) must be kept for future reference together with traceability data. This will be required by Infection Control Departments, Environmental Health Inspectors and a copy for any other Health Care establishment using the facility must be part of the documentation for the relevant batch. Also Pediatricians prescribing Donor Human Milk will need to know that their source of supply treats the milk in compliance with regulatory protocols 6 Typical Human milk temperature curve for satisfactory Pasteurisation Danger zone Reducing the bacterial hazard Rapid cooling provides the following advantages: • Minimal bacterial growth after pasteurisation • Minimal toxin production by bacterial growth • Prevention of spore outgrowth • Longer milk storage time below 5C due to lower bio burden • Lower risk to baby Vegetative bacteria Bacteria most likely to contaminate breast milk will grow at a temperature between 10C and 50C. Maximum growth will occur at temperatures around 35C. Therefore it is important that once milk has been pasteurised it is cooled rapidly to 5C to reduce the time it is kept at temperatures likely to allow growth. Under ideal conditions bacteria can multiply once every 20 minutes, so prolonged storage at temperatures between 10C and 50C could pose a potential hazard to the baby. In addition to bacterial growth some bacteria produce toxins, some of which are heat resistant. Once these toxins are produced they can’t be removed from the milk and will affect the baby. Bacterial spores Spore forming bacteria are highly likely to contaminate expressed milk due to their presence on the skin surface and hands. Spores will survive pasteurisation treatment, but will be heat shocked. This treatment will promote outgrowth of the spores so they will start to multiply if allowed to do so. The many spore forming bacteria produce toxins which will affect a baby. To reduce spore outgrowth and reduce toxin formation processed milk should remain at temperatures between 10C and 50C for the minimum time possible. Summary At the time of preparing this document in 2005 David Baum's method of Pasteurisation has become standard practice throughout the world with more than 150 installations. The method has been adopted as a Bench Mark of safety and quality by all reputable equipment manufactures. The Human Milk Bank in Umea in the north of Sweden and the one in Athens in the south of Europe, Pasteurise to exactly the same treatment data (heating & cooling) irrespective of Ambient temperature and the temperature of their cold water supply. Users of water baths with a tap water cooling method will find that they are unable to achieve consistent results, as the incoming water will vary between 10°C and 25 °C (or even higher in the Summer). Also the influence of how far the water has to travel, the proximity of the hot water supply and the use of storage tanks will all affect the calorific uptake. Therefore additional space will be required for Blast Chilling or bespoke refrigeration. The placement of large volumes of warm milk into a refrigerator already in use may warm the existing contents and contravene Food Hygiene regulations. Users of ancillary cooling will find it difficult to provide proof of treatment for the complete cycle. Conclusion Purchasers of Pasteurisation equipment must satisfy themselves that it complies with the above method in all respects and a certificate of conformity obtained. The fact that a manufacturer may have sold a few is no guarantee. It is the Medical Profession that decide the parametric requirements not the equipment manufacturer References 1. Drip Breast milk: its composition, collection, and pasteurisation (Early Human Development). John Radcliffe Hospital, Oxford Gibbs,J.H., Fisher,C., Bhattacharya,S., Goddard,P. and Baum, J.D., 1977 2. Human milk banking at Sorrento Maternity Hospital, Birmingham, S E Balmer, W A Wharton, Archives of Diseases in Childhood APRIL 1992. 3. Organisation of bank of raw and pasteurised human milk for neonatal intensive care. S. Williamson, J.H.Hewitt, E. Finucanr, H.R.Gamsu. British Medical Journal, 1978 4. The collection and storage of Human Milk, Department of Health & Social Security Report on Health and Social Subjects No 22 London 1981 5. Guidelines for the Establishment and Operation of Human Milk Banks in the UK The Royal College of Paediatrics and Child Health First Edition 1994 6. Guidelines for the Establishment and Operation of Human Milk Banks in the UK The Royal College of Paediatrics and Child Health Second Edition 1999. 7.USA Guidelines for the Establishment and Operation of a Donor Human Milk Bank. Human Milk Banking Association of North America written 2003 Revised 2005 8 Sweden THE NATIONAL BOARD OF HEATH AND WELFARE To prevent infection in the heathcare sector,II 1998:12 9 Italy Linee Guida per la costituzione e l’organizzazione di una Banco del Latte Umano Donato Societa Italiana di Neonatologia la edizione 2002 10 Affect of Water Level when Pasteurising Human Milk, S.J.Line Mphil FIBMS CBIOL MIBIOL, Sterilser Consultants Ltd. 11. Donor Breast Milk Banks: the operation of donor milk bank services N.I.C.E Guidelines – issue dated February 2010 THREE LEVELS OF SAFETY ! 1 Pasteurization treatment procedure with hermetic foil seal Bottles completely immersed during heating and cooling cycle Foil Safety Seal Foil Safety Seal Identical treatment Identical Cooling 2 Pasteurization treatment procedure for bottles without foil seal Bottles completely immersed during Heating cycle Water level below cap during Cooling cycle Vacuum inlet above water level Identical treatment 3 Pasteurization treatment procedure abandoned pre 1980 Water level below cap during heating and cooling cycle NOTE! "Bottles must be fully Immersed during the Heating cycle "(see ref.) (Williamson S, Hewitt JH, Finucane E, Gamsu HR. Organisation of raw and pasteurized human milk for neonatal intensive care. British Medical Journal 1978: 1:393- 96 ), (Public Health Laboratory Service recommendations Hewitt J.H. 1990) Milk droplets in cap area receive specified treatment Milk droplets in cap area do not receive specified treatment Medicare Colgate Ltd, Post Cross Business Park, Cullompton, Devon, EX15 2BB.Tel: 01884 266666 Sterilizer Consultants Ltd 22 Long Park Woodbury Devon EX5 1JB Telephone 01395 232583 Exeter Email: [email protected] Our Ref:sf02/02 Report Affect of Water Level when Pasteurising Human Milk And Special Diets By Stuart J Line MPhil FIBMS CBIOL MIBIOL Introduction The pasteurisation of human milk in milk banks is performed using a water bath. Traditionally the water level in the bath allowed the bottle to be entirely submerged to allow the process temperature to be attained both in the milk and headspace of the bottle. The disadvantage of this process is the reliance of a good watertight seal of the cap and bottle to prevent water from the bath entering the bottle. An alternative design has now entered the market that uses a water level just above the level of milk in the bottle. The aim of this paper is to measure the time/temperature relationship between these two methods and determine if they both allow reliable pasteurisation of milk and internal bottle surfaces. Equipment Water container – Cannon Avent electric baby bottle steriliser with a temperature controller in line with the heater, able to regulate the water temperature to 63 °C +1/-0 °C and fitted with a stirrer. IIlustrated in Figure 1. Bottles - Sterifeed 130ml plastic bottle fitted with a plastic entry port. Temperature data logger – Chessell 4100G 6 point logger with a set scale 0 – 100 °C Using 0.2mm Cu/Con thermocouple wire, Milk – UHT low fat cow’s milk. Protocol 1. The water bath was switched on and allowed to settle to 63 °C with the stirrer in operation. 2. Thermocouple wires were fitted to the test bottle as listed and one wire free to dip into the water bath water. 3. The data logger was checked for calibration by placing the all thermocouple wire in the water together with certificated mercury in glass thermometer. After equilibration of 10 minutes readings were taken of all the probes and the thermometer. The results are listed in Table 4. 4. The test bottle was filled with milk to the 130ml line and the cap carefully fitted to provide a good seal. 5. The test bottle was placed into the water bath with the water level to the shoulder for tests 1 and 2. For test 3 the water level was raised until the cap of the test bottle was covered. 6. The time was noted when the milk reached 63 °C and 30 minutes was then allowed before the test ended. 7. On completion of the 30 minutes at 63 °C the test bottle was removed from the heated bath to cool. Results Table 1. Channel 1 2 3 5 6 Test 1: Water level to top of milk level Probe site Inside cap Head space Water bath Shoulder inside bottle Threaded area inside bottle Temperature of milk at start: 23.4 °C Temperature in °C when milk at 63 °C 54.4 53.6 65.4 51.7 Temperature at end of pasteurisation °C 54.0 53.5 63.3 50.8 54.0 54.3 Table 2. Channel 1 2 3 5 6 Test 2: Water level to top of milk level Probe site Inside cap Head space Water bath Shoulder inside bottle Threaded area inside bottle Temperature when milk at 63 °C 54.5 55.8 64.3 54.5 Temperature at end of pasteurisation °C 56.5 59.2 64.6 57.8 54.5 56.6 Temperature of milk at start: 25.4 °C Table 3. Channel 1 2 3 5 6 Test 3: Water level above top of bottle Probe site Inside cap Head space Water bath Shoulder inside bottle Threaded area inside bottle Time delay of probe reaching 63 oC 6 min 20 sec 5 min 28 sec 7 min 28 sec First probe to 63 oC 5 min 08 sec Temperature of milk at start: 17.3 °C Table 4. Calibration check on thermocouple probes Temperature of water bath measured using certificated mercury in glass thermometer: 63.3 °C Temperature reading of probesProbe Temperature error 1 2 3 4 5 6 63.2 °C 63.1°C 62.9 °C 63.4 °C 63.0 °C 63.5 °C - 0.1°C - 0.2 °C - 0.4 °C + 0.1°C - 0.3 °C + 0.2 °C Comments Test 1. Gave a differential of 8.6 °C to 12.2 °C between the milk temperature and areas around the bottle headspace and walls. Pasteurisation would not be attained in these areas thus allowing bacterial survival resulting in contamination of the pasteurised milk during storage. Test 2. Gave a differential of 5.2 °C to 8.5 °C which also would cause a failure of pasteurisation. In addition at the end of 30 minutes exposure time at 63 °C the probes in and on the surface of the bottle headspace did not rise above 59.2 °C. Therefore at no time during pasteurisation did any of the headspace probes come within 3.8 °C of the required minimum temperature during tests 1and 2. Test 3. Illustrated that when the bottle was heated with a depth of water that covered the cap the slowest probe to reach 63 °C was in the milk. All the probes in the headspace area were heated to temperature at least 5 minutes longer than the 30 minutes pasteurisation time. The tests prove that it is essential to cover the milk bottles with heated water to ensure that all surfaces coming in contact with the milk are pasteurised to the required standard. Failure to heat all internal bottle surfaces will result in the survival of contaminating organisms in the bottle headspace. After pasteurisation these organisms will re-contaminate the milk and pose a potential hazard to baby consuming the product. Stuart J Line Microbiologist Date: 13 August 2002 The pasteuriser controlled defrost program facilitates with the Data Logger Probe accurate details of time and temperature of the defrosting process of the bottles. It is vital that milk is fully defrosted prior to pasteurizing Human Donor Milk. For S90 & S180 Models Only Medicare Colgate Ltd Post Cross Business Park Cullompton EX15 2ES England Tel: 0044 (0) 1884 266 666 Fax: 0044 (0) 1884 266 333 [email protected] www.sterifeed.com The pasteurizer controlled bottle warming program facilitates with the Data Logger Probe accurate details of time and temperature of the warming process of the bottles. For S90 & S180 Models Only Medicare Colgate Ltd Post Cross Business Park Cullompton EX15 2ES England Tel: 0044 (0) 1884 266 666 Fax: 0044 (0) 1884 266 333 [email protected] www.sterifeed.com INFANT FEED DATA LOGGING SYSTEM Accurate proof of treatment that can be accessed from computerised data by entering the bottle batch number. Reading taken every minute- recording the exact temperature of the milk, time and date. Operates remotely, no direct computer link during recording . Information downloaded to the software provided to give a permanent record of satisfactory treatment. Recent discussions have shown that many Milk Banks have not realized the importance of “Rapid Cooling” as part of the overall time & temperature profile as established in published medical papers for the Thermal Treatment of Mothers Milk (S.Balmer, W.A. Wharton, Human milk banking at Sorrento Maternity Hospital, Birmingham, archives of Diseases in Childhood APRIL 1992). A review of papers has indicated that a final temperature of 4 °C is desirable to prevent the multiplication of heat resistant organisms not destroyed by pasteurisation (Department of Microbiology, Bristol University) The Sterifeed data logging system and bottle probe have been fitted as standard equipment since April 1998 and is now available to all Hospitals involved in the high quality thermal treatment of infant feeds including special diets and formula Medicare Colgate Ltd Post Cross Business Park Cullompton, Devon, EX15 2BB, England Tel: +44 (0) 1884 266 666 Fax: +44 (0) 1884 266 333 www.sterifeed.com E-mail: [email protected] SPECIFICATION Comark Data logger Temperature Range (-40°C to +125°C) -104 F -/+ 257F Computer connection lead with USB cable supplied Available with: Comark Software This can be downloaded from http://www.comarkinstruments.com/software.tpl?dl_file=EVSW_Std.exe . From there you will be able to download the latest version. Bottle Test Probe & Cable cap fitting, fits most bottles Datalogger Profile The list below is an example of the list view print out from the Datalogger This shows the temperatures that the probe in the milk achieves and the time taken 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Date Time Temp C Temp F 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 12.24.41 12.25.41 12:26:41 12:27:41 12:28:41 12:29:41 12:30:41 12:31:41 12:32:41 12:33:41 12:34:41 12:35:41 12:36:41 12:37:41 12:38:41 12:39:41 12:40:41 12:41:41 12:42:41 12:43:41 12:44:41 12:45:41 12:46:41 19.577 25.697 32.350 37.091 40.827 43.886 46.438 48.608 50.491 52.162 53.666 55.035 56.307 57.502 58.612 59.465 60.090 60.555 60.964 61.266 61.548 61.767 61.946 °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C 67.239 78.255 90.229 98.764 105.489 110.995 115.588 119.494 122.884 125.892 128.598 131.063 133.352 135.504 137.501 139.036 140.162 140.999 141.735 142.280 142.786 143.181 143.502 °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F °F 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 2014-04-16 12:47:41 12:48:41 12:49:41 12:50:41 12:51:41 12:52:41 12:53:41 12:54:41 12:55:41 12:56:41 12:57:41 12:58:41 12:59:41 13:00:41 13:01:41 13:02:41 13:03:41 13:04:41 13:05:41 13:06:41 13:07:41 13:08:41 13:09:41 13:10:41 62.113 62.238 62.323 62.431 62.514 62.572 62.606 62.646 62.705 62.739 62.764 62.767 62.770 62.804 62.838 62.851 62.854 62.851 62.841 62.871 62.941 62.991 63.000 63.000 °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C °C 143.803 °F 144.028 °F 144.182 °F 144.375 °F 144.525 °F 144.630 °F 144.691 °F 144.763 °F 144.869 °F 144.930 °F 144.975 °F 144.980 °F 144.986 °F 145.047 F 145.109 °F 145.131 °F 145.137 °F 145.131 °F 145.114 °F 145.167 °F 145.293 °F 145.383 °F 145.400 °F 145.400 °F Datalogger Profile 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 2014-04-16 13:11:41 2014-04-16 13:12:41 2014-04-16 13:13:41 2014-04-16 13:14:41 2014-04-16 13:15:41 2014-04-16 13:16:41 2014-04-16 13:17:41 2014-04-16 13:18:41 2014-04-16 13:19:41 2014-04-16 13:20:41 2014-04-16 13:21:41 2014-04-16 13:22:41 2014-04-16 13:23:41 2014-04-16 13:24:41 2014-04-16 13:25:41 2014-04-16 13:26:41 2014-04-16 13:27:41 2014-04-16 13:28:41 2014-04-16 13:29:41 2014-04-16 13:30:41 2014-04-16 13:31:41 2014-04-16 13:32:41 2014-04-16 13:33:41 2014-04-16 13:34:41 2014-04-16 13:35:41 2014-04-16 13:36:41 2014-04-16 13:37:41 63.000 °C 63.000 °C 62.991 °C 63.000 °C 63.000 °C 63.994 °C 63.000 °C 62.869 °C 62.813 C 62.755 °C 62.677 °C 58.908 °C 55.800 °C 49.500 °C 44.200 °C 39.567 °C 35.382 °C 31.423 °C 28.143 °C 24.917 °C 22.296 °C 20.072 °C 17.814 °C 16.029 °C 14.314 °C 13.068 °C 11.818 °C 145.400 F 145.400 °F 145.383 °F 145.400 °F 145.400 °F 144.389 °F 145.400 °F 145.232 °F 145.237 °F 145.215 °F 145.165 °F 145.064 °F 144.958 °F 121.100 °F 111.560 °F 103.220 °F 95.687 °F 88.561 °F 82.657 °F 76.850 °F 72.132 °F 68.129 °F 64.065 °F 60.852 °F 57.765 °F 55.522 °F 53.272 °F 75 76 77 78 79 80 81 82 83 84 85 86 2014-04-16 13:38:41 2014-04-16 13:39:41 2014-04-16 13:40:41 2014-04-16 13:41:41 2014-04-16 13:42:41 2014-04-16 13:43:41 2014-04-16 13:44:41 2014-04-16 13:45:41 2014-04-16 13:46:41 2014-04-16 13:47.41 2014-04-16 13:48:41 2014-04-16 13:49:41 10.500°C 9.685°C 8.605°C 7.873°C 7.000°C 6.593°C 6.004°C 5.598°C 5.039°C 4.655°C 4.238°C 3.776°C 50.900 °F 49.433 °F 47.489 °F 46.171 °F 44.600 °F 43.867 °F 42.807 °F 42.076 °F 41.070 °F 40.379 °F 39.628 °F 38.796 °F Datalogger Graph This graph shows the temperature and time the feed takes to pasteurise in F (print out from the Datalogger) S180 Bottle Position Testing Introduction The reason for the test is to show that each individual bottle is pasteurised correctly no matter where the bottle is positioned in the pasteuriser. Method Using a calibrated Tinyview 2 data logger & thermistor probe each basket position is tested. They should each be pasteurised at 63 °C / 145.4 F +/-5°C for a minimum of 30minutes. Rapid cooled down to 25°C in approximately 10 minutes and down to below 4.0°C / 39.2 F in approximately 60 minutes. Results 130ml Result 250ml Bottles Conclusion: All positions on both 130ml & 250ml bottles reached 63°C +/- 0.5°C ( 145.4 F ) for a minimum of 30 minutes, cooled down to 25°C in approximately 10minutes, to below 4.0°C ( 39.2 F) in 60minutes. Report by: Daniel Hall Date: 05.04.11 Double storey basket loading options for S180 Double storey baskets are for foil seal bottles only This basket can only accommodate the 4oz (130ml) bottles Option A 144 Bottles CAPACITY 36 x 130ml Bottles 36 x 130ml Bottles Left side of the tank Basket x 2 Option B 192 Bottles 48 x 50ml Bottles 36 x 130ml Bottles Right side of the tank Basket x 2 48 x 50ml Bottles Basket x 2 48 x 50ml or 36 x 130ml Bottles 36 x 130ml Bottles 48 x 50ml Bottles 48 x 50ml Bottles Basket x 2 48 x 50ml or 36 x 130ml Bottles If less than four baskets are being used they need to be placed into the tank evenly! Combination basket loading options for S180 A combination basket is suitable for 130ml and 250ml bottles to be placed into the same basket. The basket consists of 3 removable spacer bars. When the spacer bars are fitted, the basket can be used for 130ml bottles. When the spacer bars are removed, they can be used for 250ml bottles. Depending on how many bars you remove this gives you multiple options on how many 130ml bottles and 250ml bottles you want to be placed into the basket CAPACITY Option C 72 Bottles Left side of the tank 18 x 250ml Basket Right side of the tank Right side of the tank 18 x 250ml Basket 18 x 250ml Basket 18 x 250ml Basket 18 x 130ml Basket 18 x 130ml Basket Basket x 4 Option D 72 Bottles 18 x 130ml Basket 18 x 130ml Basket Basket x 4 Sterifeed Pasteurizer Certification Standards Directive Description BS EN 602041:2006+A1:2009 Safety of machinery. Electrical equipment of machines. General requirements BS EN 121001:2003+A1:2009 Safety of machinery. Basic concepts, general principles for design. Basic terminology, methodology BS EN 61000-2-2 Electromagnetic compatibility (EMC). Environment. Compatibility levels for low-frequency conducted disturbances and signaling in public low-voltage power supply systems BS EN 61000-2-4 Electromagnetic compatibility (EMC). Environment. Compatibility levels in industrial plants for low-frequency conducted disturbances 2006/95/EC The Low Voltage Directive 2004/108/EC The Electromagnetic Compatibility Directive 2006/42/EC The Machinery Directive Sterifeed Pasteurizers are CE marked. CE marking is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives and is a worldwide recognized standard. HMBANA PASTEURISER INSTALLATIONS USA & CANADA: British Colombia Women’s Milk Bank – Vancouver - Canada Indiana Mothers’ Milk Bank – Indianapolis – USA Bronson Mothers’ Milk Bank – Michigan – USA Holston Medical Centre – Tennessee – USA Rogers Hixon Ontario Human Milk Bank – Ontario - Canada WakeMed Mothers’ Milk Bank and lactation centre – North Carolina – USA Inova Fairfax Hospital – Virginia – USA Calgary Mothers’ Milk Bank – Alberta – Canada Heart of America Mothers’ Milk Bank – Missouri - USA The King's Daughters Milk Bank – Virginia – USA Hema Quebec Mothers Milk Bank – Montreal – Canada Mothers Milk Bank of South Carolina - USA PUBLISHED BY: STERIFEED Medicare Colgate Ltd Post Cross Business Park Cullompton, EX15 2BB, England +44 (0) 1884 266 666 Email: [email protected] Fax: +44 (0) 1884 266 333
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