The 3M Clean-Trace Hygiene Management Guide

Transcription

1 3 The 3M Clean-Trace Hygiene Management Guide 3M Clean-Trace Hygiene Monitoring products provide information on whether a surface has been cleaned properly or whether a water sample is contaminated with biological matter. These products offer the benefit of rapid, objective verification of cleanliness and sanitation. The 3M Clean-Trace Hygiene Management Guide is designed to help with the implementation of a rapid hygiene-monitoring system tailored to specific needs. The guide is relevant to diverse sectors such as Food, Beverage, and Industrial Markets. The Clean-Trace Hygiene Management Guide will aid in the establishment of operating procedures and pass/fail limits relevant to specific circumstances. USER RESPONSIBILITY When selecting a test method, it is important to recognize that external factors such as sampling methods, testing protocols, sample preparation, handling, and laboratory technique may influence results. It is the user s responsibility in selecting any test method to evaluate a sufficient number of samples with the appropriate matrices and challenges to satisfy the user that the chosen test method meets the user s criteria. It is also the user s responsibility to determine that any test methods and results meet its customers and suppliers requirements. As with any test method, results obtained from use of this product do not constitute a guarantee of the quality of the matrices or processes tested. 3Clean-Trace 1

2 CONTENTS Page ATP Bioluminescence 3 Simple Cleaning and Validation Flow Chart 4 Implementation of ATP Bioluminescence Rapid Clean-Trace Hygiene Monitoring System: 1. Test Point Identification 5 2. Collecting Data Reference 5 3. Setting Pass/Fail RLU Levels (including examples) 6 4. Sampling Frequency 9 5. Corrective Action Procedures Continuous Improvement Program Data Management and Trend Analysis 10 3Clean-Trace 2

3 ATP BIOLUMINESCENCE 3M Clean-Trace Hygiene Monitoring Systems are centered upon the measurement of adenosine triphosphate (ATP) the energy molecule for all animal, vegetable, bacteria, yeast and mold cells. Food residues are also rich in ATP and provide nutrients for micro-organisms to grow. 3M tests are simple to use; simply collect the sample, activate the test to mix the ATP from the sample with luciferase, then measure the amount of light emitted from the luciferase/sample mix with a luminometer this gives an estimate of the level of biological material present in the sample. Rapid hygiene monitoring using ATP bioluminescence offers some key benefits over other validation methods: 1. Proactive real time monitoring The luciferase/atp reaction is instant and readings are obtained in a matter of seconds. This allows corrective action to be taken immediately. 2. Reliability The system identifies the presence of biological matter (e.g. food residue or body secretions) as well as microbial residues - even if they are not visible to the naked eye. Results can be relied on to provide a true assessment of cleaning procedures. 3. Direct and indirect risk assessment As the test measures total biological material present, it can detect not only micro-organisms but also potential risk areas where food and other biological debris could be a source of nutrients for microbes. 4. Easy to use The system from 3M is designed for use by non-technical staff and can be easily integrated into daily cleaning regimes, wherever it is needed. 5. Simple to interpret The results are produced in Relative Light Units (RLU) that directly relate to the hygienic status of equipment or work surfaces. These results can be directly compared to pre-determined pass/fail levels. The lower the RLU reading, the cleaner the surface. 3Clean-Trace 3

4 SIMPLE CLEANING AND VALIDATION FLOW CHART DETERGENT CONCENTRATION CHECK Alter to correct concentration In specification Out of specification Continue with cleaning CLEANING PROCEDURE Visibly clean VISUAL EXAMINATION OF SURFACE POST CLEANING Re-clean Surface Visibly soiled Progress with validation RAPID HYGIENE TEST Re-clean Surface PASS CAUTION FAIL Continue - Proceed with sanitizer application Continue or Re-rinse and retest Repeated fails, reassess cleaning operator training or cleaning regime 3Clean-Trace 4

5 IMPLEMENTATION OF ATP BIOLUMINESCENCE RAPID HYGIENE MONITORING SYSTEM There are a number of steps involved in the establishment of a rapid hygiene monitoring system: 1. Test Point Identification 2. Collecting Reference Data 3. Setting Pass/Fail RLU levels (including examples) 4. Deciding Sampling Frequency 5. Agreeing Corrective Action Procedures 6. Establishing a Continuous Improvement Program 7. Using Data Management and Trend Analysis 1) TEST POINT IDENTIFICATION Prior to carrying out work, the sample points for testing should be identified. If a hygiene sampling plan already exists, then this may be suitable. Where no formal sampling plans exist, a sampling plan should be devised. One approach to create a sample plan is to construct a flow chart of the process to be monitored and identify those areas of risk. Generally, these will be surfaces in contact with product. Test points to be included in the plan should be those where if the surface is not clean it will have a potential effect on product safety or quality. Other points to consider include: The selected test points should be areas where there is a potential risk of cross. Areas that are difficult to clean should be included as these test points offer the best measurement of cleaning performance and represent the areas of high risk to the product. The frequency of testing should be commensurate with the level of risk. 2) COLLECTING REFERENCE DATA To establish pass/fail RLU levels, collect reference data. This will help identify the current cleaning status of the test points that have been identified. It is important that results are recorded for future audit requirements. Read the test kit instructions fully before testing. It is recommended to collect the following sets of reference data: a. Data from test points prior to cleaning This provides information on the level of contamination on the surface prior to cleaning. Samples should be taken following the removal of initial gross debris or initial rinse but prior to detergent application. The area should be visibly clean. 3Clean-Trace 5

6 b. Data from test points after cleaning Clean to the normal standard, test and record the results. Do this on 5 separate occasions. This will indicate the level achievable after routine cleaning. c. Data from rigorously or deep cleaned test points This indicates the level of cleaning effectiveness where deep clean regimes are applied, but it may not reflect the achievable level of routine cleaning. Once the reference data has been collected, results can be tabulated for each test point. An example is shown in Table 1: TABLE 1 SAMPLE POINT X CLEAN SOILED CLEAN DEEP CLEAN Once the reference data is collected for each test point, the routine working pass/fail RLU levels can be set. 3) SETTING PASS/FAIL RLU LEVELS Note that different test points might demonstrate different RLU levels. Take this into account when setting pass/fail levels. The level of cleanliness that can be achieved is determined by a number of factors: Age of surface Degree of marking, scratching or pitting on the surface Type of soiling Type of organic matter that is in contact with the surface. In addition, the cleaning procedure itself will affect cleaning efficiency: Detergent type Method e.g. Manual or Clean In Place (CIP) A degree of judgement is required to set the initial pass and fail levels. Review results frequently during the early stages of routine use of the system to ensure that it is effective. Pass/fail limits are usually set within bands as shown in the table below. 3Clean-Trace 6

7 Typical Pass/Fail Limits TABLE 2 BAND PASS (RLU) CAUTION (RLU) FAIL (RLU) A B C D E F G H J I The band selected from Table 2 can be determined according to the following criteria: OPTION 1 - Current Cleaning Status If the current levels of cleaning are considered acceptable, the initial reference levels should be set in the band with the pass level higher than the clean reference data. OPTION 2 - Improved Cleaning Status If the aim is to improve cleaning regimes, initial reference levels should be set in the band with the pass level lower than the clean reference data. However, levels should not be set below the deep clean result, as this does not reflect the cleaning level that can be attained routinely. In situations where levels exceed 2000 RLU some judgment will be required. However, be aware that a process of continuous improvement will help to reduce the RLU results, which may in turn enable pass/fail levels to be reduced into one of the specified bands. EXAMPLES Example 1 POINT A Clean OPTION 1: reflecting current cleaning - Band C - Pass <500, Fail >1000 OPTION 2: reflecting a move towards improvement Band D - Pass <400, Fail > Clean-Trace 7

8 Example 2 POINT B Clean OPTION 1: reflecting current cleaning - Band G - Pass <200, Fail >400 OPTION 2: reflecting a move towards improvement Band H - Pass <150 Fail >300 Example 3 POINT C Clean Some judgment is required in this case as shown below OPTION 1: reflecting current cleaning - Band A - Pass <1000, Fail >2000 OPTION 2: reflecting a move towards improvement Band B - Pass <750, Fail >1500 In Option 1 two results fall into the pass level and three results fall into the caution level. Using Option 2, four results would fall into the caution level and one into the fail level. INCONSISTENT RESULTS When reviewing reference data and setting bands, it is easier if results are relatively consistent as above. However, it is more difficult when results are inconsistent as in Table 3. Table 3 POINT E Clean Here it would be advisable to collect further data before setting Pass/Fail limits. If results are still inconsistent, this suggests problems in the cleaning procedure and further investigation is required. Factors affecting consistency a. Different cleaning operatives In normal cleaning procedures, this could be a result of different operators and poor adherence to standard cleaning procedures, and it may mean that further training is required. b. Detergent concentration In CIP (Cleaning in Place) systems, this could be as a result of inconsistencies in detergent concentration or faulty probes e.g. conductivity measuring devices, temperature probes etc. c. Sample area The sample area and method of sampling should be as consistent as possible. 3Clean-Trace 8

9 If inconsistent results continue to be an issue, then levels should be set based on what is considered reasonable to expect routinely. In Table 3, it appears that the levels of results 1 and 4 can be achieved. Levels could then be set accordingly, e.g. OPTION 1: Band C - Pass <500, Fail >1000 In this type of situation use of Option 1 only is advised, until cleaning issues are resolved and greater consistency is achieved. At this point a review of the results would allow pass and fail levels to be set more effectively. REFERENCE DATA RESULTS When reference data results are found to be low: TABLE 4 POINT A Clean This may reflect cleaning, which is already at a very high level. The results lie in a range close to the normal background levels expected in the test. In this case levels should be set at the following levels: PASS 75 CAUTION FAIL 150 These represent the lowest levels that should be set for adequately identifying cleaning problems. However, if the low results detailed in Table 4 are obtained, it is important to review the swabbing technique detailed in the test kit instructions, to ensure that samples taken are representative and that the method of sampling is adequate to pick up surface residues. It is also important to check that all the detergent is removed before sampling as this may reduce the signal and cause a low result. 4) SAMPLING FREQUENCY Once sample points have been established and reference levels set, it is important to devise a sampling frequency plan. Sampling frequency should directly relate to the level of contamination risk associated with the surface in question. Factors determining the level of risk: Surface robustness and susceptibility to contamination Level of difficulty to clean the test point Frequency of contact with contaminating matter Stage in production process (e.g. raw material or finished product) Generally in the case of high-risk test points, testing is carried out after every clean. In the case of lower risk points, testing may be less frequent, or on an audit basis. 3Clean-Trace 9

10 5) CORRECTIVE ACTION PROCEDURE Once the Pass and Fail levels are set a positive release system can be established as follows: Pass Caution Fail Continue with use of surface or equipment Low risk areas - continue but monitor subsequent cleans High risk areas - re-rinse and re-test. Re-clean and re-test Action procedures may differ from site to site dependent on the judgement of those responsible for hygiene management. 6) CONTINUOUS IMPROVEMENT PROGRAM Once pass/fail RLU levels have been established and put into routine use, results should be reviewed on a regular basis to monitor how effective the system is operating. Once the system is in place and especially if a positive release system is used, it is often found that pass/fail levels may need to be reduced due to improved cleaning performance. If Option 1 (Current Cleaning Status) has been used, then following improved cleaning performance Option 2 (Improved Cleaning Status) would probably better reflect the cleaning regime capability going forward. If Option 2 was selected initially, over a period of time a similar effect may be observed. Reducing the levels down to a lower band to reflect current cleaning levels could be considered. Continuous improvement should be part of any hygiene management procedure and calls for regular review of results to enable the process to evolve. Use of the 3M Clean-Trace Data Trending Software provided with the 3M luminometer should aid this process. 7) DATA MANAGEMENT AND TREND ANALYSIS Control of cleaning procedures requires the efficient storage of data which allows accurate reporting and interpretation. 3M Clean-Trace Data Trending software is a data management and trend analysis package designed by 3M. The software simplifies the process of tracking ongoing hygiene effectiveness and also helps identify areas of concern that can be targeted for improvement. For more information on the products 3M provides for implementation of a cleaning verification system, please contact our head office or local supplier: 3M Health Care St. Paul, MN, USA 3M and Clean-Trace are trademarks of 3M or Biotrace Int l PLC, a 3M Company and used under license in Canada. 3M All rights reserved. 3Clean-Trace 10