ENVIRONMENTAL FRIENDLY CHEMICAL (EMULGEN) HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA 030/2010 i DISCLAIMER Technology review is a brief report which draws on restricted reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where appropriate. It has not been subjected to an external review process. While effort has been made to do so, this document may not fully reflect all scientific research available. Additionally, other relevant scientific findings may have been reported since completion of this review. Please contact: htamalaysia@moh.gov.my, if you would like further information. Health Technology Assessment Section (MaHTAS), Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Government Office Complex 62590 Putrajaya Tel: 603 88831246 Fax: 603 8883 1230 ii Prepared by: Puan Maharita Ab Rahman Pharmacist Health Technology Assessment Section (MaHTAS) Ministry of Health Reviewed by: Datin Dr Rugayah Bakri Deputy Director Health Technology Assessment Section (MaHTAS) Ministry of Health Malaysia DISCLOSURE The author of this report has no competing interest in this subject and the preparation of this report is totally funded by the Ministry of Health, Malaysia Available at the following website: http://www.moh.gov.my iii EXECUTIVE SUMMARY Introduction Cleaning agents are substances used to remove dirt such as dust, stains even bad smells and clutter on the surfaces. The main purpose of cleaning agents is to prepare comfortable and clean environment to avoid the spreading of dirt and any contaminants.1 Meanwhile disinfectants are chemical or physical agent which is applied to inanimate objects to kill microorganism, the process to which is known as disinfection. Disinfection means reducing the number of viable microorganisms present in a sample.2 Many cleaning agents are chemical based products. However, nowadays there is environmental friendly chemical cleaning agent available. It is claimed to be safe to environment even to human. Thus, one technology review was requested by Head of Section on Quality in Medical Care Section following the proposal from a company to introduce the locally made Emulgen into Ministry of Health (MOH) health facilities. Objective/Aim The objective of this technology review was to assess the safety, efficacy or effectiveness and cost-effectiveness of Emulgen which used as a disinfectant. The products included in this report are Emulgen 410, Emulgen Orange Gel, and Maichem Floortex. Results and conclusions The search strategy did not yield any article regarding the safety, efficacy, or effectiveness and cost-effectiveness of Environmental Friendly Chemical: Emulgen as a disinfectant. Methods Electronic databases were searched, included PubMed, Ovid Medline (R) from 19902006 (EBM Reviews – Cochcrane Databases of Systematic Reviews), (EBM Reviews – Cochcrane Databases of Controlled Trial), National Horizon Scanning, INAHTA and FDA, for published reports. There was no limit in the search. iv ENVIRONMENTAL FRIENDLY CHEMICAL: EMULGEN 1. INTRODUCTION Cleaning agents are substances used to remove dirt such as dust, stains even bad smells and clutter on the surfaces. The main purpose of cleaning agents is to prepare comfortable and clean environment to avoid the spreading of dirt and any contaminants. Normally, cleaning agents are in a liquid form and mostly water solutions which might be acidic, alkaline or neutral and some are claimed to be biodegradable and environmental friendly. Besides, some cleaning agents may also be solvent based or solvent containing and is then called degreasers.1 Acidic washing agent is made of strong mineral acid and chelants, to avoid corrosive effects; corrosion inhibitors are added as well as surfactants. The acidic cleaning agent is mainly used for removal of inorganic deposits like scaling. On the other hand, for alkaline cleaning agents, which contain the strong base such as sodium hydroxide and potassium chloride; it is able to dissolve grease, oils, fats, and protein based deposit. This cleaning agent will be added with dispersing agent to prevent re-deposition of dissolved dirt and chelants to attack rust on metal part. Other type of cleaning agent is neutral type which is claimed to have pH-neutral and is based on non-ionic surfactants that disperse different types of dirt. There is also the degreasers which are specially made to remove grease. Degreaser contains surfactant and maybe solvent based.1 Cleaning agents are different from disinfectants. Disinfectants are chemical or physical agent which is applied to inanimate objects to kill microorganism, the process to which is known as disinfection. Disinfection means reducing the number of viable microorganisms present in a sample. Disinfection process can be classified as high-level disinfection, intermediate disinfection and low-level disinfection. High-level disinfection can be expected to destroy all microorganisms, with the exception of high numbers of bacterial spores. Intermediate disinfection can inactivate mycobacterium, vegetative bacteria, most viruses and most fungi but it does not necessarily kill bacterial spores. Low-level disinfection can kill most bacteria, some viruses and some fungi but it cannot be rely on to kill resistant microorganism such as mycobacterium and spores. 2 Thus, cleaning agent is not considered as disinfectant unless it fix classification as above. Many cleaning agents are chemical based products. However, nowadays there is environmental friendly chemical cleaning agent available. It is claimed to be safe to environment even to human. Thus, one technology review was requested by Head of Section on Quality in Medical Care Section following the proposal from a company to introduce the locally made Emulgen into Ministry of Health (MOH) health facilities. 1 2. OBEJCTIVE/AIM The objective of this technology review was to assess the safety, efficacy or effectiveness and cost-effectiveness of Emulgen when used as a disinfectant. The products included in this report are Emulgen 410, Emulgen Orange Gel, and Maichem Floortex. 3. TECHNICAL FEATURES Environmental Friendly Chemical: Emulgen is a local made (LA Maxwell Enterprise Sdn. Bhd, at Rawang) product claimed to be 100% biodegradable cleaning agent. Actually there are several types of cleaning agents under Emulgen. However the three products that the company wants to introduce into MOH health facilities are Emulgen 410, Emulgen Orange Gel, and Maichem Floortex. Emulgen 410 is claims to be multipurpose water-based cleaning agent which is extremely effective to remove fats, grease and oil. The product also claimed to contain germicide which is suitable to clean kitchen tools and washroom. Emulgen 410 can be used in concentrated form or diluted without reduce the efficiency. The product removes the grease, oil and fats by destroying the binding agents within the molecule of the grease, oil or fats. This product contains Potassium Hydroxide as the alkaline base. 1,3 Then Emulgen Orange Gel is a neutral orange based waterless hand cleaner. This hand cleaner is used to clean the hand from grease, wet and dry paint even bubble gum type dirt. It also claimed to be save on human hand because it does not contain toxic solvents which can cause skin-aggressions. This product contain Carbopol which is a polymer with hydrophobic characteristic to act as thickening agent and to stabilize the solution.3 The third product is Maichem Floortex which claimed to give a smooth and shining floor as it is made of liquid micro emulsion wax. Besides, the layer of the micro emulsified wax will remain to ensure dirt does not easily stick to the floor. 2 Figure 1: Emulgen 410 and Emulgen Orange Gel 4. Methodology 4.1. Searching Electronic databases were searched, included PubMed, Ovid Medline (R) from 19902006 (EBM Reviews – Cochcrane Databases of Systematic Reviews), (EBM Reviews – Cochcrane Databases of Controlled Trial), National Horizon Scanning, INAHTA and FDA, for published reports. There was no limit in the search. The search strategy used the terms which were either used singly or in various combinations; ‘emulgen’, ‘emulgen 410’, ‘safety of emulgen’ ‘efficacy of emulgen’, ‘carbopol’, ‘carbopol AND cleaning agent’, ‘potassium hydroxide’ and ‘potassium hydroxide AND cleaning agent’ 4.2. Selection All published articles related to the efficacy or effectiveness, safety and costeffectiveness of Environmental Friendly Chemical: Emulgen were included. The product template by the company also included. 5. RESULTS AND DISCUSSION There was no retrievable evidence on efficacy, safety, effectiveness, and costeffectiveness of Emulgen as a disinfectant. However the Emulgen 410 and Emulgen Orange Gel were tested for environmental analysis. The tested was done by Environmental Chemist from Faculty of Environment Studies of University Putra 3 Malaysia. The test was showed that both products had complied with water quality standard set by Department of Environment (DOE), Malaysia. The water quality standard is evaluated based on several parameters and two parameters accessed during the test done by the chemist are Biochemical Oxygen Demand (BOD), and Chemical Oxygen Demand (COD). BOD is defined as the quantity of oxygen in milligrams needed by microorganism to metabolize organics matter and converts it to useful energy in one litre of water. So the more polluted the water the higher is the BOD. Meanwhile COD is indirectly to measure the amount of organic compounds in water. So the higher the COD amount the more oxygen require by the chemical to oxidize.5 Individual searched was done on preservative used in the products. Potassium hydroxide was a strong base used in Emulgen 410, it was stated that potassium hydroxide was commonly used in preparation of soap, detergents even bleach. Concentrated potassium hydroxide has corrosive effect which was dangerous to skin and eyes.5 Another preservative used was carbopol. Carbopol is a polymer with hydrophobic characteristic. It is used as a thickening agent in various applications including hair gel, lotions and hand sanitizers.7 According to Sulaman Gading Company, the Emulgen did not have any approval from SIRIM yet however, they did get support (supporting letter) from Deputy Minister of Ministry of Energy, Green Technology and Water, Malaysia to distribute the products. This product has not obtained United State of Food Drug Administration (USFDA) nor has CE Mark. 6. CONCLUSION There was no retrievable evidence on safety and effectiveness of Environmental Friendly Chemical: Emulgen as a disinfectant. 7. REFERENCES 1) Cleaning Agent. Available at: http://en.wikipedia.org/wiki/Cleaning_agent Accessed on 30th November 2010 2) Darus N. Virusolve. Technology Review. September 2007 3) Emulgen The Environmental Friendly Cleaner. Available at: http://www.aaaoe.com/sell/155/154716/sell_Emulgen_the_environmental_friendly_clean er.html Accessed on 30th November 2010 4) Emulgen 410. Available at: 4 http://www.getamarket.com/en/Offers/13522/emulgen_410.html Accessed on 30th November 2010.) 5) http://www.doe.gov.my/portal/water-marine-river-water/river-water-quality-monitoring/ 6) Potassium Hydroxide. Available at: http://www.answers.com/topic/potassium-hydroxide Accessed on 22nd Mac 2011 7) Carbopol Technical Data Sheet. Available at: http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolUltrez21.html Accessed on 22nd Mac 2011 8. APPENDIX 8.1 Appendix 1 DESIGNATION OF LEVELS OF EVIDENCE I Evidence obtained from at least one properly designed randomized controlled trial. II-I Evidence obtained from well-designed controlled trials without randomization. II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group. II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence. III Opinions or respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees. SOURCE: US/CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris 2001) 5