ALKAZYME. Alkaline Enzymatic Disinfectant Detergent. Technical guide

Transcription

1 ALKAZYME Alkaline Enzymatic Disinfectant Detergent for the presoaking, the predisinfection and the cleaning by immersion of invasive and non invasive medical devices Dilution 0,5% Technical guide Certified ISO Parc Biocitech, 102 avenue Gaston Roussel, Romainville, France Tél : +33 (0) Fax : +33 (0) Website : info@alkapharm.fr Page 1 of 22

2 Contents Declaration of compliance... 3 Presentation... 4 Intended use... 4 Characteristics... 4 Marketed presentations... 4 Use... 5 Regulatory information... 5 Preparation of ALKAZYME solution... 6 Instructions for use... 6 Adapted protocoles... 7 Precautions for use... 7 Handling and Storage... 7 Accidental spillage Disposal... 7 Physicochemical data... 8 Composition... 8 Physicochemical properties... 8 Microbiological data... 9 Tests to assess the detergency... 9 Tests to determine bactericidal activity Tests to determine fungicidal activity Tests to determine the activity against viruses Tests to determine disinfectant capacity Toxicological and biocompatibility data Acute toxicity Local tolerance Ecotoxicity Compatibility data Acute Analysis of material compatibility studiestoxicity Study of the corrosive action Certificates of compatibility Microbiology, toxicology and biocompatibility test reports and safety data sheets are available separately on request. Page 2 of 22

3 Declaration of compliance ALKAPHARM ensures and declares that the product ALKAZYME meets the essential requirements of Directive 93/42/EEC of 14 June 1993 concerning Medical Devices. This product was classified in Class IIb according to Rule 15 of Annex IX to Directive 93/42/EEC which states that "All devices intended specifically to disinfect medical devices are in Class IIa unless they are intended specifically for disinfecting invasive devices in which case they are in Class IIb "(Directive 2007/47/EC amending Directive 93/42/EEC). The authenticated statement is available on the website: ALKAPHARM declares that the product ALKAZYME does not contain: human blood derivatives; any substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC; tissues of animal origin; phthalates. Page 3 of 22

4 Intended use Presentation ALKAZYME is intended to the presoaking, the predisinfection and the deproteinizing cleaning by immersion immediately after use and before sterilization or disinfection of : contaminated medico-surgical instruments, invasive and non invasive medical devices, rigid and flexible endoscopy for sterile and non-sterile. Characteristics ALKAZYME transforms instantly hard water (34,2 f) in soft water (<1,8 f) to optimize detergent activity, to avoid limescale and corrosion, and to prevent mineralization of biofilms. ALKAZYME cleans, removes, and hydrolyses soil and organic matters (pus, blood, secretions, etc.) that strongly inhibit the action of disinfectants. ALKAZYME is particularly suitable for cleaning endoscopy equipment, unblocking the air and water circuits of the operative channels of flexible and rigid endoscopes by hydrolysing proteins, mucus and exudates. ALKAZYME is bactericidal, yeasticidal, virucidal on HIV, HBV, HCV and herpes simplex virus. ALKAZYME protects staff during cleaning operations and lowers the level of contamination of treated instruments. ALKAZYME protects the environment by destroying Gram+ and Gram- bacteria in waste water and thereby reduces cross-contamination. Using ALKAZYME optimizes the sterilization / disinfection procedure. Marketed presentations ALKAZYME in bucket reference Container Packing in cartons ALK kg 6 buckets + dosing shovel ALK kg 4 buckets + dosing shovel ALKAZYME in water-soluble doses ALKAZYME in water-soluble doses may be directly diluted with its container thereby avoiding any contact with skin and ensuring the correct concentration of the product. reference Container Packing in cartons ALKE doses of 25 g 25 sachets ALK doses of 5 g 6 buckets Page 4 of 22

5 Regulatory information Use ALKAZYME is classified as a medical device and according to the application of Directive 93/42/EEC, must bear a regulated label with the batch number and expiration date of each batch. XXXX-XX-XX-XXXX YYYYMMDD This information is born on the label of the product ALKAZYME. According to studies, the powder ALKAZYME is : - non toxic by inhalation - non-hazardous if swallowed According to studies, the solution ALKAZYME induced : - non-hazardous if swallowed - non-irritating to skin - non-sensitizing to skin - non-irritating to eyes - non-toxic to the environment Regulatory information in accordance with CLP Regulation (EC) No 1272/2008 and its amendments Hazard pictograms Precautionary statements Precautionary statements EUH208 Contains SUBTILISIN. May produce an allergic reaction. H315 Causes skin irritation. H318 Causes serious eye damage. P102 Keep out of reach of children. P280 Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER or doctor/physician. P362 Take off contaminated clothing and wash before reuse. Page 5 of 22

6 Preparation of ALKAZYME solution Method of preparation of 0.5% dilute ALKAZYME solution In a graduated tank with lid, prepare a little water. Tap water is suitable. Lukewarm water promotes detergent and enzyme activities. Add necessary dose (5g/L) : Products Amount Water volume Spoon (750g ) 1 mesure of 5 g 1 litre 1 mesure of 15 g 3 litres Dosing spoon 1 mesure of 25 g 5 litres (2Kg et 5Kg bucket) 1 mesure of 50 g 10 litres Hydrosoluble doses 1 dose of 5g 1 litre 1 dose of 25 g 5 litres Stir immediately with a stirrer or with gloves cuff of appropriate size until total dissolution. Complete with the necessary volume of water to obtain the final bath. Instructions for use Contact time Surgical instruments, medical devices and their accessories for non-sterile and sterile cavities should be immersed in 0.5% ALKAZYME solution. Immersion Surgical instruments and medical devices must be completely immersed in the ALKAZYME bath. The operator should ensure that the cavities and channels of the devices or any complex and hollow parts are brushed, swabbed and well irrigated with ALKAZYME solution in order to effectively remove the soil. Rinsing Tap water is used for external rinsing and internal irrigation. Instruments must be rinsed with plenty of water to remove any residual product. The operator should ensure that the channels of devices and complex or hollow parts are well rinsed with plenty of water. Renewal time of the dilute solution The ready to use solution must be renewed when visibly soiled or at least daily. Incompatibilities ALKAZYME, like any alkaline product, is incompatible with aluminum. Page 6 of 22

7 Adapted protocoles Laboratory tests conducted by GERMANDE (Group of Studies and Research on Endoscopes Cleaning Disinfecting Automatic Machines) demonstrate the particular effectiveness of deproteinizing cleaning and disinfection protocol ALKAZYME in combination with disinfection protocol ALKACIDE. This protocol validates use conditions of ALKAZYME and ALKACIDE and compared the results of microbiological activity tests in terms of : - Discipline - Material type - Material volume - Medical devices use frequency - Cleaning and disinfection Equipment Precautions for use Preparation of the ready to use solution requires the use of gloves and protective clothing. Handling and Storage ALKAZYME must be kept in its original packaging and with its original label giving directions for use, precautions for use and safety precautions. ALKAZYME must be stored tightly sealed, in a cool place, away from all heat sources. ALKAZYME doses must be kept away from frost and moisture. If the product is inadvertently left close to an intense heat source for a prolonged period it should preferably no longer be used, as the product qualities, properties and characteristics may have deteriorated. The use-by date of ALKAZYME is 3 years after its date of production. Expiry date 3 years indicated on the label as: YYYYMMDD (Year-Month-Day) Accidental spillage Disposal Dispose of container as hazardous waste except for empty clean container which can be disposed of as non-hazardous waste. Page 7 of 22

8 Physicochemical data Composition Non ionic and cationic surfactants, sequestrant, proteolytic enzyme, minerals, perfume. Physicochemical properties Appearance Odour Density Fine white powder Almond Packed: Unpacked: ph of 0.5% ALKAZYME ± 0.5 Page 8 of 22

9 Tests to assess the detergency Microbiological data Summary of definition Definition of biofilm The biofilm is a bacterial community contained in a protein and polysaccharide matrix. The film forms a layer of a few micrometres to several millimetres in thickness than strongly adheres to surfaces. Biofilm forms on all immersed surfaces or media that are often moistened. It includes many bacterial species and occasionally microscopic algae. Bacterial growth causes thickening of the biofilm in a few hours or a few months. The matrix anchors the biofilm to its carrier In a medical setting, biofilm is dangerous as it is resistant to cleaning and restricts the penetration of disinfectants because of its strong adhesion. It may harbour pathogenic bacteria that cannot be destroyed by disinfection or sterilisation. Studies prove the cleaning enzymatic action of ALKAZYME on proteins and those of the biofilm. ALKAZYME creates optimum conditions for successful disinfection or sterilisation. Tests to determine the detergency on a biofilm ALKAZYME 0.5 % Strains Pseudomonas aeruginosa 5 minutes Temperature: 20 and 40 C Test Report No of February 1998 Industrial Bacteriology, Virology and Microbiology Laboratory Faculty of Pharmaceutical Sciences - Toulouse Conclusion: Bacterial counts and assays of the residual quantities of proteins or polysaccharides on the surface of the substrate, showed that at 20 C and 40 C an ALKAZYME solution gave the following results: After 30 seconds of contact, a significant breakdown of the biofilm associated with a significant reduction (3.3 log/cm 2) in the number of bacteria adhering to the carrier surface. Complete elimination of the biofilm (bacteria, proteins and polysaccharides) after 5 minutes of contact. Analysis of the above data confirmed by scanning electron microscope findings showed that under the experimental conditions described, the product ALKAZYME 0.5% used at 40 C for 5 minutes has a very good detersive activity on a Pseudomonas aeruginosa biofilm. Page 9 of 22

10 Cleaning efficiency on a suspension of Bacillus subtilis bacterial spores containing blood ALKAZYME 0.5 % Strains Bacillus subtilis Interfering Substances: Sheep blood 2 minutes Temperature: 20 C Test Report No. 153/0295 of 15 May 1995 I.R.M.- Institut de Recherche Microbiologique Conclusion: Spore counts made after soaking contaminated flexible plastic tubes for 2 minutes in an ALKAZYME bath showed that the product ALKAZYME diluted to 0.5% (w/v) in water Hard at 30 F gave a greater detachment of Bacillus subtilis spores prepared in a coating of dried blood. Compared with the control action of hard water at 30 F used alone, ALKAZYME increased the number of dislodged Bacillus subtilis spores by 60%. During handling, visual inspection showed that spores detached more rapidly and homogeneously for the whole deposit in the ALKAZYME bath and clearly showed that cleaning was more effective than in the bath of hard water alone. Tests to determine the detergency on a biofilm of E. coli ALKAZYME 0,5 % Strains Escherichia Coli Contact time : Temperature : 20 C Test Report No Laboratoire d Hygiène Hospitalière, Faculté de médecine Strasbourg Conclusion : Used under the conditions of concentration, temperature and time recommended by Alkapharm, ALKAZYME provides a significant detergent action on biofilm of E. Coli CIP products in hemolysis tubes of glass. Page 10 of 22

11 List of hospital baseline studies comparing the detergent activities of different products : Study of proteolytic power of enzymatic cleaners J. Martino, L. Crine, M. Schoeps, C. Dupont Service Pharmacie, Laboratoire de Biochimie, C. H. Corbeil-Essonnes Did pre-disinfectants meet requirements of good practice in hospital pharmacy? F. Rochereau, X. Renan, Equipe de Stérilisation, C. Descampeaux Service Pharmacie-Stérilisation, Centre Hospitalier Public du COtention, Cherbourg-Octeville Evaluation of detergent action of enzymatic or non-enzymatic pre-disinfectants N. Boubekeur, M. H. Pic, C. Bourret Service Pharmacie-Stérilisation, Centre Hospitalier François Quesnay, Mantes-la-jolie Benchmarking of pre-disinfectants performances in CSSD C. Pichard, D. Reittar, A. Pont-Lacoat, B. Coret-Houbart, A. Fabreguettes Service de Pharmacie, CHI Robert Ballanger, Aulnay sous Bois Evaluation of process combining pre-disinfection with automated washing using soil tests C. Paumier, A. Jacobot, C. Gendron, G. Munnier, O. Petitjean Stérilisation Centrale, CHU Avicenne (APHP), Bobigny Page 11 of 22

12 Tests to determine bactericidal activity European standard NF EN 1040 (April 2006) Strains: Temperature: 20 C Test Report No REA 08 AN of 28 November 2008 Scientis Pseudomonas aeruginosa Staphylococcus aureus Conclusion: The product ALKAZYME is bactericidal according to NF EN 1040 (April 2006), after of contact at 20 C on P. aeruginosa ATCC and S. aureus ATCC 6538 at a concentration of 0.1% (w/v). Standard NF EN (July 2004) under dirty conditions Strains: Interfering Substances: Temperature: 20 C Test Report No c of 29 June 2005 Keybio Laboratory Pseudomonas aeruginosa Staphylococcus aureus Enterococcus hirae Dirty conditions: 30 F hard water and a mixture of 3 g/l bovine albumin and 3 ml/l sheep red blood cells. Conclusion: According to the methodology described in standard EN (July 2004), batch of the alkaline proteolytic pre-disinfection detergent Alkazyme had a bactericidal activity in 15 min and in 60 min at 20 C under dirty conditions (mixture of 3 g/l bovine albumin and sheep red blood cells) when diluted to 0.5% (w/v) in hard water against reference strains of Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus hirae. Standard NF EN (July 2004) in dirty conditions on Acinetobacter baumanii Strains: Acinetobacter baumanii Interfering Substances: Dirty conditions Temperature: 20 C Test Report No REA 11 of 14 March 2011 SCIENTIS Conclusion: The product ALKAZYME batch complies with standard EN It has a bactericidal activity on the strain Acinetobacter baumanii under dirty conditions at 20 C and after of contact, at a concentration of 0.5% (v/v). Page 12 of 22

13 Determination of bactericidal activity by the germ carrier method Interfering Substances: 5% bovine serum and 200 ppm hard water Temperature: 20 C Concentration: 0.5 % Test report in December 1995 Professor Syed SATTAR University of Ottawa (Canada) - Faculty of Medicine, Department of Microbiology & Immunology Conclusion: For 3 disinfectant batches tested by three tests, the product ALKAZYME is bactericidal at a concentration of 0.5% in contact at 20 C by the germ-carrier method and reduces the bacterial titre by 5 to 7 log. Tests under practical conditions of use Strains: Interfering Substances: Temperature: 20 C Test Report No REA 10 of 21 December 2010 SCIENTIS Pseudomonas aeruginosa Staphylococcus aureus Dirty conditions Conclusion: Product ALKAZYME, lot , has a: o Bactericidal activity of more than 7 log on Pseudomonas aeruginosa and Staphylococcus aureus according to the test protocol, in of contact, at a concentration of 0.5% at 20 C in the presence of interfering substances: on the carriers tested (Medical Devices) on effluents (disinfection baths) o A complexation capacity transforming water initially qualified as "hard" into "soft" water. Page 13 of 22

14 Tests to determine yeasticidal activity European standard NF EN 1275 (June 1997) Strains: Candida albicans Temperature: 20 C Test Report No. 285/ of 13 June I.R.M.- Institut de Recherche Microbiologique - COFRAC Conclusion: Product ALKAZYME is active on the reference strain Candida albicans ATCC using the methodology of European standard NF EN 1275 (June 1997) at 20 C at a concentration of 0.5% (w/v). European standard NF EN (April 2004) Strains: Candida albicans Temperature: 20 C Test Report No REA08 of 29 July SCIENTIS Laboratories Conclusion: The product ALKAZYME has a yeasticidal activity under dirty conditions at 20 C and of contact at a concentration of 0.25% (w/w). Page 14 of 22

15 Tests to determine the activity against viruses Tests on HIV under dirty conditions according to standard EN A1: Test conditions Strain HIV Interfering Substances : Dirty conditions Contact time : Temperature : 20 C Test report 079V du 10 avril 2012 Apex biosolutions Conclusion: ALKAZYME used at 0.5% is active on HIV according to EN A1, in at 20 C, under dirty condition. Tests on Herpes Simplex virus type 1 under dirty conditions according to standard EN A1: Strain Herpes simplex virus type 1 Interfering Substances: Dirty conditions 1, 5,15 and 60 minutes Temperature: 20 C Test Report A10ML1149-3H of 20 January 2011 Mikrolab Conclusion: ALKAZYME disinfectant was used at concentrations of 0.5% at 20 C with contact times of 1, 5, 15 and 60 minutes. After one minute a reduction in the virus titre of 4 log10 units was obtained. This efficiency is therefore obtained with ALKAZYME: 0.5% 1 minute. Page 15 of 22

16 Tests on PRV (virus model of Hepatitis B) under dirty conditions according to standard EN A1: Test conditions Strain PRV Interfering Substances : Dirty conditions Contact time : Temperature : 20 C Test report 041V of 10 avril 2014 Apex biosolutions Conclusion : The assays performed with the ALKAZYME batch n product demonstrated that ALKAZYME product demonstrated a virucidal activity on the Hepatitis B Virus (PRV model) from the concentration 0,50%, as required by the European standard EN 14476, following a exposure period, at 20 C, in dirty conditions. Tests on BVDV (virus model of Hepatitis C) under dirty conditions according to standard EN A1: Strain BVDV Interfering Substances: Dirty conditions Temperature: 20 C Test Report 041V of 10 avril 2014 Apex biosolutions Conclusion: The assays performed with the ALKAZYME batch n product demonstrated that ALKAZYME demonstrated a virucidal activity on the Hepatitis C Virus (BVDV model) from the concentration 0,50%, as required by the European standard EN 14476, following a exposure period, at 20 C, in dirty conditions. Page 16 of 22

17 Tests to determine disinfectant capacity Test of bactericidal activity against Pseudomonas aeruginosa of a 0.5% disinfectant solution with repeated inoculations and successive additions of protein interfering substance. ALKAZYME 0.5 % Strains Pseudomonas aeruginosa Interfering Substances: Hard water at 30 F 0.3% bovine albumin Temperature: 20 C Test Report No. 867/0294 of 09 March 1994 I.R.M.- Institut de Recherche Microbiologique Conclusion: The results showed that a 0.5% ALKAZYME bath prepared in hard water should support five successive soakings of soiled and contaminated objects representing each time the addition of protein interferences and microbial contaminants, before losing any decontaminant activity. Page 17 of 22

18 Toxicological and biocompatibility data Acute toxicity Oral toxicity according to OECD guideline 401 Pure ALKAZYME LD50> 2,000 mg / kg Preparation not dangerous if swallowed Test Report No. 265/4544 of 30 June 1994 EVIC-CEBA - Laboratoire de recherche et d expérimentation Conclusion: According to Directive 67/548/EEC, the test preparation must be classified as non-hazardous if swallowed. 0.5 % ALKAZYME LD50> 40,000 mg / kg Preparation not dangerous if swallowed Test Report No. 266/4544 of 23 August 1994 EVIC-CEBA - Laboratoire de recherche et d expérimentation Conclusion: According to Directive 67/548/EEC, the preparation 0.5% ALKAZYME in distilled water must be classified as a preparation non-hazardous if swallowed. Inhalation toxicity according to OED guideline 403 ALKAZYME powder Maximal attainable air concentration : 0,065mg/L Aerodynamic Particle-Size Distribution : 3,52 µm Powder not dangerous by inhalation Test Report No. RF of 13 mars 2014 BioAgri a Merieux NutriSciences Company Conclusion : The combined median lethal concentration in a 4 hours nose only exposure periode (4H LC50) to ALKAZYME was greater than 0,065 mg/l. When tested at the maximum attainable concentration in the chamber atmosphere, the test item ALKAZYME induced no acute inhalation toxicity in a 4 hour nose-only exposure period. Page 18 of 22

19 Local tolerance Skin irritation according to OECD guideline % ALKAZYME Non-irritating preparation for the skin Test Report No. 305/5090 of 05 July 1994 EVIC-CEBA - Laboratoire de recherche et d expérimentation Conclusion: According to Directive 67/548/EEC, the preparation 0.5% ALKAZYME in distilled water is non-irritating to skin. Ocular irritation according to OECD guideline % ALKAZYME Preparation non-irritating to eyes Test Report No. T 306/5090 of 18 July 1994 EVIC-CEBA - Laboratoire de recherche et d expérimentation Conclusion: According to Directive 67/548/EEC, the preparation 0.5% ALKAZYME in distilled water is non-irritating to eyes. Evaluation of the skin sensitisation potential according to OECD guideline % ALKAZYME Preparation non-irritating to skin Test Report No. 772/ of 9 February 1999 EVIC-CEBA - Laboratoire de recherche et d expérimentation Conclusion: According to Directive 67/548/EEC, the preparation 0.5% ALKAZYME in distilled water is non-sensitizing to skin. Page 19 of 22

20 Ecotoxicity Evaluation of environmental toxicity according to OECD guideline 203 ALKAZYME diluted at 0,5 % Preparation non toxic for fishes Preparation non toxic for daphnia Preparation non toxic for green algae Test Report No. RE-12/10836 of 13 august 2012 and RE-12/06203 of 22 may 2012 IANESCO Conclusion: According to Directive 67/548/EEC, the preparation 0.5% ALKAZYME in distilled water is non-toxic for environment. Evaluation of biodegradability according to OECD guideline 302B ALKAZYME diluted at 0,5 % Biodegradation superior to 70% (94%) Test Report No. RN of 16/01/2006 SGS Conclusion: The sample ALKAZYME is then totally biodegradable according to OECD criteria. Page 20 of 22

21 Compatibility data Acute Analysis of material compatibility studiestoxicity According to the material compatibility studies and feedback on the product, ALKAZYME is considered compatible with: Stainless Steel, Polycarbonate, Polyethylene, Polypropylene, PEEK, EPDM, FPM / FKM, PTFE, Polyamide. Incompatibility: Aluminium Study of the corrosive action Study of the corrosive action on surgical instruments of a detergent disinfectant according to standard NF S / 1 ALKAZYME diluted at 0,5 % and iridectomy scissors Test report n of 9 september 1998 LNE Laboratoire d Essai National Conclusion: According to the test conditions, the cleaner disinfectant ALKAZYME is non-corrosive. Analysis of the conservation of medical devices after use in ALKAZYME solution during the week end. ALKAZYME diluted at 0,5 % and Instruments quality service and quality operating room Study realised by the department of pharmacy-sterilization, Hospital Robert Ballanger Conclusion: The water causes significant corrosion on instruments and thus an accelerated deterioration. Results obtained with new instruments are more for the immersion of the instruments in ALKAZYME rather than in water, and this even for an immersion time up to seven days. Page 21 of 22

22 Certificates of compatibility Endoscopes: Storz: We can conclude that the product ALKAZYME, according to test conditions, is noncorrosive with metal and non-aggressive with the different optical and plastic parts, adhesives and welds of surgical equipment tested. Olympus: Je me permets de recommander pour le nettoyage des endoscopes de la marque Olympus le produit ALKAZYME. Ce produit continue à être utilisé dans nos services de nettoyage. Pentax: We confirm that the product ALKAZYME presented no problem for PENTAX endoscopes in the different sites of use, including in our workshops of After Sales Service. Probes: Siemens-Acuson: ALKAZYME is present in the list of products approved by Siemens Acuson for cleaning external, endo-cavitary and transesophageal probes. Hitachi: ALKAZYME is compatible with the Hitachi ultrasound probes. Kretz: We would like to confirm that the Kretz ultrasound probes used in your services are compatible with the disinfection method recommended by ALKAPHARM. Quantel: All tests revealed no abnormalities and no malfunction has been detected on ultrasound. The removal of sensors and their expertise showed no sign of deterioration of circuits. Medtronic : We confirm that the product can be used on GAELTEC probes we sell Diverse: Brainlab: Hospital of Strasbourg, with whom we work, recommended a product of predisinfection, ALKAZYME, that they use regularly. Brainlab has tested this product, and even if ph is greater than 9, it is quite suitable for our instruments. Sopro: ALKAZYME is compatible for decontamination of endoscopy cameras. Johnson & Johnson: The compatibility tests performed by our parent company in the United States, between our sterilization boxes Sterrad and the decontamination product ALKAZYME you kindly provide us, are quite successful. Bolusil: ALKAZYME is present in the product list whose safety has been verified. ABS: We confirm that we agree the use of cleaner ALKAZYME with our range of Oesophageal and Anorectal catheters. Page 22 of 22