NT Alkazyme en 2016-06

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 900113485

Parc Biocitech, 102 avenue Gaston Roussel, 93230 Romainville, France
Tél : +33 (0)1 41 50 59 80 - Fax : +33 (0)1 48 30 54 31
Website : www.alkapharm.fr - e-mail : info@alkapharm.fr
NT ALKAZYME EN / 2016-06
Page 1 of 22
ALKAZYME
®
Technical guide
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 ...................................................................................................... 12
Tests to determine fungicidal activity ......................................................................................................... 14
Tests to determine the activity against viruses .......................................................................................... 15
Tests to determine disinfectant capacity .................................................................................................... 17
Toxicological and biocompatibility data .................................................................................................... 18
Acute toxicity ............................................................................................................................................. 18
Local tolerance .......................................................................................................................................... 19
Ecotoxicity ................................................................................................................................................. 20
Compatibility data ........................................................................................................................................ 21
Acute Analysis of material compatibility studiestoxicity .............................................................................. 21
Study of the corrosive action ..................................................................................................................... 21
Certificates of compatibility ........................................................................................................................ 22
Microbiology, toxicology and biocompatibility test reports and safety data sheets
are available separately on request.
Page 2 of 22
ALKAZYME
®
Technical guide
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: http://www.alkapharm.fr
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
ALKAZYME
®
Technical guide
Presentation
Intended use
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
ALK0153 2 kg 6 buckets + dosing shovel
ALK0152 5 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
ALKE171 25 doses of 25 g 25 sachets
ALK0175 100 doses of 5 g 6 buckets
Page 4 of 22
ALKAZYME
®
Technical guide
Use
Regulatory information
 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 EUH208 Contains SUBTILISIN. May produce an allergic reaction.

statements H315 Causes skin irritation. H318 Causes serious eye damage.
Precautionary P102 Keep out of reach of children. P280 Wear protective gloves/protective
statements 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
ALKAZYME
®
Technical guide
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
(2Kg et 5Kg bucket)
1 dose of 5g 1 litre
Hydrosoluble doses
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 15 minutes 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
ALKAZYME
®
Technical guide
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
ALKAZYME
®
Technical guide
Physicochemical data
Composition
Non ionic and cationic surfactants, sequestrant, proteolytic enzyme, minerals,

perfume.
Physicochemical properties
Appearance Fine white powder
Odour Almond
Packed: 0.743
Density
Unpacked: 0.624
pH of 0.5% ALKAZYME 11.20 ± 0.5
Page 8 of 22
ALKAZYME
®
Technical guide
Microbiological data
Tests to assess the detergency
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

Test Conditions
ALKAZYME 0.5 %
Strains Pseudomonas aeruginosa
Contact time: 5 minutes
Temperature: 20° and 40°C
Test Report No. 97-265 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/cm2) 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
ALKAZYME
®
Technical guide
Cleaning efficiency on a suspension of Bacillus subtilis bacterial spores containing

blood
Test Conditions
ALKAZYME 0.5 %
Strains Bacillus subtilis
Interfering Substances: Sheep blood
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

Test Conditions
ALKAZYME 0,5 %
Strains Escherichia Coli
Contact time : 15 minutes
Temperature : 20°C
Test Report No. 04-004
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 57124 products in hemolysis tubes of glass.
Page 10 of 22
ALKAZYME
®
Technical guide
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
ALKAZYME
®
Technical guide
Tests to determine bactericidal activity

European standard NF EN 1040 (April 2006)
Test Conditions
Strains: Pseudomonas aeruginosa
Staphylococcus aureus
Temperature: 20°C
Test Report No. 020-1 REA 08 AN of 28 November 2008
Scientis
Conclusion: The product ALKAZYME is bactericidal according to NF EN 1040

(April 2006), after 15 minutes of contact at 20°C on P. aeruginosa ATCC 15442
and S. aureus ATCC 6538 at a concentration of 0.1% (w/v).
Standard NF EN 13727 (July 2004) under dirty conditions

Test Conditions
Enterococcus hirae
Interfering Substances: Dirty conditions: 30°F hard water and a
mixture of 3 g/L bovine albumin and 3 mL/L
sheep red blood cells.
Temperature: 20°C
Test Report No. 05-0560c of 29 June 2005
Keybio Laboratory
Conclusion: According to the methodology described in standard EN 13727 (July

2004), batch 2005-02-01-44-918 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 13727 (July 2004) in dirty conditions on Acinetobacter baumanii

Test Conditions
Strains: Acinetobacter baumanii
Interfering Substances: Dirty conditions
Temperature: 20°C
Test Report No. 015-1 REA 11 of 14 March 2011
SCIENTIS
Conclusion: The product ALKAZYME batch 2009.08.01.44 complies with

standard EN 13727. It has a bactericidal activity on the strain Acinetobacter
baumanii under dirty conditions at 20°C and after 15 minutes of contact, at a
concentration of 0.5% (v/v).
Page 12 of 22
ALKAZYME
®
Technical guide
Determination of bactericidal activity by the germ carrier method

Test Conditions
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 15 minutes 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

Test Conditions
Temperature: 20°C
Test Report No. 015-1 REA 10 of 21 December 2010
SCIENTIS
Conclusion: Product ALKAZYME, lot 2008.05.01.44, has a:

o Bactericidal activity of more than 7 log on Pseudomonas aeruginosa and
Staphylococcus aureus according to the test protocol, in 15 minutes 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
ALKAZYME
®
Technical guide
Tests to determine yeasticidal activity

European standard NF EN 1275 (June 1997)
Test Conditions
Strains: Candida albicans
Temperature: 20°C
Test Report No. 285/0697-2 of 13 June 1997.
I.R.M.- Institut de Recherche Microbiologique - COFRAC
Conclusion: Product ALKAZYME is active on the reference strain Candida

albicans ATCC 10231 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 13624 (April 2004)

Test Conditions
Strains: Candida albicans
Temperature: 20°C
Test Report No. 008-2REA08 of 29 July 2008.
SCIENTIS Laboratories
Conclusion: The product ALKAZYME has a yeasticidal activity under dirty

conditions at 20°C and 15 minutes of contact at a concentration of 0.25% (w/w).
Page 14 of 22
ALKAZYME
®
Technical guide
Tests to determine the activity against viruses

Tests on HIV under dirty conditions according to standard EN 14476+A1: 2007-01
Test conditions
Strain HIV
Interfering Substances : Dirty conditions
Temperature : 20°C
Test report 079V4-2012 du 10 avril 2012
Apex biosolutions
Conclusion: ALKAZYME used at 0.5% is active on HIV according to EN

14476+A1, in 15 minutes at 20°C, under dirty condition.
Tests on Herpes Simplex virus type 1 under dirty conditions according to standard EN
14476+A1: 2007-01
Test Conditions
Strain Herpes simplex virus type 1
Contact time: 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
ALKAZYME
®
Technical guide
Tests on PRV (virus model of Hepatitis B) under dirty conditions according to standard
EN 14476+A1: 2013-09
Test conditions
Strain PRV
Interfering Substances : Dirty conditions
Temperature : 20°C
Test report 041V03-2014-01 of 10 avril 2014
Apex biosolutions
Conclusion : The assays performed with the ALKAZYME batch n° 2012.04.01.44

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 15 minutes exposure period, at
20°C, in dirty conditions.
Tests on BVDV (virus model of Hepatitis C) under dirty conditions according to

standard EN 14476+A1: 2013-09
Test Conditions
Strain BVDV
Temperature: 20°C
Test Report 041V03-2014-01 of 10 avril 2014
Apex biosolutions
Conclusion: The assays performed with the ALKAZYME batch n°2012.04.01.44

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 15 minutes exposure period, at 20°C, in
dirty conditions.
Page 16 of 22
ALKAZYME
®
Technical guide
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.
Test Conditions
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
ALKAZYME
®
Technical guide
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
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 – 14706.309.080.13 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
ALKAZYME
®
Technical guide
Local tolerance
Skin irritation according to OECD guideline 404
0.5 % ALKAZYME
 Non-irritating preparation for the skin
Test Report No. 305/5090 of 05 July 1994

ALKAZYME in distilled water is non-irritating to skin.
Ocular irritation according to OECD guideline 405

0.5 % ALKAZYME
 Preparation non-irritating to eyes
Test Report No. T 306/5090 of 18 July 1994

ALKAZYME in distilled water is non-irritating to eyes.
Evaluation of the skin sensitisation potential according to OECD guideline 406

0.5 % ALKAZYME
 Preparation non-irritating to skin
Test Report No. 772/98-4556 of 9 February 1999

ALKAZYME in distilled water is non-sensitizing to skin.
Page 19 of 22
ALKAZYME
®
Technical guide
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

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. RN05-10014.002 of 16/01/2006
SGS
Conclusion: The sample ALKAZYME is then “totally biodegradable” according

to OECD criteria.
Page 20 of 22
ALKAZYME
®
Technical guide
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 94-402 / 1
ALKAZYME diluted at 0,5 % and 15 minutes

 iridectomy scissors
Test report n° 8090155 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 15 minutes

 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
ALKAZYME
®
Technical guide
Certificates of compatibility
Endoscopes:
 Storz: “We can conclude that the product ALKAZYME, according to test conditions, is non-
corrosive 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 pre-

disinfection, 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

NT Alkazyme en 2016-06

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ALKAZYME

for the presoaking, the predisinfection

Certified ISO 900113485

Declaration of compliance ........................................................................................................................... 3

ALKAPHARM declares that the product ALKAZYME does not contain:

ALKAZYME in water-soluble doses

 According to studies, the powder ALKAZYME is :

 According to studies, the solution ALKAZYME induced :

Precautionary EUH208 Contains SUBTILISIN. May produce an allergic reaction.

Preparation of ALKAZYME solution

Instructions for use

Renewal time of the dilute solution

 Laboratory tests conducted by GERMANDE (Group of Studies and Research on Endoscopes

Precautions for use

Handling and Storage

Accidental spillage – Disposal

Non ionic and cationic surfactants, sequestrant, proteolytic enzyme, minerals,

Appearance Fine white powder

pH of 0.5% ALKAZYME 11.20 ± 0.5

Tests to determine the detergency on a biofilm

Conclusion: Bacterial counts and assays of the residual quantities of proteins or

Cleaning efficiency on a suspension of Bacillus subtilis bacterial spores containing

Tests to determine the detergency on a biofilm of E. coli

Conclusion : Used under the conditions of concentration, temperature and time

List of hospital baseline studies comparing the detergent activities of different

 Study of proteolytic power of enzymatic cleaners

 Did pre-disinfectants meet requirements of good practice in hospital pharmacy ?

 Evaluation of detergent action of enzymatic or non-enzymatic pre-disinfectants

 Benchmarking of pre-disinfectants performances in CSSD

Tests to determine bactericidal activity

Conclusion: The product ALKAZYME is bactericidal according to NF EN 1040

Standard NF EN 13727 (July 2004) under dirty conditions

Conclusion: According to the methodology described in standard EN 13727 (July

Standard NF EN 13727 (July 2004) in dirty conditions on Acinetobacter baumanii

Conclusion: The product ALKAZYME batch 2009.08.01.44 complies with

Determination of bactericidal activity by the germ carrier method

Conclusion: For 3 disinfectant batches tested by three tests, the product

Tests under practical conditions of use

Conclusion: Product ALKAZYME, lot 2008.05.01.44, has a:

Tests to determine yeasticidal activity

Conclusion: Product ALKAZYME is active on the reference strain Candida

European standard NF EN 13624 (April 2004)

Conclusion: The product ALKAZYME has a yeasticidal activity under dirty

Tests to determine the activity against viruses

Conclusion: ALKAZYME used at 0.5% is active on HIV according to EN

Conclusion: ALKAZYME disinfectant was used at concentrations of 0.5% at 20°C

Conclusion : The assays performed with the ALKAZYME batch n° 2012.04.01.44

Tests on BVDV (virus model of Hepatitis C) under dirty conditions according to

Conclusion: The assays performed with the ALKAZYME batch n°2012.04.01.44

Tests to determine disinfectant capacity

Toxicological and biocompatibility data

Conclusion: According to Directive 67/548/EEC, the test preparation must be

Conclusion: According to Directive 67/548/EEC, the preparation 0.5%

Inhalation toxicity according to OED guideline 403

Conclusion : The combined median lethal concentration in a 4 hours nose only

Conclusion: According to Directive 67/548/EEC, the preparation 0.5%

Ocular irritation according to OECD guideline 405

Conclusion: According to Directive 67/548/EEC, the preparation 0.5%

Evaluation of the skin sensitisation potential according to OECD guideline 406

Conclusion: According to Directive 67/548/EEC, the preparation 0.5%

Conclusion: According to Directive 67/548/EEC, the preparation 0.5%

Evaluation of biodegradability according to OECD guideline 302B

Conclusion: The sample ALKAZYME is then “totally biodegradable” according