| Star Product |
Yes |
| REF No |
6071 |
| Trademark |
GBL® SANITAROSA™ GA |
| Product Name |
|
| Regulation |
2017/745 MDR Class IIB |
| Purpose |
High-level disinfection and cold sterilization of medical devices, surgical equipment, endoscopic and thermosensitive equipment. No activation is required. |
| Working Principle
|
|
| Warnings, Precautions, Recommendations
|
The product is for professional use only.
Danger. Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Avoid breathing dust/fumes/gas/mist/vapor spray. Wear protective gloves/protective clothing/eye protection/face protection. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Wash with plenty of soap and water. IF INHALED: Remove the person to fresh air and keep comfortable for breathing. IF IN EYES: Rinse cautiously with water for several minutes. Remove the contact lens if present and easy to do – continue rinsing. Store in a well-ventilated place. Keep the container tightly closed.
Glutaraldehyde is an irritant to the skin, eyes, and respiratory system. Skin contact may cause minor irritation with itching and slight local redness. Prolonged contact causes mild to moderate local redness and swelling. In concentrations less than 5% it is considered irritating to eyes, although higher concentrations can present a risk of serious damage to the eyes. These symptoms are generally temporary and should subside when the employee leaves the area of glutaraldehyde exposure. There is no evidence of adverse reproductive or carcinogenic health. |
| Ingredients
|
Glutaraldehyde (2%), corrosion inhibitor and Ro water. Does not contain any acetate, borate, phosphate, detergent, and colorant. |
| Colour
|
Light Yellowish |
| Odour
|
Aldehyde |
| Storage Temperature
|
5/35 °C |
| Shelf Life After Opening the Lid
|
3 months |
| Shelf Life
|
2 years |
| pH (at 25°C)
|
6.0 ± 0.4
~5,8 (10%~5,9) |
| Appearance
|
Limpid Liquid |
| Concentration
|
Ready-to-use. |
| Accessories
|
Ref No: 6219
ROSA-CHEM GA
Neutralizer for SANITAROSA™GA
Ref No: 7001
ROSA-STRIP GA
Glutaraldehyde MEC Test Strips |
| Application
|
Pre-cleaning: Wipe down the external surface of the surgical instrument with gauze or a cloth, to remove the mucous membrane, blood and filth that adhere to the external surface. Either moistened gauze or dry gauze is fine. After the outer surface of the instruments is wiped with a cloth, it must be treated with an enzymatic detergent (Ref no: 6160 GBL® WARECLEAN™ EC) before disinfection.
Disinfection:
Ready-to-use. Do not dilute. Pour activated SANITAROSA™ GA disinfectant solution into the disinfection container. Pre-cleaned devices with enzymatic detergent (Ref no: 6160 GBL® WARECLEAN™ EC) are immersed into the container so that all the surfaces and holes will contact the solution. Wait according to the requested activity (contact times given below the microbiological effect table). Rinse with sterile or distilled water. Keep the medical device as aseptically as possible until use. SANITAROSA™ GA can be used up to 14 days. |
| Microbiological Properties
|
|
Effect
|
Standard
|
Microorganisms (with ATCC)
|
Contact Time
|
|
Bactericidal
|
EN 13727 / EN 14561
|
Staphylococcus aureus 6538
Pseudomonas aeroginosa 15442
Enterococcus hirae 10541
|
10 min.
|
|
Fungicidal
|
EN 13624 / EN 14562
|
Candida albicans 10231
Aspergillus brasiliensis 16404
|
10 min.
|
|
Mycobactericidal
|
EN 14563
|
Mycobacterium terrae 15755
Mycobacterium avium 15769
|
10 min.
|
|
Virucidal
|
EN 14476+ A1
|
Adenovirus type 5, strain Adenoid 75, ATCC VR-5
Murine norovirus (MNV) strain S99, RVB-651
Poliovirus type 1, LSc-2ab
|
10 min.
|
|
Sporicidal
|
AOAC
|
Bacillus subtilis 6633
|
3 hours
|
|
| Ordering and Packaging Information
|
|
Order No |
Unit |
Volume |
Packaging Type |
Quantity in a Box |
Quantity in a Pallet |
|
436071025000 |
Canister |
5 L |
HDPE; 5 L White Canister |
2 |
216 |
|