CLEAN ROOM Innovation applied to sterilizable devices
CLEAN ROOM Innovation applied to sterilizable devices
CLEAN ROOM Innovation applied to sterilizable devices
A clean room is an environment subject to contamination control, commonly used in the pharmaceutical, biotechnology and electronics industries or in scientific research. This area must possess a minimum level of contamination, defined by the maximum number of par ticles per cubic meter with a specific grain size: this can be achieved and maintained only by controlling the environment, the workforce, the products and the processes within these rooms. Conversely to protecting the environment from contamination, a specific risk assessment program must define which features the PPE should have to ensure the operator adequate protection from potential contact with hazardous substances.
DOUBLE PROTECTION
ENVIRONMENT
PERSON
Univet: specialization and evolution
In the early 2000s, Univet introduced the first sterilizable goggles specifically developed for clean rooms. Our ongoing innovative drive has since led our R&D depar tment to create a full range of products with technologies capable of meeting specific clean room market requirements.
FOCUS
INNOVATION IN MATERIALS
COMPLETE RANGE
Since its establishment, Univet has specialized in eye protection. Constantly monitoring complex and poorly explored environments to capture special requirements. Thanks to this receptivity, the company was the first to create products focused on the real needs of clean room customers.
The AR Lab laboratory developed innovative materials able to withstand the extreme conditions to which they are subject during multiple sterilization cycles. The reusability combined with high-performance materials ensures cost savings while diminishing environmental impact.
The product range meets or exceeds all of the current market needs: goggles sterilizable with autoclave or beta or gamma rays, frames equipped with direct or indirect ventilation, lenses made of βγ oxene ® or polycarbonate with or without anti-fog treatment and appropriate solutions for those suffering from visual defects are available.
CONSOLIDATED TECHNOLOGY
DIRECTLY & INDIRECTLY VENTILATION
To ensure air circulation within the goggle, to prevent the formation of condensation on the lens, two technical solutions are available. A directly ventilated goggle has openings on its frame which allow the directly flow of air between the outside and the inside of the goggle. The openings on the frame ensure maximum air circulation in order to minimize the fogging. The other option is a goggle with indirectly ventilation which has openings on its structure that are protected by technical solutions able to guarantee protection against drops and splashes of liquids.
OVER THE GLASSES AND RX INSERT
Univet suppor ts a specific market demand by offering solutions for those who wear corrective lenses. A removable additional inser t with corrective lenses produced according to medical prescription is available for the 611 model. The geometry of the 619 model is designed to comfor tably allow the housing of common prescription spectacles.
5
INNOVATIVE TECHNOLOGY
NEW MATERIAL
Univet has developed βγ oxene ® , a material with unique chemical-physical characteristics, able to maintain its original transparency even after multiple cycles of sterilization according to the usual techniques by beta or gamma rays. Tests confirm that after twenty sterilization processes, the βγ oxene ® lens suffers a reduction in luminous transmittance of less than 1%. This is less than polycarbonate loses after only one cycle.
AF 121 COATING
The usual treatments applied to the lenses to prevent fogging and scratches increase the protection performance, but are not able to withstand the extreme conditions that occur in steam sterilization processes. Univet special coating Anti-Fog 121 is a film with a thickness of a few μm deposited both inside and outside of the lens able to protect from fogging and scratches according to the parameters required by EN166 standard (KN marking) enduring more than 10 steam sterilization cycles.
QUICK&SMOOTH ELASTIC BAND
The new elastic band ensures maximum stability thanks to a special superficial micro texture while the use of a special anti-static silicone provides greater elasticity for optimal comfort. The design has been developed to enable a rapid adjustment of the length in order to speed up the operations of dressing before entering the clean room. The stopper is molded into the band which removes the risk of the adjustment buckle component falling into the working area contaminating it.
PATENT PENDING
NO ADDITIONAL COMPONENTS EASY HANDLING, EVENWITH GLOVES STABILITY OF THE SLIDER TIGHTNESS OF THE ELASTIC HEADBAND
SMOOTH REGULATION ANTISTATICMATERIAL
7
POLYCARBONATE Lens 611 VERSATILITY
autoclave sterilization
611.S0.00.00 Frame:
directly vented
Lens:
clear
611.S1.00.00 Frame:
indirectly vented
Lens:
clear
042.060 Spare lens
601.OP.00.99 RX inser t
611.S0.00.01 Frame:
directly vented clear AF 121
Lens:
611.S1.00.01 Frame:
indirectly vented clear AF 121
Lens:
042.120M Spare lens
601.OP.00.99 RX inser t
ELASTIC BAND QS
STERILIZATION CYCLES
Goggles with polycarbonate lens reusable up to 40 autoclave sterilization cycles with steam at 121° C, 1 atm for 30 minutes.
The treatment AF 121 applied to the lens prevents at the same time from scratches and from fogging, bearing up to 10 steam sterilization cycles.
Pic.1 - Wear the goggles
TECHNICAL FEATURES
Pic.2 - Set the length of the elastic band by gently pulling back the ends
Available with polycarbonate lenses or with Anti-Fog 121 /Antiscratch coating
Available with directly or indirectly ventilation
Elastic band in silicone with Quick&Smooth system
RX Inser t
Pic.3 - To remove the goggles, loosen the elastic band by letting the cursors to slide for th
9
611
Lens
INNOVATION
β and γ ray sterilization
611.S0.00.02 Frame:
directly vented
Lens:
clear
611.S1.00.02 Frame:
indirectly vented
Lens:
clear
042.118 Spare lens
601.OP.00.99 RX inser t
STERILIZATION CYCLES
ANTI-STATIC ELASTIC BAND
Goggles with βγ oxene ® lens keep the transparency unaltered up to 20 cycles of sterilization.
Pic.1 - To extend the elastic band, loosen the loose end
Pic.2 - Set the adjustment by letting the loose end to slide for th
TECHNICAL FEATURES
βγ oxene ® Lenses
Pic.3 - To shor ten the band, let the elastic to slide back
Available with directly or indirectly ventilation
Elastic band in anti-static silicone
RX inser t
Pic.4 - Set the adjustment by letting slide back the loose end
11
619 OVER THE GLASSES POLYCARBONATE Lens
autoclave sterilization
619.05.23.10 Frame:
directly vented
Lens:
clear
619.04.23.10 Frame:
indirectly vented
Lens:
clear
042.085 Spare lens
STERILIZATION CYCLES
ELASTIC BAND QS
Goggles with polycarbonate lens reusable up to 30 autoclave sterilization cycles with steam at 121° C, 1 atm for 30 minutes.
Pic.1 - Wear the goggles
TECHNICAL FEATURES
Pic.2 - Set the length of the elastic band by gently pulling back the ends
Polycarbonate Lenses
Available with directly or indirectly ventilation
Elastic band in silicone with Quick&Smooth system
Over the glasses
Pic.3 - To remove the goggles, loosen the elastic band by letting the cursors to slide for th
13
VALIDATED TECHNOLOGY 611 POLYCARBONATE Lens
128 g
autoclave sterilization
Sterilization with STEAM 121°C for 30min in 1 ATM
REFERENCE PARAMETERS Lens Δl = 73.3% VLT= visible light trasmittance Δl = elongation% VLT = 85.8% Elastic Band
LIFE CYCLE
number of cycles 0 5 10 15 20 25 30 35 40 45
suggested action
suggested action Replace the goggles
Change the lens
Mask elements
Number of cycles
0÷20
20÷30
30÷40
Frame
No alteration
No alteration
No alteration
Lens
VLT = 82.6% Δl = 63.3% No alteration
VLT = 82.3% Δl = 61.2% No alteration
VLT = 81.4% Δl = 58.3% No alteration
Elastic band
Buckle
Resistance to fogging of oculars EN166:2001 Clause 7.3.2
SAMPLE
TIME TO FOGGING [s]
‘N’ MARKING REQUIREMENT [s]
AF121
>30
>8
Resistance to surface damage by fine particles EN166:2001 Clause 7.3.1
SAMPLE REDUCED LUMINANCE FACTOR [cd/lx·m 2 ]
‘K’ MARKING REQUIREMENT [cd/lx·m 2 ]
AF121
1.2
<5
611
Lens
128 g
β and γ ray sterilization
Reference
1 cycle
5 cycles
10 cycles
15 cycles
20 cycles
Visible light trasmittance (VLT) Lens
89.1%
88.9%
88.7%
89.1%
88.5%
88.3%
Variation
-0.2%
-0.4%
-0.4%
-0.6%
-0.8%
87.2%
85.6%
78.2%
73.1%
66.4%
63.6%
Visible light trasmittance (VLT) POLYCARBONATE Lens
Variation
-1.8%
-10%
-16%
-24%
-27%
REF 5 cycles 10 cycles 15 cycles 20 cycles
619 autoclave sterilization, β and γ ray sterilization POLYCARBONATE Lens
92 g
GAMMA RAY radiation with 25 kGy
REFERENCE PARAMETERS
LIFE CYCLE
Lens
VLT = 87.4%
number of cycles 0 5 10 15 20 ...
Elastic Band
Δl = 60.0%
VLT= visible light trasmittance Δl = elongation%
suggested action
suggested action Replace the goggles
Change the lens
Mask elements
Number of cycles
0÷5
5÷10
10÷15
Frame
No alteration
No alteration
No alteration
Lens
VLT = 74.9% The lens becomes light yellow
VLT = 68.8% The lens becomes yellow
VLT = 62.8% The lens becomes yellow
Elastic band
Δl = 40.0% No alteration
Δl = 18.3% No alteration
Δl = 13.3% No alteration
Buckle
BETA RAY radiation with 25 kGy
LIFE CYCLE
number of cycles 0 5 10 15 20 ...
suggested action
suggested action Replace the goggles
Change the lens
Mask elements
Number of cycles
0÷5
5÷10
10÷15
Frame
No alteration
No alteration
No alteration
Lens
VLT = 82.7% The lens becomes light yellow
VLT = 68.8% The lens becomes yellow
VLT = 65.9% The lens becomes yellow
Elastic band
Δl = 46.6% No alteration
Δl = 21.6% No alteration
Δl = 16.6% No alteration
Buckle
Sterilization with STEAM 121°C for 30min in 1 ATM
LIFE CYCLE
number of cycles 0 5 10 15 20 25 30 35 40 45
suggested action
suggested action Replace the goggles
Change the lens
Mask elements
Number of cycles
0÷5
5÷10
10÷15
Frame
No alteration
No alteration
No alterationd VLT = 84.3% Δl = 42.7% No alteration
Lens
VLT = 86.2% Δl = 54.8% No alteration
VLT = 85.8% Δl = 50.2% No alteration
Elastic band
Buckle
15
HEADQUARTERS Via Giovanni Prati, 87 25086 Rezzato (BS) Italy info@univet.it
www. u n i v e t s a f e t y. c om
tel +39 030 2499411 fax +39 030 2499430
UNIVET INTERNATIONAL OFFICES france@univet-optic.com
nor thamerica@univet-optic.com latinamerica@univet-optic.com russia@univet.it deutschland@univet-optic.com uk@univet-optic.com poland@univet-optic.com
asia@univet-optic.com spain@univet-optic.com
FOLLOW US
Univet ist ISO 9001: 2008 zer tifizier t.
Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16Made with FlippingBook - Online magazine maker