Univet Cleanroom Catalogue - ENGLISH

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.

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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

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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

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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

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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

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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

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HEADQUARTERS Via Giovanni Prati, 87 25086 Rezzato (BS) Italy info@univet.it

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