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All Categories > USP-797 Compliance 
 

USP-797 Compliance

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VFCS 3 Solid Acrylic Wall

IV 7300 Modular Cleanrooms (hard or soft wall):

The IV 7300 modular cleanroom, either with soft walls as shown on the cover or solid acrylic walls as shown on the right, can be designed and constructed to your requirements and can be fitted to uncoventional or restricted space requirements. Check out the background in the picture.

The room is designed to meet or exceed USP <797> requirments and it can be equipped with an anteroom.

The IV 7300 room is sold as a complete unit with pre-engineered filtration, temperature and relative humidity control, if required.

All Liberty modular cleanrooms can be taken down or expanded and re-installed at another location should the need arise to relocate or expand your sterile compounding facilities.


cleanroom (hard or soft)

Permanent Liberty Compounding Cleanroom

If you prefer a more permanent solution, a Liberty cleanroom can be installed to your specifications. Assembled by qualified, cleanroom in stallers, Liberty can design and build a permanent cleanroom installation to your specifications in full compliance with SUP <797> ISO 7 specifications.

THIRD PARTY CERTIFICATION

To ensure that your compounding cleanroom is in compliance with USP <797> regulations, as Liberty to arrange for an independent third party certification.


USP797 Laminar flow Glovebox

USP797 Laminar Flow Glovebox

Germfree's Barrier Isolator, the Laminar Flow Glovebox/Isolator (LFGI), meets the requirements of USP <797>.

All exhaust air is HEPA filtered, removing all particulates and reducing the risk of long-term exposure to compounding elements.

A strong negative pressure ensures the operator will not be exposed to hazardous materials being compounded fir containment is breached.

A fully sealed, all stainless steel antechamber maintains complete separation between the work area and the ambient room air. This same technology is used in the High Containment Gloveboxes that Germfree manufactures for the US Department of Defense of handling chenical and biological warfare agents.

Strong positive pressure ensures ...


Table top IV Prep

Laminar Flow Benches: Table Top IV Prep Laminar Flow Hood

The Table Top IV Prep Fume Hood, is both versatile, unique in design and an economical substitute for a biological safety cabinet.

Available with 100% exhaust or 100% recirculation. It offers complete operator protection from harmful fumes from within the work area with an air curtain across the work opening. Perforated stainless steel work surface available.

Filtration system includes HEPA filters 99.99% efficient on particles 0.3 microns and larger.

High capacity forward curved blowers with direct drive blower motor(s). The unit is statically and dynamically balanced, designed to maintain constant air flow without speed controls or belt adjustments.

115 V, single phas, 60Hz. One duplex outlet above canopy, ...


Horizontal flow

Laminar Flow Benches: Horizontal Flow 4010 Console Series

Designed for laboratory applications requiring dust-free ambient conditions.

It generates laminar air flow to reduce eddy currents set up by equipment of personnel, eliminates the need for special cleanroom garments, affords positive protection for the work surface against containmation from surrounding air. 3/4-inch novaply, white high-pressure plastic laminate on expoosed surfaces. Interior ssurfaces sealed to prevent shedding of particulates.

Also available in 16 gage, cold rolled steel, painted white, or stainless steel.

Meets ISO 5 specifications, surpassing USP <797> requirements.

Available work surfaces, include stainless steel, PVC, polyprop of other materials.

Unit can be equipped with an IV ...


H-100-Series

H-100 Series Pass Thrus:

Have you ever noticed that you are moving product more and more in and out of your cleanroom? Each time that you do, the levels of cleanliness in the cleanroom is compromised.

A custom designed unit for easy access of passage of materials between the cleanroom and outer dirties areas. Essential for maximum protection against outer contamination when objects are passed into or out of the cleanroom.

Pass thrus can be constructed of novaply laminated plastic, acrylic, enameled cold rolled steel, polypropylene, 304 stainless steel or 316L stainless steel.

An optional stainless steel mechanical interlock is a push-pin lock and turn handle system. Completely assembled and ready for installation.

Custom sizes ...


Fanfilter-units

Fan Filter Units (FFU's)

Low profile unit designed for height limited overhead installations. Reduced weight makes it easy to install and has less ceiling load.

The 2' x 4' motorized MAX8005 fan filter unit is equipped with a HEPA filter that is 99.99% efficient on 0.3 micron and larger particles. This filter face is 100% scanned as per ISO-14644-1 (Federal Standard 209E).

Fan Filter Units are also available in 24" x 24".

Both units are available in 277 volts/60 Hz

For extra cleaniness, ULPA filters are available in both units.


mainstarter

Maintenance Starter Kit:

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USP <797> places the responsiblity for cleaning, sanitizing and organizing the compounding facilities and contiguous areas directly on the trained pharmacists and technicians.

In order to help you keep your compounding facilities up to USP <797> specifications. Liberty has developed several products specifically for this purpose and put them together in a complete Maintenance Starter Kit.


Apparel

Apparel: Garments

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As stated in USP <797>, personnel are critical keys to the integrity of the compounding facility. Prior to entering the buffer or clean area, operators should remove outer lab jackets or the like, makeup and jewelry and should thoroughly scrub hands and arms to the elbow.

After drying hands and arms compounding personnel should properly don clean, non-shedding uniform comoponents, including hair covers, shoe covers, knee -length coats or coveralls, and appropriate protective gloves. In order to ensure that your operating personel are properly garbed, Libertyoffers a complete line of cleanroom apparel.


Gloves ncc

Miscellaneous: Gloves

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As stated in USP <797>, personnel are critical keys to the integrity of the compounding facility. Prior to entering the buffer or clean area, operators should remove outer lab jackets or the like, makeup and jewelry and should thoroughly scrub hands and arms to the elbow.

After drying hands and arms compounding personnel should properly don clean, non0shedding uniform comoponents, including hair covers, shoe covers, knee -length coats or coveralls, and appropriate protective gloves. In order to ensure that your operating personel are properly garbed, Liberty offers a complete line of cleanroom apparel.


Cleanroom furniture

Cleanroom Furniture

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Liberty offers a complete line of cleanroom furniture for your compounding facility.


ECU CC

Infection Control Systems, Mintie (R)

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The increased focus on infection control standards today demands a reliable contamination solution that can be deployed quickly and conveniently. The Mintie systems offer portable solution for temporary containment of airborne particulates during normal facility operation or isolation during a public health emergency, construction and/or maintenance.