USP-797 Compliant Cleanrooms
usp-797-compliant-cleanrooms
On January 1, 2004 USP 797 regulations went into effect. These regulations are FDA enforceable and the FDA has indicated that it fully intends to do so.
USP 797 applies to healthcare personnel in all healthcare facilities where sterile preparations (CSP's) are compounded, stored, and dispensed, including community pharmacies, outsourcing pharmacies, physician practices, infusion clinics, surgical clinics, home care organizations, long-term care facilities and satellite pharmacies.
In order to be in compliance with the new rules, such institutions will needed to protect their products by utilizing a Laminar Airflow Workbench (LAFW's) within a cleanroom or, depending on requirements, a positive pressure barrier isolation which takes the place of a cleanroom by providing cleanroom conditions within a contained workspace.
By January 2005, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will require an action plan for each accredited healthcare organization that will bring the organization into compliance with USP 797 within a reasonable period of time.
Liberty offers a variety of solutions to enable compliance with the regulations no matter what the risk level.
The accompanying diagram on the right features a Class 5 cleanroom with an accompanying class 8 anteroom which provides a clean area for donning gloves, gowns, etc. with a total footprint of 6' x 8'.
Unit is supplied with lights, strip curtains and a fan filter unit.
Liberty's barrier isolator, pictured at the link above, isolates areas from various contamination sources including the volume of air surrounding the equipment and the space from ceiling to floor. A barrier isolator encompasses a much smaller area around the process allowing a small volume and proper airflow and totally removes workers contamination from the process.
Whether the decision is to install a cleanroom or opt for a barrier isolators, the primary goal is safety. Both systems have their benefits and drawbacks, but it is up to the individual pharmacy directors to make the best decision for their business, their personnel and their patients. /Asset/USP-797.jpg
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 are available upon request.
Pass Thru Options:
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 phase, 60Hz. One duplex outlet above canopy, 6 ft. cord, 3-prong plug, 125 ft. candles at work surface. Noise level conforms to OSHA standards or better.
As with all types of cleanrooms, Liberty offers third party independent certification of all laminar flow benches. /Asset/a0001522.jpg
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 contamination from surrounding air. 3/4-inch novaply, white high-pressure plastic laminate on exposed surfaces. Interior surfaces 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 bar.
Optional remote work surface on legs for minimum vibration and acrylic side panels. Prefilter consist of 1" thick, 30% NBS, Final filters are HEPA type 99.99% efficient for particles 0.3 micron and larger. Positive filter sealing to prevent filter by pass. Less than 100 particles per cubic foot 0.3 micron and larger, Class 100 (ISO 5) conditions per Federal Standard 209 and ISO 14644-1. /Asset/a0001523.jpg
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. /Asset/mainstarter.jpg
Modular Cleanrooms (hard wall cleanroom or soft wall cleanroom)
Liberty's 7300 modular cleanrooms, either with soft walls or solid acrylic walls can be designed and constructed to your cleanroom requirements and can be fitted to unconventional or restricted space requirements. Check out the background in the picture. The cleanroom is designed to meet or exceed USP <797> requirements and it can be equipped with an anteroom. The IV 7300 cleanroom 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.
Liberty's Modular cleanrooms can be designed as a single-pass cleanroom, a recirculating with air-chase walls and ceiling plenum, or as a hardwall partition for existing sterile environments.
Typical Applications
- Pharmaceutical
- Medical Device
- Aerospace/Government
- Health Care
- Research Labs
- Animal Labs
- Precision Mfg.
- Metal Mfg./ Lead Industry
- Electronics
- Semiconductor
- Optical
- Hospital Pharmacy
- Automotive
- University
- Injection molding
- Plastics
- Laboratories
- Ball Bearings
- Printed Circuits
- Computer Rooms
- Nanotech
/Asset/Cleanroom pic w pass thru.JPG
USP-797 Compliance
Modular cleanrooms can be designed as a single-pass cleanroom, a recirculating with air-chase walls and ceiling plenum, or as a hardwall partition for existing sterile environments.On January 1, 2004 USP 797 regulations went into effect. These regulations are FDA enforceable and the FDA has indicated that it fully intends to do so.
USP 797 applies to healthcare personnel in all healthcare facilities where sterile preparations (CSP's) are compounded, stored, and dispensed, including community pharmacies, outsourcing pharmacies, physician practices, infusion clinics, surgical clinics, home care organizations, long-term care facilities and satellite pharmacies.
In order to be in compliance with the new rules, such institutions will needed to protect their products by utilizing a Laminar Airflow Workbench (LAFW's) within a cleanroom or, depending on requirements, a positive pressure barrier isolation which takes the place of a cleanroom by providing cleanroom conditions within a contained workspace.
By January 2005, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will require an action plan for each accredited healthcare organization that will bring the organization into compliance with USP 797 within a reasonable period of time.
Liberty offers a variety of solutions to enable compliance with the regulations no matter what the risk level.
The accompanying diagram on the right features a Class 5 cleanroom with an accompanying class 8 anteroom which provides a clean area for donning gloves, gowns, etc. with a total footprint of 6' x 8'.
Unit is supplied with lights, strip curtains and a fan filter unit.
Liberty's barrier isolator, pictured at the link above, isolates areas from various contamination sources including the volume of air surrounding the equipment and the space from ceiling to floor. A barrier isolator encompasses a much smaller area around the process allowing a small volume and proper airflow and totally removes workers contamination from the process.
Whether the decision is to install a cleanroom or opt for a barrier isolators, the primary goal is safety. Both systems have their benefits and drawbacks, but it is up to the individual pharmacy directors to make the best decision for their business, their personnel and their patients. /Asset/USP-797.jpg
H-100 Series Cleanroom Pass Thrus, Pass Boxes, Pass Throughs
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 are available upon request.
Pass Thru Options:
- Lights
- Recessed light
- U.V. light fixture with guard
- 1/4" safety plate glass windows
- Adjustable or fixed shelving
- Acrylic amber windows (Ultra violet)
Laminar Flow Cleanroom Benches: Table Top IV Prep Laminar Flow Hood, Clean Benches
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 phase, 60Hz. One duplex outlet above canopy, 6 ft. cord, 3-prong plug, 125 ft. candles at work surface. Noise level conforms to OSHA standards or better.
As with all types of cleanrooms, Liberty offers third party independent certification of all laminar flow benches. /Asset/a0001522.jpg
Laminar Flow Benches: Horizontal Laminar Flow 4010 Console Series, Clean Benches
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 contamination from surrounding air. 3/4-inch novaply, white high-pressure plastic laminate on exposed surfaces. Interior surfaces 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 bar.
Optional remote work surface on legs for minimum vibration and acrylic side panels. Prefilter consist of 1" thick, 30% NBS, Final filters are HEPA type 99.99% efficient for particles 0.3 micron and larger. Positive filter sealing to prevent filter by pass. Less than 100 particles per cubic foot 0.3 micron and larger, Class 100 (ISO 5) conditions per Federal Standard 209 and ISO 14644-1. /Asset/a0001523.jpg
Fan Filter Units (FFU's)
Low profile unit designed for height limited overhead installations for cleanrooms and cleanroom applications offered by Liberty. Reduced weight makes it easy to install and has less ceiling load.
The 2' x 4' motorized MAC 10 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
As an option. for extra cleanliness, ULPA filters are available in both units as an option. Standard units are 120 Volt, 1 phase, 60 HZ.
Maintenance Starter Kit:
(8) USP <797> places the responsibility 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. /Asset/mainstarter.jpg
