USP 795 / USP 800 Compounding Hoods
Non-Sterile Compounding ETA Series VBE
Designed for working with balances and other equipment
Available to recirculate into lab or connect to house exhaust
Vibration reduction technology for reproducibility and accuracy
Acrylic Construction with Phenolic Resin Base
PROCESS
Handling and manipulation of API (Active Pharmaceutical Ingredients) and other toxic materials where personnel protection is required.
CONTAINMENT
Heavily dependent on potency and quantity of the toxic material being worked with, this unit can contain a wide variety of OEL levels. Consult FSI about your application.
EQUIPMENT
The ETA Series can provide containment for many applications and equipment, including balances, microscopes, particle analysis, and many more.
USP 795 / USP 800 GUIDELINES
USP 800 COMPLIANCE
There are many factors and criteria that must be met to comply with the standards of USP 795 and USP 800. The containment enclosures (C-PEC) play an active role not only in containment of particulate, but also in the overall air changes in the room (C-SEC).
USP 795 / USP 800 - EXPLAINED.
The new USP 800 standards can be confusing. Many compounders are asking what they need to do to be compliant. So you can better understand what you need to do to make your pharmacy USP 800 compliant, here is the information and explanations that you need.
Defining Terms:
C-PEC : Containment Primary Engineering Control. A ventilated device designed to minimize worker and environmental hazardous drug exposure when directly handing hazardous drugs.
C-SEC : Containment Secondary Engineering Control. The room in which the C-PEC is placed.
HD : Hazardous Drug. The toxic powder or active pharmaceutical ingredient being used.
HEPA : High-Efficiency Particulate Air. Filters designed to 99.995% filtration effectiveness
ACPH : Air Changes Per Hour. Complete air changes in a C-SEC, typically measured by cubic feet.
CVE : Contained Vented Enclosure. A containment enclosure that provides personnel and environmental protection.
Class I BSC : Biological Safety Cabinet. A containment enclosure that provides personnel and environmental protection.
Class II BSC or CACI : Compounding Aseptic Containment Isolator. A containment enclosure that provides personnel and environmental protection.
Now that we have defined some terms, lets look at the requirements for USP 800.
ENGINEERING CONTROLS FOR NON-STERILE HD COMPOUNDING
C-PEC MUST BE EXTERNALLY VENTED (PREFERRED) OR REDUNDANT HEPA FILTERED IN SERIES
When compounding with your C-PEC, the enclosure must vent out of the enclosure to house exhaust. Alternatively, the enclosure can have redundant HEPA filters (dual filters) in series. Flow Sciences builds both single HEPA and dual HEPA filter units.
C-SEC MUST HAVE 12 AIR CHANGES PER HOUR
The C-SEC (room) that the C-PEC (CVE) is in must have 12 air changes per hour. This means in a room that is 15’ wide x 15’ long x 8’ tall, 1,800 cubic feet, there must be 21,600 cubic feet of air vented and exhausted in the room per hour.
C-PEC EXAMPLES : CVE, CLASS I OR II BIO SAFETY CABINET, OR COMPOUNDING ASEPTIC CONTAINMENT ISOLATOR
When compounding with your C-PEC, the enclosure must vent out of the enclosure to house exhaust. Alternatively, the enclosure can have redundant HEPA filters (dual filters) in series. Flow Sciences builds both single HEPA and dual HEPA filter units.
C-SEC MUST BE EXTERNALLY VENTED
The vented air must be exhausted outside of the room through HEPA filtration.
C-SEC MUST HAVE NEGATIVE PRESSURE BETWEEN 0.01 AND 0.03 INCHES OF WATER COLUMN
The room itself must be under negative pressure to ensure containment.
- Air handling system pumps conditioned air into the C-SEC
- 12 ACPH achieved by supplying and exhausting 21,600 cubic feet of air per hour (for 15’ x 15’ x 8’ room)
- C-PEC containment enclosure – Not connected to house exhaust to recirculate into room.
- Dual HEPA Filtration – Two 4” HEPA Filters – Fan
- HEPA filtered air externally vented from the C-SEC (room)
• RECIRCULATE into your lab to save money by requiring less make-up air and not venting out conditioned air
• FLEXIBILITY with placement in lab. Recirculate and move enclosure without moving house exhaust drops.
• Stable airflow and NO VIBRATION on the work surface
- Air handling system pumps conditioned air into the C-SEC
- 12 ACPH achieved by supplying and exhausting 21,600 cubic feet of air per hour (for 15’ x 15’ x 8’ room)
- C-PEC containment enclosure – Vented to house exhaust
- Single 4” HEPA Filter – Fan – Thimble Connection
- HEPA filtered air externally vented from the C-SEC (room)
• Safe powder handling of HDs for personnel protection and reproducibility in sensitive application
• THIMBLE CONNECTION and VENT KIT required to connect CVE to the house exhaust system
• Stable airflow and NO VIBRATION on the work surface
FEATURES & BENEFITS
BAG-IN / BAG-OUT (BIBO) TECHNOLOGY
Flow Sciences’ Top Mount Safety Enclosure with Bag-in / Bag-out (BIBO) Filtration is engineered to provide a safe, stable working environment in laboratory settings. The BIBO filter is designed for safe disposal and replacement of HEPA filter by a certified technician. Watch the video:
CLEANABLE FROM FACE TO FILTER
Unlike Alternative Technology, Flow Sciences Units Can Be CLEANED FROM FACE OPENING TO HEPA FILTER
Leaving NO Uncleanable Areas and Preventing Cross Contamination
SAFETY
The Top Mount series provides containment for various benchtop / scale up and nanotechnology applications. FSI engineering controls are built in to prevent loss of containment. Third Party testing has proven containment on these units to below 1 μg/m3 based on process and quantity.
TECHNOLOGY
Reproducibility and accuracy of weighing is achieved by engineering controls that create laminar airflow across the work surface. This also prevents product loss from turbulent airflow.
VELOCITY ALARM
This series includes a face velocity alarm that comes standard on all units, either integrated into the fan power or separate. A visual and audible alarm alerts the operator when airflow is compromised. The air velocity is measured at the face opening to be the most accurate.
DESIGN
This unit is able to effectively contain using airfoils and plenums to create laminar airflow across the work surface and reduce eddies and turbulence.The top mounted exhaust system with dual 4” HEPA filters or carbon filters can be recirculated into the lab or sent directly to house exhaust.
The Glovebox Workstation system is equipped with a 4″ HEPA filter inlet and primary and secondary 4” HEPA outlet filters that can be recirculated into the lab or sent directly to house exhaust
LED LIGHT
This enclosure features an optional internal white LED light for improved visibility inside of the enclosure that provides direct light onto the application. Ask your representative to add the LED light to your Vented Balance Enclosure. Also available in Amber LED through customization.
VIBRATION ISOLATION
Flow Sciences engineering controls provide vibration isolation to ensure 6-7 place balance stability and reproducibility of samples.
DUAL HEPA FILTER TECHNOLOGY
The Dual HEPA Series ETA systems have two 4″ Pleated HEPA filters, one primary and one secondary (redundant). The non-loading secondary HEPA filter prevents any contaminants that might migrate upstream during Bag-in/Bag-out disposal from coming in contact with the fan unit and being discharged to house exhaust or re-circulating into the room.
STANDARD OPTIONS
SAFETY
The ETA Series is available in 3, 4, 5, 6, and 8 foot standard width options. Other options include 24″ or 30” depth with 24” or 27″ internal height. Customization available.
SUPERSTRUCTURE
This series comes standard with clear acrylic construction with white acrylic rear wall (ETA Series), or all clear acrylic for increased visibility (ETC Series)
EXHAUST OPTIONS
Many exhaust options and configurations are available for both single and dual HEPA models. See below for more information.
HEPA FILTRATION
Bag-In/Bag-Out (BIBO) Dual 4″ Pleated HEPA Filtration or Single HEPA filtraiton. Also, Carbon filtration for organics, amines, aldehydes, or acids is available in conjunction with the HEPA filtration. ULPA filtration is available upon request.
ELECTRICAL OPTIONS
110V-120V 50-60HZ; 220V-240V 50-60HZ with Integrated Alarm and Separate Alarm
ELECTRICAL OPTIONS
110V-120V 50-60HZ; 220V-240V 50-60HZ with Integrated Alarm and Separate Alarm
OPTIONAL ACCESSORIES
POPULAR CONFIGURATIONS
ETA363024ABD
Dual HEPA BIBO
Acrylic Construction
3′ VENTED ENCLOSURE
36″ External Width (908mm)
30″ External Depth (762mm)
24″ Internal Height (610mm)
ETA363024AAD
Single HEPA
Acrylic Construction
Integrated Alarm
3′ VENTED ENCLOSURE
36″ External Width (908mm)
30″ External Depth (762mm)
24″ Internal Height (610mm)
ETA483024ABD
Dual HEPA BIBO
Acrylic Construction
Integrated Alarm
4′ VENTED ENCLOSURE
48″ External Width (1219mm)
30″ External Depth (762mm)
24″ Internal Height (610mm)
ETA483024AAD
Single HEPA
Acrylic Construction
Integrated Alarm
4′ VENTED ENCLOSURE
48″ External Width (1219mm)
30″ External Depth (762mm)
24″ Internal Height (610mm)
ETA603027ABD
Dual HEPA BIBO
Acrylic Construction
Integrated Alarm
5′ VENTED ENCLOSURE
60″ External Width (1520mm)
30″ External Depth (762mm)
27″ Internal Height (686mm)
ETA723024ABD
Dual HEPA BIBO
Acrylic Construction
Integrated Alarm
6′ VENTED ENCLOSURE
72″ External Width (1822mm)
30″ External Depth (762mm)
27″ Internal Height (686mm)
CUSTOM COMPOUNDING HOOD ENCLOSURE SYSTEMS
Working with a specific piece of equipment? Our design history has led to many custom solutions created for equipment that
is highly likely to be similar or exact to your specific equipment.
Our sales, engineering, and project management staff begin by creating a unified understanding of every customer’s
process and goals through the completion of the Custom Quote Request Form.
