PHARMACY

Vertical Laminar Flow Hood BVBI Series

The BVBI is Germfree’s advanced line of Vertical Laminar Flow Hoods. These USP 797 compliant units provide a high degree of localized control for critical processes and the handling of sterile products in an aseptic environment. The Direct Compounding Area (DCA) or work deck is continuously bathed with optimal ‘First Air’ that has passed through a High Efficiency Particulate Air (HEPA) filter. This protects preparations from contamination, removing organisms and particulates 0.3 micron in size with an efficiency of 99.99%. Compounding equipment placed in a cleanroom must be constructed with materials that are highly durable, non-shedding and can withstand rigorous cleaning protocols.

The Laminar Flow Hood that Enhances Airflow Efficiency
Germfree’s BVBI line of Vertical Laminar Flow Hoods is engineered to enhance the performance of the cabinet and the overall airflow efficiency of the cleanroom. The air return is positioned near the bottom of the unit. This bottom intake feature provides two advantages for a USP 797 compounding cleanroom:
1.) Provide additional cleanroom filtration
2.) Facilitates the air cleanliness

A well-designed ISO Class 5 Laminar Flow Hood significantly contributes to the required Air Changes Per Hour (ACPH) within a cleanroom. All of Germfree’s Laminar Flow Cabinets provide this benefit. The BVBI provides and additional advantage by drawing in air located toward the floor of the cleanroom. By filtering the room air with the highest potential particle count; the BVBI can augment overall cleanroom efficiency. The low position of the bottom air-intake ensures that return air is not pulled from the fan-filter ceiling modules. This facilitates the smooth downward flow of HEPA-filtered air for other cleanroom operations conducted near the hood.

The Laminar Flow Hood that is Ideal for Your Compounding Workflow
Germfree’s BVBI Series of Laminar Flow Hoods provide an efficient platform for preparing non-hazardous Compounded Sterile Preparations (CSPs). The units have an extra deep work area (28½”) with vertical laminar flow. This allows for maximum utilization of the full work area for all processes, and increased flexibility when using automated compounding devices. The units are constructed from 100% stainless steel with a pharmaceutical grade finish to ensure durability and ease of cleaning. The BVBI features a SpillGuard in the back of the full-width work area. External lighting along with acrylic rear and side panels provide additional ambient light to enhance work area visibility.

Overall Dimensions:
BVBI-3SSRX: 36 ⅛” wide ・ 38″ deep ・ 76 ¼” high (air duct is removable to reduce depth to 35 ⅛″)
BVBI-4SSRX: 49 ¼” wide ・ 38″ deep ・ 76 ¼” high
BVBI-6SSRX: 73″ wide     ・ 38″ deep ・ 76 ¼” high
BVBI-8SSRX: 96 ⅞” wide ・ 38″ deep ・ 76 ¼” high

Work Area Dimensions:
BVBI-3SSRX: 33 ⅛” wide ・ 28 ½” deep ・ 30 ¾” high
BVBI-4SSRX: 45 ¼” wide ・ 28 ½” deep ・ 30 ¾” high
BVBI-6SSRX: 69 ¼” wide ・ 28 ½” deep ・ 30 ¾” high
BVBI-8SSRX: 93 ⅛” wide ・ 28 ½” deep ・ 30 ¾” high

Compliant with USP 797 and Validated to CETA CAG-003-2006 Performance Standards
All stainless steel welded construction
16 gauge stainless steel work deck is 36″ from the floor and reinforced to support 300+ pounds
Frame is 1 ½” square stainless steel tubing with legs that terminate with heavy-duty, cleanroom-grade locking casters
Side panels are stainless steel framed ¼” acrylic
High capacity motor/blower system with speed control to extend the life of the HEPA filter
Cleanroom-compatible pre-filter increases the life of the front loading HEPA filter while reducing particulates inside the cleanroom
Filter screen panel is removable for easy cleaning
Front mounted, external fluorescent lighting
6″ demarcation line marked inside work area
1″ stainless steel, adjustable I.V. bar with hooks
Separate lighted power ON/OFF indicator switches for blower and lighting
Electrical is 115 Volt, 60 Hz (220/50-60 Hz also available)
Ten foot power cord with molded grounded plug

Compliant with USP 797 and Validated to CETA CAG-003-2006 Performance Standards
Germfree’s BVBI is engineered to meet or exceed all advanced specifications for ISO 5/Class 100 Laminar Flow Cabinets. These include: USP 797, ISO 14644-1, US Federal Standard 209E and IES Recommended Practices.

Proper disinfection protocols are critical in sterile compounding areas. SOPs demand frequent cleaning and may utilize strong chemicals. Best practices for cleanroom operations indicate that both the interior work area, as well as the exterior surfaces of hoods are effectively cleaned. Stainless steel is preferred for its resistant properties and overall ease of cleaning. It is also imperative that core compounding equipment is rugged, durable and non-shedding. Stainless steel will not corrode nor shed even when impacted by the ongoing wear of a high production environment. Certain painted or coated materials present a plausible risk of corrosion or shedding after repeated exposure to harsh chemicals and long-term use.

Programmable Electrical Stand Height Adjustment

elect panel hydrol

Stainless Steel Table – Custom sizes built to your specifications

table

Bin Cart

bin_cart_withbins

Duplex Electrical Outlet Installed In Work Area

duplex outlet

Stopcock for Air, Gas or Vacuum

stopcock

8″ Deep Perforated Shelf

perforated shelf

Sealed Data Port – Passage of 4 cables possible with individual adjustable diameters between 0.16″- 01/27″

data port

BVBI Airflow Diagram

Past Germfree Projects

Germfree consistently delivers exceptional cGMP compliant products around the globe. Browse the grid below to see a selection of relevant past projects:

Mobile Hospital Compounding Pharmacy
Mobile
The remodeling of an I.V. pharmacy presents a range of potentially difficult or costly challenges. During building renovations it is imperative that compounding operations are not interrupted or otherwise negatively impacted
USA
Microbiome Research Modular Cleanroom
Biopharma Projects
This BSL 2+ cGMP Modular Biocontainment Cleanroom Facility is made up of five (5) prefabricated modules (2,000 ft2 / 184 m2 gross area) and is housed within a renovated warehouse structure. The cleanroom is designed to comply with FDA and EU cGMP standards and utilizes a unidirectional process flow.
Alachua, FL
Mobile Viral Vector Production Facility
Biopharma Projects
This Mobile BSL-3 Viral Vector Production Facility is based on quantity 2 semi-trailer chassis (840 ft2 / 79 m2 gross area) and functions as a mobile cGMP cleanroom to facilitate Viral Vector Manufacturing (VVM).
Maryland, USA

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