HomeLab & Science NewsArticlesThe Axiom takes on USP <797>

The Axiom takes on USP <797>

Brian Garrett 2013By Brian Garrett, LEED Green Associate, Product Manager
On Tuesday, February 23, 2016
In Articles

4 Reasons the Purifier® Axiom is a PERFECT FIT for my Compounding Pharmacy

The newest anticipated subtype of Class II biosafety cabinet (BSC) is bucking many trends and decades-old canon. Through a series of innovations in airflow movement, programming, operations and safety, the Class II, Type C1* Purifier® Axiom provides multiple benefits to the modern laboratory.

Here are 4 reasons why it best suits the needs of the pharmaceutical compounding facility of tomorrow:

1.     Convertibility of BSC operation

USP <797> has long held that a total exhaust or Type B2 (BSC) is the preferred open-faced enclosure when compounding drugs that are both hazardous & sterile. USP <800> maintains that most compounding processes require only an A2 unless using hazardous chemical vapors.

The Axiom is as safe as (arguably safer than) a Type B and is operationally more flexible than a Type A. The Class II, Type C1 can be ducted in a Type B mode, and enhances chemical safety above that of a Type B BSC through use of dedicated exhaust and superior alarm condition programming. (See Active Protection Protocol)

2.     Airflow requirements closer to an A

The sheer magnitude of air volume needed to exhaust a USP <797> prescribed Class II, Type B2 BSC is a leading cause for compounding pharmacy construction and operations to fail initial commissioning. Why? It’s quite simple really; modular clean rooms are limited in their overall size, and Type B2 BSCs require more than air handling systems and the room can provide.

One of two things occur:

  1. The B2 installation causes the room to be so negatively pressurized that doors become difficult to open, or
  2. There isn’t enough air to feed the B2 so it goes into an exhaust alarm state. Let’s ignore the fact that small rooms with a Type B2 against one wall become a proverbial wind tunnel.

Because the Axiom utilizes airflow channeling, opposed to mass airflow evacuation found in a B2, it is more suitable for clean room installation. The Axiom uses approximately half as much air, making clean room balance and stability far easier to achieve and maintain. Furthermore, USP <800> requires containment devices to operate 24 hours a day, the cost savings of the Axiom is even more pronounced over any B2. This also reduces the likelihood of commissioning failures as cited above.

3.     Bag-in/Bag-out Exhaust HEPA filter

The airflow requirements (and associated cost) of a Type B2 BSC typically leads to the selection of a Type A2 BSC with exhaust canopy, and understandably so with the anticipated USP <800>. However, Type A2s lack the ability to truly house Bag-in/Bag-out (BIBO) HEPA filters.

Such filter designs are uniquely required for pharmaceutical compounding and research work. Like Type B2 BSCs, the Axiom can be factory built with BIBO exhaust HEPA filter ensuring that the filter can be changed without contaminating the lab with hazardous particles.

4.     Lower clearance height for clean rooms

An often overlooked problem for modular clean rooms and BSCs is their height compatibility. Standard cleanrooms have a total height of 8 feet. Most Type B2 BSCs on a base stand with a working height of 30” (seated height) exceed 8 feet, 4 inches of total height, necessitating specialty panels in the clean room’s ceiling, thus increasing project cost.

The Axiom, configured as the Type B2 just mentioned, has a total height of 7 feet, 8 inches. Other than the penetration required for the duct stub (needed for any Class II BSC going into a USP <797> clean room), no further modification is needed.

The Purifier Axiom addresses a number of significant gaps between Class II, Type A and Type B BSCs. As highlighted above, several of these advantages significantly benefit the needs and requirements of compounding pharmacies.

For more information on how the Class II Type C1 addresses gaps in modern BSC design and function, visit www.BSCno-brainer.com.

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