GERMFREE

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	Is laminar (unidirectional) air flow necessary in a Compounding Aseptic Isolator?
	Yes. The location of “first air” that is necessary for good aseptic technique is well defined in a laminar flow isolator. The laminar air flow ensures that particles generated by compounding are quickly swept away from critical sites and captured immediately on HEPA filters as not to contaminate the next preparation. This is proven to be the safest air flow available for compounding.
	Is it necessary to HEPA filter the air in the antechamber / airlock of a Compounding Aseptic Isolator?
	Absolutely, it is the only way to ensure that dirty room air does not enter the clean work area. Keeping the clean condition of the work area intact helps speed productivity and allows for materials to be brought into the work area without compromising the safety of preparations already inside.
	How can operators be made more comfortable while using a Compounding Aseptic Isolator?
	Comfort and productivity go hand in hand. A Compounding Aseptic Isolator should be designed to meet the needs of a wide variety of body types. Workstations should be adjustable for users of differing heights and the viewing panel should be slanted to allow users to lean into their work. Gloveports should be as large as possible and oriented to accommodate a relaxed arm position for users of varied shoulder widths. A Compounding Aseptic Isolator should allow for the use of hand size specific, gloves to provide maximum dexterity, tactility and comfort. Models that allow for use of the disposable gloves you already use are more cost effective. Foot rests, arm rests and adjustable chairs also add to operator comfort.
	Can I use a Compounding Aseptic Isolator for compounding hazardous drugs?
	Yes, if operated under negative pressure. It is recommended (by the NIOSH alert) that all exhaust from the unit be vented to the outside to reduce the chance of operator exposure to the hazards being compounded. It is also recommended that the air within the work area not be recirculated as it can lead to a build up of vapor increasing chances of exposure. Strong negative pressures will also work to protect the operator if a glove gets punctured or falls off. Ideally, the air should move away from the breathing zone of the operator even if a whole sleeve falls off the viewing panel.
	Can I use a Compounding Aseptic Isolator instead of a cleanroom for compounding sterile preparations?
	Compounding Aseptic Isolators using laminar (unidirectional) airflow function just like a cleanroom. The HEPA filtered antechamber / airlock acts like the cleanroom buffer zone. USP <797> revision puts the onus on the manufacturer to recommend if their Compounding Aseptic Isolator design can be used outside of a cleanroom. The manufacturer should be able to show that materials can be brought in and out of the unit without compromising the cleanliness / sterility of the work area.
	Can I configure a Compounding Aseptic Isolator to suit my individual needs?
	A modular Compounding Aseptic Isolator will allow for antechambers / airlocks to be placed on left, right or even both sides. Work area sizes should be variable to accommodate autocompounders or even two operators. Units that have been designed to be forward compliant with existing and proposed regulations are the most cost effective. The wider the variety of options the Compounding Aseptic Isolator has the more options you have.
	I know that there are proposed revisions to USP <797>. Is it true that Compounding Aseptic Isolators will have to be kept in a cleanroom once the new regulations are passed?
	The proposed revisions to USP <797> specifically mention the placement of Compounding Aseptic Isolators: “Barrier isolators are located, operated, and used according to manufacturers' recommendations.” (Proposed Revisions to USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations from www.USP.org) This answer is relatively vague. A better explanation of the revision was put forth by Clyde Buchanan: “USP 797 does not require that an isolator be located in a buffer room. But the cleaner the environment surrounding an isolator, the less likely unsterile particles will be taken into the isolator through the transfer port. Personnel using an isolator do not have to be garbed since isolator technology separates the person from the product; still, a cleanroom gown will lower the particles generated by a person into the environment.” (Q&A on USP Chapter 797 with Clyde Buchanan – from www.ASHP.org)
	Why is it recommended that I rotate disinfectants? Is there not one product that can effectively be used every time?
	There is a widely held belief that rotating disinfectants prevents organisms from developing a resistance to any one compound. In a recent article Elaine Kopis Sartain dispelled this idea and explained: “What actually happens is that either an ineffective chemistry (e.g., alcohol against spore-forming microorganisms) is applied or suboptimal concentrations or contact times are used, so that the expected disinfection performance is not achieved. If one continues with a microbial control program that kills only certain organisms (e.g. vegetative bacteria) while having no impact on others (e.g. spore-formers) then eventually the program does exactly what it has inadvertently been designed to do—select for specific organisms that are inherently resistant to, and cannot be controlled by, the disinfectant technology being applied.” (Regulatory Update, Elaine Kopis Sartain, March 2005 – from www.a2c2.com)

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