Jan. 17, 2014 ##EMAIL##, you've received this email because you're a valued customer of IsoTech Design. Archive
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Operating and maintaining primary engineering controls
Pharmacy Purchasing and Products
Maintaining a clean, controlled pharmacy work environment is a challenging and perpetual task. Thus, creating and controlling a defined, sterile environment for pharmaceutical compounding is typically performed through the use of primary engineering controls — usually cleanrooms, biological safety cabinets and compounding aseptic isolators.
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FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy
U.S. Food and Drug Administration
The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous injections, eye drops, pellet implants, nasal sprays, inhalation solutions and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.
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10 strategies for surface disinfection
Outpatient Surgery
The war against healthcare-associated infections can be daunting. First, the enemy is invisible. Second, there's usually pressure to fight — and win — quickly. And third, the war never ends. No matter how thoroughly you rout the opposition today, reinforcements will appear tomorrow, forcing you to engage again. So you can never let up.
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Compounding the problem
Daily Commercial
If chemical weapons killed 64 people on U.S. soil, the nation would be in a frenzy trying to determine what measures could be taken to prevent it from happening again. Yet Americans largely reacted with a shrug when 64 people died, including four in Ocala, and thousands more were sickened last year due to tainted steroid injections.
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US compounding pharmacies start to register with FDA
Reuters via KFGO-AM
A small number of U.S. compounding pharmacies have begun registering with the Food and Drug Administration under new legislation designed to tighten control of the custom medication makers following a deadly outbreak of fungal meningitis linked to a pharmacy in Massachusetts.
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Hospital pharmacy preventing outbreaks
Highlands Today
Just over a year ago, a fungal meningitis outbreak linked to contaminated pharmaceutical products sickened approximately 740 people in 20 states and killed 64. The fungus was found in injections of methylprednisolone acetate, a steroid, that was manufactured by New England Compounding in Framingham, Mass.
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MicroSphere-ST

The MicroSphere-ST is a positive pressure unidirectional RABS that complies with the USP, cGMP and FDA requirements for small volume sterility testing. It has ISO 5 classification and eliminates the need for cleanroom. It also has the added benefits of complete product and operator protection, increased SAL, sterility testing pump integration and IQ/OQ validation.


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