MEDIZONE FINALLY ADMITS OZONE CAN DAMAGE HOSPITAL EQUIPMENT
US EPA, Pesticide Product Label (excerpts)
Root Cause Investigation of Rubber Seal Cracking in Pre-filled Cartridges: Ozone and Packaging Effects.
LAY ABSTRACT: Pre-filled syringes/cartridges as primary packaging for parenterally delivered biopharmaceutical liquids contain multiple components, including a disk seal (septum) made of rubber materials. Cracking of rubber components may be cosmetically unacceptable and in extreme cases may compromise enclosure integrity. The septum, if not appropriately packaged, might crack under uncontrolled storage environment. The purpose of this study was to investigate the root cause of septum cracking and evaluate parameters/solutions to delay or prevent cracking from occurring. Custom-made chambers capable of tightly controlling ozone levels were assembled to deliberately create septum cracks. The results confirmed that ozone attack is the root cause of septum cracking during storage, and the stress-the result of crimping on the glass cartridge by the aluminum lined seal-made the septum particularly vulnerable to ozone attack. Ozone concentration as low as 10-40 ppb (levels routinely detected on a busy street) could crack the stressed septum in hours. [MZEI: ozone - 80000 ppb] Although the use of impermeable barriers could prevent cracking completely, this study suggested that any form of packaging barriers, including a highly permeable Tyvek® sheet, could postpone cracking by slowing down ozone diffusion and convection. This investigation will raise awareness of manufacturers of pre-filled cartridge/syringe parenteral products to storage and packaging requirements for the long-term physical stability of cartridge components as small as the rubber septum.
Understanding the link between ozone and rubber deterioration
MZEI Canadian Distributors
Wood Wyant:
Contamination Control Corporation:
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THE FANTASY WORLD THAT EDWIN G. MARSHALL LIVES IN...
Medizone International Announces Hospital Sterilization Initiative
10/01/2008 @ 8:35AM
PR Newswire (US)
"Mr. Edwin Marshall, Chairman and CEO of Medizone International stated, "With Dr. Shannon's leadership in this exciting new initiative, we anticipate being fully commercialized within 18 months."
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TO DATE, NOT ONE (1) SALE TO A HOSPITAL NOR ONE (1) HOSPITAL SERVICE CONTRACT HAS BEEN REPORTED, WORLDWIDE (The manufacture of the first production machine was announced back in April 2012)
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