07-19-2013 03:20 PM
I am trying to determine a reasonable frequency at which to replace the isolator sleeves on a CACI isolator. I have talked with resellers of these products and their testing is limited to 8 hours of contact testing time. Beyond that 8 hours limit there could be continued permeation through the sleeve at unknown rates. I have not found any studies beyond the ASTM requirement of 8 hours and I am not sure if the standard is appropriate for "certifying" these sleeves as safe or effective unless you replace them daily.
I would appreciate all feedback or information on this topic.
07-22-2013 11:08 AM
Hopefully your staff isn't spraying chemo within the isolator chamber. It is important to understand how the permeation studies were conducted with the material within the tested drug. The amount of exposure should be extrememly low plus your staff would still be required to wear PPE since the isolator won't protect them from exposure pre and post compounding. I dont' know what the proper change out period should be for these sleeves. The manufacturers should be doing that tested.
07-23-2013 08:52 AM
Thanks for your response...I guess in lieu of useful long term testing beyond ASTM standards, any end user, manufacturer or reseller of CACI sleeves for compounding hazardous drugs willing to comment on their replacement practice or recommendation for the purpose of forming a loose anecdotal consensus would be greatly appreciated.
Our current practice is replacement every 6 months at hood recertification or immediately for tears, holes or degradation.
We use IPA 70% and sterile water only.
07-29-2013 12:03 PM
As I understand the purpose for protective equipment permiation studies, they are only to give some indication of the relative resistance of the tested protective material to the diffusion of the drug molecule used for the test. Since the isolator sleeves are not being used in the same conditions by which the permiation test is being perfomed, these test would offer little to no guideance about when to change out your sleeves.
I was taught that physical inspection of the sleeves was key to when they are changed. If the material of the sleeves is showing decreased flexibility or brittleness, surface cracking, crazing or if it is becoming soft or sticky, the sleeves should be changes immediately. If the sleeves are showing a color change, this could be due to chemical or UV light exposure and the sleeves should be closely examine for physical damage. Of couses, as you stated, sleeves should be replaced when they pysically damaged.
Your plan for replacement every six months or when damaged is reasonable, depending upon the composition of the sleeves, their chemical an UV exposure and the frequency of use for your isolator. Your isolator manufacturer should give you some more specific guideance about when to change the sleeves.