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Occasional Advisor
Posts: 7
Registered: ‎05-19-2011
0

PhSeal approval from FDA K120384

http://www.accessdata.fda.gov/cdrh_docs/pdf12/K120384.pdf

 

 

 

The PhaSeal system is a closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of, drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal Protector also prevents microbial ingress.

 

Occasional Advisor
Posts: 7
Registered: ‎05-19-2011
0

Re: PhSeal approval from FDA K120384 and microbial ingress

 On Sept 12,2012 the FDA re-labeled the Phaseal product to add the indication "prevent microbial
ingress" with the FDA 510(k) statement #K120384. I
f Phaseal prevents microbial ingress (tested for 7 days) could we then extend sterility to 7 days?

Expert
Posts: 1,044
Registered: ‎02-23-2010
0

Re: PhSeal approval from FDA K120384 and microbial ingress

Traci,

 

Good question.  I have a question into the FDA about what it means. You should ask your BD rep to tell you what it means to them?  Stay tuned and thanks for asking.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Advisor
Posts: 13
Registered: ‎01-16-2011
0

Re: PhSeal approval from FDA K120384 and microbial ingress

Although it does prevent bacterial "ingress" it is difficult to swab the membrane (critical inj site) with alcohol prior to use. The truth is it goes largely undone. If we hold on to the vial there will likely be surface contamination of the site and the risk of introduction with repeated needle punctures. Thanks. 

Frequent Visitor
Posts: 1
Registered: ‎07-13-2010
0

Re: PhSeal approval from FDA K120384 and microbial ingress

Has there been any follow-up on this?

Regular Visitor
Posts: 3
Registered: ‎09-13-2011
0

Re: PhSeal approval from FDA K120384

Hello,

 

We are in the process of evaluating CSTD for our Hazardous compounding Drugs.Amongsts the CSTDs available out there  does anyone prefer a specific product? Pros and Cons of different products.

we are looking at Paseal currently. Phaseal seems to have good claims about the closeness of their system. Anyone using Phaseal and can comment on the product  is highly appreciated

thank you

Sunny

Sunanda Baviskar

Lead Pharmacist

Morristown Medical Center

New Jersey

Occasional Advisor
Posts: 5
Registered: ‎10-04-2013
0

Re: PhSeal approval from FDA K120384

It is the nice can you tell me how we track this. is there any shortcut.