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Administrator
Posts: 578
Registered: ‎02-22-2010
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Lessons from NECC Webinar

[ Edited ]

Thanks for joining Eric in his webinar, "Lessons to be Learned from the NECC 483."

 

Have a question for Eric? Post it here and he will answer your question as best as he can.

Occasional Visitor
Posts: 1
Registered: ‎02-20-2013

Re: Lessons from NECC Webinar

We all know that patients were harmed during this event. But since there were bacteria discovered in the mask bin....have any of the compounding employees become sick?

Advisor
Posts: 31
Registered: ‎09-08-2011
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Re: Lessons from NECC Webinar

Also want to confirm - the chapter says that surfaces in the LAFW, etc, are cleaned and "This shall be followed by wiping with a residue-free disinfecting agent such as sterile 70% IPA, which is alowed to dry..."   It does not specify cleaning and disinfecting agents for work suraces in the ISO 7 & 8 areas. During the Webinar, you said that a "germicidal detergent" should be used on all surfaces daily. Does this include the inside of the hood? Is that in the chapter and I am not seeing it? Could you give an example of a germicidal detergent that would be appropriate for use in the hood?

 

Advisor
Posts: 31
Registered: ‎09-08-2011
0

Re: Lessons from NECC Webinar

Would you allow the germicidal detergent to dry, then wipe off with alcohol?

Administrator
Posts: 578
Registered: ‎02-22-2010
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Re: Lessons from NECC Webinar

Here are questions from our live presentation:

 

Q: Do you have a preference between modular cleanrooms and purpose-built cleanrooms (contractor-built)?


Q: Can you comment on BUD for products like Vial-to-Bag, Add Vantage, etc... (hooking vials to minibags).

 

Q: Should non-sterile pads be used in Hoods? CSP Buffer rooms?    Some come in cardboard without any other protective packaging

 

Q: Can you comment on BUD for products like Vial-to-Bag, Add Vantage, etc... (hooking vials to minibags)?

Visitor
Posts: 2
Registered: ‎02-20-2013
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Re: Lessons from NECC Webinar

While sterile IPA is required in the ISO Class 5 environment and on gloved hands, is sterile IPA required in the ISO Class 7 or 8 areas for disinfecting tables, carts, chairs, etc.?

 

In addition, must sterile alcohol in a closed spray system be used?

Advisor
Posts: 31
Registered: ‎09-08-2011
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Re: Lessons from NECC Webinar

Would like to confirm that we should be in the IV room - doing media fill testing or cleaning - while the certifiation company is her doing the every six month certification of our hoods and rooms.

Visitor
Posts: 2
Registered: ‎02-20-2013
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Re: Lessons from NECC Webinar

What are your recommendations for the best practice in choice of sterile mask to be worn in the ISO environment? i.e. Regular surgical masks vs. N95 Cone Surgical masks?

In particular, what are your thoughts on the theory that utilizing NIOSH Approved N95 Particulate/Surgical Masks provide a tighter fit and help reduce the bioburden on the ISO environment?
Occasional Visitor
Posts: 1
Registered: ‎02-20-2013
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Re: Lessons from NECC Webinar

Few Questions for you Eric:

1.  At my facility we are doing air impaction sampling using vertically placed paddles once a month.  We get our hoods certified every 6 months and I believe that they also do air impaction sampling as part of certification. In the webinar: You recommended against the use of setting plates/paddles as part of the air sampling.  No benefit in doing the air impaction sampling with paddles?

2.  I couldn't find anything on USP797 on doing fingertip sampling after completion of compounding. Is this no longer a requirement?  We are doing fingertip sampling for new compunders x3 and then annually as part of the garbing competency.

thanks in advance!!

Expert
Posts: 1,167
Registered: ‎02-23-2010
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Re: Lessons from NECC Webinar

[ Edited ]

KPharm wrote:

We all know that patients were harmed during this event. But since there were bacteria discovered in the mask bin....have any of the compounding employees become sick?


 

Good question but I haven't read anything about the employees or the impact the conditions had on them.  It needs to make you wonder what it was like working under those conditions that were reported by the FDA.  The water puddle by the prep room door stupefies me. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.