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Administrator
Posts: 578
Registered: ‎02-22-2010
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10 Tips for a Compliant Cleanroom Webinar

[ Edited ]

We hope you enjoyed Eric S. Kastango's presentation, "10 Tips for a More Efficient USP 797 Compliant Cleanroom."

View the on-demand webinar or download the slides.

 

What is the toughest challenge of staying USP 797 compliant? Have a question for Eric on operational efficiencies to keep your cleanroom compliant? Ask him here and he will do his best to answer your question.

Valued Contributor
Posts: 72
Registered: ‎02-22-2010
0

Re: 10 Tips for a Compliant Cleanroom Webinar

Drug Topics article mentioned on the call: Hospital pharmacy savings achieved through lean management practices

http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Hospital-pharmacy-savings-achiev...

Frequent Advisor
Posts: 81
Registered: ‎04-05-2010

Re: 10 Tips for a Compliant Cleanroom Webinar

Would you please post the other articles that Eric cited.

Thank you,

 

Robert B. Martin, PharmD

Administrator
Posts: 578
Registered: ‎02-22-2010
0

Re: 10 Tips for a Compliant Cleanroom Webinar

Here are questions from our live presentation:

 

Q: Given the evidence that drug residue exists on chemo products, do you recommend they are stored in negatively-pressurized BSC clean room?

 

Q: In England one can purchase syringes in bulk packaging to reduce particles from opening individual packages in cleanrooms.  Will we have such products in the US?

 

Q: In regards to tech check tech, what will they be limited to checking?

 

Q: Please verify complete garbing requirements for those non-USP ready rooms and the less than 12 hour BUD satellites. 

Pharmacy OneSource
Posts: 5
Registered: ‎08-16-2010

Re: 10 Tips for a Compliant Cleanroom Webinar

[ Edited ]

Robert,

 

I have included the links to the remaining articles Eric included in the References of his presentation below:

 

Davis J, Use of lean production to reduce waste when compounding sterile pharmaceutical products. Hospital Pharmacy. 2009; 44(11): 974-7. http://www.factsandcomparisons.com/assets/hpdatenamed/20091101_Nov2009_peer3.pdf.

 

Heller A. Centers use lean methods to boost safety, reduce waste. Pharmacy Practice News. April, 2010. http://www.pharmacypracticenews.com/index.asp?section_id=53&show=dept&issue_id=624&article_id=14998.

 

HintzenB, KnoerSJ, Van Dyke CJ and MilavitzBS. Effect of lean process improvement techniques on a university hospital inpatient pharmacy. AJHP. 2009. 66(22): 2042-7. http://www.ajhp.org/cgi/content/full/66/22/2042?maxtoshow=&hits=10&RESULTFORMAT=1&andorexacttitle=an....

 

Jenkins A, Rowe E, GrankoR, PfeiffenbergerT and Daniels R. Effects of a new sterile product preparation and delivery process on operational efficiency and cost. AJHP. 2010; October: 1645-9. http://www.ajhp.org/cgi/content/full/67/19/1645?maxtoshow=&hits=10&RESULTFORMAT=1&andorexacttitle=an....

 

Milano C. Speeding drug delivery with lean management tools. Pharmacy Practice News. March, 2010. http://www.pharmacypracticenews.com/index.asp?section_id=53&show=dept&issue_id=618&article_id=14890.

 

TribbleD, vanEngenS, Harvey E. Lean pharmacy. Using time-tested manufacturing process tools to achieve efficiencies in pharmacy operations. An ACPE approved CE offering sponsored by BaxaCorporation. http://pppmag.com/digitalmag/Main.php?MagID=5&MagNo=22.

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Occasional Visitor
Posts: 2
Registered: ‎10-08-2010

Re: 10 Tips for a Compliant Cleanroom Webinar

Thanks for the great webinar, Eric.  You inspired me to look at our pharmacy processes.

At one point you mentioned makeup in the clean room:  if we have our staff wear a mask that has an attached eye shield, would that contain any shedding makeup particles?  I admittedly haven't enforced this for our staff yet.

Occasional Contributor
Posts: 6
Registered: ‎06-07-2010

Re: 10 Tips for a Compliant Cleanroom Webinar

I missed the presentation yesterday, but was able to view it today.  Over the last several months we have changed from the q12h batch process to a 3 batch per 24 hours process.  I based the changes on the article Eric referred to in a presentation late last year about the 5 batch process.  I could not achieve the 5 batch process because of our lean staffing model.  The compounding techs do the delivery to the nursing units and could not be away from the compounding area to deliver 5 batches.  In the original article they did not say who was responsible for the delivery.  Do most compounding personnel also do the deliveries?  If not, whose staff does the delivery?  Is this a case of using over qualified staff to deliver?

Occasional Advisor
Posts: 7
Registered: ‎06-02-2010

Re: 10 Tips for a Compliant Cleanroom Webinar

Thank you Eric for such an informative presentation. My class of future pharmacy technicians loved it.

You inspired them greatly.

 

As you know they had some questions that they typed before the presentation began. If you can send me an email with your replies when you have a chance that would be great. They are so eager to hear from you. Here are some comments that they had:

 

1. "It is great to hear from a professional that is so well known and an authority in his field".

2. "Watching this webinar helped me to further understand some of the concepts that have been discussed in class". 

3. " I felt I could apply much of what I learned to other areas of my life, including but not limited to pharmacy".

4. " I plan to check out the slides of archived Pharmacy One Source webinars"

5. "I think the hour was well worth it and we should have more of these types of webinars to get other perspectives in addition to our two teacher's and our own"

6. "Ms Mastron has mentioned some of the topics that were brought up in her lectures before , while I did not understand everything you spoke about I was able to follow along on many of the concepts, and it made them clearer".

7. "We should do this more often to get to listen to hot topics".

8. "Thank you! It was nice to hear someone talk about the importance of techs in addition to our instructor. A nice touch to have a pharmacy technician as the "moderator'".

 

 

Looking forward to your reply. There are different schools of thoughts on the two questions they asked about: 1) tearing paper in the hood and leaving it in the hood vs removing the the paper before puncturing vials 2) when to open the needle and syringe when a dilutent syringe and drug withdrawal syringe will both be used: both before puncturing any vial OR open diluent needle/syinge dilute, then open widrawal needle and syringe just before withdrawal?.  

 

These are actual questions that they have as they disagree on procedure and look to you for the answer from the 'expert'.  Their conern is regarding particles in the hood and 'correct' USP procedure if there is one on this.   Answering them will be the encouragement they need to continue to be inquisitive and active in the process of learning.

 

Thank you again, especially for contributing to the technician learning process. By the way they plan to 'honor' you during our celebration of National Technician Day! Smiley Wink

 

We look forward to hearing from you whether on post or via email.

 

Jeanetta Mastron CPhT BS Chemistry

Pharm Tech Program Educator/Director

National Pharmacy Technician Advocate

AAPT Newsletter CE Developer/Author

rxjm2002@yahoo.com

 

 

 

 

Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: 10 Tips for a Compliant Cleanroom Webinar

Vivian,

 

Thanks for the email.  I am not sure who is making the deliveries.  If you get a copy of the article, you can correspond directly with the author of the paper and pose your question to them.  Thanks.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,166
Registered: ‎02-23-2010
0

Re: 10 Tips for a Compliant Cleanroom Webinar

 

Q: Given the evidence that drug residue exists on chemo products, do you recommend they are stored in negatively-pressurized BSC clean room?

 

A: Absolutely!  USP Chapter <797> requires that hazardous drugs (HDs) be stored in negative-pressure environments.  If you have a negative-pressure ISO Class 7 buffer area, you can store all of your HDs in there include your refrigerated items (within a refrigerator).

 

Q: In England one can purchase syringes in bulk packaging to reduce particles from opening individual packages in cleanrooms.  Will we have such products in the US?

 

A: Syringes in bulk packs are available from BD.

 

Q: In regards to tech check tech, what will they be limited to checking?

 

A: It will depend on the limits of your specific state board of pharmacy regulations.  You can visit  http://www.clinicaliq.com/797-state-survey, you click on your state and find the link to your state.  

 

Q: Please verify complete garbing requirements for those non-USP ready rooms and the less than 12 hour BUD satellites.

 

A: You need all of the garb as you do when doing low, medium and high-risk level compounding.  Please refer the chapter for complete guidance.   I have attached a copy of it for your consideration.

 

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.