SterileAF Podcast

By Seth DePasquale, R.Ph., BCSCP

What's SterileAF Podcast about?

The SterileAF Podcast is a show dedicated to discussing issues and topics related to sterile and non-sterile pharmacy compounding and compliance with industry standards.

Download our free app to listen on your phone

SterileAF Podcast episodes:

04.15.2022
Greg Stanley - IV Workflow
Thanks for tuning in to the Pharmacy Inspection Podcast! Today we have Pharmacist Greg Stanley on the show and we're going to be talking about implementation of an IV workflow system! Greg Stanley received his Bachelor of Science in Pharmacy...
01.18.2022
Pharmacy Inspection Podcast - Cleanrooms!
In this weeks episode we welcome Bryan Prince back to the show to talk about cleanrooms. We discuss common issues that we see with cleanrooms, talk about particle counts and certification reports as well as some cool technology being used...
12.21.2021
Pharmacy Inspection Podcast - Building a Compliance Team
Today on the podcast we welcome Lilit Smith. Lilit is a board certified sterile compounding pharmacist and is currently the Manager of Compounding and Compliance at Baptist Health South Florida. In her role she supports across the pharmacy enterprise with...
11.26.2021
USP 797 Revision
In this episode of the pharmacy inspection podcast I go over some of the changes to USP <797> in the latest revision to the chapter.
10.08.2021
USP 795 Revisions
In this episode we go over some of the major changes in the revision to USP Chapter <795> and what you need to potentially know if it becomes finalized.
11.06.2020
FDA 483 #10 – Non-Viable Particle Counting
Learning Objectives Discuss the importance of particulate in relation to microorganisms Explain why 0.5 micron and larger sized particles are of great importance Discuss 3 ways that we can minimize the...
10.16.2020
FDA 483 #9 – Bacterial Endotoxin Testing
Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various routes of administration Discuss ways to control the levels of endotoxins...
10.13.2020
Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?
10.09.2020
FDA 483 #8 - Using ungraded ingredients
Learning Objectives Discuss the use of USP graded ingredients in pharmaceutical preparations and the importance Explain what prompted the FD&C; act of 1938 to be enacted In this...
10.06.2020
Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust
10.02.2020
483 Friday #7 - Viable Air Sampling
Learning Objectives Explain the purpose of viable air sampling Discuss how conclusions can be made from the results of viable air sampling Happy Friday! This weeks...
09.29.2020
Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
09.25.2020
483 #6 - Cross-Contamination
The learning objectives for this week’s 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be used to deactivate...
09.18.2020
483 Friday #5 - Potency Testing
The learning objectives for this week's 483: Explain the typical out of specification range of potency for many compounded formulations Discuss a type of testing that is both economical and scientifically...
09.12.2020
Pharmacy Inspection Podcast - Episode 41 - 483 #4 - Investigations & CAPAs
In this week's 483 we're going to talk about investigating microbial contaminations inside the cleanroom to find out possible sources and remediate the issue. We're also going to talk about writing up that investigation and the resulting corrective...
05.20.2020
Pharmacy Inspection Podcast - Episode 40 - Cleanroom design mistakes you shouldn't make
Bryan lays out two mistakes that he recently came across in a very well designed 3D model of a cleanroom...the only problem, there were two fairly critical mistakes. Don't make these mistakes...
03.17.2020
Pharmacy Inspection Podcast - Episode 39 - PAYING TOO MUCH FOR VIABLE SAMPLING!?
03.09.2020
Pharmacy Inspection Podcast - Episode 38 - Environmental Sampling Plan
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM iHeart...
02.25.2020
PIP - Episode 37 - Materials of Construction
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM iHeart...
02.18.2020
Pharmacy Inspection Podcast - Episode 36 - Controlling Temperature by putting holes in my cleanroom?
Having issues controlling temperature in your cleanroom? Here's what NOT to do and what you should do... Do you have a question or comment for the show? Leave us a VOICEMAIL, right on...
02.09.2020
Pharmacy Inspection Podcast - Architects, Engineers & the case of the missing mini-split...
Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM iHeart Spotify Radio Public ...
12.12.2018
Pharmacy Inspection Podcast Episode 34 - Viable Air Sampling
This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their pharmacy careers as technicians over 30 years at an Air Force Base and now consult pharmacies, large and small, in compounding...
11.13.2018
Pharmacy Inspection Podcast Episode 33 - Tom Kupiec from Analytical Research Laboratories
This week we welcome Tom Kupiec to the podcast. Tom is the owner of ARL (Analytical Research Laboratories) Oklahoma City, Oklahoma. To learn more about the contamination control webinar go to: https://pharmacyinspection.com/product/a-compounders-guide-to-hazardous-drug-compounding-workflow/ Join us for the USP...
11.02.2018
Pharmacy Inspection Podcast Episode 32 - Kim Kieffer USP Chapters OTHER THAN 795, 797 & 800!
This week we welcome Kim Kieffer to the podcast. Kim is the Director of Corporate Relations at Empower Pharmacy in Houston Texas. She’s been a compounding consultant at Spectrum, Letco and Freedom Pharmaceuticals. Most recently she was the Academy Manager...
10.12.2018
Pharmacy Inspection Podcast Episode 31 - Melissa Stefko
This week we welcome Melissa Stefko, from Wells Pharmacy Network to the podcast. Melissa Stefko, Senior Director of Quality for 503B Wells Pharmacy Network, will be discussing contamination control as it relates to pharmaceutical compounding. Ms Stefko is an experienced Pharmaceutical...
09.05.2018
Pharmacy Inspection Podcast - Episode 30 - USP Designated Person
This week Greg Stowell and Jon Pritchett from PCAB (ACHC) speak with us about a new course they've released that teaches you all about becoming compliant with the Designated Person requirement within USP 800. Found out more about the...
08.28.2018
Pharmacy Inspection Podcast Episode 29 - Process Improvement
This week Bryan and I talk about Process Improvement! We give specific examples of how to start out improving a few processes within your own pharmacy. Announcement: Upcoming FREE Webinar! SIGN UP HERE (CLICK HERE) ...
08.08.2018
Pharmacy Inspection Podcast Episode 28 - Bryan and Seth talk Compounding Design Theory
This week Bryan and I talk about Compounding Design Theory! This podcast stemmed from a conversation Bryan and I had about a hood that he helped design for Encore Scientific (pictured on left); a hood with a clear view from any...
07.31.2018
Pharmacy Inspection Podcast Episode 27 - RECORDED - USP 797 Proposed Revision with Jon Pritchett
Thanks SO so much for everyone that did tune in; I promise next live event I will DEFINITELY RAISE THE BAR!!! I've fixed most of the audio issues and I believe we'll revisit this conversation again the very near future!...
07.25.2018
Pharmacy Inspection Podcast Episode 26 - Vitae Industries (AutoCompounder 3D Printer!)
This week we broadcast our interview that we recorded at CCH in June. Bryan was able to sit down with Jeanine Sinanan-Sing, co-founder and CEO of Vitae Industries, maker of the AutoCompounder 3D printer . They talk about their platform and the...
07.10.2018
Pharmacy Inspection Podcast Episode 25 - Kim Kieffer
This week we welcome Kim Kieffer! Kim is the Director of Corporate Relations at Empower Pharmacy in Houston Texas. She's been a compounding consultant at Spectrum, Letco and Freedom Pharmaceuticals. Most recently she was the Academy Manager at Fagron educating...
06.19.2018
Pharmacy Inspection Podcast - Episode 24 - Christine Roussel
This week we welcome Christine Roussel, assistant Director of Pharmacy at Doylestown Hospital in Pennsylvania and Program Facilitator for Medisca's LP3 Network. This was a great conversation about containment practices and we really hope to have her on again sometime...
05.21.2018
Pharmacy Inspection Podcast - Episode 23 Greg Stowell
This week we welcome Greg Stowell, Education and Consulting Manager for Accreditation University. We discuss how ACHC is helping to bring continuous quality education to compounders. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form...
05.01.2018
Pharmacy Inspection Podcast - Episode 22 (795 discussed)
On April 20th the USP had an online open forum where they discussed the proposed revision of 795. Today on the show Bryan and Seth discuss some of the proposed changes to 795. WE'RE NOW ON iHEART RADIO PODCASTS (click here)!...
04.17.2018
Pharmacy Inspection Podcast Episode 21 - Lauren Bernick
This week we welcome Lauren Bernick, Director of Advertising for the International Journal of Pharmaceutical Compounding. Lauren also runs a website called wellelephant.com, where she consults on nutrition using a whole foods, plant based diet. This week we talk about...
04.04.2018
Pharmacy Inspection Podcast Episode 20 - Endotoxin vs Endospores
This week Bryan and I discuss the differences between endotoxin and endospores; diving a little deeper into the post from last week. We talk about the basics of these two, why they're important and how to kill or deactivate them....
03.21.2018
Pharmacy Inspection Podcast Episode 19 - Donnie Calhoun
This week we welcome Donnie Calhoun, Pharmacist, Pharmacy owner and CEO & Executive Director for the American College of Apothecaries (ACA). Donnie brings a lot of experience and knowledge to the podcast this week as we discuss the topic...
03.13.2018
Pharmacy Inspection Podcast Episode 18 - Denise Frank
This week we welcome Denise Frank, Pharmacist, Consultant, Educator...within compounding Denise has done a LOT! We met Denise at the ACA meeting in Florida and had to have her on the podcast. Denise has also worked for the National...
03.08.2018
Pharmacy Inspection Podcast Episode 17 - Erika Fallon of Fallon Wellness Pharmacy
This week we welcome Erika Fallon, Supervising Pharmacist at Fallon Wellness Pharmacy to the podcast. Erika is heavily involved in the International Academy of Compounding Pharmacists as she is on their Board of Directors and also sits on the legislative...
02.27.2018
Pharmacy Inspection Podcast Episode 16 - Bryan and Seth talk PPE
This week Bryan and I discuss proper donning and doffing of Personal Protective Equipment (PPE) - there seems to be much discussion this topic and how to perform properly when it comes to hazardous drug handling. Honestly, I think this...
02.20.2018
Pharmacy Inspection Podcast Episode 15 - Bill Fixler part 2
In our 15th episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also...
02.13.2018
Pharmacy Inspection Podcast Episode 14 - Herschell Hitchcock
This week we welcome Herschell Hitchcock, President of EOC1 to the podcast. Herschell is an industrial hygienist by training and has a ton of experience in how exactly cleanrooms work and how to troubleshoot problems when something goes wrong. His company...
02.06.2018
Pharmacy Inspection Podcast Episode - Brenda Jensen and Jim Hack
This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their pharmacy careers as technicians over 30 years at an Air Force Base and now consult pharmacies, large and small,...
01.31.2018
Pharmacy Inspection Podcast Episode 12 - Dr. Loyd Allen Jr.
This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of Pharmaceutical Compounding (click here) and has been an outspoken advocate for improving quality in compounding as well as advising on multiple...
01.23.2018
Pharmacy Inspection Podcast Episode 11 - Java Coleman
Java Coleman joins us this week. He is a consultant for the pharmaceutical industry through XLN Collaborative Consulting. Java has been working for many year now in the area of process improvement. He's also worked at large organizations like...
01.16.2018
Pharmacy Inspection Podcast Episode 10 - Rad Dillon
This week we talk with Rad Dillon. He is a pharmacist and certified surveyor and consultant for the Accreditation Commission for Health Care with a lot of experience performing PCAB accreditation audits. Rad also has experience in writing Standard...
01.09.2018
Pharmacy Inspection Podcast Episode 9 - Joe Cabaliero and Bill Mixon
In our 9th episode we speak with Joe Cabaliero and Bill Mixon. Both of these gentlemen have a history in compounding pharmacy that is interesting and impressive. Recently, they have submitted a proposal to include sterile compounding as one...
01.02.2018
Pharmacy Inspection Podcast Episode 8 - Pharmetric Labs
HAPPY NEW YEAR! Welcome to 2018. In our 8th episode we speak with James Brown and Dr. Wayne Dehaven of Pharmetric Laboratory. We'll be talking about the importance of method suitability, why it's necessary and what Pharmetric specializes in:...
12.12.2017
Pharmacy Inspection Podcast 7 - Jon Pritchett
In our 7th episode we speak with Jon Pritchett, Associate Director of Pharmacy for Accreditation Commission for Health Care. Jon has not only worked in compounding pharmacy for many years but is now director of pharmacy of the accrediting body that...
12.05.2017
Pharmacy Inspection Podcast Episode 6 - Bill Fixler
In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also...

What's SterileAF Podcast about?

Download our free app to listen on your phone

SterileAF Podcast episodes:

Greg Stanley - IV Workflow

Pharmacy Inspection Podcast - Cleanrooms!

Pharmacy Inspection Podcast - Building a Compliance Team

USP 797 Revision

USP 795 Revisions

FDA 483 #10 – Non-Viable Particle Counting

FDA 483 #9 – Bacterial Endotoxin Testing

Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?

FDA 483 #8 - Using ungraded ingredients

Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust

483 Friday #7 - Viable Air Sampling

Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?

483 #6 - Cross-Contamination

483 Friday #5 - Potency Testing

Pharmacy Inspection Podcast - Episode 41 - 483 #4 - Investigations & CAPAs

Pharmacy Inspection Podcast - Episode 40 - Cleanroom design mistakes you shouldn't make

Pharmacy Inspection Podcast - Episode 39 - PAYING TOO MUCH FOR VIABLE SAMPLING!?

Pharmacy Inspection Podcast - Episode 38 - Environmental Sampling Plan

PIP - Episode 37 - Materials of Construction

Pharmacy Inspection Podcast - Episode 36 - Controlling Temperature by putting holes in my cleanroom?

Pharmacy Inspection Podcast - Architects, Engineers & the case of the missing mini-split...

Pharmacy Inspection Podcast Episode 34 - Viable Air Sampling

Pharmacy Inspection Podcast Episode 33 - Tom Kupiec from Analytical Research Laboratories

Pharmacy Inspection Podcast Episode 32 - Kim Kieffer USP Chapters OTHER THAN 795, 797 & 800!

Pharmacy Inspection Podcast Episode 31 - Melissa Stefko

Pharmacy Inspection Podcast - Episode 30 - USP Designated Person

Pharmacy Inspection Podcast Episode 29 - Process Improvement

Pharmacy Inspection Podcast Episode 28 - Bryan and Seth talk Compounding Design Theory

Pharmacy Inspection Podcast Episode 27 - RECORDED - USP 797 Proposed Revision with Jon Pritchett

Pharmacy Inspection Podcast Episode 26 - Vitae Industries (AutoCompounder 3D Printer!)

Pharmacy Inspection Podcast Episode 25 - Kim Kieffer

Pharmacy Inspection Podcast - Episode 24 - Christine Roussel

Pharmacy Inspection Podcast - Episode 23 Greg Stowell

Pharmacy Inspection Podcast - Episode 22 (795 discussed)

Pharmacy Inspection Podcast Episode 21 - Lauren Bernick

Pharmacy Inspection Podcast Episode 20 - Endotoxin vs Endospores

Pharmacy Inspection Podcast Episode 19 - Donnie Calhoun

Pharmacy Inspection Podcast Episode 18 - Denise Frank

Pharmacy Inspection Podcast Episode 17 - Erika Fallon of Fallon Wellness Pharmacy

Pharmacy Inspection Podcast Episode 16 - Bryan and Seth talk PPE

Pharmacy Inspection Podcast Episode 15 - Bill Fixler part 2

Pharmacy Inspection Podcast Episode 14 - Herschell Hitchcock

Pharmacy Inspection Podcast Episode - Brenda Jensen and Jim Hack

Pharmacy Inspection Podcast Episode 12 - Dr. Loyd Allen Jr.

Pharmacy Inspection Podcast Episode 11 - Java Coleman

Pharmacy Inspection Podcast Episode 10 - Rad Dillon

Pharmacy Inspection Podcast Episode 9 - Joe Cabaliero and Bill Mixon

Pharmacy Inspection Podcast Episode 8 - Pharmetric Labs

Pharmacy Inspection Podcast 7 - Jon Pritchett

Pharmacy Inspection Podcast Episode 6 - Bill Fixler