Episodi

  • Greg Stanley - IV Workflow

    Greg Stanley - IV Workflow
    Apr 15 2022

    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 degree in 1998, having also completed undergraduate research fellowships in Biological/Environmental Sciences and Polymer Sciences.  He has over twenty-five years of experience with compounded sterile products; both in hospital and home infusion settings.  Greg has extensive experience with policy development, staff training, pharmacy management and regulatory compliance. 

    Currently, Greg is an Associate Director at SUNY Upstate Medical University.  He is involved with several projects related to USP <797> and USP <800>.  His oversight includes sterile compounding, hazardous compounding, and robotic/automated technologies. 
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    33 min
  • Pharmacy Inspection Podcast - Cleanrooms!

    Pharmacy Inspection Podcast - Cleanrooms!
    Jan 18 2022

    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 to simulate a cleanroom before it's even built (computational fluid dynamics - CFD).
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    31 min
  • Pharmacy Inspection Podcast - Building a Compliance Team

    Pharmacy Inspection Podcast - Building a Compliance Team
    Dec 21 2021

    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 cleanroom design and construction, regulatory compliance and process and policy standardization. We're going to be talking about her experience with building a compliance team to oversee compounding operations at a large health system.
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    23 min
  • USP 797 Revision

    USP 797 Revision
    Nov 26 2021

    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.
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    29 min
  • USP 795 Revisions

    USP 795 Revisions
    Oct 8 2021
    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.
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    18 min
  • FDA 483 #10 – Non-Viable Particle Counting

    FDA 483 #10 – Non-Viable Particle Counting
    Nov 6 2020
    Learning Objectives Discuss the importance of particulate in relation to microorganismsExplain why 0.5 micron and larger sized particles are of great importanceDiscuss 3 ways that we can minimize the number of particles in our cleanroom In todays 483 we're going to be looking at non-viable particle counts otherwise and more accurately known as total particle counts and why they're so important. So let's take a look at the 483 observation first then we'll dive into it a little deeper. In this 483 it's noted that there was an out of specification result for environmental monitoring samples. I've talked in a previous podcast and posts about viable particles, but this week let's focus on non-viables. In observation 2 under section "d" it talks about not further investigating sterility failures for two particular compounds. The investigation documentation did not include and evaluation of production batch record reviews, EM for hoods and rooms (non-viable or viable particulates, personnel monitoring, press plates), cleaning logs for the room, qualification of the hoods, retain samples or previous OOS. FDA 483 Observation 2 So why does it mention specifically looking at non-viable samples, aside from all of the others? Let's take a quick look at a table that's from USP <797>, which is actually from an international document, ISO 14644. I'm sure you've seen this before but if you haven't here it is. But what exactly do all of these numbers mean and why are they so important? In the left column you have ISO classes which are the classes of different areas of the clean room. Your primary engineering controls or your hoods are typically ISO class 5 and your secondary engineering controls or your room are typically ISO class 7 or you may have an anteroom that's ISO class 8. In the right hand column you have the limits of the particle counts per cubic meter, meaning if you have particle counts higher than the numbers in this column corresponding to the particular ISO class that area fails and cannot be classified as such. One thing to note here, at the bottom of the table in small writing it specifically mentions the numbers pertain to particles of a particular size 0.5 micron or larger. Why are 0.5 micron sized particles of importance? Well, there's one thing you should know about microorganisms. Rarely are microorganisms free floating by themselves. They actually travel on particles, and if you haven't already guessed they're usually attached to particles that are 0.5 micron or larger. One other interesting point worth mentioning and this may seem like common sense but the larger the particle, the more dense it is and the heavier it is. These larger sized particles are the ones that tend to settle on surfaces. Smaller, lighter particles can stay free floating in the air but it's the job of our engineering controls to push them away from our critical areas and hopefully push them down toward the ground where they're not a threat to our preparations. Now, if you have high particle counts in your cleanroom or primary engineering control does that mean that every one of those particles has a microorganism attached to it? No, not necessarily. However, taking particle counts is a great, general way of looking at the state of cleanliness of your cleanroom. Another question is, do we know the percentage of particles that have microorganisms attached to them? To be completely honest, I'm not sure if there's been a study done to make that correlation but one thing that's for certain is that the higher the particle counts in your classified areas, the higher the chance for contamination. One point I really want to drive home is that when we get our cleanroom certified and we're looking at the numbers of particle counts, you can glean a lot of information from that report. If you have high particle counts in a particular area, you can look inside your room and see what might be causing those high particle counts. How do particles get inside our cleanroom? GREAT question, they travel on materials that are brought into the cleanroom, equipment, and of course people that are going in and out of the cleanroom. Ok, great...we know what particle sizes we're looking for, why those particular particle sizes are important (because they carry microorganisms) and we know how they get in the cleanroom. The next question is how do we keep them OUT of the cleanroom? This comes down to a few simple and easy practices that you can do on a daily basis to minimize the number of particles you're bringing into the cleanroom. First, people. It's inevitable that people are going to be in the cleanroom since they're the ones performing the compounding. It comes down to how these people are gowned, how much skin is visible, and their general behavior while inside the cleanroom. As I said before if our engineering controls are doing their job properly they're hopefully pushing particles out of our ...
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    12 min
  • FDA 483 #9 – Bacterial Endotoxin Testing

    FDA 483 #9 – Bacterial Endotoxin Testing
    Oct 16 2020
    Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparationsDiscuss the limits for endotoxins for various routes of administrationDiscuss ways to control the levels of endotoxins in final preparations In this weeks' 483 we're going to be talking about Bacterial Endotoxins and the testing related to endotoxins. Let's first take a look at the observation then we'll discuss what endotoxins are and why it's important to keep them out of your preparations. First thing that should be talked about specific to this 483 is that we're dealing with preparations that are intrathecals or will be injected into the spinal fluid. One thing to know about intrathecal injections in particular is that they have a lower limit for endotoxins than other injections. When performing final testing for preparations one of the tests is a bacterial endotoxin test. This test is performed according to USP Chapter <85> Bacterial Endotoxins Test. For parenterals that are not intended for intrathecal administration the limit is 5 EU/kg (Endotoxin Units). For intrathecal injections the limit is 0.2 EU/kg. The per kilogram is the weight of the patient. The fact that there is a much lower limit of endotoxin specifically for intrathecal injections should give an indication as to the importance of having very low levels of endotoxin in the final preparation. This particular pharmacy is probably compounding the intrathecal in either very low batch sizes (less than 5) or one at a time as they're ordered by a physician. By not batch compounding the intrathecals there's not enough of the final preparation to send off for testing. My guess is that these are being made one at a time per order and are delivered to be administered within 24 hours. What are Bacterial Endotoxins and where do they come from? Most common, endotoxins are by-products of the gram negative bacterial cell lysis. They are lipopolysaccharides that make up part of the cell wall. Gram negative bacteria are commonly found in water sources. So if at any point you are using water either in the preparation itself or using materials that have been washed (i.e. glassware), there is a very high risk of having bacterial endotoxins in the preparation if there aren't any controls in place to limit the level of bacterial endotoxins. If glassware is being washed and re-used for processing the preparation, the glassware should go through a depyrogenation cycle meaning they would be held at a temperature of 250 degrees celsius for a minimum of 30 minutes. The time may vary depending on the glassware and oven that's being used for the depyrogenation process. Depyrogenation cycles of glassware should be validated to show that the process of depyrogenation is producing a 3-log reduction in bacterial endotoxins. Even if the process for limiting endotoxins in glassware in place you still need to consider any of the raw materials you're using (i.e. the active pharmaceutical ingredient or API). Water is used quite frequently in the manufacturing of pharmaceutical ingredients and the certificates of analysis for your API should include the limit for endotoxin and the results of testing for endotoxins. It's pointed out in this 483, that the certificates of analysis (COAs) do not include results of endotoxin limits for the APIs. Why are Endotoxin limits so critical? When a sufficient amount of endotoxins are injected this could result in a fever or can be as severe as death; particularly if injected into the spinal fluid where there is no immune system. Since this pharmacy doesn't have COAs that show the endotoxin results and are not testing for endotoxin in their final preparation, they really have no way of showing that their intrathecal injections are meeting the required limits for endotoxins. There are several ways that this pharmacy could increase the level of assurance that their process is limiting the endotoxin in the final preparation. According to USP Chapter <1228> there are 3 ways of controlling endotoxin in parenteral products: Indirect Control, "which is comprised of a series of preventive measures that control bioburden, the potential endotoxin contribution by formulation components (e.g., raw materials, APIs, excipients), water, primary packaging components, equipment, and the manufacturing environment, including personnel."Process Control, "in which endotoxin is monitored at Critical Control points (CCP) during processing to ensure that there is no increase in endotoxin. These process control elements are subject to validation or qualification."Direct Control, "or the direct destruction or removal of endotoxins from product streams, equipment, and primary packaging materials. As with controls on processing, direct measures of endotoxin destruction or removal must be validated." First, you'd need to evaluate the process for compounding the preparation. At any point is water being used in the process (i.e. glassware...
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    10 min
  • Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?

    Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?
    Oct 13 2020
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    9 min