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ARL Bio Pharma
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Добавлен 17 июл 2017
ARL Bio Pharma's RUclips channel offers education videos for the pharmaceutical and pharmacy industries. Content is focused on analytical and microbiological testing to meet regulatory requirements and deliver high-quality drug products to patients.
Sterility and Alternative Sterility Testing
This presentation discusses requirements for sterility testing as per USP 71 and 797. Attendees gain detailed insights into sterility test methods, a clear understanding of rapid sterility testing, and an exploration of the review of Certificates of Analysis.
Просмотров: 233
Видео
USP 795 Updates and Cultivating a Culture of Quality within Your Team
Просмотров 1904 месяца назад
This presentation covers essential updates to USP 795 and explores strategies for instilling a quality-driven culture within your team. Learn effective approaches for educating both healthcare providers and the public on these updates, ensuring widespread understanding of the importance of these changes. Additionally, gain insights from practical practice pearls that aim to enhance the efficien...
Today’s USP 797: A Functional Approach to Quality Sterile Compounding
Просмотров 1,2 тыс.8 месяцев назад
This presentation explores the nuances and practical application of USP 797 standards in your sterile compounding environment.
Beyond The Survey Top Findings and How to Implement Change in Your Pharmacy
Просмотров 2310 месяцев назад
In the compounding pharmacy community, Accreditation Commission for Health Care (ACHC) surveyors are experiencing what the pain points are in pharmacies. Particularly items related to compliance with USP Chapters. This session gives a look behind the curtain as to what ACHC’s surveyors find onsite and tips to improve.
Rapid Sterility Testing: An Alternative Microbiological Method
Просмотров 1,3 тыс.Год назад
This webinar reviews FDA and USP requirements for alternative microbiological methods, validation considerations, and advantages for your pharmacy. Join us to learn more about this technology and how you can release drug products faster and get the most out of your beyond use dates.
USP 51 Antimicrobial Effectiveness Testing & USP 71 Sterility Testing When, Why, and How
Просмотров 2,9 тыс.Год назад
This webinar covers USP 51 Antimicrobial Effectiveness Testing and USP 71 Sterility Testing and how these tests apply to implementing BUD assignments per the revised chapters. Participants learn when to test, what to test, how to interpret the results, the limits of the test, and specific actions required when a preparation does not meet specifications.
Understanding USP 797 Microbiology Testing Requirements
Просмотров 1,9 тыс.Год назад
With the release of USP General Chapter 797 on November 1, 2022, comes a variety of different microbiology testing requirements. Understanding these requirements and how they affect sterile compounding operations is essential to compliance and patient safety. This webinar will explore chapter changes to viable air and surface sampling, gloved fingertip testing, media-fill testing, sterility tes...
Compounding Lab Design and Engineering Considerations per USP 800 Guidelines
Просмотров 1,7 тыс.Год назад
This presentation identifies USP 800 hazardous drug handling guidelines for a successful compounding laboratory and cleanroom design. The dissection and understanding of the engineering controls to maintain correct temperature, humidity, air changes, and pressurization is clearly defined. Budgeting for the remodeling and/or new construction project are discussed as well. Speaker: Bryan Prince, ...
The Itch You Cannot Scratch: Veterinary Dermatology
Просмотров 2,2 тыс.2 года назад
This webinar provides a review of common dermatological conditions affecting canine patients. It also covers current practice standards and recommendations for pharmacists and technicians for treating common dermatological conditions.
Stability Testing Science and Compliance
Просмотров 3,1 тыс.2 года назад
This session reviews regulatory guidelines for stability testing and reveals the science of a stability indicating method. Attendees learn practical applications for 503A pharmacies and 503B outsourcing facilities and identify factors that affect the stability of compounded preparations.
QCS Session #9 - Panel Discussion
Просмотров 802 года назад
This session brings together industry experts to talk about the hot topics facing compounding pharmacists and technicians today. The panel discusses future opportunities for hospitals and compounding pharmacies and examples for clinical pharmaceutics intervention. Attendees also gain insight into the importance of process validation and identify real world solutions to preparing for regulatory ...
QCS Session #2 - Pharmacist/Provider/Patient Triad: A Multidisciplinary Approach to Patient Care
Просмотров 632 года назад
This presentation highlights the importance of a multidisciplinary approach to patient care and the importance of pharmacist collaboration with the patients' providers and caregivers. Building a foundation of trust and knowledge between the pharmacy and the provider can ultimately lead to more positive patient outcomes and a more comprehensive approach to their health. This also highlights the ...
QCS Session #1 -NABP Implementation of the FDA Compounding MOU
Просмотров 872 года назад
This presentation explains to pharmacists and technicians the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (MOU), including the responsibilities of the State agency that chooses to sign the MOU in investigating and responding to complaints related to drug products compounding in a state and distributed outside that State and in addressing the in...
QCS Session #8 - Sterility Assurance using Sterile Compounding Automation and Technology
Просмотров 3782 года назад
Activities related to sterile, nonsterile, and hazardous drug compounding for humans and animals. This includes best practices and USP quality assurance standards, environmental testing and control, record keeping, error detection and reporting, and continuous quality improvement processes. Sterile compounding involves myriad of environmental, equipment, and product influences that can impact t...
QCS Session #7 - API or Approved Product: Where do we start with veterinary compounds?
Просмотров 1052 года назад
QCS Session #7 - API or Approved Product: Where do we start with veterinary compounds?
QCS Session #6 - Cleanroom Certification - Digging Deeper
Просмотров 3352 года назад
QCS Session #6 - Cleanroom Certification - Digging Deeper
QCS Session #4 - Regulatory and Quality Considerations in the Selection of API
Просмотров 1372 года назад
QCS Session #4 - Regulatory and Quality Considerations in the Selection of API
QCS Session #3 - Quality Compounding and Clinical Pharmaceutics
Просмотров 1352 года назад
QCS Session #3 - Quality Compounding and Clinical Pharmaceutics
QCS Session #5 - Root Cause of Stability Failures
Просмотров 2452 года назад
QCS Session #5 - Root Cause of Stability Failures
What are Important Topics in the Industry Today?
Просмотров 112 года назад
What are Important Topics in the Industry Today?
QCS: Regulatory and Quality Considerations in the Selection of Active Pharmaceutical Ingredients
Просмотров 892 года назад
QCS: Regulatory and Quality Considerations in the Selection of Active Pharmaceutical Ingredients
Quality Compounding Summit: What Session Are You Most Excited About?
Просмотров 142 года назад
Quality Compounding Summit: What Session Are You Most Excited About?
QCS Session 2: Pharmacist/Provider/Patient Triad: A Multidisciplinary Approach to Patient Care
Просмотров 602 года назад
QCS Session 2: Pharmacist/Provider/Patient Triad: A Multidisciplinary Approach to Patient Care
A Pharmacist's Prescription for Bringing in New Customers
Просмотров 1833 года назад
A Pharmacist's Prescription for Bringing in New Customers
An Inside Look at ARL's Rapid Sterility Test
Просмотров 1,7 тыс.3 года назад
An Inside Look at ARL's Rapid Sterility Test
Insurance Considerations for Pharmacists and Professional Liability in Compounding
Просмотров 1443 года назад
Insurance Considerations for Pharmacists and Professional Liability in Compounding
Brilliant overview, thanks Cynthia
Hi we use DI but using syringes to transfer from product container to media - would you still class this as higher risk than filtration even though its closed system? Also I've spoken with tech advisor from a major sterility test consumable supplier and they advised no issues with large volumes over filters but need validate. I've never heard of an upper limit of volume that you can filter? Thanks
Thank you for your question. In performing direct inoculation testing as you described, since there is a transfer step between the sample and the media jar, where the syringe / needle is outside of either container, it wouldn’t be considered a “closed system”. However, with proper aseptic technique and environmental controls in place, this process can be performed in an aseptic manner. Regarding volumes of sample per filter, there is no defined maximum sample volume which can be passed through a filter, assuming no clogging / filterability issues are observed. However, USP <71> does state for testing of aqueous solutions to not exceed rinsing with “5 times 100 mL per filter, even if during method suitability, it has been demonstrated that such a cycle does not fully eliminate the antimicrobial activity.” As you mentioned, proper validation (method suitability) is required to demonstrate the chosen method is effective for the formulation and sample volume being tested. Please contact us if you have additional questions: info@arlok.com.
@@ARLBioPharma thanks for getting back to me. I'll drop you an email as I have some more questions.
@@ARLBioPharma confusion re the closed system aspect as with filtration one must still use a needle from a sterility test kit? 🙄
It's informative
Thank you for the presentation
Thank you so much.very helpful.
This was an excellent presentation. Thank you.
how we evaluated simple physical stability test that everyone can do by times for oil product (color, smell, and separation) or give the citation
Very much informative. Thanks
Thank you for the presentation 😊
Is the product validation done by arl or onsite?
Sir, what is description as per USP monographs, it nomenclature and definition or it's something else
Hello, thank you for the video! I have a couple of questions according to the ATP Bioluminescence test. According to different sources, oxygen is required for the reaction to occur and luminescence to be produced (Luciferin needs oxydation to be converted into its light-producing form). How can anaerobic organisms be detected with this assay if oxygen is not present in the media for them? (for example FTM) Thank you in advance.
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Thanks for sharing all these information. A lot of congratulations to Thomas Kupiec for an excellent explanation.
Question. I'm attempting to put together a method for suitability using membrane filtration method (millipore pump). Should all challenge organism be pumped into canister be exposed to both TSB and FTM? Leaving you with 6 TSB samples and 6 FTM samples for incubate? Or should it only be 3 and 3 representing 3 TSB challenge organisms and 3 FTM organisms?
Great work there, totally clear explanation.Thanks.
Thank you for this lecture