Eagle

Staying up to date with the latest regulations is essential for any consulting firm. The Eagle team had an incredible experience attending this year's Compounding Quality Center of Excellence Annual Conference hosted by the FDA. It was a fantastic opportunity to connect with industry leaders, exchange knowledge and build partnerships for the future. A special thanks to the FDA for organizing such a valuable and impactful event. We look forward to applying the insights gained to further support our partners and clients in achieving the highest standards of quality and safety. #FDA #EagleTeam #CGMP

We’ll be exhibiting at the PDA/FDA Joint Regulatory Conference 2024, the annual FDA co-sponsored pharmaceutical CGMP conference! Now in its 33rd year, this conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of CGMPs. Make time on your schedule to connect with us at our booth #322 in the Exhibit Area! We hope to see you there! #PDAFDA #eagleanalytical #EagleTeam

🧪 USP Bacterial Endotoxin Test (turbidimetric technique) ⚠️ What is the Bacterial Endotoxin Test? The test is to detect or quantify endotoxins from Gram-negative bacteria using limulus amoebocyte lysate (LAL) from the horseshoe crab. ⚠️ What to test? • Category 2 injectables compounded from one or more nonsterile component • CSPs Category 3 injectables must be tested ⚠️ When to test? • Every time before product release • To extend BUD ⚠️ Requirements to submit the samples for testing: • Sample size is at least 1 mL per batch • The endotoxin limit (EU/mL), if it’s known OR • The maximum dose in (mL/hr) using the average weight of the patient (kg), and the route of administration ⚠️ Requirements to complete the submission at Eagle: • Method Suitability Test should be on file before submitting the samples. ⌛ The turnaround time of the testing is 2 business days. #microbiology #endotoxins #compounding

⚠️ What is Antimicrobial Effectiveness Testing? The test demonstrates the effectiveness of added antimicrobial preservatives. ⚠️ Why to test? - Compounded non-sterile preparations must be tested for antimicrobial effectiveness to extend BUDs Per USP 51 in conjunction with UPS - Multi-dose Compounded sterile preparations must pass antimicrobial effectiveness testing in conjunction with USP aqueous, ⚠️ When to test? Once per each formulation per every container closure system. ⚠️ Requirements to submit the samples for testing: • Product in the original, sealed container in which it was distributed by the manufacturer ⚠️ Requirements to complete the submission at Eagle: • Method suitability Test should be on file before submitting the samples. ⌛ Turnaround time of the testing is 35 business days. #enviromentalmonitoring #EMprogram #microbiology #pharma #pharmacy

Congratulations to Dr. David Hussong and his colleagues on their recently published research article in the journal Current Microbiology! An established quality expectation of pharmaceuticals is microbiological safety. Sterile products must contain no living microorganisms, while non sterile products must not be adulterated with too many microorganisms or harmful microorganisms. Raw materials that are components of pharmaceuticals also must not be adulterated since these can introduce microbial contamination. Current pharmaceutical testing methods for microorganisms use culture based technologies that are described in USP chapters such as , and . These are culture based methods that have limitations due to their lack of sensitivity and speed. This research demonstrated the application of metagenomic analysis as an alternative method that provided highly sensitive and rapid detection of specified microorganisms in water samples. These studies were performed at FDA’s National Center for Toxicological Research in Jefferson, Arkansas, in collaboration with researchers from other FDA sites, Albany State University, and the University of Michigan. To read the article, please use the following link: https://bit.ly/3WkMZ6f #microbiology #EagleTeam

⚠️ What is the Test for Specified Microorganisms? The test determines the absence or limited occurrence of objectionable microorganisms / microbial species. ⚠️ Why to test? This test is required for all nonsterile compounded preparations before release, Per in conjunction with ⚠️ When to test? Frequency of testing is defined in the Quality Assurance Program of your facility. ⚠️ Requirements to submit the samples for testing: • At least 10 g or 10mL of product. For fluids or solids in aerosol form, sample 10 containers. For transdermal patches, sample 10 patches. For exceptions, check USP section “Amount used for the test”. ⚠️ Requirements to complete the submission at Eagle: • Specify the product type: Water-soluble product, nonfatty product insoluble in water, fatty products, fluids or solids in aerosol form, transdermal patches. • Specify what Objectionable Organisms should be detected: Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, Escherichia coli, Bile-tolerant Gram-negative Bacteria, Clostridia, Candida albicans • Method suitability Test should be on file before submitting the samples. ⌛ Turnaround time of the testing is 7 business days. #enviromentalmonitoring #EMprogram #microbiology #pharma #pharmacy

⚠️ What is Microbial Enumeration Test? The Microbial Enumeration Test determines whether a product or formulation demonstrates an accepted limit of aerobic microorganisms such as yeast, mold, fungi, mesophilic bacteria. ⚠️ Why to test? This test is required for all nonsterile compounded preparations before release, per USP <1163> in conjunction with USP <795>. ⚠️ When to test? Frequency of testing is defined in the Quality Assurance Program of your facility. ⚠️ Requirements to submit the samples for test: • At least 10 g or 10 mL of product. For fluids or solids in aerosol form, sample 10 containers. For transdermal patches, sample 10 patches. For exceptions, check USP section “Amount used for the test”. ⚠️ Requirements to complete the submission at Eagle: • Specify the product type: Water-soluble product, nonfatty product insoluble in water, fatty products, fluids or solids in aerosol form, transdermal patches. • Provide Specification for Total Aerobic Microbial Count (TAMC) based on route of administration. For reference, check USP Acceptance Criteria for Microbiological Quality of Nonsterile Dosage Forms. • Provide Specification for Total Yeast and Mold Count (TYMC) based on route of administration. For reference, check USP Acceptance Criteria for Microbiological Quality of Nonsterile Dosage Forms. • Method suitability Test should be on file before submitting the samples. ⌛ Turnaround time of the testing is 7 business days. #enviromentalmonitoring #EMprogram #microbiology #pharma #usp795 #usp1163

WHEN YOU NEED ENVIRONMENTAL PLATES. In the context of consumables used in the compounding process, sampling media devices are essential to meet the compounding facility's requirements. Eagle recognizes the demand for high-quality consumables and provides self-locking, triple-wrapped, gamma-radiated TSA plates stored at room temperature, meeting the standards of USP . Instances where plates are crucial include: **Initial Competency Evaluation** Staff involved in compounding in Categories 1, 2, and 3 must undergo an initial competency evaluation. This involves visual observation and gloved fingertip and thumb sampling of both hands before commencing compounding. Personnel involved in compounding must consistently demonstrate garbing competency based on their Category. For Category 1 and 2 CSPs, a garbing competency evaluation is required every 6 months, while Category 3 CSPs must conduct it at least once every 3 months. **Aseptic Manipulation Competency** Surface sampling is a component of aseptic manipulation competency, mandated initially and at least every 6 months for Category 1 and 2 CSPs, and initially and at least every 3 months for Category 3 CSPs. **Microbiological Air and Surface Monitoring Program** Viable volumetric airborne particulate sampling and surface sampling are integral to the microbiological air and surface monitoring program. Viable air sampling for entities compounding Category 1 and 2 CSPs must be completed at least every 6 months; for Category 3, at least monthly thereafter, irrespective of compounding frequency. Surface sampling is conducted at the end of a compounding activity or shift but before the area is cleaned and disinfected. (and it must be conducted in conjunction with media-fill testing to assess aseptic manipulation competency). Visit our Shop page (link provided in the comment) and explore the services we offer in conjunction with TSA plates! #enviromentalmonitoring #EMprogram #microbiology #pharma

Dear followers and customers, We are happy to inform you that Eagle is open and operational with normal business hours. We thank you for your understanding and support during this time! #HurricaneBeryl

UPDATE. Eagle’s Houston site remains closed today, Tuesday July 9 due to the aftermath effects of Hurricane Beryl which has brought heavy rains and severe winds to the Houston area. Our team is working diligently to minimize any disruptions to our services and ensure that all operations return to normal as quickly as possible. We apologize for any inconvenience this may cause and appreciate your understanding, patience and support during this time.