Eagle

⚠️ 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.

Eagle’s Houston site is currently closed due to Hurricane Beryl. 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 and patience during this time. For all those affected by this, please stay safe and dry! #hurricaneBeryl

Happy 4th of July! Today, we honor the bravery and vision that gave birth to our nation. Enjoy the celebrations, and may your day be filled with joy and pride. Eagle is closed today in observance of Independence Day, and we will resume regular operations tomorrow, July 5th. Stay safe and have a fantastic holiday! 🇺🇸 #IndependenceDay #eagleanalytical

Today, Eagle had the honor of hosting a very special guest! Joscelyn Roberson, daughter of our own Ashley Roberson, is representing Women's Olympic Gymnastics Team USA at the 2024 Summer Olympics in Paris. Proud mom Ashley brought Joscelyn to visit the facility that made their move to Houston possible. Joscelyn enjoyed a tour led by Eagle's President, Ross A. Caputo, PhD, and nearly every Eagle team member took a photo with her. We're immensely proud of Joscelyn's incredible achievement and equally proud of our dedicated employees! Good Luck Joscelyn!!!! #USAGTrials24 #MTUSA #ParisOlympics

Dear followers, Eagle will be closed on Thursday, July 4th, in observance of Independence Day. We will resume regular operations on Friday, July 5th.Thank you for your understanding and continued support. #IndependenceDay #eagleanalytical

Eagle had the pleasure of hosting PCCA's Clinical Services team and providing a teaching session on the operations of the ScanRDI sterility testing machine. With a 1 day turn around time, ScanRDI is the world's fastest sterility testing alternative, approved under the latest USP 797 standards.