Bonfiglioli Engineering srl’s Post

VALIDATION - Enzyme/Clean booths AFMS offers Validation and certification of Enzyme/Clean booth in accordance with ISO14644:1 and manufacturers' requirements. These standards and guidelines play a crucial role in ensuring a sterile environment and protection of products. Enzyme/ Clean booth is commonly used in laboratories, pharmaceutical facilities, and other environments where a sterile and particle-free workspace is essential. The booth uses clean HEP filtered air to create a clean and controlled environment, preventing the contamination of sensitive materials or experiments. AFMS Testing of the clean booth involves various procedures to ensure their proper functioning and compliance with cleanliness standards. Here are some aspects of testing offered by AFMS: HEPA FILTER INTEGRITY: The High-Efficiency Particulate Air (HEPA) filters in clean benches need to be regularly tested to ensure they effectively capture particles. DOP test is employed to check for leaks or breaches in the filter. Calibrated photometers and aerosol generators are used for this purpose. Visit our website to find out more: https://www.afms.bz Contact Us: Call: +2711 462 0120 | +2781 111 2367(SA) Email: afms@afms.bz #laboratorylife #laboratory #laboratoryequipment #biosafety #biologicalsafety

VALIDATION - Enzyme/Clean booths AFMS offers Validation and certification of Enzyme/Clean booth in accordance with ISO14644:1 and manufacturers' requirements. These standards and guidelines play a crucial role in ensuring a sterile environment and protection of products. Enzyme/ Clean booth is commonly used in laboratories, pharmaceutical facilities, and other environments where a sterile and particle-free workspace is essential. The booth uses clean HEP filtered air to create a clean and controlled environment, preventing the contamination of sensitive materials or experiments. AFMS Testing of the clean booth involves various procedures to ensure their proper functioning and compliance with cleanliness standards. Here are some aspects of testing offered by AFMS: HEPA FILTER INTEGRITY: The High-Efficiency Particulate Air (HEPA) filters in clean benches need to be regularly tested to ensure they effectively capture particles. DOP test is employed to check for leaks or breaches in the filter. Calibrated photometers and aerosol generators are used for this purpose. Visit our website to find out more: https://www.afms.bz Contact Us: Call: +2711 462 0120 | +2781 111 2367(SA) Email: afms@afms.bz #laboratorylife #laboratory #laboratoryequipment #biosafety #biologicalsafety

VALIDATION - Enzyme/Clean booths AFMS offers Validation and certification of Enzyme/Clean booth in accordance with ISO14644:1 and manufacturers' requirements. These standards and guidelines play a crucial role in ensuring a sterile environment and protection of products. Enzyme/ Clean booth is commonly used in laboratories, pharmaceutical facilities, and other environments where a sterile and particle-free workspace is essential. The booth uses clean HEP filtered air to create a clean and controlled environment, preventing the contamination of sensitive materials or experiments. AFMS Testing of the clean booth involves various procedures to ensure their proper functioning and compliance with cleanliness standards. Here are some aspects of testing offered by AFMS: AIRBORNE PARTICLE COUNTING: Regular monitoring of airborne particles within the clean bench is essential. Particle counters are used to measure the concentration of particles in the air and verify that it meets the specified cleanliness class. Visit our website to find out more: https://www.afms.bz Contact Us: Call: +2711 462 0120 | +2781 111 2367(SA) Email: afms@afms.bz #laboratorylife #laboratory #laboratoryequipment #biosafety #biologicalsafety

JUST ANNOUNCED: our next live webinar, "End-to-End Primary Packaging Solutions for Pharmaceuticals and Devices" is scheduled for Tuesday, August 13 at 1 p.m. EDT presented by Charles Felter. You can register for free here, https://ow.ly/oIF850SLaX9 The objective of this webinar is to address USP and FDA regulatory trends to demonstrate how to integrate various analytical tests into a robust program that addresses product integrity/compatibility throughout the product lifecycle. This includes selection and development of the packaging systems and associated challenges of the packaging systems (stability storage, accelerated aging, freeze-thaw, altitude, drop, and vibration distribution simulation, and routine release of commercial product). Topics will include: Component / Container Functionality and Dimensional testing per USP/EP/JP/ISO/Custom Methods, Container Closure Integrity testing per USP <1207> , Extractable and Leachable testing, Distribution testing per ISTA, ASTM and ISO, and Compendial / Analytical Testing / Stability per USP/EP/JP/ISO/Custom Method. #PharmaPackaging #USPStandards #FDARegulations #AnalyticalTesting #ContainerIntegrity #StabilityTesting #PackagingSolutions #Pharmaceuticals #MedicalDevices #RegulatoryCompliance

VALIDATION - Enzyme/Clean booths AFMS offers Validation and certification of Enzyme/Clean booth in accordance with ISO14644:1 and manufacturers' requirements. These standards and guidelines play a crucial role in ensuring a sterile environment and protection of products. Enzyme/ Clean booth is commonly used in laboratories, pharmaceutical facilities, and other environments where a sterile and particle-free workspace is essential. The booth uses clean HEP filtered air to create a clean and controlled environment, preventing the contamination of sensitive materials or experiments. AFMS Testing of the clean booth involves various procedures to ensure their proper functioning and compliance with cleanliness standards. Here are some aspects of testing offered by AFMS: AIRBORNE PARTICLE COUNTING: Regular monitoring of airborne particles within the clean bench is essential. Particle counters are used to measure the concentration of particles in the air and verify that it meets the specified cleanliness class. Visit our website to find out more: https://www.afms.bz Contact Us: Call: +2711 462 0120 | +2781 111 2367(SA) Email: afms@afms.bz #laboratorylife #laboratory #laboratoryequipment #biosafety #biologicalsafety

📈 Rising to Meet the New Standards in Aseptic Manufacturing   As regulatory standards advance, so too must our approach to aseptic processing. The recent updates in Annex 1 of the EU Good Manufacturing Practice (GMP) have heightened the bar for quality and sterility in pharmaceutical production. This is not just an update—it's a call to innovate. The latest guidelines transform how we approach Aseptic Process Simulation (APS), or Media Fill Testing. Traditionally reliant on manual inspections, this critical process can be vulnerable to human error and fatigue. But automation offers a solution.   Our advanced solutions are designed to streamline Media Fill testing, aligning your operations seamlessly with Annex 1 requirements. See how automation can redefine efficiency, bolster compliance, and reinforce sterility assurance in your manufacturing process.   Learn more about how our solutions are evolving Media Fill testing: https://lnkd.in/dRhyyb_v #WILCO #BeingSure #MediaFill #Annex1 #APS

Join us on Tuesday, August 13 at 1 p.m. EDT for "End-to-End Primary Packaging Solutions for Pharmaceuticals and Devices" with our expert, Charles Felter. Register for FREE here: https://ow.ly/wTzX50SRpMx Dive deep into the world of USP and FDA regulatory trends, and learn how to create a robust program that ensures product integrity and compatibility throughout the entire lifecycle. Here's what we'll cover: 🔹 Selection and development of packaging systems 🔹 Overcoming packaging challenges (stability storage, accelerated aging, freeze-thaw, altitude, drop, vibration distribution simulation, routine release of commercial product) 🔹 Component/Container functionality and dimensional testing per USP/EP/JP/ISO/Custom Methods 🔹 Container Closure Integrity testing per USP <1207> 🔹 Extractable and Leachable testing 🔹 Distribution testing per ISTA, ASTM, and ISO 🔹 Compendial/Analytical Testing/Stability per USP/EP/JP/ISO/Custom Method Don't miss this opportunity to enhance your knowledge and stay ahead in the pharmaceutical packaging game. See you there! #PharmaPackaging #USPStandards #FDARegulations #AnalyticalTesting #ContainerIntegrity #StabilityTesting #PackagingSolutions #Pharmaceuticals #MedicalDevices #RegulatoryCompliance

[SPONSORED POST] Airflow Visualisation Studies: The Impact of Annex 1 on Sterility Assurance The experts at Particle Measuring Systems bring you a technical review of airflow in pharmaceutical manufacturing. Given the wide range of applications, airflow visualisation studies affect several topics in relation to Annex 1. The following four topics are discussed in detail in this paper: 1. Cleanroom and clean air equipment qualification 2. Environmental monitoring program 3. Training and qualification of personnel 4. CCS (Contamination Control Strategy) For an additional bonus, watch the corresponding webinar here: https://lnkd.in/dAwWE9ry #Annex1 #Airflow #cleanrooms

Join us on Tuesday, August 13 at 1 p.m. EDT for "End-to-End Primary Packaging Solutions for Pharmaceuticals and Devices" with our expert, Charles Felter. Register for FREE here: https://ow.ly/2bAW30sFE5l Dive deep into the world of USP and FDA regulatory trends, and learn how to create a robust program that ensures product integrity and compatibility throughout the entire lifecycle. Here's what we'll cover: 🔹 Selection and development of packaging systems 🔹 Overcoming packaging challenges (stability storage, accelerated aging, freeze-thaw, altitude, drop, vibration distribution simulation, routine release of commercial product) 🔹 Component/Container functionality and dimensional testing per USP/EP/JP/ISO/Custom Methods 🔹 Container Closure Integrity testing per USP <1207> 🔹 Extractable and Leachable testing 🔹 Distribution testing per ISTA, ASTM, and ISO 🔹 Compendial/Analytical Testing/Stability per USP/EP/JP/ISO/Custom Method Don't miss this opportunity to enhance your knowledge and stay ahead in the pharmaceutical packaging game. See you there! #PharmaPackaging #USPStandards #FDARegulations #AnalyticalTesting #ContainerIntegrity #StabilityTesting #PackagingSolutions #Pharmaceuticals #MedicalDevices #RegulatoryCompliance

HROs vs GMPs In this episode, we explore the distinct dynamics of High-Reliability Organizations (HROs) and industries regulated by Good Manufacturing Practices (GMP), such as pharmaceuticals and medical devices. We delve into how each sector prioritizes safety and reliability, the differences in regulatory oversight, operational procedures, and cultural approaches towards risk management. By comparing these sectors, we uncover unique strategies and cultural orientations that each adopts to navigate their specific challenges and enhance reliability. Join us as we unpack the crucial elements that define the operational success and safety standards in HROs and GMP-regulated industries. https://lnkd.in/evx6ypjh