LWS (Lighthouse Worldwide Solutions)

Webinar Reminder: Jason K., LWS Applications Director is presenting on Continuous Microbial Monitoring to meet EU GMP Annex 1. This webinar will increase your knowledge of continuous microbial monitoring and you will learn how to choose the best technologies to develop a monitoring system that will safeguard your products and ensure your process is being fully monitored. What will you get from this webinar? A full overview of microbial monitoring plus you'll learn how to implement a robust continuous microbial monitoring system, understand the cost impact, learn how to supercharge your existing traditional monitoring systems to meet compliance, and a full overview of old and new air sampling technologies. Topics covered: •Aseptic Sterile Process •EU GMP Annex 1 •ISO 14698 •EN 17141 •Use of Settle Plates •In-depth analysis of Active Air Sampling •Biofluorescence and Rapid Microbial Detection methods available •How to effectively use traditional and new microbial monitoring tools •Importance of low flow in active air samplers •Case study example on how to monitor a BSC and a parental filling line using both traditional and new technologies •Limitations of microbial detection methods Who Should Attend? If you are impacted by EU GMP Annex 1 requirement for continuous microbial monitoring and feel overwhelmed or need good sound advice on how to implement a system then this webinar is for you. Registration Links - * Please note the time zones when registering, as this may differ from your local time 1am PST / 9am GMT https://lnkd.in/gcx7Xm-q 2am PST / 10am GMT https://lnkd.in/gK3arwTZ 10am PST / 6pm GMT https://lnkd.in/gu_KX_pY

We are excited to announce the planned opening of a dedicated calibration space located in Austin Texas! Once this location is setup, we look forward to offering expedited service and calibration in the Texas area. Our dedicated team at Lighthouse knows that we play a key part in the success and quality of products you deliver to the world. We take that role seriously and pride ourselves on a history of innovation that makes your life easier. We look forward to working with you.

Have you checked out our FREE eBook on Real-Time Monitoring Systems yet? If you're looking to enhance your understanding of how real-time data can transform your operations, this resource is a must-read! In this eBook, you'll discover: • The benefits of real-time monitoring in various industries • Key features to look for in monitoring systems. • Best practices for implementation and data management Don't miss out on the opportunity to elevate your monitoring strategies and ensure optimal performance in your environment! 👉 Download your free copy here: www.golighthouse.com Let's embrace innovation together! If you have any questions or insights after reading, feel free to share in the comments. We'd love to hear from you! #RealTimeMonitoring #eBook #Innovation #DataManagement #Lighthouse

Data integrity is a critical component of current good manufacturing practices (CGMP) as it ensures that data is complete, consistent, and accurate. The U.S. Food and Drug Administration (FDA) has issued guidance to clarify the expectations around data integrity within the pharmaceutical industry. So let's dive in a bit deeper and find out exactly what you need to know!

As the industry continues to evolve, the importance of maintaining optimal conditions in cleanrooms cannot be overstated. With advancements in technology, incorporating new monitoring equipment has become essential for ensuring compliance and enhancing air quality. At Lighthouse, we understand that selecting the right tools can be a daunting task. 🤔 What are your biggest concerns when incorporating new monitoring equipment into your cleanroom? Is it about ease of use, data integration, or perhaps training staff on new technology? Let's share insights and experiences to help each other navigate these challenges! Looking forward to hearing your thoughts! 💬 #Cleanroom #MonitoringEquipment #AirQuality #Lighthouse #IndustryInsights

We're excited to announce that Hasim Solmaz and Jason Kelly will be attending the International Symposium on Contamination Control (ISCC 2024) from October 15-18, 2024, at the Hotel Melià in Milan, Italy. This prestigious event will bring together industry leaders, technology providers, and academic experts to discuss the latest advancements in contamination control. It's a fantastic opportunity for networking and sharing insights that drive innovation in our field. Stay tuned for updates from the symposium! #ISCC2024 #ContaminationControl #Innovation

Back to Basics: Mastering Portable Particle Counters for Cleanroom Monitoring Join us for a comprehensive Back to Basics Tutorial Webinar with Jason Kelly, Director of Applications at Lighthouse Worldwide Solutions. This session is designed for professionals looking to sharpen their skills in cleanroom monitoring, particle counting, and contamination control. Whether you're just starting or looking to refresh your knowledge, this webinar will take you through the fundamentals and advanced best practices for utilizing portable particle counters like the ApexZ. Why Attend? In today's high-stakes industries—pharmaceuticals, electronics, aerospace, and medical devices—accurate contamination control is non-negotiable. This webinar goes back to the basics, offering a refresher on essential principles while exploring advanced techniques that ensure regulatory compliance and data integrity. What You Will Learn: • Particle Counter Technology Simplified: Learn how particle counters work and their role in maintaining cleanroom standards. • Understanding Flowrates: Why flowrate selection matters and how it impacts particle sampling accuracy. • Calibration Essentials: Discover why regular calibration is crucial for accuracy, compliance, and extending the life of your equipment. • Back to Basics on Data Integrity: How to ensure your environmental monitoring data is accurate, reliable, and audit-ready. • Sampling System Fundamentals (ISO/TR 14644-21): Avoid common pitfalls in sampling systems and learn best practices for minimizing particle losses. • Cleanroom Certification Made Simple (ISO 14644-1): Get a step-by-step guide on certifying cleanrooms with portable particle counters like the ApexZ, ensuring compliance with the latest ISO standards. Who Should Attend: • Cleanroom operators • Quality assurance professionals • Environmental monitoring specialists • Compliance and validation teams • Engineers in pharmaceuticals, biotechnology, aerospace, and electronics industries Why Back to Basics Matters: Even the most seasoned professionals need to return to the core principles that make cleanroom monitoring effective. This webinar focuses on foundational skills and knowledge, ensuring you're equipped to meet today's industry demands while maintaining the highest standards of cleanliness and compliance. Date: October 18, 2024 Register Now: Don't miss this opportunity to fine-tune your skills and stay ahead in contamination control! Register for 1am Pacific https://lnkd.in/gfYgdjFP Register for 2am Pacific https://lnkd.in/gm9_B-e3 Register for 10am Pacific https://lnkd.in/gYk6h-Mt

Someone today asked me why do I wear an N95 mask instead of a KN94 mask? The person who was asking me was wearing a KN95 mask. Here is what I shared with them: The pandemic popularized KN94 masks and the media plus our State and Federal governments all have made statements that the masks are equivalent. The truth is they are not equivalent. Then I explained how a KN95 mask utilizes ear loops to keep the mask to the face and the ear loops do not provide enough compression against your face to seal out unwanted contaminants. The person then said they find the KN94 masks more breathable than the N95 masks. I then explained why this is the case. Due to the lack of compression (ear loops vs head straps) the KN94 masks tend to leak air around the nose, cheeks and chin thus giving a perception of breathability. I explained for testing (qualitative and quantitative) and how we have tried to fit test people in KN95 masks and we have had 100% failure. Wearing a mask no matter if it’s N95 or KN95 will help protect you but if you are really relying on the mask to do its job then N95 masks are the way. At the end of the conversation the person asked me for one of my masks. In summary if you see me in the airport don’t ask me mask questions (or anything related to airborne contamination) unless you have free time. 🤗

Building the Perfect Environmental Monitoring System (EMS) 🏗️ An Environmental Monitoring System (EMS) is like the silent guardian of pharmaceutical manufacturing. It monitors the environment to ensure it's clean, controlled, and compliant with strict regulations like GAMP5 and ISO standards. But building an EMS is more than just plugging in a machine—it's a step-by-step journey: 1. Planning: Start with a risk assessment—what could go wrong, and how do you prevent it? 2. Design: Blueprint your system with a strong focus on user requirements (URS). Get the details right from the start. 3. Procurement: Choose your equipment carefully, ensuring it meets compliance needs. 4. Implementation & Validation: Install and test your system to ensure it performs exactly as planned. 5. Performance & Maintenance: Keep it running smoothly with regular checks and updates. Like a car, your EMS needs tune-ups to stay in top shape. 💡 Pro Tip: Risk assessment is key! It's like mapping out potential issues before they arise and building safeguards into your system. Start with a well-constructed User Requirements Specification (URS)—it's your wish list for the perfect EMS. Bonus Tip: Choose a trusted vendor with experience (we've been doing this for over four decades!) and conduct a vendor audit. It's like checking references before making a big hire. 🛠️ Check out our recent webinar with Jason Kelly on using risk assessments to build compliant, reliable EMS And make sure to visit our Knowledge Center for additional information on this topic! https://lnkd.in/g7eqktbv #EMS #PharmaManufacturing #RiskAssessment #DataIntegrity #VendorAudit

GMP, GAMP5, and 21CFR11: The Big Three of Pharma Quality Control Pharmaceutical manufacturing isn't just about mixing ingredients and hoping for the best. It's about following stringent guidelines to ensure the final product is safe, effective, and consistent. Meet the Big Three ensuring pharma processes run like clockwork: 1. GMP (Good Manufacturing Practice): The foundation for making quality sterile products. It's the rulebook that keeps everything clean, controlled, and compliant. 2. GAMP5 (Good Automated Manufacturing Practice, Version 5): The tech-focused cousin of GMP. GAMP5 handles computer systems and automated processes, ensuring they meet regulatory standards. It emphasizes Risk Management and ensures that your automated systems aren't just efficient but also safe. 3. 21CFR11: The record-keeper. This FDA regulation ensures all electronic records and signatures are secure, trustworthy, and meet data integrity standards. ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) is a helpful guide for keeping everything in check. Together, these guidelines evolve with technology, addressing new challenges and keeping pharmaceutical manufacturing safe and compliant. 🌍 📢 Pro Tip: Check out our latest webinar on Data Integrity and the role of 21CFR11—available now Make sure you head over to our Knowledge Center for additional info! https://lnkd.in/g7eqktbv #GMP #GAMP5 #CFR21 #PharmaStandards #RiskManagement