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

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

Do you want to be part of an Awesome Team? Do you have an outstanding work ethic, are self-motivated and have a "can do, get it done" positive attitude? Competitive wages and benefits! Great team! Great culture and benefits! Employer Matched 401 k! Sick and Vacation! Health benefits! (Vision, dental, medical, disability, life insurance, educational assistance, career pathways, tuition reimbursement, apprenticeships, wellness programs and much more) Contact Andy at Express Professionals andy.linerud@expresspros.com to learn more!

Take a moment to learn how ISO 2150-4 is changing Semiconductor Cleanroom Management!

📽️ LWS Boot Camp 2024 Playlist is Now Live! 🎉 Missed the action or want to relive the best moments from Boot Camp 2024? We’ve got you covered! Check out the full playlist, capturing all the energy, fun, and team-building challenges from this year’s event. 💪 Whether it was the sports challenges, group activities, or unforgettable memories, this playlist has it all! 🎥 Watch the full Boot Camp experience here: https://lnkd.in/gpMBQqYg #BootCamp2024 #TeamBuilding #LWSBootCamp #LighthouseExperience

Precision Without Compromise: Vertex Liquid Particle Counter Are you still wasting time with count subtraction in your liquid particle analysis? With our Vertex liquid particle counter, that's a thing of the past! Why Vertex stands out: • Industry's lowest false count rate • Eliminates the need for count subtraction • Saves time and increases accuracy Our advanced photodetector technology delivers unparalleled signal-to-noise ratio, ensuring you get the most precise measurements possible. The Vertex50, our smallest and lightest 50nm liquid particle counter, sets the standard for accuracy and efficiency. Don't settle for less when it comes to your critical measurements. What's your experience with false counts in liquid particle analysis? Share your thoughts below!#LiquidParticleCounter #Vertex #PrecisionMeasurement #CleanroomTechnology

What's GAMP All About? GAMP (Good Automated Manufacturing Practice) might sound complex, but it's your friendly guide to ensuring the medicines we rely on are made safely, with the help of modern technology. 🛠️ At its core, GAMP emphasizes that every step of the manufacturing process needs to be checked for quality, not just the final product. It's like baking—using the best ingredients and following every step carefully leads to the perfect cake. 🍰 GAMP covers: • Ingredients: The raw materials used • The Facility: Ensuring a sterile, controlled environment • Equipment: Tools that meet strict pharma standards • Staff: Well-trained professionals following the best practices And it gets even better—GAMP uses the "V" model for setting up and validating computer systems, making sure everything from data collection to final product testing works like a charm. It's all about ensuring medicines are safe, effective, and produced with repeatable quality every time. ✨ Ready to learn more? Check out our Knowledge Center: https://lnkd.in/dEun4bsF #GAMP #PharmaTech #QualityControl #VModel #PharmaInnovation