As part of our unwavering commitment to maintaining the highest standards in our pharmaceutical manufacturing processes, we would like to highlight some key challenges we face in cleaning validation and propose effective solutions to address them 🌟 Challenges and Solutions 🔧 Complex Equipment Design : ⚠️ Challenge: The intricate design of some manufacturing equipment can make thorough cleaning a daunting task. ✅ Solution: Implementing Clean-In-Place (CIP) systems can greatly simplify the cleaning process for complex equipment. CIP systems are designed to clean the interior surfaces of pipes, vessels, process equipment, and associated fittings without disassembly, ensuring consistent and efficient cleaning. 🔬 Analytical Method Development: ⚠️ Challenge: Detecting low levels of residues requires highly sensitive and specific analytical methods. ✅ Solution: It is imperative to invest in robust and advanced analytical methods. Techniques such as High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) can provide the necessary sensitivity and specificity to detect even trace amounts of residues, ensuring that our cleaning processes meet stringent quality standards. 📜 Regulatory Changes: ⚠️ Challenge: The regulatory landscape is constantly evolving, with new guidelines and requirements emerging regularly. ✅ Solution: To stay compliant, we must proactively keep abreast of regulatory updates and integrate them into our cleaning validation protocols. This involves regular review and updates to our standard operating procedures (SOPs) and continuous training for our staff on the latest regulatory requirements. By addressing these challenges head-on with effective solutions, we can enhance our cleaning validation processes, ensuring product safety and compliance with regulatory standards. For more info, contact us! 📩 [email protected] 📱 962 7 9153 3337 #KSA #iraq #challenges #cleaning #validation #ccs #cv
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My Project Work UHPLC with fraction collector By : Thermo Scientific Model: Ultimate 3000 ✓ UHPLC became the modern standard HPLC platform due to its power for increasing sample throughput, chromatographic efficiency, sensitivity and decreasing run time. ✓Purpose of fractional collector is it allows samples to be collected in fixed volumes, or can be controlled to direct specific fractions detected as peaks of protein concentration, into separate containers. ✓This system is with DAD and Charged aerosol detector. ✓The most important instrument parameters are displayed on bright LCDs and are clearly visible—even from a distance. also having touch pen control ✓system operated by Thermo Scientific Chromeleon Chromatography Data System (CDS) software ✓This Software Creates comprehensible reports and enables rapid data processing while supporting full compliance with GLP, cGMP, and 21 CFR Part 11. ✓ Having the feature of remote access to data and instruments Real-time monitoring of your instrument with automatic email notifications Store data in secure accounts. * I hope you find this information useful. * . . . . . . . . . #niper #analysis #analyticalinstruments
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And our latest automated report sync software enables full Data Integrity (DI) compliance to ALCOA principles
𝗕𝗲 𝗟𝗲𝗮𝗻 and bring Your 𝗿𝗮𝘄 𝗺𝗮𝘁𝗲𝗿𝗶𝗮𝗹𝘀 𝘃𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 process 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗟𝗮𝗯 𝘁𝗼 𝘁𝗵𝗲 𝗪𝗮𝗿𝗲𝗵𝗼𝘂𝘀𝗲 𝗳𝗹𝗼𝗼𝗿 with Progeny handheld Raman. ✔ 𝗥𝗮𝘄 𝗠𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝗩𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵𝗶𝗻 𝘀𝗲𝗰𝗼𝗻𝗱𝘀: Get instant results at the warehouse floor. ✔ 𝗡𝗼𝗻-𝗜𝗻𝘃𝗮𝘀𝗶𝘃𝗲 𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀: Analyse materials without opening sealed packaging. ✔ 𝗖𝗹𝗲𝗮𝗿 𝗣𝗔𝗦𝗦/𝗙𝗔𝗜𝗟 𝗥𝗲𝘀𝘂𝗹𝘁𝘀: Easy interpretation for all operators. ✔ 𝟮𝟭 𝗖𝗙𝗥 𝗣𝗮𝗿𝘁 𝟭𝟭 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁: Proven in cGMP Environments ✔ 𝗟𝗲𝗮𝗻 𝗤𝗔/𝗤𝗖: Optimise your quality assurance and control processes Contact us for more information ➡️ https://lnkd.in/df3DhtfB #RawMaterialsID #RMID #HandheldRaman #QualityControl
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🚨 Webinar Alert: Join us for an insightful discussion on Pharma Product Quality Inspection. Uncover the latest solutions, practical applications, testing methods, and Annex 1 compliance essentials. 🔍 Explore Key Topics Including: ✔ Annex 1 - Solutions to points ‘8.22, 8.23, & 8.24’ using Bonfiglioli Engineering srl machines and its non-destructive, deterministic validated methods. ✔ USP 1207 - Exploring vital differential and alternative pressure methods for quality assurance. ✔ Headspace Gas Analysis: An overview of how it works. ✔ Container Closure Integrity Testing (CCIT): How CCIT operates, its significance, and the latest trends that ensure product safety and compliance. ✔ Live Demo's: Witness HGA, CCIT & Automated Visual Inspection in action. Join your industry peers & learn from the experts. Register now and keep up to date with the latest trends in product quality inspection. https://lnkd.in/eHr6kK62 #PharmaQualityInspection #Annex1Compliance #pharma #ccit
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Standard Operating Procedure (SOP) on Guidelines for Retiring or Decommissioning an HPLC System Including Proper Disposal of Components - "Safely retire and decommission your HPLC system with our comprehensive guidelines. Learn how to dispose of components, manage hazardous waste, and ensure regulatory compliance for environmentally responsible decommissioning." https://lnkd.in/ebTuE4XT
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Standard Operating Procedure (SOP) on Guidelines for Retiring or Decommissioning an HPLC System Including Proper Disposal of Components - "Safely retire and decommission your HPLC system with our comprehensive guidelines. Learn how to dispose of components, manage hazardous waste, and ensure regulatory compliance for environmentally responsible decommissioning." https://lnkd.in/ebTuE4XT
Standard Operating Procedure (SOP) on Guidelines for Retiring or Decommissioning an HPLC System Including Proper Disposal of Components
https://pharmaceuticalcarrier.com
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⚡Cleaning Validation Tip: Online #cleaningvalidation offers process understanding, process control, risk management, efficiency gains, and optimization that cannot be achieved with laboratory monitoring. Implementing an online #TOC analyzer allows users to track three key metrics in real-time: TOC, inorganic carbon, and #conductivity. Learn more here! https://bit.ly/3KloSzl #LifeScience #Manufacturing #Pharmaceutical #Sievers
Take the downtime out of your cleaning validation program. | Veolia
watertechnologies.com
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🚨 Webinar Alert: Join us for an insightful discussion on Pharma Product Quality Inspection. Uncover the latest solutions, practical applications, testing methods, and Annex 1 compliance essentials with our partners @SteriTech in the UK & Ireland. 🔍 Explore Key Topics Including: ✔ Annex 1 - Solutions to points ‘8.22, 8.23, & 8.24’ using our machines and their non-destructive, deterministic validated methods. ✔ USP 1207 - Exploring vital differential and alternative pressure methods for quality assurance. ✔ Headspace Gas Analysis: An overview of how it works. ✔ Container Closure Integrity Testing (CCIT): How CCIT operates, its significance, and the latest trends that ensure product safety and compliance. ✔ Live Demo's: Witness HGA, CCIT & Automated Visual Inspection in action. Join your industry peers & learn from the experts. Register now and keep up to date with the latest trends in product quality inspection. https://hubs.la/Q027S1cN0 #PharmaQualityInspection #Annex1Compliance #pharma #ccit”
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ENVIRONMENT MONITORING PROCEDURE IN PHARMA Environmental monitoring (EM) is a critical process in the pharmaceutical industry that ensures the quality of controlled environments For Detail Click Below: https://lnkd.in/gsB-cyS5
ENVIRONMENT MONITORING PROCEDURE IN PHARMA
https://pharmaguidehub.com
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Sterile Injectable Production Operations @ Sudair Pharmaceutical Company (Lyophilization Injectable)
#Isolator #PQ Performance Qualification (PQ) of an Isolator Steps: 1. Preparation: Documentation: Create detailed PQ protocols. Training: Train personnel. Calibration: Ensure all instruments are calibrated. 2. Pre-Qualification Activities: IQ: Verify correct installation. OQ: Confirm operational functionality. 3. Test Parameters and Conditions: Air Quality: Validate ISO Class 5 standards. Pressure Differential: Ensure correct pressure differentials. Temperature & Humidity: Maintain specified levels. Particle Count: Measure airborne particles. Microbiological Monitoring: Ensure low bioburden levels. 4. Test Procedures: Simulated Operations: Perform routine and non-routine operations. Environmental Monitoring: Monitor during operations. Cleaning & Decontamination: Validate procedures. Sterility Tests: Confirm aseptic conditions. 5. Data Collection and Analysis: Monitoring: Record all parameters. Analysis: Use statistical methods for data analysis. 6. Acceptance Criteria: Air Quality: Meet ISO Class 5. Pressure Differential: Maintain specified ranges. Temperature & Humidity: Within specified limits. Particle Count: Within acceptable limits. Microbiological Levels: Meet specified limits. Sterility Assurance: Maintain aseptic conditions. 7. Documentation and Reporting: Report Preparation: Summarize results and analysis. Review & Approval: Obtain approvals from relevant departments. Regulatory References: 1. FDA: Guidance for Industry on Sterile Drug Products 2. EMA: Annex 1 for Manufacture of Sterile Medicinal Products 3. ISO: ISO 13408-1 for Aseptic Processing
