Applied Industrial Technologies’ Post

Turnkey projects have witnessed substantial growth in recent years. The streamlined solutions offered by turnkey projects have led to the efficient and timely establishment of production units. Ambitious pharmaceutical and bio-pharmaceutical projects demand turnkey solutions for accelerated development in healthcare to meet the needs of a growing population. Fabtech’s start-to-finish turnkey solutions comprehensively cater to the diverse needs of pharma projects. This blog highlights the important considerations of the complete project life cycle. Read our blog : https://lnkd.in/dKkHQwC6 #TurnkeySolutions #PharmaIndustry #BioPharma #Healthcare #ProjectManagement #PharmaProjects #Fabtech #Efficiency #ProductionUnits #HealthcareInnovation #PharmaTech #ProjectLifeCycle #Growth #PopulationNeeds #PharmaDevelopment #Fabtechnologies #Engineering #Pharma #Cleanroom #Granulation #FillingLine #HVAC #Sterilization #StartToFinish #Solutions

Facilities Validation in the pharmaceutical industry is a systematic process that confirms that a facility's physical environment, utilities, and services meet the necessary requirements to produce high-quality pharmaceutical products consistently. Facilities validation includes: 1. HVAC system validation (Heating, Ventilation, Air Conditioning) 2. Water system validation 3. Utility system validation 4. Environmental monitoring 5. Cleanroom validation 6. Building structure validation This validation process helps ensure that the facility's infrastructure supports the proper functioning of the manufacturing process and safeguards product quality. Facilities validation is often carried out simultaneously with equipment validation and forms part of the overall validation strategy required by regulatory authorities like the FDA.

𝐈𝐧𝐬𝐭𝐫𝐮𝐦𝐞𝐧𝐭 𝐂𝐚𝐥𝐢𝐛𝐫𝐚𝐭𝐢𝐨𝐧 - 𝐌𝐞𝐚𝐬𝐮𝐫𝐢𝐧𝐠 𝐐𝐮𝐚𝐥𝐢𝐭𝐲⚖️ Pharmaceutical Manufacturing standards tend to be higher than many other sectors, and every process is heavily regulated by Regulation Authorities (𝐻𝑃𝑅𝐴 𝑎𝑛𝑑 𝐹𝐷𝐴). Pharma companies need to ensure that manufacturing equipment is maintained to the highest standard by a routine maintenance schedule. Calibration of instrumentation and execution of preventative maintenance routines are key to ensuring accuracy and compliance 🔑 It is important that calibrations are performed in order to ensure the quality and integrity of manufactured products and confirm that all systems are reliable and accurate to ensure compliance ✅ For more information check out our website➡️ https://lnkd.in/eb6qnS9R #Calibration #Instrumentation #PharmaceuticalIndustry #QualityAssurance #HanleyCalibration

Are you curious about how gas flow calibrators contribute to accuracy in industrial processes? 🌍✨ From ensuring compliance with stringent regulations to maintaining the highest standards in product quality, gas flow calibrators are vital tools in both the industrial and pharmaceutical sectors. Our latest blog discusses the importance of precise gas flow measurement, how calibrators work, and why they are indispensable for operational success. Ready to dive deep into the world of calibration? Discover how these devices make a difference in industries prioritizing precision and safety. Click the link below to explore more! 👇 https://lnkd.in/eJCzbWdK Hashtags: #GasFlowCalibration #IndustrialSafety #PharmaceuticalExcellence #Inteccon #PrecisionMatters #OperationalSuccess

Calibration and maintenance of lab instruments

CAD (Clean & Aseptic Design) valves were created by experienced pharmaceutical process and operations engineers. These engineers were convinced that some non‐productive but extremely necessary processes (especially CIP & SIP) in our industry have potential for improvement which can result in substantial overall productivity increases for pharmaceutical facilities. #Rodesta #CAD #Valves #Aseptic #Pharma #Installation #Valves #StainlessSteel #RVS #Pharma #Foodindustry #CIPcleaning

Best practices in analytical instrument calibration and maintenance

Best Practices

Best practices in analytical instrument calibration and maintenance

ANALYTICAL INSTRUMENT QUALIFICATION AND COMPUTER SYSTEM VALIDATION Dear Laboratory and Pharmaceutical Professionals,   We are pleased to announce our forthcoming 2-day workshop on Analytical Instrument Qualification and Computer System Validation scheduled for the 28-29 February 2024.   Objective   Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance’s. Recent EU and FDA regulatory enforcement actions demonstrate that qualification, validation and electronic records are priority areas for inspection. Recently there have been many FDA warning letters and the frequency of EU enforcement action in these areas.   This training course guides you through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidances from national and international regulatory sources. Once completed you will have the confidence to conduct analytical instrument qualification and computer system validation, ensuring you are compliant with global regulations.   Learning Outcomes   ·       Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5 ·       Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute suitable qualification/validation protocols ·       Understand the logic and principles of instrument qualification and system validation from planning to reporting ·       Be able to develop a qualification and validation strategy ·       Understand how to archive raw data from hybrid systems: electronic vs. paper ·       Be able to define and demonstrate regulatory compliance to auditors and inspectors ·       Learn how to ensure, document and audit the integrity of GMP records   Target Audience   This course is aimed at professionals involved in qualifying and validating analytical equipment and computer systems. These includes IT/IS managers and system administrators | Quality Assurance Personnel | Quality Control Professionals | Laboratory Personnel | Analytical Scientists | Validation Scientists | Regulatory Affairs |Training Departments | Documentation Departments.  Booking   Should you require booking prior to our sales staff contacting you, kindly complete the registration form (last page of the brochure). Limited seats available.   Kind Regards   Kind Regards, Charles T: 072 613 1947/ E: info@cstvalconsulting.co.za , www.cstvalconsulting.co.za