McClure Engineering-St. Louis (MEP)’s Post

Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. The good manufacturing practice (GMP) requirements for the prevention of contamination and cross-contamination are an essential design consideration of an HVAC system. The validation of HVAC system involves systemized and assembled documents of its functional specifications such as design drawings, plans, and specifications. The main purposes of a Heating, Ventilation and Air-Conditioning (HVAC) system are to help maintain good indoor air quality (IAQ) through adequate ventilation with filtration and provide thermal comfort.

📢LAST TECHNOLOGY designed the Steam Generator type 𝗖𝗦𝗚 for the production of clean steam used in sterilization equipment processes. ➡️𝑷𝒓𝒐𝒄𝒆𝒔𝒔 𝒐𝒇 𝒔𝒕𝒆𝒂𝒎 𝒈𝒆𝒏𝒆𝒓𝒂𝒕𝒊𝒐𝒏 by means of heat exchange between clean water – heating element. ➡️𝑻𝒉𝒆 𝒉𝒆𝒂𝒕𝒊𝒏𝒈 𝒔𝒚𝒔𝒕𝒆𝒎 𝒄𝒂𝒏 𝒃𝒆 𝒐𝒇 𝒕𝒘𝒐 𝒕𝒚𝒑𝒆𝒔: electrical or steam to steam. ☑️ On the electrical system the heating elements are directly immerged into the water (this system is also called “direct heating”). ☑️While for the steam-to-steam version, the heating media is running inside the coils (this system is called “indirect heating”). ➡️Both systems can be equipped with a cartridge 0.2 μm filter and a water separation unit to guarantee the cleaning and saturation (free of condensate) of the generated clean steam. 📌For more details, visit:‎ https://lnkd.in/dMDSqkY6 📌Follow us on LinkedIn lnkd.in/drvyxjp #Lasttechnology #Innoxengineering ‎#Pharmaceutical #Pharma #Pharmaceuticals #Pharmaceuticalindustry #Laboratory #containment #pharmaindustry #GMP #autoclaves #sterilizer #RSA #steamautoclave #decontamination #Dryheatsterilizer #Healthcare #LABsterilizer #labequipment #lab #cGLP #dpb #H2O2 #sterilization

AIR FLOW VISUALIZATION STUDIES IN PHARMACEUTICAL Smoke studies or airflow visualizations are planned activities; these are performed as part of the HVAC qualification of clean rooms. The purpose of this test is to confirm either the airflow direction or airflow pattern or both in regard to the design and performance specifications. The smoke test or airflow visualizations are required to be done in clean rooms at both “at rest” and “In operation” conditions. This test helps identify and minimize airflow disruptions or turbulence in the unidirectional airflow zones caused during manufacturing. https://lnkd.in/gt7kE5ad

𝐇𝐕𝐀𝐂 𝐬𝐲𝐬𝐭𝐞𝐦𝐬 𝐚𝐫𝐞 𝐯𝐢𝐭𝐚𝐥 𝐟𝐨𝐫 𝐂𝐆𝐌𝐏 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞  (especially in sterile environments of pharmaceutical manufacturing) 𝐊𝐞𝐲 𝐂𝐨𝐦𝐩𝐨𝐧𝐞𝐧𝐭𝐬: ➤ Air Handling Unit (AHU) ➤ Exhaust fans ➤ Returns ➤ Dampers ➤ Terminal HEPA filters 𝐐𝐮𝐚𝐥𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 & 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧: 𝐈𝐐: Includes turnover package, ductwork testing, and HEPA filter test reports. 𝐎𝐐: Covers operational checks, pressure differential checks, and non-viable particle counts. 𝐏𝐐: Involves extensive environmental monitoring over a full year. Important Tests: Balancing report for airflow adequacy and HEPA filter efficiency testing. 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬: Compliance with ISO 14644 for cleanliness levels. Ensuring a well-qualified and validated HVAC system is crucial for maintaining compliance and product quality. Rees Scientific is committed to ensuring regulatory compliance, product quality, and operational efficiency through precise HVAC qualification and continuous environmental monitoring. #Pharmaceutical #HVAC #CGMP #Compliance #QualityAssurance

SCADA & Automation The demand for automation and monitoring systems is steadily increasing. Automated systems offer benefits like improved efficiency, reduced errors, and minimal human intervention. All equipment from Bright Pharma is available in automated versions. In an automated plant, pneumatic valves are controlled by a solenoid and a PLC. This PLC manages various parameters, such as agitator and homogenizer motors, transfer pumps, and utilities. Users can adjust the "Recipe" through the HMI interface. The SCADA system allows real-time oversight of plant processes from anywhere, making it easy for managers to monitor production remotely. Bright Pharma specializes in automatic ointment, liquid syrup, and sterile manufacturing plants, with installations in over 35 countries. To know more: Visit us: https://brightpharma.net/ Call us: +91 98203 31626 / 915201 7001/2/3/4 #SCADA #Automation #biotech #maintenance #medical #pharmaceuticals #engineering #healthcare #pharma #pharma #pharmaceutical #pharmaceuticalindustry #healthcare #engineering #QualityService #manufacturing #Compliance #cosmetics #sterilevessel #vessels #injectables #injectables #sterileprocessing #magneticstirrer #blendingvessel #integratedskid #Vaccines #covid #tubing #integratedsolutions #eyedrops #preparationtank #preparationvessel #ointmentcreammfgplant #ointmentplant #creammanufacturingplant #cream #shampoo #bodylotion #toothpaste #cosmeticmanufacturingplant #CosmeticDentistry #cosmetics #processingequipment #stirrer #inline #liquidation #syrup #homogenizer #liquidsyrupprocessingplant #injections #syrupmanufacturingplant #emulsion #LiquidHandling #contramixer #liquid #liquidoral #liquioralplant #pharmaliquid #pharmaceuticalliquid #cosmeticliquid #coughsyrup #syrup #syrups #pharmasyrups #quality #pharmaceuticals

Our client is a multinational biopharmaceutical firm that required assistance in setting up its new production unit in Belgium. We assisted our client in meeting the high regulatory standards for their new production site in line with #GMP practices authorization and #FDA regulatory compliance standards. Additionally, we enabled the client to standardize and automate the production site, perfectly aligning with the #ISA88regulations for #automation. Let's dive deeper into the details: Client Challenges: - Non-standardized Equipment: Equipment from various suppliers needed standardization. - Unreadable Equipment for Automation: Required modifications to Piping and Instrumentation Diagrams (P&IDs). - Non-uniform Automation Philosophy: Necessitated tailored Functional Description Specifications (#FDS). - Regulatory Compliance: Needed to meet FDA and GMP regulations, especially for cleaning processes. Our Approach: Standardization: -We built and refined P&IDs. -Developed larger modules after creating smaller modules with proper testing and validation. -Connected the Equipment Modules (EMs) to form a fully automated unit compliant with #ISA88 automation standards. Building the Automation Philosophy: -Using a modular approach, we created small, efficient modules and then connected those modules into a larger unit. -Enabled #digitalmaturity by integrating Siemens #PCS7 to achieve control and monitoring. Functional Description Specification (FDS) - Standardized FDS: -Evaluated processes through RFIs (Requests for Information). -Established a unified automation framework for the production unit and facilitated collaboration among various suppliers. Standardized Cleaning-In-Place (CIP). -Adjusted equipment for common cleaning standards. -Improved cleaning efficiency to meet FDA’s best cleaning practices. The Results: -Enabled automated production: The site is fully #automated, achieving compliance with #FDAregulations and the ISA 88 standards for automation. -Interconnection achieved using Siemens PCS7: Processes are connected to the MAIN USER SYSTEM, monitored, and controlled centrally. -Improved Control of Operations: Enhanced precision and reduced production variability. -Error Reduction: Minimized human errors, ensuring consistent quality. -Operational Efficiency: Streamlined processes, leading to cost savings and reduced human reliance. -Regulatory Compliance: Met all FDA and GMP standards, ensuring global certification. By the end of the project, the client attained digital maturity and gained a strong foothold in #Industry40 initiatives. In an industry where such initiatives are difficult and complex, the client gained a strong #competitiveedge in the long run while improving product quality and reducing costs in the short term. Read our Blog to discover more- https://lnkd.in/e83Pwn4z

Ensure a method that meets even the stringent requirements of FDA. Join our exclusive webinar by Expert John Fetzer ‎and enhance your skills of analytical method validation and instrument validation. https://lnkd.in/dH-wKxxZ #webinar #seminar #analyticalvalidation #FDA #compliancetrainings #regulatorycompliance #HPLC

Our team’s dedication to exceeding ASME BPE and GMP standards with modular design and fabrication paved the way for our global pharmaceutical partner to achieve their $2 billion expansion. The successful collaboration resulted in far more than the two hygienic solvent recovery systems and eight sanitary mixing systems, the project: ⏰ Saved time and adhered to an accelerated timeline 📈 Expanded production capacity and overall growth 📄 Exceeded industry standards and regulations Dive deeper into this partnership and its impacts: https://lnkd.in/gzbfe-ta #PharmaceuticalEngineering #ProcessInnovation #ModularDesign #ASMEBPE #GMPCompliance #HygienicDesign #SolventRecovery #SanitarySystems #OperationalEfficiency #QualityAssurance #PharmaManufacturing #TechnologyInPharma #ManufacturingExcellence #AutomationInPharma #EngineeringSolutions #processsystemengineering #processsystems #fabrication #designbuild #industrialintegrator #ModularConstruction #processoptimization #modularsolutions

𝗡𝗲𝘄! 𝗣𝗿𝗼𝗷𝗲𝗰𝘁𝗫: 𝗖𝘂𝘁𝘁𝗶𝗻𝗴-𝗘𝗱𝗴𝗲 𝗦𝗲𝗿𝗶𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝘀 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 Serialization presents unique challenges because of the regulatory requirements for product traceability and anti-counterfeiting measures in the pharmaceutical industry. Our team’s work falls under GrayMatter’s Automation & Controls Offering, which includes PLC programming, SCADA/HMI design, machine control, control logic testing, and many other services. Full ProjectX Case Study: https://lnkd.in/g65Ch3N3 #serialization #pharmaceuticals #industrialcontrols

What is IQ OQ PQ in the Pharmaceutical Industry? 🌐 Ever wondered about IQ, OQ, PQ in the Pharmaceutical Industry? 🧪 Let's dive into the significance of these acronyms that drive quality and compliance. 🔍 Curious minds, this one's for you! 💡 Installation Qualification (IQ) Review of Installation Documentation: Ensure that all installation documentation, manuals, and drawings are available and accurate. Verification of Equipment Placement: Confirm that equipment is located in the correct position as per design and safety standards. Functional Checks: Perform basic functional checks to ensure that all components are properly connected and operational. Operational Qualification (OQ) Functional Testing: Conduct thorough testing to ensure that equipment functions as intended. Performance Verification: Confirm that the equipment meets predefined performance criteria. Instrument Calibration: Verify the accuracy and reliability of instruments used in the process. Load and Stress Testing: Subject the equipment to variations in load and stress to ensure performance under different conditions. Performance Qualification (PQ) imulated Production Runs: Conduct production simulations to assess the equipment's performance under actual operating conditions. Process Monitoring: Monitor the equipment over an extended period to ensure sustained performance. Documented Evidence: Compile comprehensive documentation providing evidence that the equipment consistently meets predefined criteria. For more information and Services Contact me Afnan Zafar or visit https://lnkd.in/eewuQBYr #PharmaQuality #IQOQPQ #qualityassurance #pharmaceuticals #compliancematters #industrystandards #qualitycontrol #PharmaProcesses #regulatorycompliance #continuousimprovement