Resilience’s Post

When discussing process validation, we are referring to routine monitoring of the sterilization process performance. The aim of the routine monitoring is to allow validation of the sterilization process (meaning performing sterilization to STAATT IV). Additionally, when conducted in parallel with parametric monitoring (temperature, time and concentration of the active substance), it aims to re-validate the parameters values at which the sterilization process was initially validated. The Envomed Self Validation Kit makes this process straightforward and efficient. Want to learn how it works? Let us show you! #envomed

Scalable, cost efficient and time sensitive. These three pillars are why we created the Essential AAV & LVV offering. We’ve brought speed & rigor together to help deliver your GMP batch of vector in under 12 months on a scalable platform designed to support you through Phase I and beyond. Is Essential the right fit your advanced therapy needs? Learn more: https://hubs.ly/Q02wNWxf0

Using closed expansion process for your suspension cell lines can reduce the potential risk of microbial ingress and with automation reduce manual errors. Find out more. #upstream #celllines #safety #cellbankmanufacturing #closedprocessing #ccs #productquality #biosafetytesting #regulatorycompilance #annex1 #BioReliance #merckgroup

The Calibrator is used alongside the M300 ISM or M800 ISM transmitters and UniCond conductivity sensors, and is the only digital system available that meets pharmacopeia calibration standards. The Calibrator incorporates a convenient dial to select NIST-traceable resistances for all ranges of the UniCond’s measuring circuit. This convenient calibration accessory permits in-line calibration without disturbing the integrity of the water system. The UniCond Calibrator uses NIST-traceable precision resistors to verify the performance of the system’s temperature and conductivity circuitry and exceeds the required accuracy of ±0.1μS/cm

Worried About Compliance Gaps? Our Thermal Validation Holds the Key! 🌡️ Elevate Pharma Excellence with Expert Thermal Validation Services. Bridge Compliance Gaps Effectively. Try Our Free Demo! 🧪💼 Book your FREE demo here https://lnkd.in/gAVWghwR . . . #ThermalValidation #TemperatureValidation #PharmaQuality #GMPCompliance #ValidationServices #QualityAssurance #TemperatureMapping

🔊 Exciting News! 🔊   James Drinkwater, Head of GMP compliance at Franz Ziel GmbH, in collaboration with Di Morris, PNR Pharma / ex-MHRA, who were co leads of the PHSS Annex 1 commenting platform, have produced an insightful article on protective airflow applied in aseptic manufacturing. The article explores the nuances and critical role that protective airflow provides in preventing critical surfaces and sterile products from airborne contamination.   🌬️The article underscores the critical role of protective airflow, notably First Air in protecting sterile products from contamination in aseptic manufacturing, focussing on GMP compliance and the 2023 revision of Annex 1. It advocates Computational Fluid Dynamics (CFD) analyses to understand airflow dynamics, emphasizes the distinction between airflow patterns in protecting open containers during aseptic filling, and highlights the need for improved design and monitoring to align with the revised standards and ensure product quality and patient safety.   💡Check out the article for valuable insights into this critical aspect of our industry: https://lnkd.in/eeyU3y_V   #AsepticManufacturing #ProtectiveAirflow #FirstAir #fz #franzziel #protectinglifewithtechnology

ISPE CaSA is up and running! If you're in Raleigh come see Diane Jacober, Julia Feiler and Ryan Heffner, PE in Booths 833 and 835. Be sure to bring your challenging fluid control or single use questions. #pharmaceuticalengineering #biotech #biomedicalengineering

https://lnkd.in/geVnnS2V Autoclave Function: Autoclaves use steam under pressure to eradicate bacteria, viruses, and spores, preventing contamination of sterile injectables. Sterility Assurance: Autoclaves are crucial for achieving and maintaining aseptic conditions, safeguarding the quality and safety of injectable pharmaceuticals. Validation: Rigorous validation protocols must be established and regularly conducted to ensure autoclave efficacy, with documentation to meet regulatory standards. Temperature and Pressure Control: Accurate control of temperature and pressure parameters is essential to achieve effective sterilization without compromising product integrity. Cycle Development: Autoclave cycles must be optimized for different materials and product types, considering factors such as load size, container materials, and product sensitivity. Preventive Maintenance: Regular maintenance is imperative to prevent equipment malfunction and ensure consistent performance, minimizing the risk of batch failures. Regulatory Compliance: Adherence to cGMP (current Good Manufacturing Practices) and regulatory guidelines is paramount to ensure product quality and patient safety. #AutoclaveQuiz #SterilizationChallenge #SteamSterilizerTrivia #AsepticKnowledge #PharmaQuiz #BiotechTrivia #MicrobialControl #QualityAssurance #ValidationQuiz #PharmaceuticalTechnology #SteamSterilization #InfectionControl #GMPQuiz #BioprocessingQuiz #SterilityTesting #AutoclaveMastery #CleanroomQuiz #PharmaLearning #MicrobiologyQuiz #RegulatoryCompliance #SterilizationProtocols #EquipmentValidation #QuizTime #PharmaIndustryInsights #SterileManufacturing #HealthcareQuiz #GxPStandards #DrugSafetyQuiz #BioPharmaEducation #PharmaceuticalEngineering #SterileProcessingQuiz #PharmaceuticalManufacturing #SterileProcessing #AutoclaveValidation #AsepticTechnique #QualityControl #cGMPCompliance #PharmaSafety #Biopharmaceuticals #InnovationInPharma #DrugManufacturing.

Is colony picking taking up the bulk of your precious time? Do you want to free up your time for other tasks? Talk to us about automating your workflow with Colibri and Phenomatrix software for truly automated colony picking and integration with other systems for AST/ID

Get the best performance of the R&D process for the development of new medicines. Ensure the #integrity of thermo-sensitive products and the preservation of biological samples. Use the latest generation of R&D freeze-dryers.    Telstar LyoQuest Arctic. An #innovative bench-top #laboratory freeze dryer that operates with HFC & HFO free refrigerant gases. ensuring long-term compliance with increasingly restrictive international regulations (F-gas normative). An extremely #compact unit with large condensation capacity of up to 8 litres.    Telstar LyoBeta, the range of pilot-scale freeze dryers particularly #effective when testing and developing new recipes, designed for #research, development and scale-up of recipes for #pharmaceutical freeze-drying processes.     Induce the start of nucleation in the freeze-drying process with Telstar Lyonuc, a new #nucleation induction method that facilitates scaling up and optimization from a laboratory #pilot scale to industrial scale. It enables R&D centres and pharmaceutical laboratories to run freeze-drying process more efficiently, increasing the #productively and #improving the batch uniformly.     Telstar LyoBeta Mini is a #compact version of LyoBeta pilot-scale freeze dryer (W94cm x H76cm x D63cm) specifically intended for small scale #formulation, research, and #development work. It has been designed with a condenser capacity of 6 Kg which is separate from the product chamber.     Flexibility, high performance, and small footprint required in a laboratory unit, including advanced process control systems, management software and interface features.     Learn more https://lnkd.in/e5pmshPe #Hospitals #MedicalResearch #PharmaceuticalLabs #Freezedryers