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Surely you have always asked yourself this question. Why at Biovac don't we talk about quality? Because we live it.  Our biocompatibility is unquestionable and each implant is free of residue.  At Biovac we control each step of the process as if it were the only one, to guarantee an impeccable final product. Our ISO 7 certified Clean Room ensures sterile packaging that exceeds expectations. With ISO 9001, ISO 13485 and specific certifications for porous and plasma coatings, we comply with the most rigorous international standards. Do we talk? #hydroxyapatite #Surgicalimplants #Prosthesis #Osseointegration #Biovacwithyou

#USFDA-ASEPTIC PROCESSING ISOLATORS: #FILLING #LINE #STERILIZATION: 1. To ensure sterility of product contact surfaces from the start of each operation, the entire path of the sterile processing stream should be sterilized. 2. In addition, aseptic processing equipment or ancillary supplies to be used within the isolator should be chosen based on their ability to withstand steam sterilization (or equivalent method). 3. It is expected that materials that permit heat sterilization (e.g., SIP) will be rendered sterile by such methods. 4. Where decontamination methods are used to render certain product contact surfaces free of viable organisms, a minimum of a six-log reduction should be demonstrated using a suitable biological indicator. REFERENCE: USFDA - GUIDANCE FOR INDUSTRY STERILE DRUG PRODUCTS PRODUCED BY ASEPTIC PROCESSING — CURRENT GOOD MANUFACTURING PRACTICE.

A clean bench that provides a sterile work environment is critical for performing sensitive tasks. Choose from @Emerald Scientific variety of laminar flow hoods and choose the size and configuration to meet the needs of your applications. https://bit.ly/3wRGdfL #emeraldscientific #erlab #captair #mystaire #flowhoods #laminarflowhood #airquality #labbuilds #labequipment #labsafety #labequipmentsupplier #labsafetysupply #cannabis #cannabislabsafety #cannabislab #cannabislabtesting #cleanair #labairquality #laboratoryairquality #labfacility #labplanning #cleanbench #cleanbenchtop #laminarflowworkstations #airfiltration #airfiltrationunit #airfiltrationsystem #cleanroom #cleanroomequipment #cleanroomproducts #cleanroomtechnology

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

#YUYAN_BIOTECH #Freeze_Dryer #PILOFD_Series Sterile isolation design -- the freeze dryer can be placed standalone in lab or in clean room by through-wall mode, easy for use in multiple sites. Food and Pharma piot freeze dryer customization. Vacuum control in whole process -- control vacuum in different drying phases and realize automatic operation. End discrimination-- the program will enter end discrimination program automatically after secondary drying is completed, and enter next step after confirming sample is dried. Whole process automatic operation-- total automatic process from pre-freezing, sublimation, secondary freeze drying, end discrimination ,stoppering, pressure recovery, defrosting to shutdown.  Standard pilot freeze dryer: sample temperature ≤-55℃, cold trap temperature ≤-75℃, ultimate pressure ≤1Pa. #laboratoryequipment #medicaltechnology #medtech #laboratory #pharma #medicaldevices

Frequently Asked Questions Of Eo SterilizationFrequently Asked Questions Q: Why should I consider optimizing the amount of sterilant in my existing EO sterilization cycle? A: Ethylene oxide (EO) has been used as a sterilization method for healthcare products since the 1960s. However, there are human safety and environmental challenges associated with its use. To address these issues, STERIS AST offers the Sustainable EO® sterilization services program, which provides strategies to reduce EO sterilant usage while achieving the prescribed Sterility Assurance Level (SAL). Optimizing sterilant input offers benefits such as lower product residuals, improved occupational safety, and enhanced supply chain efficiencies. Q: Is the Sustainable EO program a validation approach using alternative bioburden-based methods? A: While bioburden-based methods per ISO 11135:2014 may be used, the focus of the Sustainable EO program is predominantly on utilizing an Overkill approach. Qualified Sustainable EO cycles using the overkill approach have demonstrated delivery of the required SAL of 10-6, minimizing overprocessing seen on legacy cycles. Q: Does ISO 11135:2014 specify that the biological indicator (BI) should be placed within the most challenging location of the product? A: No. The standard requires the BI to be placed in a Process Challenge Device (PCD) that presents a challenge to the sterilization process equivalent or greater than the natural bioburden at the most difficult location within the product. Q: Does my cycle need to use the same EO concentration as that used to establish the D-value of the BI? A: No. The D-value of a BI is established under specific conditions, but industrial EO processes may be qualified at a range of temperatures and EO concentrations based on product limitations. Q: Given the criticality of the Test of Sterility on products with natural bioburden, are there particular considerations regarding sampling for this assay? A: Comparative studies should be performed using product bioburden representative of normal production. Refer to ISO 11737-2:2009 for selection of samples and assessment of test method. Q: How do I perform a comparative resistance study? A: A comparative resistance study involves performing a sublethal fractional exposure time process to compare the relative resistance of Process Challenge Devices (PCDs) and product Test of Sterility units. Q: What do I do if I get no growth from both the product Test of Sterility and the PCD? https://lnkd.in/gFjph37V

In the complex world of laboratory safety and efficiency, choosing the right air filtration system for your Biosafety Cabinet (BSC) is crucial. Our latest guide, "HEPA vs. ULPA Filters in Biosafety Cabinets," offers an in-depth comparison to help you navigate this decision with confidence. From operational principles, standards compliance (NSF/ANSI 49 and EN12469), to the impact on airflow dynamics and cabinet functionality, we cover the essentials that matter to your lab's operations. Understand the differences in filtration efficiency, cost implications, and how these filters affect the safety and success of your critical research. Join us in advancing lab safety and operational excellence. #LabSafety #BiosafetyCabinets #HEPAvsULPA #ResearchExcellence - https://bit.ly/3KPBzzQ

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

5 common mistakes to avoid in cleanrooms and laboratories 🏥 #cleanrooms #pharmaceuticalindustry #laboratories #cableandpipeseals #certifiedsealing #biocontrol

Enhance your upstream and downstream bioprocessing with our One2Fill™️ 10x Simultaneous Fill system, allowing you to: 🍶 Fill your bottles in 5 minutes or less as opposed to 1 hour with ±3% filling accuracy. 🏢 Bottle-fill volumes ranging from 125mL to 2L SaniSure PharmaTainers™️ with high accuracy. 👩🔬 Reduce risk and time for filter testing with one-vent hub technology. By easing media or buffer preparations, sampling and aliquoting, integrating One2Fill™️ into your biomanufacturing process accelerates production, so that you can deliver essential therapeutics to market and to patients at speed. Find out more about the first simultaneous bottle filling system for bioprocessing: https://loom.ly/NZp8g1A #bioprocessing #upstreamprocessing #downstreamprocessing #drugsubstance