CCIT S.A.’s Post

Manufacturers of pharmaceutical products have long placed a high priority on maintaining the integrity of pharmaceutical packages. But over the last few decades, advancements in the health care field have also intensified problems with pharmaceutical packaging integrity. Testing the quality of the packaging for all healthcare products is crucial, but for parenteral drugs, the necessity is significantly increased. Even a minute breach in the package can cause microbial contamination leading to product deterioration. Hence ensuring container closure integrity is a critical process in the life cycle of parenteral products. Check out our video to know more. #microcurrenthvld #leaktestingparenteralproducts #containerclosureintegrity #parenteralproductsleakdetection #highvoltageleakdetection #ccit #ccitechnologies https://lnkd.in/dunFMv4w

Manufacturers of pharmaceutical products have long placed a high priority on maintaining the integrity of pharmaceutical packages. But over the last few decades, advancements in the health care field have also intensified problems with pharmaceutical packaging integrity. Testing the quality of the packaging for all healthcare products is crucial, but for parenteral drugs, the necessity is significantly increased. Even a minute breach in the package can cause microbial contamination leading to product deterioration. Hence ensuring container closure integrity is a critical process in the life cycle of parenteral products. Check out our video to know more. #microcurrenthvld #leaktestingparenteralproducts #containerclosureintegrity #parenteralproductsleakdetection #highvoltageleakdetection #ccit #ccitechnologies https://lnkd.in/dunFMv4w

Manufacturers of pharmaceutical products have long placed a high priority on maintaining the integrity of pharmaceutical packages. But over the last few decades, advancements in the health care field have also intensified problems with pharmaceutical packaging integrity. Testing the quality of the packaging for all healthcare products is crucial, but for parenteral drugs, the necessity is significantly increased. Even a minute breach in the package can cause microbial contamination leading to product deterioration. Hence ensuring container closure integrity is a critical process in the life cycle of parenteral products. Check out our video to know more. #microcurrenthvld #leaktestingparenteralproducts #containerclosureintegrity #parenteralproductsleakdetection #highvoltageleakdetection #ccit #ccitechnologies https://lnkd.in/dunFMv4w

Ventilated Balance Enclosure (VBE) - Ensuring Stability and Accuracy of Powder Weighing Tasks Safety measures are required before changing or setting up a new disposal bag due to the application of VBE in hazardous drug handling environments. This video demonstrates how to safely change the disposal bag of the VBE. It provides guidance on the proper procedure for operating your VBE in your laboratory or pharmaceutical industry. Before Starting the Procedure: 1. Make sure that the new disposal bag is appropriate for the VBE 2. Ensure that the system is turned on to provide airflow and prevent contamination during the bag change 3. Wear the appropriate PPE for your application prior to entering the area where the VBE is located. Steps on How to Safely Change the Disposal Bag: 1. Remove O-ring 1 (ventilation bag entry) from the port 2. Position the new disposal bag over the old disposal bag 3. Secure the new bag by placing O-ring 2 around both bags 4. Pull the old disposal bag off the port 5. Reattach O-ring 1 to the disposal port 6. Pull the old disposal bag towards the end of the new bag 7. Seal of a portion of the bag using a zip tie, tape, or thermo sealer 8. Cut the bag to separate the dirty disposal bag Note: Leave half of the bag at the port to prevent sudden pressure changes and turn of the unit before removing the bag. Know more about Esco's VBE through this link:  https://lnkd.in/dwPQs7P8 #EscoLifesciencesGroup #EscoHealthcare #EscoPharma #Pharmaceutical #PharmaIndustry #PharmaEquipment #Pharmacy #Pharmacist #Pharma #VentilatedBalanceEnclosure #VBE #EscoLifesciences #EscoEurope https://lnkd.in/gXtjtZQR

Current Shortages from the FDA Website (from Dec 2023) "Current and Resolved Drug Shortages and Discontinuations Reported to FDA" • December 20, 2023: "Amphetamine, misc salts; dextroamphetamine (currently in shortage)" "Ketamine Hydrochloride Injection (Currently in Shortage)" • December 19, 2023: "Dopamine Hydrochloride Injection (Currently in Shortage)" "Methamphetamine Hydrochloride Tablet (Currently in Shortage)" These are not new problems - Adderall's been in shortage since October 2022! With no end in sight. If Enthereal has been funded when we originally pitched a handful of VCs in 2021, we'd have a flexible production capability that could be that much closer to solving these shortages - with our single platform From https://lnkd.in/e9UK_f8

The USFDA issued a WL to Fenwal International, Inc. (a Fresenius Kabi company), located in Puerto Rico that manufactures terminally sterilized products. https://https://lnkd.in/eRfWTiGC ➡ Failure to conduct adequate investigations was cited as a repeat deficiency notated during the 2010, 2012, 2013 and 2021 inspections. Specifically,  Microbial growth reported as Too Numerous to Count (TNTC) are not investigated although required by procedure.  ➡ Failure to reject lots of bulk solutions and finished unsterilized units with in-process bioburden results of TNTC. ➡ Failure to adequately validate the sterilization process to achieve the established minimum Sterility Assurance Level (SAL) because the bioburden levels present in the unsterilized units is TNTC and as such not a number to calculate the SAL. Accordingly, the firm erroneously calculated the impact of TNTC results on the sterility assurance of the impacted lots. ➡ The firm 483 response lacked sufficient evidence of corrective actions to reduce bioburden levels and to address the "recurring" failure to conduct adequate failure investigations. The "dosimetric" release of terminally sterilized products requires the development, validation and routine control of the sterilization process including the determination of the bioburden levels present in the un-sterilized product to determine the dosage required to meet the targeted SAL. At PCGI, we provide the necessary expertise to ensure your sterilization processes are adequately validated and controlled. Contact us today.  www.pharmacgi.com #FDA #WL #Inspection #Investigations #SAL #Sterileproducts

The Mundus Mini HD from EQUASHIELD® improves hazardous drug compounding with advanced automation that instills safety, quality, and efficiency. The critical element is the Closed-Back Syringe Unit (CSTD), which effectively protects healthcare professionals from exposure to hazardous drugs. Check out the full #industryspotlight below! #pharmacy

I've refreshed Enthereal's pitch. I've found it more challenging to "find my people" here on LinkedIn than I anticipated, but that's okay because it takes the time it takes. However, I can't wait any longer to hold back on this, because this invention could have been preventing the current supply chain fiascos going on with ADHD medications, if I had received funding from the handful of VCs I pitched, two years ago. We're pinpointed a real need with the ADHD meds shortages roiling supply chains across the country, really. Even the FDA is being clear that it knows there is not enough amphetamine, methamphetamine, dopamine, and ketamine in the pharmaceutical supply chain channels. How ironic that people can't get medicines from their pharmacist, but they can get it from illegal sources where the quality and identity of substances is uncertain. We need to create more regulated markets that allow for a broad swath of entrepreneurs to participate who have passions for quality, safety, and creating products that people demand. I've held back for too long. The Enthereal tech stake is a technology for an existing market with a new twist on a more and more used approach. The time has come for it to make an even bigger impact. I discovered, invented enabling modifications, and patented a more efficient process to make ADHD medicines from the commodity amino acid L-Phenylalanine. This is a world-changing discovery and its application is only the first step in the realization of a more resilient way our essential medicines will be made, more and more. We're here at the beginning, standing on the shoulders of giants, and we're inviting you all to be part of our growth and development from the very beginning. Tell a friend. They'll be glad you did. More numbers upon request. Turn-key business, once we validate several high-risk, high-reward hypotheses. We're focused on essential medicines and that includes amphetamine, ketamine, methamphetamine, dopamine, epinephrine, norepinephrine; the patented technology also produces MDMA, mescaline, DOM, and others and related precursors.

Twin screw feeders can be used for free flowing powders and fine granulates but they are ideal for feeding difficult materials such as pigments, sticky, bridging or flooding powders, fiber and fiberglass. Screw feeders are the most common and economical volumetric feeders you can buy. Coperion K-Tron makes both single screw and twin screw volumetric feeders in a wide range of sizes to meet your feed rate requirements and solve your material handling problems. Some are optimized for quick material changes and can even be configured for differing material properties. Others feature easy cleanability and meet food and pharmaceutical sanitary requirements. #materialhandling #pharma #feeders #processequipment

Are you sure your stopper is dry enough to be safe enough for your lyophilized drug product's stability? Have you ever experienced increase in residual moisture content in your lyophilized drug product and could not explain why? Do you know the moisture uptake capacities & water release characteristics of your lyo stopper? An increased residual moisture content could be caused by incomplete drying of the stopper after sterilization. Some stoppers feature a higher moisture uptake potential, weaker stopper drying kinetics and lower water release characteristics than others. Some stoppers are simply subjected to an inefficient drying process at the CMO – without anyone noticing. Check out our “check your lyo stopper“ service offering: You do not need to have a project running with us. You do not need to disclose your API nor any other details of your drug product. We simply need the sterilization and drying process protocol for your stoppers as performed at your CMO, and some stoppers (~ 100 pcs). Our experts will conduct a comparative evaluation on your stoppers versus modern state-of-the-art stoppers and carefully evaluate stopper drying kinetics, moisture uptake potential & water release characteristic. If you also want to find out whether you are already using a stopper that safeguards your lyo product, contact us at info@project-pharmaceutics.com. To learn more about our fields of expertise visit: https://lnkd.in/ePm5bWyF #processdevelopment #lyophilization #freezedrying #pharmaceuticalmanufacturing #CRO