ExoXpert’s Post

I am proud to share this blog that was collaboratively developed by the NovaSterilis and iFyber teams on the topic of sterilization validation - https://bit.ly/3TQ8QD0. Also, a shoutout to former team member Devin Zysling Craven whose work and imagery while at iFyber makes this topic easier to process and understand. For those of you bringing new medical products to market, I hope you find this informative as you think about your sterilization strategies. #sterilization #validation #supercritical #regulatory

Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale. Try this ÄKTA system in 3D https://lnkd.in/eYBQk_Di

Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot 600 supports scale-up from process development to GMP clinical scale. Try this ÄKTA system in 3D https://cytiva.link/fajey

Prefilled ApiJect Injector: - combination of two trusted technologies: the Blow-Fill-Seal (BFS) aseptic drug packaging process, and a pen needle-style needle hub. - Administer a 0.1mL to 2.0mL delivered dose on a 0.2mL to 2.1mL fill. Credit to API Ject

https://lnkd.in/gw_VfP4T There plenty of folks on this platform that are clean room experts, they design them, they built them, they service them and clean them. Obviously this was not the case for this case. For the rest of that are not experts but do wind our way into them more than occasionally, you can tell within a very few minutes if the place was built to appear to be a clean room and ends not even been a "controlled” area. You instantly think did someone take the firm for a ride or did the firm take itself for one when it was built. Who is fooling who? From fancy equipment that was never used to the equipment that was overused and not serviced according to validation. You ask for the basics of validation of the room and you quickly learn the validation parameters were breached long ago due to additional equipment, processes and personnel not even remotely resembling the original study. This is common in small to medium medical device firms, and drug firm. You quickly learn that the production personnel has not dusted (sorry had to) off the study and have no idea of what’s in the study, done fretting before they were hired. That said enjoy this W/L on the subject.

Pharma packaging security is critical to ensuring patient safety, and one way to do this is to make packages more tamper-evident. The most common method of accessing a package is to cut the closure seal and cover the evidence with transparent tape. Labeling specialist Schreiner MediPharm has launched a new cut-through indicator that makes it easy to spot when a seal has been tampered with. Read more here: https://lnkd.in/d924x49u #packaging #labeling  #TamperEvident  

🔬💡 Exciting Update: Explore the World of Sterilization Methods! 🎥✨ Join us as we unravel the differences between Terminal Sterilization and Aseptic Processing in our latest video! 🌐🔒 Discover the key distinctions and advantages of each method, shedding light on crucial processes in the pharmaceutical and healthcare industries. 🏥⚗️ 👉 Click the link below to watch the video and deepen your understanding of these essential sterilization techniques! 📽️🔍 #SterilizationMethods #PharmaIndustry #Healthcare #ContinuousLearning

Clinical manufacturing needs for your nasal spray project can vary depending on scale and scope, and can revolve around: 👉 Accounting for a limited supply of API. 👉 Working with an API requiring cold chain storage. 👉 Working with controlled substances. 👉 Supporting multiple devices and containers. That’s why your CDMO partner must offer flexibility throughout clinical manufacturing. Discover how we can meet the needs of your next nasal spray project in our application note. #ClinicalManufacturing #NasalSprays #CDMO #DrugDevelopment

Are you facing challenges in meeting the requirements outlined in Annex 1 for your early phase drug products? Dive into our whitepaper to discover how our sterile fill/finish services are designed to ensure compliance and precision. From Contamination Control Strategies to Pre-Use Post Sterilization Integrity Testing, we provide the expertise and technology to navigate the complexities of Annex 1. #eurofins #testingforlife #sterilefill #smallbatch #earlyphase

The market for complex generics in oral solid dosage (OSD) forms is expanding swiftly, yet it brings distinct challenges. 💊 Tackling complicated formulations and adhering to stringent regulatory requirements demands that drug sponsors secure a partnership with an adept CDMO to surmount these obstacles. Our most recent blog delves deeper into these issues and offers perspectives on how choosing the appropriate CDMO partner can be crucial for project triumph. 🗝️ Discover more by clicking below. 👇 https://gag.gl/eDHMce #OSD #ComplexGenerics #CDMO #Alcami