Sterigenics’ Post

FDA recently issued two guidelines relating to sterility. In October 2023, Quality Considerations for Topical Ophthalmic Drug Products draft guidance was issued due to several incidents of contaminated eye drops. https://lnkd.in/gZPbKGSN In addition, an updated revision of the guidance: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” was issued on 8 Jan 2024. https://lnkd.in/dwgKis6c Struggling with Sterile and Aseptic F&F processes? We are here to help you align with the FDA's latest guidelines. 𝐂𝐨𝐧𝐭𝐚𝐜𝐭 𝐮𝐬 𝐡𝐞𝐫𝐞: https://lnkd.in/d_8jYVxw #biotech #biotechnology #biopharma #regulatorycompliance #regulatoryaffairs

Storage of #ATMPs frequently requires ultra-low temperatures (-80 °C ) or potentially even cryogenic temperatures (-150 °C) which challenges container closure integrity (#CCI). Lena Mungenast (Hochschule für Life Sciences FHNW) investigates the effects of storage at these temperatures for prefilled syringes using headspace analysis. She applies advanced strategies for temperature control, including precise control of cooling and heating rates as well as storage at any temperature between -160 to -20 °C. Lena just presented our latest results at 2024 PDA - Parenteral Drug Association Parenteral Packaging Conference in Copenhagen. A very challenging but equally rewarding topic with current implications for container closure integrity testing (#CCIT) strategies in the pharmaceutical industry. #PharmaceuticalPackaging #cryogenic #storage #Prefilled #Syringes

EDQM: New General Chapter on Extractable Elements in Plastic Materials Adopted While the European Pharmacopoeia (Ph. Eur.) already includes parts of the ICH Q3D guideline on elemental impurities in the general chapter on Elemental impurities (5.20), the requirements for extractable elements from plastic containers for pharmaceutical use and closures are legally binding. >>> read more: https://lnkd.in/eGj4z2KE #gmp #gmpnews #ichq3d #extractables

Dr. Reddy’s is among the earliest generic API manufacturers globally to file the USDMF for Linagliptin API. Besides this, we have DMFs filed in Brazil, Europe, Canada, and Korea. Our offerings: A mixture of crystalline Form A and Form B (a prior art form) Customized particle size distribution (PSD) to meet customer needs commercially. Producing Linagliptin in a greener approach with a high atom economy compared to the innovator, resulting in lesser formation of undesirable by-products Linagliptin API produced by the DRL process is free from all the GTIs Manufacturing process improved over the process disclosed in the product patent. To learn more about our API, download the tech sheet here: https://bit.ly/3KuscZ5. #WeAreDrReddys #GoodHealthCantWait #DrReddysAPI #APIPartner #Pharmaceuticals #DrReddysXSustainability #API #USDMF #LinagliptinAPI #BrazilDMF #EuropeDMF #KoreaDMF #CanadaDMF

Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Linagliptin API. Besides this, we have DMFs filled in Brazil, Europe, Canada, and Korea. We offer a mixture of crystalline Form A and Form B (a prior art form) and customized particle size distribution (PSD) requirements to meet the most desired PSDs commercially. We produce Linagliptin using a greener approach since the atom economy is high compared to that of the innovator due to the lesser formation of undesirable by-products. In addition, our manufacturing process has improved over the process disclosed in the product patent and is designed around the innovator's process of intellectual property (IP). To learn more about our API, download the tech sheet here: https://rb.gy/qohg76 #DrReddysXSustainability #GoodHealthCantWait #WeAreDrReddys #DrReddysAPI #ESG #Sustainability #APIPartner #Pharmaceuticals #LinagliptinAPI #USDMF #BrazilDMF #CanadaDMF

Recently, Tofflon achieved successful registration and public disclosure of a groundbreaking pharmaceutical packaging material: injection-grade cyclic olefin polymer (COP) vials and pre-filled syringe components. This accomplishment was recognized and acknowledged by both the China National Medical Products Administration (CDE) and the U.S. Food and Drug Administration (FDA). 🌟   Cyclic Olefin Polymers (COP) have revolutionized the field of packaging with their exceptional properties. Offering high purity, biocompatibility, and minimal extractables, COP materials overcome the limitations of glass while preserving transparency. COP exhibits numerous advantages, such as safeguarding sensitive biologics, withstanding ultra-low temperatures, and facilitating small-batch production. 🧪✨   Click to read the full white paper for more details: 👇   #COP #pharmaceuticalpackaging #biopharma #lifescience

🌡️ This #TemperatureThursday, we delve into the world of temperature mapping. The science of assessing temperature distribution is a linchpin for upholding precision. Discover more in our latest article, "The Significance of Temperature Uniformity in Pharmaceutical Temperature Mapping."  If you have temperature questions for our experts, feel free to send us an email. 📖  https://lnkd.in/e7KFTkjU #TemperatureMapping #ExpertInsights #ContactUs

Tune in for my live webinar tonight and learn everything you need to know about the new specialty and biosimilar approvals for 2023! Join me as I review the hottest specialty approvals and discover how you can incorporate these novel therapies into your practice! #pharmacists #freece #specialtypharmacy

In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable biosimilar presented a higher hurdle to approval: Applicants needed to show that a patient could be switched from the Reference Product to the biosimilar and back without issue. Read the blog post written by Sara Wexler Koblitz that discusses the guidance in further detail here: https://lnkd.in/eG2YKZKK #fda #biosimilars #fdalawblog

Ensure 100% cold chain compliance—every time. Real-time shipment tracking helps prevent the loss of precious, expensive pharmaceutical and life sciences shipments. Tive covers the full range of temperatures to all your support cold chain requirements—including dry ice and cryogenic shipments. Learn more 👉  https://hubs.li/Q02msH9b0