Erich Bozenhardt, PE’s Post

Just finished two days of exciting sessions related to the current (and future!) state of aseptic processing during the ISPE Aseptic Conference in beautiful Vienna. Additionally, the ISPE Aseptic Conference provided great networking opportunities and an excellent Expo Hall allowing for great discussions between supply and demand👏. Now it's time to digest, discuss and delegate the newly obtained knowledge with the rest of Aseptic Processing Consult.🤙 #GMP #Aseptic #APC #ISPE

Join me and & Liquid Handling Specialist Steve Beckett, to learn all about #cellculturecontamination #cellculture #cancerresearch #academicresearch vs. #pharmabiotech #drugdevelopment #ATMPs #GMP #CGTs #bestpractices & validated solutions NOT to be missed 🧐 ❓ Learn about the types, sources, & consequences of #contamination in #research vs. #GMP production 🔔 Learn how to mitigate contamination risks through implementing effective prevention strategies. 🛠 Understand the critical factors that need to be considered for #labequipment & #consumables 🔍 Recognize validated solutions & tactics for effective disinfection in research vs. GMP, as per latest edition of EU Pharmacopeia Thursday July 4 at 15:00 BST / 16:00 CEST Register now! https://lnkd.in/esgZHhbK #CellCulture #Webinar

7 days to go until the 2023 #ISPE Pharma 4.0™ and Annex 1 Conference in Barcelona, olé! This year's focus is an exciting mix - among other things Annex 1 implementation, Rapid Monitoring and Testing & Pharma 4.0™ integration have secured themselves a first-class ticket!   🤫 Spoiler alert: Applications that can benefit from using alternative and rapid microbiological methods (#ARMM) for monitoring include: - Continuous automated monitoring of aseptic & support environments - Improved root cause investigations & room release, and many others!   We are looking forward to chat about your experience and questions regarding the #Annex1, #bfpc, #contaminationcontrol and #GMP

There is heightened focus on the Contamination Control Strategy (CCS) centered around not only physical mechanisms to control contamination but now also emphasizes how the mechanisms work together and how they are managed as a group. Join us for the ISPE Annual meeting and attend our workshop on Sunday, October 15th 9 a.m. to noon. WHAT'S IN IT FOR ATTENDEES: - Engage in the development of a CCS using a case study and supporting documentation from an existing cGMP facility. - Gain exposure to a methodology to develop a CCS that was performed for the actual facility that is used for the case study. - Interact with different procedures and design documents and see how the documents support each other and work together to ensure that the facility operates in a way to prevent contamination of drug products. - Learn how to use of Layers of Protection Analysis (LOPA) for the CCS. - Experience realistic challenges during the creation of the CCS and gain valuable lessons learned from Genesis SMEs who helped industry leaders successfully execute their CCS methodology. Speakers include: Norman Goldschmidt, David Raab, Jeff Odum, CPIP, Stephen M. Hall (Genesis AEC) and Jose A. Caraballo (Kite Pharma). Learn more. https://lnkd.in/e2VDBHuZ #GenesisAEC #facilitymanagement #contamination #ispe

A #RestrictedAccessBarrierSystem (RABS) is an advanced aseptic processing system that can be utilized in many applications in fill-finish and processing areas. https://bit.ly/2Za4EE4 #RABS #PharmaSafety #CleanroomTechnology #ContainmentSystems #SterileManufacturing #BarrierIsolation #pharmaceuticalsindustry #QualityControl #Biopharmaceuticals #pharmaceutical #healthcare #research #inos #inostechnologies

A #RestrictedAccessBarrierSystem (RABS) is advanced aseptic processing system that can be utilized in many applications in fill-finish & processing areas. https://bit.ly/2Za4EE4 #RABS #PharmaSafety #CleanroomTechnology #ContainmentSystems #SterileManufacturing #BarrierIsolation #pharmaceuticalsindustry #QualityControl #Biopharmaceuticals #pharmaceutical #healthcare #research #inos #inostechnologies

Aurobindo Pharma's Eugia Unit III Sterile manufacturing facility has received a 483 with nine observations, bringing the company back into the regulatory spotlight. The USFDA inspection conducted from Jan 22 to Feb 2, 2024, revealed poor aseptic techniques and inadequate environmental monitoring practices, linked to data integrity concerns. Further enforcement actions are expected based on the seriousness of the observations. A redacted copy of the 483 is attached. At PCGI, we specialize in implementing robust and compliant sterile manufacturing processes and controls to prevent potential 483 observations. Contact us today to learn more. #AurobindoPharma #USFDA #manufacturingcompliance #sterilemanufacturing #483observations #dataintegrityconcerns

🧠 Here are our three highlights from the PDA - Parenteral Drug Association #ATMP conference in Amsterdam: 1️⃣ Particle Control and Visual Inspection: Roman Mathaes and Antonio Burazer discussed the holistic challenges of particle control and visual inspection for cell therapy products in the industry. Key issues include: - Manual manufacturing processes - Quality of manufacturing materials, which shed particles - Absence of sterile filtration processes - Poor performance of traditional particle control analytical methods - Visual inspection is also often impacted by turbid solutions. 2️⃣ Leaks in Single-Use Manufacturing Components: Rebecca Jordan presented on assessing leaks in single-use components. She emphasized that not every leak compromises sterility, advocating for a risk-based approach to evaluate patient safety risks. 3️⃣ Development and Compliance of ATMP Products: Patrick Buschor shared insights on supporting the development of multiple ATMP products, highlighting considerations for GCP, GDP, and GMP systems. 🙏 A big thank you to PDA, Caroline Lynar, Christopher Haertig, and the fantastic chairs Richard Denk and Renske ten Ham for the excellent organization and support. Contact us for support in particle control & visual inspection for cell&gene therapy products #healthcare #pharmaceuticalindustry #CGT

⏳ 𝗔𝗡𝗡𝗨𝗔𝗟 𝗖𝗢𝗡𝗚𝗥𝗘𝗦𝗦 𝗔𝟯𝗣 𝗠𝗜𝗗𝗗𝗟𝗘 𝗘𝗔𝗦𝗧 𝟮𝟬𝟮𝟰 🗓 May, 29 & 30 in Cairo (Egypt) CCS / APS / Single Use / Freeze Drying Discover the full programme: 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀: 🔊 ROUGING - Management and solutions to Rouge in pharmaceutical settings By Walid EL Azab - QP PRO SERVICES 🔊 PDE - Approach for Cross Contamination Control By Pierre Devaux - THERAXEL 🔊 CCS - Aseptic Filling Line Case Study By Patrick Coppens - ISOTEC'XEL 🔊 MICROBIOLOGY - Rapid Methods and Evolution of Microbiology Testing By Marc MAURO - PMM 🔊 SINGLE USE - Technology & Perspectives in light of GMP Annex 1 Requirements By Jean-Philippe MINNE - PARKER 🔊 MICROBIOLOGY - Rapid Sterility Testing Method By Guillaume Devun - BIOMERIEUX 🔊 Gloves of Isolator & RABS What quality and operational criteria are used to select a supplier By Antoine Toussaint - GSK 🔊 Centrifuge Separation technology either Multiuse or Single use for Biotech Up Stream By Björn Gustavsson - ALFA LAVAL 📒 𝟱 𝘄𝗼𝗿𝗸𝘀𝗵𝗼𝗽𝘀 𝗶𝗻 𝟮 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝘀𝗲𝘀𝘀𝗶𝗼𝗻𝘀: 💬 ROUGING - Rouge, dergouging and passivation management 💬 CCS 1 - Return on experience after 1 years of application of new GMP Annex 1, case study 💬 CCS 2 - GMP Annex 1 Gap Analysis and Building a robust CCS 💬 VALIDATION - Sterile Filtration Validation, Approach and Deployment 💬 STERILIZATION - Sterilization of indirect product contact parts 🔳 𝗔𝗻 𝗲𝘅𝗵𝗶𝗯𝗶𝘁𝗶𝗼𝗻 INFORMATION & REGISTRATION: https://lnkd.in/e5iTTcYX #a3p #pharma #cairo #congress #ccs #aps #singleuse #freezedrying

TRIO.BAS™ REMOTE HEAD SYSTEM for Continuous Air Microbial Monitoring https://ow.ly/SIHa50RJIkk The new generation of ORUM microbial air samplers called “CM” have been developed to follow these new indications of GMP Annex 1. - #triobas #airsampler #microbiological #environmentalmonitoring