PDA - Parenteral Drug Association’s Post

👉Why clean rooms are important? 👉What is a clean room? 👉ISO 14644-1 For cleanrooms? 👉EU GMP Cleanrooms? 👉Viable Vs Non viable Particles? 👉Sterile products are prepared in? 👉OSD cleanrooms Class? Read all these in following 👇👇👇👇👇👇👇👇👇👇👇👇👇👇👇 https://lnkd.in/dKtN9bRT

👉Why clean rooms are important? 👉What is a clean room? 👉ISO 14644-1 For cleanrooms? 👉EU GMP Cleanrooms? 👉Viable Vs Non viable Particles? 👉Sterile products are prepared in? 👉OSD cleanrooms Class? Read all these in following 👇👇👇👇👇👇👇👇👇👇👇👇👇👇👇 https://lnkd.in/dccpQRaR

👉Why clean rooms are important? 👉What is a clean room? 👉ISO 14644-1 For cleanrooms? 👉EU GMP Cleanrooms? 👉Viable Vs Non viable Particles? 👉Sterile products are prepared in? 👉OSD cleanrooms Class? Read all these in following 👇👇👇👇👇👇👇👇👇👇👇👇👇👇👇 https://lnkd.in/dDpshh5s

thanks #BSM for this extensive and fascinating description of the asepting filling process showing state-of-the-art technology. #siberg is also there, implementing significant part of the automation software, integrating #Steriline machines and isolators with other units and achieving FDA 21CFR Part 11 compliance of the whole filling line

🔹 The revised EU GMP #Annex 1 is intended to provide comprehensive guidance to manufacturers of sterile products. Changes include the design and control of facilities, equipment, systems, and procedures ensuring that microbial, particulate and endotoxin/pyrogen #contamination are prevented. 🔹 It's important to note - not only are these new regulations beneficial for #manufacturing sterile products, but for any products where the control and reduction of microbial, particulate and endotoxin/pyrogen contamination are important. #annex1 #contamination #manufacturing #onlinecourses #SymmetricTraining with James Drinkwater

Clean in Place vs Sterile in Place, Similarities and Differences ⬇️⬇️⬇️⬇️ Similarities 1. Both ensure equipment cleanliness without disassembly. 2. Automation for repeatability and efficiency. 3. Time efficient compared to manual cleaning. 4. Used in pharmaceutical, food, and biotech sectors. 5. Crucial for hygiene standards compliance. Differences 1. CIP removes soils, SIP achieves sterilization. 2. CIP uses cleaning solutions, SIP uses steam or chemicals. 3. SIP guarantees sterility, CIP does not. 4. SIP requires stricter validation processes. 5. SIP uses higher temperatures for sterilization. #cloudbridge #lifesciences #boston #healthcare #validation #IQ #pharma #validation #analytical

Clean in Place vs Sterile in Place, Similarities and Differences ⬇️⬇️⬇️⬇️ Similarities 1. Both ensure equipment cleanliness without disassembly. 2. Automation for repeatability and efficiency. 3. Time efficient compared to manual cleaning. 4. Used in pharmaceutical, food, and biotech sectors. 5. Crucial for hygiene standards compliance. Differences 1. CIP removes soils, SIP achieves sterilization. 2. CIP uses cleaning solutions, SIP uses steam or chemicals. 3. SIP guarantees sterility, CIP does not. 4. SIP requires stricter validation processes. 5. SIP uses higher temperatures for sterilization.

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Aseptic Processing and Fill Finish Equipment: 𝐂𝐨𝐧𝐭𝐚𝐢𝐧𝐦𝐞𝐧𝐭 | 𝐒𝐭𝐚𝐭𝐞-𝐨𝐟-𝐭𝐡𝐞-𝐚𝐫𝐭 𝐈𝐬𝐨𝐥𝐚𝐭𝐨𝐫 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲     Our isolators are designed to ensure safe filling of aseptic and high potent medications, protecting both products and personnel in the best possible way. The maximum process safety is ensured by reliable cycles with lower H2O2 consumption, and, above all, a significantly reduced cycle time for the entire system. 𝐊𝐞𝐲 𝐛𝐞𝐧𝐞𝐟𝐢𝐭𝐬 of our containment systems:    ✔ Aseptic production through H2O2 decontamination of the isolator  ✔ Robot safety to minimize risk to operator and process  ✔ Design is simple to clean and to operate  ✔ State-of-the-art technology to ensure efficient processes  ✔ Design in accordance with cGMP, CE, GAMP5 and 21 CFR Part 11 guidelines    You want to learn more about our equipment solutions?  🌐 https://lnkd.in/eAwEVYYP  📧 info@ebetech.de    #equipmentsolutions #IsolatorTechnology #containment #asepticprocessing #fillfinishtechnology #steriline 

We know that USP regulations can be challenging, to say the least. DiNovo is here to help you push through those challenges, establish effective procedures and meet your compliance requirements. Our "Best Practices for Compounding Pharmacy USP Regulation Compliance" PDF goes through each of the five stages of the compounding process where various operating procedures and validation protocols would be required. We help break down each stage to create a checklist for your facility. Click the button below to see how well your pharmacy is doing! Download our Cleanroom USP Compliance Checklist Here: https://lnkd.in/etpjygU #compoundingpharmacy #compounding #503A #503B #sterileprocessing #asepticprocessing #sterile #USP #USP797 #USP800 #pharmacytechnician #pharmacytech #pharmacytechnicians #pharmacysaftey #pharmaceuticalsaftey #cleanrooms #medicaldevice #microorganisms #disinfectant #disinfecting #healthcare #hospital #hospitals #complianceregulations #hospitalequipment #lab #labsupplies #bestpractices #SOP #compliance #FDA