PDA - Parenteral Drug Association’s Post

The Joint Commission has increased its focus on sterile processing departments. What can you do to get a passing grade? Are you going above and beyond to monitor every load? Do you have service agreements with your equipment manufacturers to ensure everything is running at optimal performance? Are you investing in your staff to keep them properly trained? "Monitoring of each piece of processing equipment should be performed to ensure the units are functioning properly. Sterilizer monitoring should be performed for each type of sterilizer in use and includes the use of challenge devices such as biological indicators (BIs) and chemical indicators (CIs). A surveyor will review this process, the frequency it’s performed, and whether the findings are documented during accreditation surveys. " #sterileprocessing #infectionprevention #accreditation #hospital #everyloadmonitoring #biologicalindicator

If you’d like to know about the Annex 1 contamination control strategy, then read on…

Introducing AWS Bio-Pharma Technologies' USA-made semi-automated IV Bag inspection systems. Our systems are meticulously designed, assembled, and supported to meet FDA standards and comply with USP 790 and USP 1790 for manual inspection requirements. Key Features: >  Delivering inspection results equal to or surpassing manual inspection (subject to your current SOPs). >  Enhanced lighting and magnification to reduce eye strain during inspection. >  Automated and synchronized material handling for a hands-free and streamlined inspection process, minimizing operator repetitive motions. >  Ensuring consistent bag presentation for easy inspector observation. >  Minimizing bubbles and agitating particles in the bag before inspection. Our IV Bag inspection systems will enhance your inspection efficiency and accuracy while adhering to FDA and USP standards. #AWS #inspection #asepticfilling #Innovation #IVFilling #QualityControl #qualitymatters #sterileprocessing #superiorquality #excellence #contaminationcontrol #costeffectivesolutions #GMPCompliance

We asked our Pure Primer: Sterile Compounding and Handling Hazardous Drugs instructors why USP <800> is so important. Read Patti's response below. https://loom.ly/SGOF_VQ

Introducing AWS Bio-Pharma Technologies' USA-made semi-automated IV Bag inspection systems. Our systems are meticulously designed, assembled, and supported to meet FDA standards and comply with USP 790 and USP 1790 for manual inspection requirements. Key Features: >  Delivering inspection results equal to or surpassing manual inspection (subject to your current SOPs). >  Enhanced lighting and magnification to reduce eye strain during inspection. >  Automated and synchronized material handling for a hands-free and streamlined inspection process, minimizing operator repetitive motions. >  Ensuring consistent bag presentation for easy inspector observation. >  Minimizing bubbles and agitating particles in the bag before inspection. Our IV Bag inspection systems will enhance your inspection efficiency and accuracy while adhering to FDA and USP standards. #AWS #inspection #asepticfilling #Innovation #IVFilling #QualityControl #qualitymatters #sterileprocessing #superiorquality #excellence #contaminationcontrol #costeffectivesolutions #GMPCompliance

CURIS Academy: Real-Life Decontamination Bloopers Blooper #3 - A Cautionary Tale of (Mis)measurement... ☣ One facility, aiming for precision, measured their room's cubic footage and input this figure into all four of their decontamination devices, treating the room at 4x the recommended amount. 🔬 Another facility, treating a 10x10x10' laboratory, programmed their system to decontaminate a 10,000 cu.ft. space (accidentally adding an extra zero and increasing their measurement by 10x the size). The result? Each room was significantly over-treated, wasting valuable consumables. These tales highlight two essential lessons: 📋  Always ensure you're well-acquainted with how your decontamination devices function, especially when deploying multiple units. 📐 Double-check your math. Alternatively, opt for systems like CURIS that auto-adjust for multi-device usage and can save dimensions and cycles, reducing chances of oversight. Remember, precision and understanding in your processes can save time, money, and resources. *Each story is a real life situation where those involved agreed to anonymously share their stories for others to learn. Interested in learning more about CURIS or requesting a quote? https://lnkd.in/gYEsJWp #biopharma #biotechnology #contaminationcontrol #annex1 #H2O2 #vaporH2O2 #biodecontamination #technology #riskmanagement #compliance #VHP #decontamination #validation #sterilization #lowtemperaturesterilization #cleanroom #isolatordecon #pharmamanufacturing #laboratoryanimalscience #HHP #7000ei #7000fi #laboratoryequipment #sterilityassurance #biosafety #microbialcontamination #microbialcontrol #bioburden #gmp #qualitycontrolsafety #spillresponse #asepticprocessing

5 common mistakes to avoid in cleanrooms and laboratories 🏥 #cleanrooms #pharmaceuticalindustry #laboratories #cableandpipeseals #certifiedsealing #biocontrol

A special thank-you to all who attended the presentation this morning at the Aseptic Processing Summit in Philadelphia: Elizabeth McQuade enjoyed the discussions after the presentation and getting to know so many who share her biosafety passion. Beth's focus today was: 'Efficacy and material compatibility of your decontamination process is critical to aseptic processing. Unwanted outcomes can greatly increase costs associated with equipment replacement, revalidation, and downtime. This presentation will take a risk-based approach investigating the effects of vaporous hydrogen peroxide (H2O2) on isolator and cleanroom surfaces to examine variations in efficacy and material effects. Studies will be examined to understand consequences of hydrogen peroxide concentrations on sporicidal results, residue accumulation and equipment failure to help determine suitable approaches that safeguard efficient processes in the GMP environment and help support new Annex 1 regulations. This presentation will aid industry professionals in making informed decisions in selecting appropriate decontamination methods that strike the right balance of efficient processes and superior outcomes.' Please reach out with questions or to request a quote: https://lnkd.in/ewx9XmJM Safe travels home and we will see you next year! #asepticprocessing #annex1 #decontamination #ccs #asepticfilling #contaminationcontrol #biodecontamination #materialcompatability #GMP #H2O2 #HHP #VpHP #biosafety

Sterile Compounding Requirements Demystified Leading sterile compounding experts share tips about the new USP <797> regulations. https://okt.to/2Eyprt

NEW VERSION of ISO 18562: Critical Implications   A new version of ISO 18562 has been released. Despite awaiting formal harmonization in Europe, this version is now in effect. Some important notes:   * Targeted Substances Reporting: Any targeted substances exceeding 1 microgram/m³ needs to be evaluated * Airflow Requirements: When sampling volatile organic compounds (VOCs), new airflow rates are described * Revised TTC Values: Updated Toxicological Threshold of Concern (TTC) values * Condensate Volume Assessment: Volumes exceeding 0.1 mL warrant thorough evaluation.   For accredited testing according to ISO 18562-2, -3, and -4, we invite you to explore our expertise at Emmace Consulting https://lnkd.in/dCqE9mmq