INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Natoli Scientific’s preclinical stability studies represent a critical facet of our pharmaceutical testing services, providing essential data on the shelf life and storage conditions of drug candidates. These studies are expertly designed to evaluate physical, chemical, and microbiological stability, ensuring that formulations retain their safety, efficacy, and quality over time. Our state-of-the-art facilities simulate various environmental conditions to scrutinize the integrity of products under stress-testing scenarios. The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.

  • Per Center for Disease Control (CDC) guidelines for cleaning and disinfecting viruses and other pathogens, any form of disinfection necessarily follows cleaning. The process of cleaning will remove any residues that might shield any virus or pathogen from the disinfection step that comes next. Disinfection, following thorough cleaning and rinsing, can be done with bleach solutions, 70% alcohol solutions, or other products with EPA-approved emerging viral pathogens claims. As outlined by CDC, bleach solutions should reside on surface for at least one minute and can be made as follows:

    • 5 tablespoons (1/3rd cup) bleach per gallon of water, or
    • 4 teaspoons bleach per quart of water

    An excellent cleaning and wiping solution can be made with 0.5% (0.75- 1.5 oz/gal or 5 mL/L) Alconox® Powdered Precision Cleaner or Liquinox® Critical Cleaning Liquid Detergent, depending on preference for powder or liquid concentrate, respectively. Following which, per the CDC guidelines, wipe with the above bleach solution or other disinfectant solution. Allow wiped-down surfaces to sit for several minutes before rinsing to complete the disinfection.

  • Unused Watson-Marlow Flexicon (WMFTS) vial filler, Type Cellefill Ibio, designed for biohazard applications (OEB Level 3-4). Fills up to 25 vials per minute with Flexicon integrated peristaltic pump infeed. Features IPC via built-in load cell with automatic feedback, stoppering, and crimp capping for flip-top caps with built-in force measurement. Pick-and-place discharge, EM monitoring, SQL database data collection, and automatic vial size adjustment. Built 2022.

  • Safer hazardous compounding starts with contained airflow, dependable asepsis, and operator-first ergonomics. See how compact design, glove testing, and remote support come together to improve control.

  • ZEROC is the new RTP tester developed to perform a complete integrity test on Rapid Transfer Ports (Alpha part), installed on isolators or RABS, and their containers (Beta part) in a fully automatic way.

FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.