INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Extract Technology integrated the necessary viable and non-viable particle monitoring within the machine along with the use of a 21CFRPart 11 validated paperless (touch screen) chart recorder to enable the customer to review each stage of the cycle in full detail.

  • Explore a broad range of ready-to-use culture media designed to detect a wide range of microorganisms and meet the highest requirements of microbial monitoring in sterile production environments.

  • Speed-to-market is the number one driver in the pharma/bio industry today ... the faster our clients can build facilities, the quicker they can get treatments into the hands of the patients who need them the most. The AES Fast Lane program is an accelerated Design, Manufacture, and Installation program that fast tracks your cleanroom facility project in seven months.

  • Unused IWT cGMP compact parts washer, model 200EVO-060. The model 060 is a high-efficiency compact washer designed for precision cleaning in regulated environments. With a 21.2 ft³ (0.6 m³) chamber volume, it optimizes cleaning capacity while maintaining a small footprint of 12.9 ft² (~1.2 m²). The unit stands 8.2 ft (2,500 mm) tall, with a total volume of 105.8 ft³ (3 m³) and a 20% chamber-to-volume ratio, ensuring effective space utilization and thorough cleaning performance. Serial# 251139, built 2022. The unit is already packaged, and installation is included with the sale for seamless setup and operation.

  • R&D, pilot work, and commercial manufacturing operate side by side, helping complex APIs scale smoothly with strong process insight, containment, and regulatory focus.

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.