Ask Rapid: Your EM Questions Answered

POSTED BY Rapid Micro Biosystems | 7 minute read

Discussing new TR-13 guidance on environmental monitoring, plus frequently asked questions about the Growth Direct® System.

pda-conference

With its 2022 revision of Technical Report No. 13, Fundamentals of an Environmental Monitoring Program, the Parenteral Drug Association (PDA) is urging consideration of rapid microbiological methods and automated monitoring by makers of sterile pharmaceutical products. TR-13 notes that RMM and automation have come a long way since the original report was issued in 1990, becoming “more convenient, performant and accepted, or even recommended, by regulatory bodies.”

If you’re still doing conventional environmental monitoring (EM) but feel growing pressure to modernize, the report is well worth reading. In Section 5.5 it notes that RMM or automated monitoring methods can offer a variety of EM uses:

  • Confirmation in real-time (or close to real-time) of microbial control during manufacturing activities such as manual aseptic manipulations, filling, and packaging
  • Confirmation of microbial control in manufacturing suites or gowning rooms
  • Rapid assessment of controlled areas during facility qualification activities
  • Evaluation of contamination remediation efforts, from finding contamination sources to assessing cleaning and disinfection procedures

A critical first step for any microbiologist proposing a replacement EM method such as our Growth Direct® System is asking questions. In this post we’ll share answers to some of the most frequently asked questions that we hear about environmental monitoring.

How does the Growth Direct® System achieve the same results as the compendial method?
Based on traditional media formulations and incubation conditions set by standards-making (compendial) industry bodies, the Growth Direct® System simply automates environmental monitoring by integrating digital imaging, robotic handling, incubation, and software control within a single test instrument. After sample collection, bar-coded cassettes containing growth media are loaded in bulk and sorted by a robotic arm for scanning and imaging, before entering built-in incubators and being checked automatically every four hours. Microcolonies exposed to LED light are captured as illuminated pixels on a photosensitive charge-coupled device (CCD) chip, then counted automatically by image analysis software without errors and contamination caused by human handling.

Is the Growth Direct® System validated as an alternative method?
Our method mirrors the current environmental method and generally requires only accuracy and precision testing for validation. Unlike novel or alternative detection methods, the Growth Direct® System has been proven to meet conditions for an automated system of traditional microbial plate counting according to USP <1223>. Consequently, it does not require full validation and may be implemented in a microbiology laboratory after simple method verification of enumeration accuracy.

What samples can be tested?
Our Growth Direct® instruments can test air, surface, and personnel samples.

What is the expected throughput?
A single Growth Direct® instrument can hold up to 659 active cassettes, enabling high-throughput EM testing that accommodates varying factors such as test duration, incubation schema, and the number of cassettes already loaded. For example, a three-day test at a single temperature can be conducted on up to 219 samples per day.

Does my sample preparation need to change?
No, sample preparation would mirror your existing processes.

Does the Growth Direct® System need to be in my lab?
Because the instrument is self-contained with built-in incubators, imaging, and detection software, the system can be placed virtually anywhere. Some companies have chosen to place the instrument closer to the manufacturing area to shorten travel time, particularly in large facilities.

Is integration to LIMS available?
Yes. The Growth Direct® System for environmental monitoring has been seamlessly integrated into a wide range of laboratory information management systems (LIMS) – accelerating the availability of sample data beyond the lab and eliminating potential human errors associated with manual processing.

What kind of services and support are available?
One of the strengths of Rapid Micro Biosystems is the experience and depth of our support team. We can provide:

  • On-site installation
  • Instrument services
  • Validation services (i.e., IOQ, PQ, and Method Validation, including full documentation package and on-site support)
  • Regulatory compliance assistance
  • Technical support throughout the Americas, Europe, and the Asia Pacific region
  • System certification training and new personnel/training refreshers


Where can I learn more?
For extensive data on use of the Growth Direct® System in environmental monitoring, try these articles:

Have more questions? Simply contact Rapid Micro Biosystems today. We’ll be happy to discuss ways to modernize your environmental monitoring program, resulting in faster time-to-result and shorter cycle times for the release of finished product.