Rapid microbial enumeration is making big waves in pharmaceutical quality control. Through the use of digital imaging technology and robotic cassette handling, manufacturers can realize significant labor savings, minimize out-of-specification investigations and better allocate human capital.
With the current generation Growth Direct™ System each step, product and environment in the manufacturing process can be tested with a single instrument. Once installed, validated and programmed, the Growth Direct™ System can perform the following microbiology tests.
Water and Bioburden
The Growth Direct™ System can automate all of the quality control applications required for raw materials bioburden testing, whether those materials are solids or liquids. Perhaps the most important of these applications is standard water testing, where the traditional 3- to 5-day test leads to a constant, unknown and unacceptable risk status for water usage. With such long incubation times, manufacturers can only ever be sure last week's water was clean – and last week's production didn't start with tainted materials.
Growth Direct™ System shortens this process with its proprietary charged-coupled device (CCD) imaging technology, which detects micro colonies of as few as 100 cells. Compared to the traditional method, QC analysts can determine the microbial levels of water supplies in half the time or less, ultimately allowing for more confidence during production. Fewer finished products are lost, and QC personnel can address contamination events far more quickly.
In addition to water-filterable materials, the Growth Direct™ System can analyze surface, air and personnel samples for environmental monitoring. The system detects all molds, yeasts and bacteria commonly found in manufacturing clean rooms, and its CCD technology allows for positive results within hours.
The Growth Direct™ System’s high-capacity incubators also enable fewer resources to perform more testing than manual methods. For the traditional 3-day environmental test, the instrument will process about 466 samples per day at a single temperature. For the 5-day test, it can process about 280 samples per day at a single temperature or around 233 cassettes across two temperatures.
Finally, the Growth Direct™ System is capable of testing the sterility of finished products with both aerobic and anaerobic cassettes in high- and low-volume environments. The device handles samples from vials, ampules, syringes and IV bags, and an average of 20 sterility samples can be run per day. Positive results are available within hours, and final results typically in half the time of traditional sterility tests.
Because these methods are non-destructive, quality control personnel can quickly follow up with additional tests to identify the microbes on out-of-specification cassettes, and take any preventative actions.
A Comprehensive Solution
With all of these capabilities in one device, pharmaceutical companies can drastically reduce their quality control costs at each phase of the manufacturing process. Implementing the Growth Direct™ System for bioburden, environmental monitoring and sterility testing also enables:
- Efficient Training: Each application uses a sample preparation technique identical to the traditional method, so no new training is required. Employing the same process across different applications also makes it easier to train new employees and reallocate labor.
- Regulatory Compliance: When using the Growth Direct™ System for multiple applications, manufacturers simply need to validate the accuracy of the instrument's imaging technology and the performance of alternative growth media. Since the device automates a proven process, the validation of alternative methods is not required.
- Labor Savings: QC personnel can spend far less time inspecting plates and counting colonies – and far more time designing tests and addressing standard operating procedures. When installed directly on production lines, the Growth Direct™ System can be operated by manufacturing personnel.
Discover more about the benefits of automated rapid detection and enumeration by downloading our free eBook here.