Clean Facility Roundtable Part 1: Must-Have Technologies

A robust environmental monitoring program is essential in demonstrating that your aseptic processes are in control.  Even though it has been around for decades, active air sampling remains one of the best tools for EM. However in order for air samplers to generate the best data, they need to be in calibration. Is calibrating once or twice a year enough? Having the ability to calibrate your fleet of air samplers on a routine basis is the best way to show regulatory inspectors that your data is the best that can be. Also, incorporating integrated active air samplers into isolators is a must-have. These systems are calibrated in place and can be automatically decontaminated. Lastly media plates are now packaged in gamma irradiated beta bags for isolator applications in which plates are brought in only when you need them.

The core regulatory guidelines for microbial monitoring have not changed dramatically in recent years, but the guidance documents around these guidelines have become more explicit in calling out the risk of manual observations. The guidelines call for a risk based approach to contemporaneous secondary verification and have suggested that computer interface and automated technology is one way to reduce the risk associated with human observations.

There are certain technologies and methods for microbial monitoring which are very well-established. Testing should be done at regular intervals. Viable sampling, air and surface bacterial and fungi counts, is a must to observe general trending and determine if cleaning regiments are sufficient. Methods will vary depending on the areas of interest but examples include: air samples, fallout plates, contacts and swabs.

These tools are efficient and cost-effective, and will serve a pharmaceutical company well in meeting microbial monitoring requirements. Looking to the future, we are seeing increasing interest in rapid bioburden and sterility.

There are situations when clients will need to implement continuous monitoring process, for example manufacturers and when validating a clean room.

Many of our clients, looking to establish a more robust microbial monitoring program, are requesting that we add microbial identification to their testing package.

You cannot have a secure environmental monitoring (EM) program without quality culture media. To validate fertility of the media, a growth promotion test must be performed on each incoming batch with strains both referenced in the pharmacopeia as well as those isolated from the plant. High-quality reference strains as well as customized plant isolates can be purchased commercially and deliver accurate, consistent results.

EM media must also be able to neutralize the harsh disinfectants used in pharmaceutical manufacturing facilities. Suitable testing should be performed to validate efficacy of neutralization before first use and repeated any time a change of disinfectants is made.

The sampling process itself should be standardized since different contact times and different sampling pressures lead to different recovery results. Sampling devices such as contact plate applicators and frequent re-training of the persons doing the sampling can help mitigate inconsistencies.

Data Integrity is of critical importance. To ensure the EM data are accurate, trustworthy and reliable, any source of human error should be avoided as much as possible. Since any manual step is a potential source of error, it would be ideal to automate the reading step and the administrative steps.

Lastly, data trending. The clean areas around the very protected cleanroom zone must be sampled on a regular basis and colonies detected should be identified systematically. Both the number of colonies and identification of the microorganisms found must be noted in a trending software tool. Any change in count and identification is valuable information in case of contamination. The review of those data on a frequent basis should be defined accordingly.