Speeding Investigations Using Instantaneous Microbial Detection™

Many pharmaceutical, biotechnology, ophthalmology and food and beverage companies manufacture and package their products in cleanrooms or other highly controlled environments using operating procedures designed to minimize or preclude microbial contamination of products. If an out-of-specification event occurs, then finding the root cause, taking remediation steps, and getting the manufacturing line back to full operational level becomes critically important.

Traditionally, the investigative tools and processes available to companies are retrospective, time-consuming, and may provide only circumstantial evidence supporting one or more root causes of microbial contamination. Growth-based methods using agar plates require three to seven days or more to incubate before meaningful results are obtained. This can cause a multi-day delay in every step of the process requiring microbial detection, including:

• Initial detection of microbial contamination
• Investigating root cause/probable cause
• Implementing remediation and corrective environmental control activities
• Verifying effectiveness of corrective and preventative actions