BioVigilant – April 2018
New Rapid Microbiological Method (RMM) instruments permitting the instantaneous detection of microbes in water are emerging for use in the assessment of pharmaceutical water quality.
This fact sheet provides a summary of microbial test results obtained with the IMD-W-series instantaneous microbial detection™ system for water.
The IMD-W™ system has been designed to provide continuous, online monitoring of ultrapure water systems for bioburden.
IMD-W technology is based upon the principle of using Mie scatter and autofluorescence to detect microbes on a particle-by-particle basis (as opposed to bulk detection used by certain chemical methods).
IMD-A systems offer a unique opportunity to provide technicians with immediate feedback on microbial and particle levels, delivering a valuable tool for operator training programs and assessments.
The purpose of this document is to help guide material characterization testing which investigates the particulate shedding of commonly used cleanroom materials during typical use, to aid in their selection, and to gain a greater knowledge and control of one’s cleanroom environment.
Compressed air and other gases are used for a range of applications in pharmaceutical and food and beverage manufacturing, including applications involving direct product contact. As such, these gases should be monitored for levels of microbial and particulate contamination.
Cleanroom product manufacturing is common across multiple industries including pharmaceutical, biotech, ophthalmological, and food and beverage manufacturing. The procedures, acceptable practices, and quality metrics during periods of production are often clearly delineated within industry standards documents or internal SOPs. Environmental Monitoring (EM) is typically a key element of production, as manufacturing in controlled environments would be unnecessary were it not important to the final product quality.
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.
This application note provides some ideas on ways in which air quality can be managed by using the Azbil BioVigilant’s IMD-A® system as tool for airflow reduction assessments leading to utility cost reductions. The IMD-A system can be used as a way to accurately quantify microbial variability within an environment, both passively and continuously, thus supporting the reduction of Heating, Ventilation, and Air-Conditioning (HVAC) operation in cleanrooms to reduce energy costs within a facility.
For pharmaceutical manufacturing, it is important to understand cleanroom environments’ microbial content and dynamics so that manufacturing operations can be performed with minimal risk. This is reflected in the need to generate rationales for environmental monitoring (EM) sample site selection,
to review and understand the impact of specific activities within that cleanroom, and to perform proactive risk assessment on the product manufacture or process itself.