Secure, gap-free records for regulatory compliance with 21 CFR Part 11
The key objective of the cleanroom monitoring system is to protect products and to maintain cGMP (Current Good Manufacturing Practice) to meet FDA requirements. A continuous record of data is always available even during network interruptions. Many cleanroom facilities have traditionally used chart recorders to track conditions. Unfortunately, chart recorders are vulnerable to mechanical problems and other issues like overwritten charts, dry pens, or failure during power outages, which results in data gaps. Even more problematic is the fact that most chart recorders lack methods for remote alarming when conditions go out of tolerance. Over the last few years an increasing number of cleanrooms have begun to use data loggers for monitoring critical environments to meet the requirements of ISO 13485 and ISO 14644.
Monitoring systems can be installed on any existing network via Ethernet, PoE (Power over Ethernet), WiFi or any combination. All monitoring systems should produce:
Cleanroom Monitoring Parameters:
All Cleanroom monitoring depends on highly sensitive sensors. Every type of sensor becomes less accurate over time. Component aging, the environment, and handling all have an impact on accuracy. All sensors should be calibrated on a yearly basis. On site calibration assures minimum disruption to the system and completing the calibrations quickly.
Regulatory compliance to demonstrate cleanroom performance may also include controlled product bioburden monitoring of the environmental conditions in the cleanroom environment. Environmental Monitoring (E/M) is a program designed to demonstrate the control of viable (living microorganisms) and non-viable particles in critical areas. These areas include clean-rooms for drug fill/finish, formulation tank rooms, laminar flow hoods, biological safety hoods, isolators, glove boxes, molding machines, kit assembly lines, Intravenous (IV) compounding areas and sterile packaging. Viable monitoring refers to testing for the detection and enumeration of bacteria, yeast and mold. It includes the monitoring of personnel, air and area surfaces for microbial contamination. And differs from non-viable environmental monitoring which is a reference for particle counts measured by a laser counter. Viable counts provide metrics on the potential for contamination of a company’s products as well as demonstrating the veracity that a clean room is functioning as designed and being properly maintained. Surface and air monitoring exhibit the asepsis of the product manufacturing operation,
Bioburden Testing, per ISO 11737-1, and USP 1231 may be required to help establish sterilization validations accordance with ISO11737 and as part of in-process checks to ensure production processes are not compromising sterilization validations. In addition, water samples may be tested for bioburden to ensure that water systems are performing within the required specifications.