The environmental data generated during the environmental monitoring program allow the analysts to ascertain the functionality of all the systems in place to provide aseptic conditions during the pharmaceutical production. Data are analyzed to determine whether the systems are in control. Manual collection of data requires the generation of worksheets describing sample site, date, analyst signature, and sample type, e.g., air, water, contact. Sta- tistical analysis of test results is trended by using a database computer pro- gram or laboratory information system (LIMS).
Several commercial computer systems are available. A thorough dis- cussion on the capabilities of computerized systems for supporting data management and analysis in environmental monitoring by Moldenhauer [34] has recently been published. A reliable software system includes:
Environmental sites to be sampled Types of samples, e.g., air, water, surface Data collection
Reporting
Automated generation of worksheets
Automated generation of labels
Automated alert limit notification Automated action limit notification
Automatic generation of deviation notification Record tests to be performed
Record specifications Methods
Monitoring frequencies
Capability to input microorganism identification
Automatic objectionable microorganism notification with review of
the previous microbial data
Trending and statistical analysis
Computer security to prevent data modification
Computer security to restrict access only to authorized personnel Software validation requirements must be determined before routine use for product testing and release. It is important that the software chosen complies with 21CFR part 11 regarding issues such as security, audit trail, and restoration of lost data.
13. CONCLUSION
Environmental monitoring programs for sterile and nonsterile pharmaceu- tical facilities comprise the analysis of personnel, processes, raw materials, and finished products. Critical areas during pharmaceutical manufacturing must always be in control to minimize the distribution, viability, and prolif- eration of microorganisms. When an environmental monitoring program is in place, environmental monitoring data are evaluated to determine whether or not the series of environmental controls continue to operate as intended. Statistical analysis is used to evaluate an environmental monitoring program. A gradual increase or decrease in microbial counts over time, or a change in microbial flora or counts on several plates of a particular area on a given day, would constitute a trend. Environmental fluctuations are intrinsic of an en- vironmental monitoring system. This is because clean rooms and controlled environments are not supposed to be sterile, and constant intervention by personnel and materials represents continuous challenge to process control and cGMP. Optimization of pharmaceutical manufacturing relies on the in- tegration of different systems and processes to minimize microbial insult resulting in safe and efficacious products.
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