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There is a constant challenge for companies involved with aseptic processing to attain a higher degree of environmental control in order to avoid product contamination.
Since 1987 when the FDA Guidelines on Aseptic Processing were issued, there has been an ever increasing focus on environmental monitoring as it relates to the potential contamination of products. The evidence of the regulatory agency's heightened interest in environmental monitoring comes from the increasing number of FDA-483's and Warning Letters issued.
In response, industry trade associations including the Parenteral Drug Association (PDA), the Institute for International Research (IIR), and the International Society for Pharmaceutical Engineers (ISPE) established task forces and published guidelines to address these issues.
Over the years, companies attempting to comply with the regulations and industry standards have struggled with spread sheets, custom developed applications, and ultra-expensive LIMS packages.
Manufacturers are now seeking cost-effective solutions for their environmental monitoring operations that are meaningful, manageable, and defendable.
The Microbiology Information Management System (MIMS®) is one such system.
MIMS has been specifically designed to manage environmental monitoring data in accordance with regulatory requirements and industry guidelines.