Environmental Monitoring

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Advanced Cleanroom Services offers daily, weekly, quarterly, and bi-annual EM programs. Environmental Monitoring (EM) programs are to establish alert and action limits withing your cleanroom. ISO 14698-1&2 along with USP 797 outline the criterial to help validate the integrity of the cleaning and disinfection programs used inside your cleanroom. 

Examples of areas that we samples are:

·  Fill/Finish

·  Formulation

·  Tank Rooms

·  Laminar Flow Hoods

·  Biological Safety Cabinets

·  Isolators/Glove boxes

·  IV Compounding

·  Sterile Packaging

·  Medical Device

·  Personnel Monitoring

·  Gloved Finger Tips

·  Media Fill Simulations

Air samples are measured in two ways; the first being by drawing in predetermined volumes of air over a sterile growth plate and the second exposing growth plates to the environment for a specific period of time.

Surfaces are monitored to measure the effectiveness of the cleaning program. High contact equipment such as tabletops, process equipment, walls and floors are monitored regularly to ensure that the cleaning program is consistent and comprehensive.

EM Program Features:

• Establish static and dynamic monitoring times and locations
• Use calibrated instruments and media within expirations
• Sample air and surfaces for viable bio-burden
• Sample water and steam lines
• Incubate samples according to ISO 14648 or customer’s SOPs
• Count, record gross morphology and as required, Gram stain
• Perform species identification as requested.
• Test air and nitrogen lines and send sampling canisters out for testing.
• Perform trend analysis.  Trend analysis will be sorted by Gram staining, gross morphology, quantity and locations.  Species identification will be performed as required and included in the trending chart.
• Input data into customer software.
• Participate in, investigate excursions as requested or required.