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Environmental Monitoring

These services include quantification analysis of Viable Particles in Environmental Air and Surfaces, as well as quantification analysis of Non-Viable Particles in Environmental Air. Recovery of microorganisms from the air and different types of surfaces using TSA or SDA culture media, for bacteria and fungi. This analysis is commonly used to meet the requirements of the environmental monitoring program based on ISO 14698 requirements. Measurement of non-viable particles using laser scattering equipment for particle sizes from 0.3 µm to 10.0 µm, for confirmation of compliance with ISO 14644-1.

Microbiología y Calidad Industrial, MCI

Consulting Services

Consulting/training services

Consulting and training in different areas: Good manufacturing practices, Environmental monitoring program and bio-contamination control, Quality audits, Clean room and other controlled environments validation, Compressed air system validation, Water purification system validation, Sterilization qualification and routine monitoring (radiation, ETO, dry heat and steam), Sanitization methods and performance evaluation, Laboratory QMS implementation as per ISO 17025 requirements, among others.

Microbiología y Calidad Industrial, MCI

Consulting Services

Analysis in Products

These services include Bacterial endotoxin testing (LAL or pyrogen test), Bioburden Test and Biological indicators (BIs) sterility testing. LAL qualitative method (gel-clot) and quantitative method using photometric technique (turbidimetric or chromogenic) for determination of endotoxin on product, raw material or water samples. Validation and testing technique in accordance with ANSI/AAMI ST72 and USP [85]. Enumeration of bio-contamination present on samples (finished product, component or raw material) as per ISO 11737 standard. Four testing categories available on request: aerobic and anaerobic bacteria, bacterial spores and fungi. Sterilization´s routine monitoring and performance qualification. Sterility verification on biological indicators (BIs) for dry heat, steam, ETO processes as per ISO 11138 and USP [1229.5]. Population verification on BIs, inoculation of products and PCDs preparation are available upon customer´s request.

Microbiología y Calidad Industrial, MCI

Consulting Services

Water testing

Potable and process water testing for routine monitoring and qualification of purification systems. Heterotrophic plate count (R2A, TGE, or TSA media) by filtration method and coliform bacteria / E. coli by both qualitative technique (P/A method) and quantitative technique (MPN method). Testing methods executed as per current Standard Methods for the Examination of Water and Waste Water.

Microbiología y Calidad Industrial, MCI