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Licensing
Consulting Services
Testing includes viable and non-viable particulate, oil content, humidity (pressure dew point) test and other contaminants, commonly executed to demonstrate compliance with ISO 8573 requirements.
Microbiología y Calidad Industrial, MCI
Consulting 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
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
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
Consulting Services
We develop energy management innovating way that adapt to each of our clients, allows us to develop projects based on savings and not investment. We created a monitoring control center from where our operation is carried out, we transform data into knowledge and translate it into efficiency and savings. Energy consumption analysis and control Load factor optimization Technological projects Alternative energy systems implementation
Apame
