LexaMed services include providing our clients with environmental monitoring services for their certified cleanroom, classified spaces or clean controlled production areas. LexaMed can provide your organization with rental sampling equipment (viable and non-viable samplers) and consumables (growth media) so that you can perform your validation and routine EM sampling activities yourself. As an option, LexaMed can provide a trained technician/microbiologist to perform the environmental monitoring.
All broad-spectrum media such as TSA (Tryptic Soy Agar), typically in RODAC or standard 100mm plate format, and any selective or differential media such as SDA (Sabouraud Dextrose Agar), Rose Bengal Agar, etc. will be sourced from certified and approved vendors. The media will pass Quality Control checks (growth promotion) prior to release for use both in house and in the field (at client site). All EM samples may be processed in our ISO 13485, ISO 17025 certified laboratories where they will be incubated, enumerated and reported by our Quality System. At your discretion LexaMed can characterize and identify your recovered environmental organisms (surface or air) to Genus-species level. All C of A documentation and growth promotion records are maintained by LexaMed Quality Department.
LexaMed maintains Bioscience International SAS Super 100 air samplers for viable organism environmental monitoring of the air within production or support areas of your facility. The air samplers are fully compliant to national and international standards for environmental air monitoring (including ISO 14698-1, EU GLP-GMP, EN45001, ACGIH, USP <1116>, and USP <797>). The SAS units are calibrated to sample 100 liters of air per minute thus providing a 1 cubic meter (1000L) sample in a 10-minute time frame. The air samplers are maintained on an annual calibration frequency and all NIST traceable calibration certification and documentation is on file within LexaMed Quality Department.
LexaMed maintains Lighthouse SOLAIR 5350 model non-viable particulate air sampler for use in cleanroom qualification or routine EM activities. The SOLAIR 5350 unit has an intuitive color touch screen interface, built in thermal printer and calibrated vacuum pump flow rate delivering 3.53 CFM or 100 LPM performance. The laser diode and detection optics enable an 8 channel particle size resolution from 0.3 micron to 25 micron including the typical ISO particle reporting sizes of 0.5 and 5.0 microns. The printed report is available in 3 formats (Federal Standard 209E (ft), EU GMP Annex 1 and ISO 14644-1). The air sampler is maintained on an annual calibration frequency and all NIST traceable calibration certification and documentation is on file within LexaMed Quality Department.
LexaMed also provides a smaller hand-held version of Lighthouse non-viable air sampling equipment (model 3016 Particle Counter) for use in smaller production areas and cleaned controlled environments. This unit offers the same software interface and reporting structure as the larger SOLAIR model but with a 0.1 CFM (2.83 LPM) NIST calibrated flow rate.
Please contact LexaMed for a rental quotation or inquiry about the availability of a trained LexaMed representative to carry out your environmental monitoring needs.
If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.