MedicalDevice_TLB_8.25

Microbiology/Chemical Testing

Available from Element

Located in Warsaw, Indiana, Element Warsaw has broad microbiological and chemical analysis capabilities. With a recent relocation to a 15,000 sq ft facility, Element Warsaw has expanded its laboratory capabilities and specificity. Additional expansion within the new facility also includes ISO Class 5 Workstations and ISO class 7 Cleanroom Laboratories.
Element Warsaw is proud to support the medical device and pharmaceutical industries providing analytical support to Quality, Process Validation and R&D programs. Companies across the country depend on our technical expertise, industry-leading turn-times and attention to changing regulations.

STANDARDS WE SUPPORT
• USP Test Methods, ISO Test Methods, FDA BAM Test Methods, USDA FSIS Test Methods, AOAC Test Methods, AOCS Test Methods

OUR SERVICES - Medical Device and Pharmaceutical
• Bioburden
• Pathogens
• Endotoxin (BET/LAL) – Kinetic Chromogenic or Turbidimetric
• Cytotoxicity

Special Analyses and Services
• Shelf-Life Studies
• Growth Promotion Studies
• Container Rinse Testing
• Direct Microscopic Examinations
• Air Testing

Chemistry
• Percent Moisture
• pH
• Water Activity

ACCREDITATIONS
• ISO/IEC 17025:2005, Laboratory Accreditation Bureau (L-A-B)
• Indiana State Department of Health (ISDH) Drinking Water

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