www.pacelifesciences.com
pace analytical life sciences puerto rico laboratory
EL RETIRO INDUSTRIAL ZONE P.O. BOX 325 / CALLE B&C SAN GERMAN, PR 00683 P: 787.892.2650 F: 787.892.1054
pace analytical life sciencesnew jersey laboratory
12 WORLDS FAIR DR SOMERSET, NJ 08873 P: 651.738.2728F: 651.714.9360
pace analytical life sciences minnesota laboratory
1311 HELMO AVE. N OAKDALE, MN 55128 P: 651.738.2728 F: 651.714.9360
wolfe laboratories a subsidiary of pace analytical life sciences
19 PRESIDENTIAL WAYWOBURN, MA 01801 P: 781.305.4940 F: 781.305.3780
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ETHYLENE OXIDE, RADIATION AND MOIST HEAT Pace Analytical Life Sciences (PLS) offers a wide array of laboratory services to support sterilization validation, requalification and routine sterilization. PLS procedures meet the requirements of USP, EP and ISO/AAMI standards for sterility, bioburden, endotoxin and biological indicator testing. PLS provides a fully trained staff who are highly experienced in GMP requirements, and a robust and well-supported quality assurance program. Laboratory support covers a wide range of product types: from aseptically-filled to terminally- sterilized parenteral solutions through a wide range of medical devices and sub-components.
Ethylene Oxide• Bioburden - ISO 11737-1 - Routine Method Suitability - Routine Testing• Test of Sterility - ISO 11737 - Method Validation - Routine Testing• Biological Indicator Testing• Ethylene Oxide Residuals - ISO 10993-7 - FTIR Methodology for Low Level Analysis• Endotoxin Testing – USP <85>• Material Testing
Radiation• Bioburden - ISO 11737-1 - Routine Method Suitability - Dose Setting / Dose Audits• Test of Sterility - ISO 11737-2 - Method Suitability - Dose Setting / Dose Audits• Endotoxin Testing – USP <85>• Physical and Functional Testing• Material Testing
Our labs are cGMP-compliant, FDA registered, DEA registered and ISO/IEC 17025:2005 accredited.
Moist Heat• Biological Indicator Testing• Sterility Test – USP <71>• Endotoxin Testing – USP <85>• Material Testing• Particulate Testing
Life Sciences_Sterilization Support
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