ethylene oxide, radiation and moist heat

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 SCIENCES NEW JERSEY LABORATORY 12 WORLDS FAIR DR SOMERSET, NJ 08873 P: 651.738.2728 F: 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 WAY WOBURN, MA 01801 P: 781.305.4940 F: 781.305.3780 LIFE SCIENCES | STERILIZATION SUPPORT 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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Page 1: ETHYLENE OXIDE, RADIATION AND MOIST HEAT

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

LIFE

SCI

ENCE

S | ST

ERIL

IZAT

ION

SUP

PORT

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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