Sterilization Program Management


Excel partners closely with contract sterilizers to validate sterilization processes and perform routine sterilization cycles and associated testing for EtO and Gamma sterilization programs. Excel manages sterilization programs for customers to ensure that requalifications and dose audits are performed per applicable standards at the appropriate times.

Testing Offered

Excel utilizes a wide array of measuring and monitoring devices (MMD) and techniques to ensure compliance with all applicable specifications, standards, and regulations. High precision test equipment is utilized throughout all stages of product realization. MMD is routinely calibrated according to Excel’s calibration program utilizing highly qualified ISO 17025 laboratories as appropriate. All state of the art testing is performed in accordance with internationally recognized standards and internally established procedures.

Package Strength Testing

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    Tensile Strength / Seal/Peel Testing (ASTM F88)

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    Burst Testing (ASTM F1140, ASTM F2054)

Package Integrity Testing

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    Visual Inspection (ASTM F1886)

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    Dye Penetration Testing (ASTM F1929)

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    Bubble Emission Testing (ASTM F2096)

Sterilization Laboratory Testing Coordination

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    Bacterial Endotoxin Testing (LAL)

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    Bioburden Testing

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    EtO Residual Testing

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    Product and Biological Indicator Sterility Testing

Additional Testing Offered

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    Product Functionality Testing

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    Pressure Testing

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    Tension and Compression Testing

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    Dimensional Measurement

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    Biocompatibility Testing Coordination per ISO 10993

Validation

We offer comprehensive, customized, data driven validation services to customers for their new and existing products. We are experienced in coordinating the appropriate validations to bring products to market in a timely and cost effective manner, while complying with all applicable standards and regulatory requirements. Our customers trust us to handle their protocol development, sample preparation, testing coordination, and report preparation.


  • Process Validations (IQ, OQ, PQ)
  • Cleaning Validations
  • Shelf Life Studies – Real Time Aging and Accelerated Aging (ASTM F1980)
  • Distribution Testing (e.g., ASTM D4169, ISTA 2A)

  • Packaging Validations (Pouch and Tray Sealing)
  • Sterilization Validations
  • Sterilization Program Maintenance (Bioburden Action/Alert, Process Parameter Review, Requalifications / Dose Audits: EtO and Gamma Radiation)