Midwest Sterilization Corporation


Midwest Sterilization Corporation is a leading provider of contracted ethylene oxide (EO) sterilization services for the medical device industry. With a focus on quality, innovation, and community involvement, MSC operates two centrally-located U.S. facilities offering extensive sterilization capacity and state-of-the-art technology. The company is woman-owned, FDA-registered, and committed to excellence in sterilization services, supporting public health and the healthcare industry worldwide.

Industries

health-care
manufacturing
medical
medical-device
pharmaceutical

Nr. of Employees

medium (51-250)

Midwest Sterilization Corporation


Products

Ethylene Oxide (EO) Sterilization

Provides contract sterilization services for medical devices using ethylene oxide, a method essential for many types of medical equipment.

Rapid Sterility Release

Offers quick release of sterilized products, ensuring they are ready for use in a timely manner.

Testing and Validation

Conducts testing and validation for new product development, ensuring compliance with sterilization standards.

Quality Inspections

Performs inspections of finished products using customer-specified procedures to ensure quality standards are met.

Project Management

Supports new product launches and cycle/product validation, assisting with supply chain and packaging needs.


Services

Contract EO sterilization

Facility-based ethylene oxide sterilization for a variety of medical device types using validated or custom cycles.

Parametric/rapid sterility release

Release approaches that use validated process parameters and monitoring (parametric release) to accelerate sterility release timelines, supported by biological indicator monitoring where applicable.

Testing and validation services

New cycle development, validation testing (fractional, half, and full cycles), and testing of new devices to establish validated sterilization processes in accordance with standards.

Finished product inspection

Quality inspection services performed using customer SOPs or developed inspection processes to verify finished-product conformance prior to release.

Project management and commercialization support

Project coordination for new product market launch, validation support, packaging and supply chain considerations for sterilized products.

Expertise Areas

  • Contract ethylene oxide sterilization
  • Sterilization process validation and qualification (IQ/OQ/PQ)
  • EO sterilization process engineering and cycle development
  • Quality management and regulatory compliance (ISO 13485, FDA registration)
  • Show More (3)

Key Technologies

  • Ethylene oxide sterilization
  • Parametric release (rapid sterility release)
  • Self-contained biological indicators
  • Process challenge devices (PCDs)
  • Show More (3)

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