QUALITY SOLUTIONS, INC.

MEDICAL DEVICE STERILIZATION CONSULTING

CSM - Complete Sterilization Management

Rather than delegate sterilization management to an inexperienced or overworked staff member, contract with us for a comprehensive program of sterilization assurance services. To most effectively outline our services, the following is a program we would suggest for a start up company intending to design, produce and market a new device.

• Initial site visit to review the product family details and manufacturing environment.
• Establish lines of communication with key members of the management team via telephone, fax, email.
• Conduct training seminars with key employees covering biocompatibility, bioburden, manufacturing environment, sterilization, major regulatory concerns.
• Assist with the selection and start up of a cleanroom for device production.
• Establish an in-house laboratory, or select a qualified contract laboratory, and perform a full GLP audit.
• Review product design concept and proposed materials for biocompatibility evaluation.
• Establish written program and standard operating procedures for biocompatibility test requirements each time a change in material occurs.
• Provide the device design team with relevant information regarding all available sterilization methods in order to select most compatible materials.
• Select the most appropriate sterilization method.
• Design and install in-house sterilization system, or evaluate all potential contract sterilization service providers.
• Select contract sterilization service provider, negotiate service contract, perform complete GMP audit of the facility.
• Design and perform sterilization process development; design and execute sterilization process validation protocol.
• Specify all sterilization related product and packaging testing.
• Generate the sterilization validation final report, routine processing specification, and all standard operating procedures necessary for routine sterilization.
• Establish a sterilization compliance program in which sterilization device history records are sent to a consultant's office for review and approval.
• Perform process deviation investigations to determine probable cause, suggest corrective action, evaluate need to resterilize.
• Perform sterility failure investigations to determine probable cause, recommend corrective action, and determine the impact on the process validation.
• Perform study and develop protocol to allow adoption of new products and/or packaging configurations into previously validated sterilization process.
• Schedule and perform annual revalidations.
• Demonstrate process equivalency in additional sterilizers through reduced microbiological validations. 

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