Sterilization

1. Partner with Venture Capitalists to evaluate potential business opportunities (i.e., due diligence, support to VC after purchase of new company for consolidation of departments and strategic planning and/or management).

2. Support to healthcare manufacturers

• Develop sterilization strategic goals for companies – focus on reduction in cost and optimization of sterilization processes.

• Partner with R&D during the device design phase where finished product sterilizability must be determined.

• Provide training on sterilization principles to companies that have an in-house capability, but lack experience.

• Coordinate sterilization development, testing and validation services using contract or in-house laboratories.

• Trouble-shoot sterilization aberrations relative to qualification studies, positive sterility tests, etc.

• Create product categories to streamline the number of different cycles/doses that are required for its products and possibly take out cost at the same time.

• Provide technical responses to 483 observations relative to sterilization.

• Conduct audits of in-house and contract laboratories or sterilization facilities.

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Quality Assurance / Regulatory Affairs

• Provide strategies and assist in the development of documentation to meet the Quality Systems Regulations (QSR).  Preparation and/or guidance in the development of Quality Manuals and Standard Operating Procedures.

• Develop strategies for responding to inspectional observations in the area of Quality.

• Develop appropriate and accurate product complaint systems.

• Trouble-shoot environmental monitoring failures.

• Provide training for GMP, Deviation Reporting and Investigations.

• Conduct internal and vendor audits.

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Pyrogen

• Develop LAL test validation programs for finished products, components or raw materials.

• Develop validation programs for depyrogenation processes.

• Resolve process and product endotoxin testing problems including:

  1. product inhibition and enhancement of LAL tests,

  2. false positive LAL test results due to non-endotoxin LAL-reactive materials, and

  3. disagreement between LAL test results and rabbit pyrogen tests.

• Draft position papers justifying changes to USP or FDA LAL test guideline methodologies.  For example:

  1. reducing LAL test sample sizes, and

  2. conducting LAL testing of medical devices prior to sterilization as opposed to post-sterilization.

• Draft technical responses to LAL test or rabbit pyrogen test 483 observations and/or other regulatory or compendial compliance issues.

• Provide educational seminars about endotoxins and endotoxin testing.
  Provide LAL test and rabbit pyrogen test training.

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Maintenance of Sterility (Packaging)

• Develop strategic goals for companies – focus on reduction in cost and optimization of packaging processes.

• Partner with R&D during the device design phase where finished product sterile barrier systems must be determined.

• Provide training on packaging to companies that have an in-house capability, but lack experience.

• Coordinate packaging development, testing and validation services using contract or in-house laboratories.

• Trouble-shoot packaging aberrations relative to qualification studies, problems with packaging systems following distribution.

• Conduct audits of in-house and contract packagers, or laboratories.

• Perform Packaging Design, Development and Qualification Protocol and Testing; Production Equipment Selection, Manufacturing Process Development, Critical Process Validation and Package Shelf Life Test Protocols and Testing.

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