Process Development and Validation
Life Science Outsourcing’s manufacturing and engineering experts act as an extension of your team to identify the critical processes and test methodologies necessary to qualify the associated manufacturing steps. We can write the protocol, perform the required testing, and provide you with a well-documented final report.
Process Development and Validation Services:
- Assembly process definition and design
- Test procedure definition and design for process
- Tooling and fixture design plus fabrication
- Equipment and Process Validations (IQ, OQ and PQ)
- Design of Experiment (DOE)
- Validation protocol development, testing, and reports (IQ, OQ and PQ)
- Sterile package seal strength characterization
Tooling and Fixture Design
Over the past 24 years, Life Science Outsourcing has developed a specialty in tooling and fixture design. This industry-leading expertise helps reduce costs and creates the possibility to bring products to market that might otherwise be cost-prohibitive or too difficult to manufacture utilizing standard methods.
- Starts with our experienced team of engineers evaluating the products and manufacturing processes.
- We then work closely with product design engineers to determine the most efficient and effective tooling and fixture solutions.
- Next, our engineers coordinate with our qualified vendors to develop the tooling and fixtures, while ensuring that they meet the exact drawing specifications.
- Finally, all tooling and fixtures are validated to the most rigorous standards to ensure that no issues arise once production begins.
From sealing tools to multipurpose manufacturing and assembly fixtures, our team is committed to helping you to identify and create the best tooling and fixture solutions to streamline your manufacturing process, save on costs, and bring the highest quality products to market.
Process Optimization & Efficiency
Life Science Outsourcing’s engineering team works to create and maintain high levels of Process Repeatability and Process Capability (CpK). Optimizing the process such that output values fall well within the prescribed specification range ensures an effective product and process, which in turn leads to reduced costs in terms of waste (scrap and labor), reduced cycle times, and higher yields of qualified products.
Developing manufacturing documentation and a quality system that is compliant, efficient, and easy to maintain as you grow can be a burdensome effort which, if done improperly, can lead to significant consequences and challenges.
Partnering with the Life Science Outsourcing team provides access to manufacturing documentation and a quality system that has been audited by the FDA and is reviewed and audited over 50 times a year by our customers.
Because we are building from this extensively audited quality system, the manufacturing documentation that we develop is efficient and easy to use while exceeding industry and regulatory standards. Our quality and process engineers can build customized manufacturing documentation that meets your specific needs and allows your company to tap into existing documentation and processes.
Manufacturing Documentation Services:
- Development of customized documentation
- Process development
- Implementation and adoption into practice
- Training of personnel – including ISO 13485, FDA QSR (GMPs), Corrective Actions
- Continuous Improvement/Gap Assessments – including ISO 13485, FDA QSR (GMPs)
Front-end Design Assistance
Life Science Outsourcing’s product and package design and engineering support services provide guidance on design, details, and development. This includes comprehensive consultation services.
- Design for manufacturability analysis
- Consult on parts design
- Consult on material selection
- Sterile package design
- Shelf and shipping box design and configuration
Shelf and Shipping Box Design and Configuration
Through our extensive work with startups, Life Science Outsourcing’s engineering teams have regularly manufactured products for the customer’s clinical trials. For clinical trial production, our experts provide label designing, tooling and fixture designing, risk analysis, failure mode effect analysis (FMEA), product inspections, and process validations.
Through our comprehensive suite of solutions, Life Science Outsourcing coordinates support services such as sterilization validations and package testing and validations. In addition, our engineers can assist you in defining and developing assembly processes, writing product and packaging specifications, and creating validation protocols and reports.