Expert Sterilization Validation Consulting: Ensuring Product Safety and Compliance
Having effective sterilization validation is critical in ensuring product safety and regulatory compliance. Lumino has decades of experience in validation and testing at your disposal to help define the most efficient path forward for this critical processing step. Lumino has the expertise to perform sterilization validation studies using Ethylene Oxide, Gamma, or Steam as appropriate to support ANSI, AAMI, and ISO 11135, 11137, and 17665 standards. In addition, we can review your microbiology processes to ensure regulatory compliance, including environmental monitoring and clean room evaluations; bioburden monitoring and trending programs; package shelf life evaluations; and on-site steam sterilizer validations.
Customized Solutions for Your Sterilization Validation Consulting Needs
We offer customized consulting solutions tailored to your specific requirements. Our team will work closely with you to understand your challenges, objectives, and regulatory obligations, and provide targeted consulting services to address them effectively. We leverage our expertise and industry knowledge to deliver practical solutions that drive product safety and regulatory compliance.
Ensuring Product Safety and Compliance
With our deep expertise in sterilization processes and a client-centric approach, we offer tailored consulting solutions to address the unique challenges and regulatory requirements of various industries. Our team of experienced professionals is committed to helping you navigate the complexities of sterilization validation and achieve your quality objectives.
Regulatory Compliance and Standards
Navigating the complex regulatory landscape is a key aspect of sterilization validation. Our expert consultants have in-depth knowledge of global regulations, including FDA, ISO, and industry-specific guidelines. We can assist you in developing effective sterilization validation strategies, preparing regulatory submissions, and ensuring compliance with the applicable standards. With our guidance, you can navigate the regulatory processes smoothly and efficiently, saving time and resources while meeting the necessary requirements.
Sterilization Method Selection and Validation
Choosing the appropriate sterilization method is critical for ensuring product safety and efficacy. Our consultants can help you assess and select the most suitable sterilization method for your product. We provide guidance on method validation, including biological indicator testing, sterilization cycle development, and documentation. With decades of experience, Lumino has the expertise to design regulatory accepted sterilization validation studies using ethylene oxide, gamma, or steam (moist heat) as appropriate to support ANSI, AAMI, and ISO 11135, 11137, and 17665 standards. We design and coordinate the execution of studies for validation of sterilization processes at your site (field validations) or at a contract sterilization facility. Our microbiology, chemistry, and toxicology laboratories are available to perform the testing associated with the studies including package integrity, stability, biocompatibility, bioburden, and expiration dating.
Small Batch Sterilization
Lumino can guide you through the sterilization process for the release of product from a single batch during research and development or for clinical trial product, or using the batch release approach as part of a full validation study.
Process Development and Optimization
Developing and optimizing sterilization processes require a deep understanding of the principles and best practices. Our consultants work closely with your organization to evaluate and optimize your sterilization processes. By conducting process audits, assessing cycle parameters, and implementing process improvements, we help you achieve sterilization efficiency, reduce costs, and enhance product quality.
Microbiological Monitoring and Control
Maintaining microbiological control throughout the manufacturing process is crucial for product safety. The knowledgeable, experienced staff at Lumino are able to evaluate the impact of changes to manufacturing operations, product or packaging configurations, or sterilization process to your validated processes. We can also guide you through required documentation including creating a sound rationale or the design of cycles and testing needed to support the change.
Microbiology Process Evaluation
Environmental control is a requirement of all Good Manufacturing Practices and monitoring, trending, and ongoing evaluations are key to maintaining control in your manufacturing operation or your microbiological laboratory. Lumino can help meet the requirements of your quality system regulation of your operation or laboratory by helping you design and optimize your monitoring programs, and through clean room evaluations and sterilizer validations. We can assist you with the setting of action and alert limits for your product and area monitoring. Lumino’s expertise includes:
- Environmental monitoring
- Bioburden monitoring
- Trending programs
- Clean room evaluations
- On-site ethylene oxide and steam sterilizer validation
Why Choose iuvoBioscience for Sterilization Validation Consulting?
As your partner for sterilization validation consulting, you benefit from our expertise, client-centric approach, and commitment to excellence. We have a proven track record of helping organizations establish and optimize their sterilization processes, ensuring product safety and regulatory compliance. Our focus on collaboration, integrity, and delivering actionable insights sets us apart as a trusted consulting partner.