Risk Assessments & Master Validation Plans
Our validation philosophy is to provide focused expertise that assists firms to compliantly and cost effectively execute a validation program. B&R can provide a broad range of validation services, including:
Risk Assessments: The foundation of any system qualification or validation is a proper risk assessment. B&R is proficient in utilizing the Failure Mode and Effects Analysis (FMEA), as well as the Hazard Analysis of Critical Control Points (HACCP), which are accepted by FDA.
Analytical Method Validation: We can assist you in developing and/or executing validation and system qualification protocols to establish that your analytical methodologies and equipment are equal or superior to the USP / NF compendia methods, and have over 20 years experience in this activity.
Manual and Automated Cylinder Fill Validation: B&R has stock validation protocol templates that we can easily and cost effectively adapt to your business and compliance needs. Using our protocol templates and assistance you can easily validate your high pressure and cryogenic liquid filling systems to meet current FDA requirements. If you are contemplating purchasing or in the process of installing a new fill system, we can provide guidance on documentation you need to have the system manufacturer provide that will facilitate validating your system in the future.
Electronic Recordkeeping and Signature System Validation: Today firms are moving towards maintaining production records electronically, as well as capturing signatures of individuals electronically. Using these systems to maintain FDA records requires that you appropriately validate the system. B&R has hands on experience in validating recordkeeping systems commonly used in the Medical Gases industry. We have the expertise to guide you through this process as painlessly as possible.
Computer Controlled Systems: Manufacturing and analytical equipment that are computer controlled or operated are required by FDA to be validated. B&R has the experience and expertise to develop and execute a validation that is both FDA compliant and cost effective.
Automated Plant Validation: B&R has hands on experience in developing and executing FDA compliant validation protocols for automated plants that produce medical products. We have successfully validated Air Separation and Helium facilities, as well as Carbon Dioxide facilities that manufacture medical grade gases. The principals of B&R participated directly in the development of the current approach to ASU validation used by the majority of the industry today.
Cleaning Validations: B&R has assisted firms to design and execute programs and procedures to validate their cleaning processes related to gases. With our practical and focused approach to validation they were able to successfully achieve their goals without breaking the bank.