Call 619-842-1099
Product Validation
Assisted dose mappings, family groupings, and package design.
Validation Solutions Tailored to Your Sterilization Needs
Quantum EBX will provide clients with a deep understanding of industry standards and best practices for product validation.
We offer product validation services that encompass a wide range of activities aimed at ensuring the safety, efficacy, and regulatory compliance of radiation-sterilized products.
Key Services:
Product Validation
-
Product Evaluation and Optimization for Sterilization
We analyze packaging materials and configurations to provide recommendations that optimize dose distribution and throughput.
-
Dose Mapping
We conduct comprehensive dose mapping studies to determine dose distribution within product loads. We also optimize loading configurations for throughput and ensure all documentation meets regulatory requirements.
-
Dose Audits
We assist with routine dose audit testing to reduce risk and ensure ongoing compliance with internal procedures and regulatory requirements.
-
Maximum Dose Validation
We perform testing to determine the maximum dose a product can tolerate without compromising facility safety and efficacy.
-
Induced Radioactivity Evaluation
We evaluate products for potential induced radioactivity following radiation sterilization to ensure your product meets regulatory limits for release.
-
Establishment of Product Release Criteria
We assist in establishing product release criteria based on dosimetry data and control parameters established during product qualification (PQ) studies, ensuring only sterile and safe products are released to the market.
-
Special Handling and Storage Requirements
We provide guidance and create tailored procedures for products that require special handling and/or storage requirements.
-
Family Groupings
We assist in establishing family groupings for products with similar sterilization requirements, and creating procedures and records to support grouping rationale.
Call 619-842-1099
Product Validation
Assisted dose mappings, family groupings, and package design.
Validation Solutions Tailored to Your Sterilization Needs
Quantum EBX will provide clients with a deep understanding of industry standards and best practices for product validation.
We offer product validation services that encompass a wide range of activities aimed at ensuring the safety, efficacy, and regulatory compliance of radiation-sterilized products.
Key Services
-
Product Evaluation and Optimization for Sterilization
We analyze packaging materials and configurations to provide recommendations that optimize dose distribution and throughput.
-
Dose Mapping
We conduct comprehensive dose mapping studies to determine dose distribution within product loads. We also optimize loading configurations for throughput and ensure all documentation meets regulatory requirements.
-
Dose Audits
We assist with routine dose audit testing to reduce risk and ensure ongoing compliance with internal procedures and regulatory requirements.
-
Maximum Dose Validation
We perform testing to determine the maximum dose a product can tolerate without compromising facility safety and efficacy.
-
Induced Radioactivity Evaluation
We evaluate products for potential induced radioactivity following radiation sterilization to ensure your product meets regulatory limits for release.
-
Establishment of Product Release Criteria
We assist in establishing product release criteria based on dosimetry data and control parameters established during product qualification (PQ) studies, ensuring only sterile and safe products are released to the market.
-
Special Handling and Storage Requirements
We provide guidance and create tailored procedures for products that require special handling and/or storage requirements.
-
Family Groupings
We assist in establishing family groupings for products with similar sterilization requirements, and creating procedures and records to support grouping rationale.
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