Comprehensive Packaging Testing & Validation
- Packaging integrity testing and validation (ISO 11607-1 & ISO 11607-2)
- Performance testing of medical-grade paper and Tyvek pouches
- Sterilant penetration testing (ISO 17665, ANSI/AAMI/ISO 11135)
- Drying time validation (ISO 17665, ANSI/AAMI/ISO 11135)
- Indicator performance testing (steam, EO, gamma) (ISO 11140-1)
- Chemical indicator color stability testing (AAMI, ISO 11138-7)
What is packaging integrity testing?
It evaluates the ability of packaging to maintain sterility and protect the product throughout its lifecycle.
Do you support sterilization validation?
Yes, we provide validation for sterilization processes including steam, EO, and gamma.
Can you test Tyvek and medical-grade packaging materials?
Yes, we perform performance testing for medical-grade paper and Tyvek packaging.
What is indicator performance testing?
It evaluates the effectiveness of chemical and biological indicators used in sterilization processes.
Are your tests compliant with global standards?
Yes, our services align with ISO, AAMI, and ANSI standards for packaging validation.
Package Integrity. Trusted Outcomes.
Packaging plays a critical role in maintaining product sterility, integrity, and safety, especially for medical devices and healthcare products. At Accuprec, we provide comprehensive packaging testing and validation services aligned with global standards to ensure packaging performance and regulatory compliance.
Our capabilities include packaging integrity testing, sterilization validation, performance testing of medical-grade materials, and indicator evaluation. We support various sterilization methods including steam, ethylene oxide (EO), and gamma radiation.
With expertise in ISO and AAMI standards, we deliver reliable, reproducible, and audit-ready results to support product safety and regulatory approvals.
Our Approach to Accurate & Compliant Testing
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
