Life Science & Package Integrity Testing Services
Tasatec proudly provides a complete suite of Life Science Development, CCI Analytical Testing, and Helium Leak Testing services to support pharmaceutical, biologics, and medical device manufacturers. Our solutions help ensure reliable package integrity, regulatory compliance, and high-confidence decision-making throughout the product lifecycle.
Life Science Development Service
Keywords: recipe creation, test method development, validation
Our Life Science Development team offers end-to-end support for establishing robust container closure integrity (CCI) methods.
We begin with recipe creation, evaluating positive and negative controls to define initial acceptance criteria. These parameters form the basis for accurate and repeatable test method development tailored to your specific package type.
All methods are optimized to meet GMP expectations and USP <1207> requirements. Once development is complete, we provide full validation support with structured protocols, clear documentation, and traceability to ensure your CCI method is fully compliant and ready for long-term use.
CCI Analytical Testing Service
Keywords: feasibility study, detection limit
Tasatec offers third-party CCI analytical testing using deterministic, nondestructive technologies including Vacuum Decay and MicroCurrent HVLD.
Our service begins with a feasibility study to evaluate method suitability and assess the sensitivity of your packaging system.
Through statistically supported testing and laser-drilled defects, we establish the detection limit (LOD) of each method. This ensures the method can reliably detect critical leaks and aligns with regulatory expectations such as Maximum Allowable Leakage Limit (MALL), USP <1207>, and FDA guidance.
This service is ideal for sterile products, high-value batches, and organizations without in-house CCIT capability.
Helium Leak Testing Service
Keywords: comprehensive helium leak test, cold storage testing
Tasatec provides comprehensive Helium Leak Testing, the gold standard for quantitative package integrity evaluation. Our service supports R&D, material selection, qualification, and ongoing quality monitoring for all package types.
For temperature-sensitive products, we offer cold storage testing using cryogenic modules capable of testing between –20°C and –160°C. Both glass and polymer containers can be evaluated to ensure performance under extreme storage conditions.
Helium testing provides unmatched sensitivity and is ideal for confirming package integrity during development, validation, and troubleshooting.
Complete Package Integrity Support in One Place
By combining Life Science Development, CCI Analytical Testing, and Helium Leak Testing into one integrated service platform, Tasatec ensures:
- Faster method development
- Reliable, validated test methods
- High-sensitivity leak detection
- Confidence in product sterility and regulatory compliance
Our unified approach helps manufacturers maintain the highest standards of safety and performance from early development to commercial production.
