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Lab Testing & Analysis

Rigorous, standards-driven testing at every stage — from raw materials through finished filters — so you can trust the performance and compliance of every Strainrite product.

Comprehensive Filter Testing

Every Strainrite filter undergoes rigorous testing in our third-party validated clean rooms. From 100% integrity testing at the factory to bacterial retention audits and USP compliance verification, we ensure that each product meets the precise specifications your application demands.

Validation & Compliance Documentation

We provide comprehensive validation guides and test documentation for our pharmaceutical-grade product lines, including the Pur-MAXX SG, Vent-MAXX, Endo-MAXX CN, and MAXX-Cap series. Each guide details bacterial retention data, integrity test correlations, cytotoxicity results, and USP compliance — giving you the documentation you need to satisfy regulatory audits.

Vessel & Housing Quality Assurance

Strainrite vessels are ISO 9001:2008 certified and hydrostatically tested to industry-accepted standards. We offer specialized quality assurance testing including X-ray, magnetic particle, liquid penetrant, ultrasonic, and Brinell hardness testing to verify the structural integrity of every housing we manufacture.

Why Our Testing Sets the Standard

100% Factory Integrity Testing

Every pharmaceutical-grade filter is integrity tested at our factory before shipment. No sampling, no shortcuts — each unit is individually verified to meet performance specifications.

USP & cGMP Compliance

Our filters are tested and certified to USP Class VI Biological Reactivity standards, USP Physicochemical Tests for Plastics, and manufactured under cGMP and ISO 9001-certified quality management systems.

Steam Sterilization Durability

Products are audit tested to verify integrity after exposure to 20–25 one-hour steam cycles at 135°C (275°F), ensuring reliable performance through repeated sterilization in demanding production environments.

Third-Party Validated Clean Rooms

All pharmaceutical-grade filters are manufactured and tested in independently validated clean room facilities, maintaining the controlled environment necessary for products used in critical life science and biotech applications.

Why Strainrite for Lab Testing & Analysis

Bacterial Retention & Integrity Correlation

Our sterilizing-grade filters undergo documented bacterial retention testing using Brevundimonas diminuta challenge at concentrations of 10⁷ CFU/cm². Each product line includes correlation data linking bacterial challenge results to non-destructive integrity tests, enabling reliable in-process verification.

Endotoxin & Biocompatibility Testing

Every applicable filter is tested using the Limulus Amebocyte Lysate (LAL) method to verify endotoxin levels below 0.0050 EU/ml. Cytotoxicity testing and USP Class VI Biological Reactivity In Vivo testing confirm the biocompatibility of our materials for pharmaceutical and biotech use.

Advanced Materials Testing

For vessels and housings, we go beyond standard quality checks with specialized non-destructive testing: X-ray inspection, magnetic particle examination, liquid penetrant analysis, ultrasonic evaluation, and Brinell hardness testing — ensuring structural integrity under the most demanding operating conditions.

Complete Validation Packages

Validation guides are available on request for our key pharmaceutical product lines, including the Pur-MAXX SG, Vent-MAXX, Endo-MAXX CN, and MAXX-Cap series. Each package documents bacterial retention, integrity test data, cytotoxicity, LAL results, and USP compliance — streamlining your regulatory submissions.

ISO 9001-Certified Quality System

Our entire manufacturing and testing operation runs under an ISO 9001-certified Quality Management System. From raw material receiving through final inspection and shipment, state-of-the-art equipment and highly skilled technicians maintain the highest levels of product reliability and repeatability.

Our Testing Process

Manufacture & Test

Filters are produced in our validated clean rooms and subjected to a comprehensive battery of tests: 100% integrity testing, bacterial retention audits, LAL endotoxin sampling, USP oxidizable substances checks, and physicochemical testing for plastics. Vessels undergo hydrostatic pressure testing and optional advanced NDT inspections.

Document & Deliver

Every tested product is accompanied by the appropriate quality documentation. Validation guides, certificates of compliance, and test reports are compiled and delivered alongside your order — giving your quality and regulatory teams the traceable, audit-ready records they need.