PRODUCT TESTING EXPERTISE.
A SINGLE POINT OF CONTACT.
Decrease lead times and accelerate time to market with a single, expert partner for in-process testing within production. Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.
Comprehensive Regulatory Testing Services
- PRODUCT TESTING
- PACKAGING TESTING
- ENVIRONMENTAL testing
Safeguard quality with testing to detect contamination level at any stage, from initial manufacturing to final distribution.
Confirm that your sterilization process repeatably delivers the required sterility assurance level for your product.
Meet critical patient safety requirements with limulus amebocyte lysate (LAL) testing for bacterial endotoxin testing.
Minimize the risks of contamination and downtime and ensure compliance with testing that identifies microbial presence and type.
Ensure patient safety with particulate analysis with meaningful and appropriate particulate limits.
Assess new product materials or assure lot-to-lot acceptability of polymers and plastics with easy, economical toxicity testing.
STERILIZATION & CLEANING VALIDATIONS OF REUSABLE DEVICES
Reduce risk, support patient safety, and ensure compliance with validation of cleaning and sterilization processes.
GAMMA STERILIZATION VALIDATIONS
Establish and validate the dose at which your product will be irradiated using gamma ray sterilization.
EO RESIDUAL TESTING
Evaluate whether EO residuals following sterilization meet EO residual testing limits for the intended device use.
PRESERVATIVE EFFICACY TESTING
Determine the efficacy of preservative systems with protocols that include initial sterility testing and challenge testing.
PEEL STRENGTH TESTING
Ensure your packaging maintains a sterile barrier for your product with evaluation of seal failure. Testing includes data on maximum force and mode of failure.
DYE PENETRATION TESTING
Protect package integrity by testing for seal leaks with dye penetration testing.
Bubble Emission Testing
Test for large leaks in flexible packaging under vacuum, with maximum test sensitivity.
Prove product shelf life with testing that simulates real-time aging in a shortened time period.
Ensure safety and remain in compliance with air sampling tests for production and storage facilities.
Evaluate and monitor safety of production and storage facilities to reduce risk of contamination on surfaces — and remain in compliance.
Verify safety with water quality analysis and validations of water systems.
TESTING AVAILABLE FOR TIER 1 SERVICE
Uphold quality while streamlining your supply chvain. Millstone offers a simplified approach to expert sourcing with our Tier 1 service, with a single PO and point of contact for contract manufacturing, clean room packaging, and sterilization. Tier 1 service can now include Millstone Testing Service capabilities.
Unlock your Growth potential.
Find Out Why your Operations are driving up your costs and hampering your growth.
Make savvier resource allocation decisions in these key operational areas to transform your business, capture more market share, and change patient lives for the better.