Reduce Risk
Ensure Compliance
Save Cost
Fuel Growth
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
Product Testing
Bioburden
Safeguard quality with testing to detect contamination level at any stage, from initial manufacturing to final distribution.
STERILITY
Confirm that your sterilization process repeatably delivers the required sterility assurance level for your product.
BACTERIAL ENDOTOXIN
Meet critical patient safety requirements with limulus amebocyte lysate (LAL) testing for bacterial endotoxin testing.
MICROBIAL IDENTIFICATIONS
Minimize the risks of contamination and downtime and ensure compliance with testing that identifies microbial presence and type.
PARTICULATE ANALYSIS
Ensure patient safety with particulate analysis with meaningful and appropriate particulate limits.
CYTOTOXICITY TESTING
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.
PACKAGING 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.
ACCELERATED AGING CHAMBERS
Prove product shelf life with testing that simulates real-time aging in a shortened time period.
ENVIRONMENTAL TESTING
AIR SAMPLING
Ensure safety and remain in compliance with air sampling tests for production and storage facilities.
SURFACE SAMPLING
Evaluate and monitor safety of production and storage facilities to reduce risk of contamination on surfaces — and remain in compliance.
WATER ANALYSIS
Verify safety with water quality analysis and validations of water systems.
TIER 1
TESTING AVAILABLE FOR TIER 1 SERVICE
Uphold quality while streamlining your supply chain. 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.
10 Steps to Choosing the Right Testing Services Partner
Asking the right questions
When you’re evaluating testing services, choosing the right partner can be a challenge. Download this 10-step checklist as a guide in evaluating potential partners and finding the right strategic support.
