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Reduce Risk

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Ensure Compliance

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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

ISO Certified Testing

Millstone Medical Testing – CT

Download Millstone Medical Testing – CT’s ISO certificate and request testing services

Millstone Medical Testing – RI

Download Millstone Medical Testing – RI’s ISO certificate and request testing services

Product Testing

Bioburden

Safeguard quality with testing to detect contamination level at any stage, from initial manufacturing to final distribution.

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STERILITY

Confirm that your sterilization process repeatably delivers the required sterility assurance level for your product.

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BACTERIAL ENDOTOXIN

Meet critical patient safety requirements with limulus amebocyte lysate (LAL) testing for bacterial endotoxin testing.

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MICROBIAL IDENTIFICATIONS

Minimize the risks of contamination and downtime and ensure compliance with testing that identifies microbial presence and type.

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PARTICULATE ANALYSIS

Ensure patient safety with particulate analysis with meaningful and appropriate particulate limits.

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CYTOTOXICITY TESTING

Assess new product materials or assure lot-to-lot acceptability of polymers and plastics with easy, economical toxicity testing.

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STERILIZATION & CLEANING VALIDATIONS OF REUSABLE DEVICES

Reduce risk, support patient safety, and ensure compliance with validation of cleaning and sterilization processes.

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GAMMA STERILIZATION VALIDATIONS

Establish and validate the dose at which your product will be irradiated using gamma ray sterilization.

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EO RESIDUAL TESTING

Evaluate whether EO residuals following sterilization meet EO residual testing limits for the intended device use.

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PRESERVATIVE EFFICACY TESTING

Determine the efficacy of preservative systems with protocols that include initial sterility testing and challenge testing.

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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.

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DYE PENETRATION TESTING

Protect package integrity by testing for seal leaks with dye penetration testing.

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Bubble Emission Testing

Test for large leaks in flexible packaging under vacuum, with maximum test sensitivity.

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ACCELERATED AGING CHAMBERS

Prove product shelf life with testing that simulates real-time aging in a shortened time period.

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ENVIRONMENTAL TESTING

AIR SAMPLING

Ensure safety and remain in compliance with air sampling tests for production and storage facilities.

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SURFACE SAMPLING

Evaluate and monitor safety of production and storage facilities to reduce risk of contamination on surfaces — and remain in compliance.

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WATER ANALYSIS

Verify safety with water quality analysis and validations of water systems.

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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.

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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.

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