Eurofins Packaging Testing Services
Eurofins Scientific
Eurofins Packaging Testing Services offers comprehensive testing and consulting for packaging shelf-life, ensuring product quality and regulatory compliance. They support businesses in meeting global market standards.
Eurofins Packaging Testing Services is a leading provider of specialized testing solutions for the packaging industry, focusing on shelf-life analysis. As part of the global Eurofins Scientific network, they leverage extensive expertise and a vast network of laboratories across 60 countries to support businesses worldwide. Their services are designed to help companies ensure their products meet stringent quality and regulatory requirements. This includes comprehensive testing and consulting for REACH and similar regulations, crucial for market access in Europe and beyond. They offer a wide range of services covering chemical, physical, mechanical, and environmental testing, as well as quality assurance and control throughout the supply chain. With a commitment to scientific excellence and customer support, Eurofins Packaging Testing Services assists clients in navigating complex regulatory landscapes, from raw materials to finished goods. Their goal is to enable businesses to bring safe, effective, and compliant products to market, enhancing consumer confidence and brand reputation.
About
**Who they are**
Eurofins Packaging Testing Services, operating as Infinity Laboratories, provides comprehensive analytical testing and consulting for the pharmaceutical and medical device industries. They focus on ensuring product quality, safety, and regulatory compliance.
**Expertise & scope**
* **Analytical Chemistry & Physical Testing:** Method development, validation, and testing for product understanding throughout the lifecycle.
* **Wet Chemistry Testing:** Characterization of drug products using techniques like titration, gravimetric analysis, colorimetry, and spectrophotometry, adhering to USP-NF, EP, and JP standards.
* **Stability Testing:** Conducting studies (real-time, accelerated, forced degradation) in GMP-compliant chambers to determine storage conditions and shelf life, guided by ICH Q1A(R2).
* **Water Testing:** Comprehensive testing for all grades of water used in pharmaceutical manufacturing, meeting USP-NF, EP, and JP standards.
* **Microbiology Testing:** Method development, validation, and testing to assure the absence of microorganisms, including antimicrobial effectiveness, bacterial filter retention, and endotoxin testing.
* **Sterility Assurance Testing:** Services for medical devices and pharmaceutical products, including bioburden testing, LAL/pyrogen testing, and sterilization validation, adhering to USP, EP, JP, ISO, ASTM, and AAMI standards.
* **Container Testing:** Evaluating container suitability, material compatibility, closure integrity, and performing extractable and leachable studies.
**Reputation / proof points**
* Operates a network of nationwide labs.
* Assures strict compliance with GMP and other regulatory standards.
* Guided by the standards of the world’s leading regulatory agencies.
Eurofins Packaging Testing Services, operating as Infinity Laboratories, provides comprehensive analytical testing and consulting for the pharmaceutical and medical device industries. They focus on ensuring product quality, safety, and regulatory compliance.
**Expertise & scope**
* **Analytical Chemistry & Physical Testing:** Method development, validation, and testing for product understanding throughout the lifecycle.
* **Wet Chemistry Testing:** Characterization of drug products using techniques like titration, gravimetric analysis, colorimetry, and spectrophotometry, adhering to USP-NF, EP, and JP standards.
* **Stability Testing:** Conducting studies (real-time, accelerated, forced degradation) in GMP-compliant chambers to determine storage conditions and shelf life, guided by ICH Q1A(R2).
* **Water Testing:** Comprehensive testing for all grades of water used in pharmaceutical manufacturing, meeting USP-NF, EP, and JP standards.
* **Microbiology Testing:** Method development, validation, and testing to assure the absence of microorganisms, including antimicrobial effectiveness, bacterial filter retention, and endotoxin testing.
* **Sterility Assurance Testing:** Services for medical devices and pharmaceutical products, including bioburden testing, LAL/pyrogen testing, and sterilization validation, adhering to USP, EP, JP, ISO, ASTM, and AAMI standards.
* **Container Testing:** Evaluating container suitability, material compatibility, closure integrity, and performing extractable and leachable studies.
**Reputation / proof points**
* Operates a network of nationwide labs.
* Assures strict compliance with GMP and other regulatory standards.
* Guided by the standards of the world’s leading regulatory agencies.
Additional information
Infinity Laboratories emphasizes rigorous method development and validation, crucial for ensuring the reliability of test results across all service areas. They operate under GMP-compliant laboratories and adhere to standards set by major regulatory bodies like USP, EP, and JP, as well as ICH guidelines for stability testing. Their approach involves acting as an extension of the client's team to support product development from pre-clinical stages through commercial production. Buyers should note that while they offer comprehensive testing, specific study designs and timelines will be tailored to individual product needs and regulatory requirements.
Key Highlights
-
Offers comprehensive analytical chemistry, physical testing, wet chemistry, stability, water, microbiology, sterility assurance, and container testing services.
Source
“Analytical Chemistry & Physical Testing; Wet Chemistry Testing; Stability Testing; Water Testing; Microbiology Testing; Sterility Assurance Testing; Container Testing”
-
Conducts stability testing in GMP-compliant chambers, adhering to ICH Q1A(R2) guidelines.
Source
“Infinity Laboratories stores samples in our GMP-compliant stability chambers and conducts the required testing at specified intervals.”
-
Performs microbiology and sterility assurance testing under standards set by USP, EP, JP, ISO, ASTM, and AAMI.
Source
“All tests are conducted in our GMP-compliant laboratories and under standards set by the United States Pharmacopeia (USP).”
-
Provides container testing, including material compatibility, closure integrity, and extractable & leachable studies.
Source
“Container Material Compatibility; Extractable & Leachable Studies; Closure Integrity Testing”
Certifications & Trust Signals
-
Operates under strict compliance with GMP and other regulatory standards.
Source
“Operating under the governance of our internal quality assurance group, we assure strict compliance with GMP and other regulatory standards.”
-
Guided by the standards of the world’s leading regulatory agencies.
Source
“Guided by the standards of the world’s leading regulatory agencies, we deliver on-time results with high data integrity.”
-
Adheres to standards set by the United States Pharmacopeia (USP) for microbiology testing.
Source
“All tests are conducted in our GMP-compliant laboratories and under standards set by the United States Pharmacopeia (USP).”
Buyer Snapshot
Best for
- Pharmaceutical companies requiring comprehensive analytical and microbiological testing.
- Medical device manufacturers needing sterility assurance and container testing.
- Companies seeking support for method development and validation.
How engagement typically works
- Collaborative partnership
- Extension of client's internal team
- Project-based support
Typical deliverables
- Stability study reports
- Method validation protocols and reports
- Microbiological testing results
- Container compatibility and integrity reports
- Water quality analysis reports
Good to know
- Best when requiring adherence to major pharmacopeial and regulatory standards (USP, EP, JP, ICH, GMP).
HQ:
New York, LUXEMBOURG
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, Netherlands, Asia
Industries:
Medical Devices
Packaging Tests Offered:
Seal strength, Burst strength, Compression, Vibration, Drop
Shelf Life Methods Offered:
Accelerated aging
Distribution Tests Offered:
Vibration, Drop, Compression, Climate
Standards Supported:
Other
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Regions Served:
Czech Republic, Netherlands, New Zealand, Philippines, Switzerland, United Kingdom, UNITED ARAB EMIRATES, United States
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Container Closure Integrity Testing, Permeation Testing, Extractables and Leachables Testing, Package Testing
Standards Supported
GMP, USP-NF, EP, JP, ICH Q1A(R2), ISO 11737, AAMI/ANSI/ISO 11737, ISO, ASTM, AAMI
Shelf Life Methods Offered
Real-time aging, Accelerated aging, Forced degradation studies
Distribution Tests Offered
N/A
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
N/A
