Infinity Laboratories
Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical and medical device industries, specializing in biocompatibility testing, sterility assurance, and material characterization.
Infinity Laboratories is a leading analytical testing partner for raw materials, in-process materials, finished products, and packaging. They offer a wide range of services including materials characterization, facility and process validation, sterilization, and sterility assurance. Their expertise covers package testing, environmental monitoring, EO residuals, gas & water testing, chemistry testing, wet chemistry testing, microbiology testing, stability testing, and laboratory & process instrumentation services. With a network of nationwide labs, Infinity Laboratories provides high-quality, reliable data under demanding timelines, ensuring strict compliance with GMP and other regulatory standards. They support analytical method development and validation for a diverse range of techniques and products, guided by the standards of the world’s leading regulatory agencies. Their services are crucial for ensuring product quality and patient safety throughout the entire product lifecycle. Specializing in biocompatibility testing, Infinity Laboratories offers comprehensive wet chemistry testing, stability testing, water testing, and microbiology testing. They adhere to standards set by organizations like USP-NF, EP, and JP, providing critical insights into product integrity and safety for pharmaceutical and medical device clients.
About
**Who they are**
Infinity Laboratories is a provider of comprehensive analytical testing services for the pharmaceutical and medical device industries. They operate a network of nationwide labs, offering the flexibility of local service with national resources.
**Expertise & scope**
* Specializes in biocompatibility testing, sterility assurance, and material characterization.
* Offers analytical method development and validation for various techniques and products.
* Provides wet chemistry testing, including compendial testing against USP-NF, EP, and JP standards.
* Conducts stability testing, including storage condition determination, shelf-life assessment, forced degradation, and photostability studies, referencing ICH guidelines.
* Performs water testing for all grades, adhering to USP-NF, EP, and JP standards.
* Offers comprehensive microbiology testing, including method development, validation, and testing for microbial contamination, with services conducted in GMP-compliant laboratories under USP standards.
* Provides sterility assurance testing for medical devices and pharmaceutical products, including bioburden testing, endotoxin testing, and sterilization validation, adhering to standards like USP <61> and ISO 11737-1.
* Conducts container testing, focusing on material compatibility, extractables and leachables studies, and closure integrity testing.
**Reputation / proof points**
* Operates under strict compliance with GMP and other regulatory standards, guided by an internal quality assurance group.
* Delivers on-time results with high data integrity, guided by the standards of leading regulatory agencies.
Infinity Laboratories is a provider of comprehensive analytical testing services for the pharmaceutical and medical device industries. They operate a network of nationwide labs, offering the flexibility of local service with national resources.
**Expertise & scope**
* Specializes in biocompatibility testing, sterility assurance, and material characterization.
* Offers analytical method development and validation for various techniques and products.
* Provides wet chemistry testing, including compendial testing against USP-NF, EP, and JP standards.
* Conducts stability testing, including storage condition determination, shelf-life assessment, forced degradation, and photostability studies, referencing ICH guidelines.
* Performs water testing for all grades, adhering to USP-NF, EP, and JP standards.
* Offers comprehensive microbiology testing, including method development, validation, and testing for microbial contamination, with services conducted in GMP-compliant laboratories under USP standards.
* Provides sterility assurance testing for medical devices and pharmaceutical products, including bioburden testing, endotoxin testing, and sterilization validation, adhering to standards like USP <61> and ISO 11737-1.
* Conducts container testing, focusing on material compatibility, extractables and leachables studies, and closure integrity testing.
**Reputation / proof points**
* Operates under strict compliance with GMP and other regulatory standards, guided by an internal quality assurance group.
* Delivers on-time results with high data integrity, guided by the standards of leading regulatory agencies.
Additional information
Infinity Laboratories emphasizes rigorous method development and validation across its service offerings, ensuring compliance with global standards such as USP, EP, JP, ICH, ISO, ASTM, and AAMI. They support clients throughout the product lifecycle, from pre-clinical stages to commercial production, in GMP-compliant facilities. Their approach involves acting as an extension of the client's team to determine appropriate analytical procedures and assays. Buyers should consider Infinity Laboratories for projects requiring comprehensive analytical characterization, stability assessment, and microbiological safety evaluations for pharmaceuticals and medical devices.
Key Highlights
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Offers comprehensive analytical testing for pharmaceutical and medical device industries.
Source
“Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical and medical device industries”
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Specializes in biocompatibility testing, sterility assurance, and material characterization.
Source
“specializing in biocompatibility testing, sterility assurance, and material characterization.”
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Conducts testing under GMP compliance and adheres to standards from major regulatory agencies.
Source
“Operating under the governance of our internal quality assurance group, we assure strict compliance with GMP and other regulatory standards.”
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Provides method development and validation services for a wide range of analytical techniques.
Source
“Infinity Laboratories supports analytical method development for a wide range of analytical techniques and products, and we provide method validation services”
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Offers wet chemistry testing aligned with USP-NF, EP, and JP standards.
Source
“Infinity offers comprehensive wet chemistry testing services to characterize drug products based on standards set by the world’s leading standards organizations, including United States Pharmacopeia – National Formulary (USP-NF), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP).”
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Performs stability testing guided by ICH Q1A(R2) standards in GMP-compliant chambers.
Source
“The International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products – Q1A(R2) is the primary guidance”
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Provides sterility assurance testing adhering to USP, ISO, ASTM, and AAMI standards.
Source
“Infinity provides a comprehensive range of sterility assurance testing solutions throughout all phases of development and manufacturing. All tests are conducted under standards set by the United States, European, and Japanese pharmacopeias and standards bodies, including the ISO, ASTM, and AAMI.”
Certifications & Trust Signals
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Operates under GMP compliance.
Source
“Operating under the governance of our internal quality assurance group, we assure strict compliance with GMP and other regulatory standards.”
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Adheres to standards from leading regulatory agencies and pharmacopeias.
Source
“Guided by the standards of the world’s leading regulatory agencies, we deliver on-time results with high data integrity.”
Buyer Snapshot
Best for
- Pharmaceutical companies seeking comprehensive analytical testing.
- Medical device manufacturers requiring sterility and biocompatibility assessments.
- Companies needing method development and validation services.
How engagement typically works
- Collaborative partnership, acting as an extension of the client's team.
- Flexible service delivery across various testing needs.
- Focus on data integrity and regulatory compliance.
Typical deliverables
- Analytical test reports
- Method validation reports
- Stability study reports
- Microbiological testing results
- Sterility assurance level assessments
- Container compatibility and integrity reports
Good to know
- Best when requiring services aligned with USP, EP, JP, ICH, ISO, ASTM, and AAMI standards.
- Ideal for projects requiring GMP-compliant testing environments.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Netherlands, Japan, Europe, Asia
Industries:
Medical Devices
Iso10993 Standards Supported:
USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Biodegradation
Glp Compliant:
Yes
Rush Available:
Yes
sterilization_microbiology_testing
packaging_shelf_life_testing
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 11737-1 (mentioned for bioburden testing)
Test Types Offered
Analytical Chemistry & Physical Testing, Wet Chemistry Testing, Stability Testing, Water Testing, Microbiology Testing, Sterility Assurance Testing, Container Testing, Extractables and Leachables Testing, 510(k) Testing, PMA Testing, Package Testing, Appearance Evaluation, Chromatography, Container Closure Integrity Testing, Dosage Uniformity, Antimicrobial Agents, Titration, Gravimetric Analysis, Colorimetry, Spectrophotometry, Precipitation Reactions, Qualitative Analysis, Forced Degradation Studies, Freeze/Thaw Studies, Photostability Studies, Nitrogen Testing, Carbon Dioxide Testing, Compressed Air Testing, Ammonia Testing, Calcium Testing, Bacterial Filter Retention, Endotoxin Testing, Media Fill, Bioburden Testing, BI Testing (BI Sterility), BI Testing (Population Verification), Cleaning Residuals, LAL/Pyrogen Testing, Container Material Compatibility, Closure Material Compatibility
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
Custom
Pricing Model
Custom
