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 under strict GMP compliance and adhere to standards set by leading regulatory agencies.
**Expertise & scope**
* Specializes in biocompatibility testing, sterility assurance, and material characterization.
* Offers analytical method development and validation for various analytical techniques.
* Provides wet chemistry testing, including compendial testing according to USP-NF, EP, and JP standards.
* Conducts stability testing, including forced degradation, freeze/thaw, and photostability studies, following ICH guidelines.
* Performs water testing for all grades, ensuring quality and purity based on USP-NF, EP, and JP standards.
* Conducts comprehensive microbiology testing, including method development and validation, to ensure product safety and prevent microbial contamination.
* Offers sterility assurance testing for medical devices and pharmaceutical products, including bioburden testing and endotoxin testing.
* Performs container testing, including material compatibility, extractable & leachable studies, and closure integrity testing.
**Reputation / proof points**
* Operates a network of nationwide labs, offering local service with national resources.
* Assures strict compliance with GMP and other regulatory standards through an internal quality assurance group.
Infinity Laboratories is a provider of comprehensive analytical testing services for the pharmaceutical and medical device industries. They operate under strict GMP compliance and adhere to standards set by leading regulatory agencies.
**Expertise & scope**
* Specializes in biocompatibility testing, sterility assurance, and material characterization.
* Offers analytical method development and validation for various analytical techniques.
* Provides wet chemistry testing, including compendial testing according to USP-NF, EP, and JP standards.
* Conducts stability testing, including forced degradation, freeze/thaw, and photostability studies, following ICH guidelines.
* Performs water testing for all grades, ensuring quality and purity based on USP-NF, EP, and JP standards.
* Conducts comprehensive microbiology testing, including method development and validation, to ensure product safety and prevent microbial contamination.
* Offers sterility assurance testing for medical devices and pharmaceutical products, including bioburden testing and endotoxin testing.
* Performs container testing, including material compatibility, extractable & leachable studies, and closure integrity testing.
**Reputation / proof points**
* Operates a network of nationwide labs, offering local service with national resources.
* Assures strict compliance with GMP and other regulatory standards through an internal quality assurance group.
Additional information
Infinity Laboratories emphasizes rigorous method development and validation across its service offerings, ensuring that testing procedures are robust and suitable for the entire product lifecycle. They work with clients to characterize drug products, understand degradation pathways, and ensure product quality and patient safety. Their services are guided by international standards such as ICH, USP, EP, JP, ISO, ASTM, and AAMI, ensuring compliance and data integrity. Buyers can expect timely, dependable results from state-of-the-art instrumentation utilized by experienced professionals.
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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Operates under strict GMP compliance and adheres to standards from leading 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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Conducts testing according to USP-NF, EP, JP, ICH, ISO, ASTM, and AAMI 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).”
Certifications & Trust Signals
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Operates a network of nationwide labs, providing flexibility and service of a local lab with national resources.
Source
“Infinity Laboratories operates a network of nationwide labs, providing the flexibility and service of a local lab with the resources and expertise of a national organization.”
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Assures strict compliance with GMP and other regulatory standards.
Source
“we assure strict compliance with GMP and other regulatory standards.”
Buyer Snapshot
Best for
- Pharmaceutical companies seeking comprehensive analytical testing.
- Medical device manufacturers requiring biocompatibility and sterility assurance.
- Companies needing method development and validation services.
How engagement typically works
- Collaborative approach, acting as an extension of the client's team.
- Flexible service delivery leveraging a national lab network.
Typical deliverables
- Analytical test reports.
- Method validation documentation.
- Stability study reports.
- Microbiological and sterility testing results.
- Container compatibility and integrity reports.
Good to know
- Best when requiring testing aligned with major pharmacopeial and international standards.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Netherlands, Japan, Europe, Asia
Industries:
Medical Devices
Pricing model:
Per project
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
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
sterilization_microbiology_testing
packaging_shelf_life_testing
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 11737-1
Test Types Offered
Analytical Chemistry, Physical Testing, Wet Chemistry, Stability Testing, Water Testing, Microbiology Testing, Sterility Assurance Testing, Container Testing, Extractables and Leachables Testing, 510(k) Testing, PMA Testing, Package Testing, Antimicrobial Agents, Appearance Evaluation, Chromatography, Container Closure Integrity Testing, Dosage Uniformity, Titration, Gravimetric Analysis, Colorimetry, Spectrophotometry, Precipitation Reactions, Qualitative Analysis, Chemical Stability, Physical Stability, Microbiological Stability, Therapeutic Stability, Toxicological Stability, Forced Degradation, Freeze/Thaw, Photostability, Nitrogen Testing, Carbon Dioxide Testing, Compressed Air Testing, Ammonia Testing, Calcium Testing, Bacterial Filter Retention, Endotoxin Testing, Media Fill, Bioburden Testing, BI Testing, Cleaning Residuals, LAL/Pyrogen Testing, Container Material Compatibility, Closure Material Compatibility, Permeation Testing
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
Per project
