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. They specialize in supporting the pharmaceutical and medical device industries.

**Expertise & scope**
* Biocompatibility testing (ISO 10993)
* Sterility assurance
* Material characterization

**Reputation / proof points**
* Serves the pharmaceutical industry
* Serves the medical device industry

Additional information

Infinity Laboratories focuses on analytical testing crucial for medical device and pharmaceutical development. Their expertise in biocompatibility testing, sterility assurance, and material characterization helps clients navigate regulatory requirements. Buyers can expect detailed analytical reports supporting product safety and compliance. Engagement typically involves defining specific testing protocols based on the device's intended use and contact classification, followed by laboratory analysis and final report generation.

Key Highlights

  • Offers comprehensive analytical testing for pharmaceutical and medical device industries. Source
    “Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical and medical device industries”
  • Specializes in biocompatibility testing, sterility assurance, and material characterization. Source
    “specializing in biocompatibility testing, sterility assurance, and material characterization.”
  • 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.”
  • 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”
  • 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

  • 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.”
  • Assures strict compliance with GMP and other regulatory standards. Source
    “we assure strict compliance with GMP and other regulatory standards.”

Buyer Snapshot

Best for
  • Medical device manufacturers
  • Pharmaceutical companies
How engagement typically works
  • Project-based testing
  • Consultative approach to testing needs
Typical deliverables
  • Biocompatibility test reports
  • Sterility assurance data
  • Material characterization results
Good to know
  • Best when requiring specialized analytical testing for regulatory submissions.
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: ISO 10993-1, ISO 10993-5, USP <87>, USP <88>
Test Types Offered: Cytotoxicity, Hemocompatibility
Glp Compliant: Yes
Rush Available: Yes
Lead Time Band: Start in 0-2 weeks
Quote SLA: < 24 hours
Has In House Toxicology: Yes
Contact Types Supported: Surface contact, External communicating, Implant
Duration Types Supported: Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)

sterilization_microbiology_testing

packaging_shelf_life_testing

Additional biocompatibility_testing Details

Iso10993 Standards Supported
ISO 11737-1
Test Types Offered
Biocompatibility testing, Sterility assurance, Material characterization
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
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