Infinity Laboratories

Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical, medical device, and packaging industries. Specializing in chemistry, microbiology, stability, and package testing to ensure product quality and patient safety.

Infinity Laboratories is your analytical testing partner for raw materials, finished products, and packaging, serving the pharmaceutical and medical device sectors. They provide expertise in materials characterization, facility and process validation, sterilization, and sterility assurance to help bring products to market safely and effectively. Their extensive testing capabilities include 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, and Package Testing. Infinity Laboratories operates a network of nationwide labs, offering the flexibility of local service with the resources of a national organization, all while adhering to GMP and other regulatory standards. They specialize in method development and validation, ensuring rigorous testing for product quality and patient safety. Whether it's compendial testing according to USP, EP, and JP standards, or specialized studies like forced degradation and photostability, Infinity Laboratories provides timely and dependable results with high data integrity.

About

Infinity Laboratories is a provider of analytical testing services for the pharmaceutical, medical device, and packaging industries. They specialize in chemistry, microbiology, stability, and package testing to ensure product quality and patient safety. Their services aim to support clients in meeting regulatory requirements and safeguarding their products throughout their lifecycle.

Additional information

Infinity Laboratories focuses on delivering comprehensive analytical testing to support product development and quality assurance. Their expertise in stability and package testing is crucial for understanding how products will perform under various conditions and over time. This helps clients mitigate risks associated with product degradation or packaging failure, ensuring market readiness and consumer trust.

Key Highlights

  • Offers comprehensive analytical chemistry, physical, wet chemistry, microbiology, and stability testing services. Source
    “Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical, medical device, and packaging industries.”
  • Provides stability testing services compliant with ICH Q1A(R2) guidelines, including forced degradation studies. 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...”
  • Conducts microbiology and sterility assurance testing adhering to USP, European, and Japanese pharmacopeias. Source
    “All tests are conducted in our GMP-compliant laboratories and under standards set by the United States Pharmacopeia (USP).”
  • Performs container testing, including material compatibility, extractables & leachables, and closure integrity. Source
    “Some of the critical aspects of pharmaceutical container testing include: 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.”
  • Delivers on-time results with high data integrity, guided by leading regulatory agencies. Source
    “Guided by the standards of the world’s leading regulatory agencies, we deliver on-time results with high data integrity.”
  • Maintains a network of nationwide laboratories offering local service 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.”

Buyer Snapshot

Best for
  • Pharmaceutical companies requiring stability testing.
  • Medical device manufacturers needing packaging validation.
  • Companies seeking comprehensive analytical testing services.
How engagement typically works
  • Project-based engagements.
  • Collaborative approach to testing needs.
Typical deliverables
  • Stability study reports.
  • Package performance validation.
  • Analytical testing data and summaries.
Good to know
  • Best when specific testing protocols are defined or can be developed collaboratively.
HQ: USA
Languages: English
Claim status: Listed

Services & Capabilities

Packaging + Shelf-life + Distribution Testing

Countries: United States, Netherlands, Asia
Industries: Medical Devices
Pricing model: Per project
Packaging Tests Offered: Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Shelf Life Methods Offered: Real-time aging, Accelerated aging
Distribution Tests Offered: Vibration, Shock, Drop, Compression, Climate
Standards Supported: ISO 11607, ASTM D4169, ISTA, ISO 16775, FDA Guidance
Has Climate Chambers: Yes
Has Distribution Simulation: Yes
Lead Time Band: Start in 0-2 weeks
Quote SLA: < 24 hours
Is Accredited: Yes
Accreditation Body: ISO 17025
Rush Available: Yes
Nda Support: Yes
Minimum Project Size: $25-50k

Additional packaging_shelf_life_testing Details

Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop, Other
Standards Supported
ISO 11607, ASTM D4169, ISTA, ISO 16775, ISO 13485, FDA Guidance, Other
Shelf Life Methods Offered
Real-time aging, Accelerated aging, Both
Distribution Tests Offered
Vibration, Shock, Drop, Compression, Stacking, Climate, Other
Lead Time Band
Start in 0-2 weeks, Start in 2-4 weeks, Start in 4-8 weeks, Start in 8-12 weeks, Start in 12+ weeks
Quote SLA
< 24 hours, 24-48 hours, 3-5 business days, 1-2 weeks
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
<$10k, $10-25k, $25-50k, $50k+, No minimum
Pricing Model
Per project, Fixed package, Tiered, Custom
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