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
**Who they are**
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.
**Expertise & scope**
* **Analytical Chemistry & Physical Testing:** Method development and validation, appearance evaluation, chromatography, container closure integrity testing, and antimicrobial agent assays.
* **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 under GMP-compliant conditions, including real-time, accelerated, and forced degradation studies to determine storage conditions and shelf life, referencing ICH Q1A(R2) guidelines.
* **Water Testing:** Comprehensive testing for all grades of water used in pharmaceutical manufacturing and medical device production, meeting USP-NF, EP, and JP standards.
* **Microbiology Testing:** Method development, validation, and testing for microbial contamination, including antimicrobial effectiveness, bacterial filter retention, container closure testing, endotoxin testing, and media fills.
* **Sterility Assurance Testing:** Method development, sterilization validation, and testing for medical devices and pharmaceutical products, including bioburden, BI testing, cleaning residuals, and endotoxin/LAL/pyrogen testing, adhering to USP, ISO, ASTM, and AAMI standards.
* **Container Testing:** Evaluating container suitability, material compatibility, extractables and leachables, and closure integrity testing for pharmaceutical packaging.
**Reputation / proof points**
* Operates a network of nationwide labs.
* Assures strict compliance with GMP and other regulatory standards.
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.
**Expertise & scope**
* **Analytical Chemistry & Physical Testing:** Method development and validation, appearance evaluation, chromatography, container closure integrity testing, and antimicrobial agent assays.
* **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 under GMP-compliant conditions, including real-time, accelerated, and forced degradation studies to determine storage conditions and shelf life, referencing ICH Q1A(R2) guidelines.
* **Water Testing:** Comprehensive testing for all grades of water used in pharmaceutical manufacturing and medical device production, meeting USP-NF, EP, and JP standards.
* **Microbiology Testing:** Method development, validation, and testing for microbial contamination, including antimicrobial effectiveness, bacterial filter retention, container closure testing, endotoxin testing, and media fills.
* **Sterility Assurance Testing:** Method development, sterilization validation, and testing for medical devices and pharmaceutical products, including bioburden, BI testing, cleaning residuals, and endotoxin/LAL/pyrogen testing, adhering to USP, ISO, ASTM, and AAMI standards.
* **Container Testing:** Evaluating container suitability, material compatibility, extractables and leachables, and closure integrity testing for pharmaceutical packaging.
**Reputation / proof points**
* Operates a network of nationwide labs.
* Assures strict compliance with GMP and other regulatory standards.
Additional information
Infinity Laboratories supports clients throughout the entire product lifecycle, from pre-clinical stages to commercial production. They emphasize rigorous method development and validation to ensure data integrity and compliance with global regulatory standards. Their services are designed to help clients understand product characteristics, identify potential contamination sources, and demonstrate product stability and safety. Buyers can expect timely turnaround and dependable results, with a focus on supporting product quality and patient safety through comprehensive analytical testing.
Key Highlights
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Offers comprehensive analytical testing services for pharmaceutical, medical device, and packaging industries.
Source
“Infinity Laboratories offers comprehensive analytical testing services for pharmaceutical, medical device, and packaging industries.”
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Specializes in chemistry, microbiology, stability, and package testing to ensure product quality and patient safety.
Source
“Specializing in chemistry, microbiology, stability, and package testing to ensure product quality and patient safety.”
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Conducts stability testing referencing ICH Q1A(R2) guidelines for drug products and substances.
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 for drug products and substances marketed in the United States, Europe, and Japan.”
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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.”
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Performs container testing including material compatibility, extractables and 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
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Operates under the governance of an internal quality assurance group, assuring 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.”
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Delivers on-time results with high data integrity, 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.”
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Conducts testing in GMP-compliant stability chambers.
Source
“Infinity Laboratories stores samples in our GMP-compliant stability chambers and conducts the required testing at specified intervals.”
Buyer Snapshot
Best for
- Pharmaceutical companies requiring comprehensive analytical testing.
- Medical device manufacturers needing sterility and container integrity assessments.
- Packaging companies seeking shelf-life and material compatibility studies.
How engagement typically works
- Collaborative approach, acting as an extension of the client's team.
- Method development and validation services.
- Testing conducted under GMP-compliant laboratories.
Typical deliverables
- Analytical method validation reports.
- Stability study reports (real-time, accelerated, forced degradation).
- Microbiological contamination assessment reports.
- Container compatibility and integrity test results.
- Water quality and purity reports.
Good to know
- Best when clients require testing aligned with USP, EP, JP, ICH, ISO, ASTM, and AAMI standards.
HQ:
USA
Languages:
English
Status:
listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, Netherlands, Asia
Industries:
Medical Devices
Packaging Tests Offered:
Package integrity, Other
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Vibration, Drop, Compression, Climate, Other
Standards Supported:
FDA Guidance, Other
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Container Closure Integrity Testing, Container Material Compatibility, Extractable & Leachable Studies, Closure Material Compatibility, Permeation Testing, Plastic Packaging Systems & Materials of Construction 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
Pricing Model
Per project
