Pace Life Sciences
★★★★★
3.8
/ 5
•
18 reviews
Pace Life Sciences offers comprehensive microbiology testing solutions for pharmaceutical, biopharmaceutical, and medical device industries. They ensure product safety and compliance with cGMP standards.
Pace Life Sciences provides specialized microbiology testing services to ensure the safety, efficacy, and quality of pharmaceutical, biopharmaceutical, and medical device products. Their services are tailored to meet stringent industry standards, including USP/NF, EP, JP, and client-specific methodologies, all while adhering to current Good Manufacturing Practices (cGMP). Key offerings include Bioburden and Microbial Limits Testing (MLT) to assess microbial levels and ensure the absence of specified pathogens, aligning with USP <60>, <61>, <62>, EP 2.6.12, 2.6.13, and ISO 11737-1:2018. They also perform Antimicrobial Effectiveness Testing (AET) per USP <51> and EP 5.1.3 to evaluate preservative system efficacy over 28 days. Furthermore, Pace Life Sciences conducts Sterility Testing according to USP <71> and ISO 11737-2, utilizing methods like membrane filtration and direct inoculation in controlled environments. Their Endotoxin Testing services, compliant with USP <85> and EP 2.6.14, detect bacterial endotoxins in various product types, including parenteral formulations and medical devices. With state-of-the-art facilities and a team of experienced scientists, Pace Life Sciences is committed to delivering accurate, reliable results and customized solutions to support clients' product development, regulatory compliance, and market timelines. They are a registered facility with the U.S. Food and Drug Administration (FDA) and hold a registration with the Drug Enforcement Administration (DEA).
About
**Who they are**
Pace Life Sciences provides comprehensive microbiology testing solutions for the pharmaceutical, biopharmaceutical, and medical device industries. They focus on ensuring product safety and compliance with cGMP standards.
**Expertise & scope**
* Offers tailored microbiology testing services aligned with USP/NF, EP, JP, and client-supplied methodologies.
* Specializes in Bioburden Testing, including recovery method suitability tests and microbial limits testing (MLT) per USP <60>, <61>, <62> and EP 2.6.12, 2.6.13.
* Performs Antimicrobial Effectiveness Testing following EP 5.1.3 and USP <51>, monitoring preservative efficacy over 28 days.
* Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2, utilizing membrane filtration, direct inoculation, and the Steritest™ system.
* Provides Bacterial Endotoxin Testing (BET) for various products including parenteral formulations, medical devices, and raw materials, following USP <85> and EP 2.6.14.
* Offers Particulate Matter Testing for liquid injectable pharmaceutical and biopharmaceutical products using USP <788> Method 1 (Light Obscuration) and Method 2 (Microscopic Particle Count).
**Reputation / proof points**
* Operates state-of-the-art facilities under current Good Manufacturing Practices (cGMP).
* Registered with the U.S. Food and Drug Administration (FDA).
* Holds a registration with the Drug Enforcement Administration (DEA), enabling handling of controlled substances.
Pace Life Sciences provides comprehensive microbiology testing solutions for the pharmaceutical, biopharmaceutical, and medical device industries. They focus on ensuring product safety and compliance with cGMP standards.
**Expertise & scope**
* Offers tailored microbiology testing services aligned with USP/NF, EP, JP, and client-supplied methodologies.
* Specializes in Bioburden Testing, including recovery method suitability tests and microbial limits testing (MLT) per USP <60>, <61>, <62> and EP 2.6.12, 2.6.13.
* Performs Antimicrobial Effectiveness Testing following EP 5.1.3 and USP <51>, monitoring preservative efficacy over 28 days.
* Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2, utilizing membrane filtration, direct inoculation, and the Steritest™ system.
* Provides Bacterial Endotoxin Testing (BET) for various products including parenteral formulations, medical devices, and raw materials, following USP <85> and EP 2.6.14.
* Offers Particulate Matter Testing for liquid injectable pharmaceutical and biopharmaceutical products using USP <788> Method 1 (Light Obscuration) and Method 2 (Microscopic Particle Count).
**Reputation / proof points**
* Operates state-of-the-art facilities under current Good Manufacturing Practices (cGMP).
* Registered with the U.S. Food and Drug Administration (FDA).
* Holds a registration with the Drug Enforcement Administration (DEA), enabling handling of controlled substances.
Additional information
Pace Life Sciences emphasizes rigorous method validation and suitability testing to ensure accurate results, particularly for products with potential antimicrobial properties. They collaborate closely with clients to develop customized protocols and recovery methods that align with specific product formulations and industry specifications. Their services are designed to support quality manufacturing, product safety, and regulatory compliance throughout the product lifecycle, from raw materials to finished products. Engagement typically involves detailed method development, testing execution, and comprehensive data reporting to support client submissions and market release.
Key Highlights
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Offers comprehensive microbiology testing for pharmaceutical, biopharmaceutical, and medical device industries.
Source
“Ensure the safety and effectiveness of your pharmaceutical, biopharmaceutical, or medical device product with our reliable microbiological lab testing services.”
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Expertise in Bioburden Testing aligned with USP, EP, and ISO standards.
Source
“Our Microbial Limits Testing (MLT) meets the requirements of the United States Pharmacopoeia (USP) general chapters <60>, <61>, and <62>, and harmonize with the requirements of European Pharmacopoeia (EP) general chapters 2.6.12 and 2.6.13.”
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Performs Sterility Testing according to USP <71> and ISO 11737-2.
Source
“Ensure product safety and safeguard your patients with our sterility testing. Our comprehensive sterility testing services adhere to pharmaceutical, biopharmaceutical, and medical device industry standards by following the guidance from the United States Pharmacopoeia USP <71> and ISO 11737-2.”
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Conducts Bacterial Endotoxin Testing (BET) following USP <85> and EP 2.6.14.
Source
“USP General Chapter <85>, Bacterial Endotoxins, and European Pharmacopoeia (EP) general chapter 2.6.14, Bacterial Endotoxins, provide method guidance to detect and quantify the levels of bacterial endotoxins present in or on the sample.”
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Performs Particulate Matter Testing per USP <788>.
Source
“We support both methods outlined in the United States Pharmacopoeia (USP) General Chapter <788> for your product.”
Certifications & Trust Signals
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Registered with the U.S. Food and Drug Administration (FDA).
Source
“Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.”
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Holds a registration with the Drug Enforcement Administration (DEA).
Source
“Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.”
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Operates under current Good Manufacturing Practices (cGMP).
Source
“With our state-of-the-art facilities and current Good Manufacturing Practices (cGMP) we offer comprehensive microbiology testing solutions for medical device, pharmaceutical, and biopharmaceutical industries.”
Buyer Snapshot
Best for
- Pharmaceutical companies seeking cGMP-compliant microbiology testing.
- Biopharmaceutical developers requiring sterility and endotoxin analysis.
- Medical device manufacturers needing bioburden and particulate matter testing.
How engagement typically works
- Collaborative method development and validation.
- Project-based testing with detailed reporting.
- Support for regulatory submissions.
Typical deliverables
- Microbiology testing reports.
- Method validation protocols and reports.
- Certificates of Analysis.
- Customized testing protocols.
Good to know
- Best when clients have specific product formulations requiring tailored testing approaches.
- Requires clear communication regarding product characteristics and potential antimicrobial properties.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Sterilization Methods Supported:
Other
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Revalidation, Other
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Other
Standards Supported:
ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility), Other
Is Accredited:
No
GMP Compliant:
Yes
Glp Compliant:
No
Has In House Sterilization:
No
Has In House Microbiology:
Yes
Rush Available:
No
Nda Support:
No
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
N/A
Validation Types Offered
N/A
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring, Particulate Matter Testing, Antimicrobial Effectiveness Testing
Lead Time Band
N/A
Quote SLA
N/A
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Per project
