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 solutions aligned with USP/NF, EP, JP, and client-supplied methodologies.
* Specializes in Bioburden Testing, including Recovery Method Suitability Tests and testing for specified microorganisms according to USP <62>/<60> and EP 2.6.13.
* Performs Antimicrobial Effectiveness Testing following EP 5.1.3 and USP <51> standards, monitoring preservative system efficacy over 28 days.
* Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2, utilizing membrane filtration, closed filtration (Steritest™ system), and direct inoculation methods in ISO Class 5 hoods within an ISO Class 7 cleanroom.
* Provides Bacterial Endotoxin Testing (BET) for various products including parenteral formulations, medical devices, raw materials, and APIs, following USP <1085>, 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 Particle Count Test) and Method 2 (Microscopic Particle Count Test).
**Reputation / proof points**
* Operates with state-of-the-art facilities and 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 solutions aligned with USP/NF, EP, JP, and client-supplied methodologies.
* Specializes in Bioburden Testing, including Recovery Method Suitability Tests and testing for specified microorganisms according to USP <62>/<60> and EP 2.6.13.
* Performs Antimicrobial Effectiveness Testing following EP 5.1.3 and USP <51> standards, monitoring preservative system efficacy over 28 days.
* Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2, utilizing membrane filtration, closed filtration (Steritest™ system), and direct inoculation methods in ISO Class 5 hoods within an ISO Class 7 cleanroom.
* Provides Bacterial Endotoxin Testing (BET) for various products including parenteral formulations, medical devices, raw materials, and APIs, following USP <1085>, 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 Particle Count Test) and Method 2 (Microscopic Particle Count Test).
**Reputation / proof points**
* Operates with state-of-the-art facilities and 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 testing protocols to ensure product safety and regulatory compliance. Their approach includes thorough method suitability testing to account for potential antimicrobial properties in product formulations, preventing false negatives. They are equipped to handle diverse product types and dosage forms, including small- and large-volume parenterals, aseptically compounded products, and terminally sterilized medical devices. Engagement typically involves close collaboration with clients to develop customized protocols and ensure alignment with specific GMP microbiology testing requirements and industry standards.
Key Highlights
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Specializes in Bioburden Testing, Antimicrobial Effectiveness Testing, Sterility Testing, Endotoxin Testing, and Particulate Matter Testing.
Source
“We offer comprehensive microbiology testing solutions for medical device, pharmaceutical, and biopharmaceutical industries.”
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Adheres to key industry standards including USP/NF, EP, JP, ISO 11737-1, ISO 11737-2, USP <71>, USP <51>, USP <62>, USP <60>, USP <788>, USP <1085>, USP <85>, and EP 2.6.14.
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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Registered with the U.S. Food and Drug Administration (FDA) and holds a registration with the Drug Enforcement Administration (DEA).
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.”
Certifications & Trust Signals
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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.”
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Conducts testing in ISO Class 5 hoods within an ISO Class 7 cleanroom for sterility testing.
Source
“This sterility testing is carried out in ISO Class 5 hoods in an ISO Class 7 clean room.”
Buyer Snapshot
Best for
- Pharmaceutical companies requiring cGMP-compliant microbiology testing.
- Biopharmaceutical firms needing to ensure product safety and quality.
- Medical device manufacturers seeking validation and compliance testing.
How engagement typically works
- Collaborative protocol development.
- Tailored testing solutions.
- Support throughout product lifecycle.
Typical deliverables
- Microbiology testing reports.
- Validation reports.
- Compliance documentation.
Good to know
- Best when clients have specific USP/NF, EP, JP, or ISO standards to meet.
- Requires clear product formulation and manufacturing process details for method suitability.
HQ:
US
Languages:
English
Timezones:
UTC, EST
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:
Other
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring, 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:
Yes
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
Custom
