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, 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 enumeration of aerobic organisms, Total Aerobic Microbial Count (TAMC), and Total Yeast and Mold Count (TYMC).
* Performs Test for Specified Microorganisms to determine the presence or absence of specific objectionable organisms, following USP <62> / <60> and EP 2.6.13 procedures.
* Conducts Antimicrobial Effectiveness Testing (USP <51>) to assess preservative system efficacy over 28 days.
* Provides 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 clean room.
* Offers Endotoxin Testing (Bacterial Endotoxin Testing - BET) for various products including parenteral formulations, medical devices, raw materials, and APIs, using kinetic methods (96-well plate and cartridge systems).
* Performs Particulate Matter Testing using laser diffraction instrumentation (USP <788>, Method 1) and microscopic particle count tests (USP <788>, Method 2).
**Reputation / proof points**
* 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, 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 enumeration of aerobic organisms, Total Aerobic Microbial Count (TAMC), and Total Yeast and Mold Count (TYMC).
* Performs Test for Specified Microorganisms to determine the presence or absence of specific objectionable organisms, following USP <62> / <60> and EP 2.6.13 procedures.
* Conducts Antimicrobial Effectiveness Testing (USP <51>) to assess preservative system efficacy over 28 days.
* Provides 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 clean room.
* Offers Endotoxin Testing (Bacterial Endotoxin Testing - BET) for various products including parenteral formulations, medical devices, raw materials, and APIs, using kinetic methods (96-well plate and cartridge systems).
* Performs Particulate Matter Testing using laser diffraction instrumentation (USP <788>, Method 1) and microscopic particle count tests (USP <788>, Method 2).
**Reputation / proof points**
* 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 adherence to industry standards and regulatory requirements. Their bioburden testing includes a crucial Recovery Method Suitability Test to identify and mitigate potential antimicrobial properties in product matrices, ensuring accurate results. For sterility testing, they operate within controlled environments (ISO Class 5 hoods in an ISO Class 7 clean room) and implement robust procedures to minimize contamination risk and potential false positives. Their endotoxin testing capabilities support various product types, and they collaborate with clients to develop phase-appropriate testing strategies aligned with global standards. Buyers should note that Pace Life Sciences is registered with both the FDA and DEA, indicating their capacity to handle regulated materials and products.
Key Highlights
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Offers comprehensive microbiology testing solutions 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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Performs Bioburden Testing in accordance with ISO 11737-1:2018.
Source
“Our bioburden test procedure is performed in accordance with ISO 11737-1:2018 to determine the population of viable microorganisms in or on a pharmaceutical product, medical device, or component prior to sterilization.”
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Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2.
Source
“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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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.”
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.”
-
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.”
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 approach to develop customized protocols.
- Support throughout product lifecycle for phase-appropriate testing.
Typical deliverables
- Microbiology test reports.
- Bioburden and sterility testing results.
- Antimicrobial effectiveness data.
- Endotoxin and particulate matter testing reports.
Good to know
- Best when requiring adherence to USP, EP, JP, and ISO standards.
- Best when needing testing for pharmaceutical, biopharmaceutical, or medical device products.
HQ:
US
Languages:
English
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, Antimicrobial Effectiveness Testing, Particulate Matter Testing
Lead Time Band
N/A
Quote SLA
N/A
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
N/A
