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 offers comprehensive microbiology testing solutions for the pharmaceutical, biopharmaceutical, and medical device industries, ensuring product safety and compliance with cGMP standards.
**Expertise & scope**
* Provides reliable microbiological lab testing services with a strong focus on GMP compliance and industry standards.
* Offers tailored solutions aligned with USP/NF, EP, JP, and client-supplied methodologies.
* Specializes in Bioburden Testing to assess microbial levels and confirm the absence of pathogens, following ISO 11737-1:2018.
* Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2, supporting various dosage forms and product types.
* Performs Bacterial Endotoxin Testing (BET) to detect endotoxins in parenteral drug formulations, medical devices, raw materials, and more, following USP <85> and EP 2.6.14.
* Offers Particulate Matter Testing for liquid injectable pharmaceutical and biopharmaceutical products using USP <788> methods (Light Obscuration and Microscopic Particle Count).
**Reputation / proof points**
* Operates state-of-the-art facilities adhering to current Good Manufacturing Practices (cGMP).
* Possesses multiple locations across the U.S.
Pace Life Sciences offers comprehensive microbiology testing solutions for the pharmaceutical, biopharmaceutical, and medical device industries, ensuring product safety and compliance with cGMP standards.
**Expertise & scope**
* Provides reliable microbiological lab testing services with a strong focus on GMP compliance and industry standards.
* Offers tailored solutions aligned with USP/NF, EP, JP, and client-supplied methodologies.
* Specializes in Bioburden Testing to assess microbial levels and confirm the absence of pathogens, following ISO 11737-1:2018.
* Conducts Sterility Testing services adhering to USP <71> and ISO 11737-2, supporting various dosage forms and product types.
* Performs Bacterial Endotoxin Testing (BET) to detect endotoxins in parenteral drug formulations, medical devices, raw materials, and more, following USP <85> and EP 2.6.14.
* Offers Particulate Matter Testing for liquid injectable pharmaceutical and biopharmaceutical products using USP <788> methods (Light Obscuration and Microscopic Particle Count).
**Reputation / proof points**
* Operates state-of-the-art facilities adhering to current Good Manufacturing Practices (cGMP).
* Possesses multiple locations across the U.S.
Additional information
Pace Life Sciences emphasizes a collaborative approach, working closely with clients to develop customized protocols and recovery methods appropriate for specific materials and dosage forms. They are equipped to handle products with potential antimicrobial properties by adjusting sample preparation steps, including dilution, filtration, neutralization, or inactivation. Their sterility testing is conducted in ISO Class 5 hoods within an ISO Class 7 clean room, with robust procedures to minimize contamination risk and false-positive results. The provider also offers support for various approval pathways and product development stages, ensuring phase-appropriate testing.
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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Specializes in Bioburden Testing according to 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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Performs Sterility Testing in compliance with 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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Provides Particulate Matter Testing using USP <788> methods.
Source
“We support both methods outlined in the United States Pharmacopoeia (USP) General Chapter <788> for your product. Method 1 involved an automated instrument method, whereas method 2 leverages a manual counting method using visual observation.”
Certifications & Trust Signals
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Operates in compliance with 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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Has multiple laboratory locations across the U.S.
Source
“Our expert team of scientists and lab technicians conducts comprehensive microbiology testing services to ensure the safety and efficacy of medical devices. With multiple locations across the U.S., we perform hundreds of rigorous tests daily.”
Buyer Snapshot
Best for
- Pharmaceutical companies seeking cGMP-compliant microbiology testing.
- Biopharmaceutical developers requiring safety and efficacy assessments.
- Medical device manufacturers needing to ensure product compliance.
How engagement typically works
- Collaborative protocol development.
- Tailored testing solutions.
- Support throughout the product lifecycle.
Typical deliverables
- Microbiology testing reports.
- Bioburden testing results.
- Sterility testing validation.
- Bacterial endotoxin test reports.
- Particulate matter analysis.
Good to know
- Best when clients require adherence to USP, EP, JP, and ISO standards.
- Best when clients need testing in cGMP-compliant facilities.
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:
EtO (Ethylene Oxide), Gamma Radiation, Steam (Moist Heat)
Validation Types Offered:
Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11138 (Biological indicators)
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, Environmental monitoring, Particulate Matter
Lead Time Band
N/A
Quote SLA
N/A
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Per project
