Alcami
Alcami Corporation
Alcami offers comprehensive sterilization and microbiology testing services for the pharmaceutical and medical device industries. Ensure product safety and compliance with expert analysis.
Alcami provides specialized sterilization and microbiology testing solutions crucial for the pharmaceutical and medical device sectors. Our expert services ensure your products meet stringent regulatory requirements and maintain the highest standards of safety and efficacy. We offer a wide range of testing capabilities, including sterility testing, microbial limit testing, endotoxin testing, and validation of sterilization processes. Our state-of-the-art facilities and experienced scientists are dedicated to delivering accurate, reliable, and timely results. Partner with Alcami to navigate complex regulatory landscapes and accelerate your product development lifecycle. We are committed to providing exceptional service and scientific expertise to support your success in bringing safe and effective products to market.
About
**Who they are**
Alcami is a provider of sterilization and microbiology testing services, leveraging decades of expertise to support the pharmaceutical, biopharmaceutical, and medical device industries. They focus on ensuring product safety, efficacy, and quality through advanced methodologies.
**Expertise & scope**
* Comprehensive range of microbiological services supporting product development.
* Specialized testing for biologic and biopharmaceutical products.
* Services include Analysis of Non-Sterile Products, Antimicrobial Effectiveness Testing, Container Closure Integrity Testing, and Environmental Monitoring and Facility Support.
* Expertise in meeting rigorous demands for product development and regulatory compliance.
**Reputation / proof points**
* Decades of expertise in microbiological testing.
* Advanced methodologies honed through years of experience.
Alcami is a provider of sterilization and microbiology testing services, leveraging decades of expertise to support the pharmaceutical, biopharmaceutical, and medical device industries. They focus on ensuring product safety, efficacy, and quality through advanced methodologies.
**Expertise & scope**
* Comprehensive range of microbiological services supporting product development.
* Specialized testing for biologic and biopharmaceutical products.
* Services include Analysis of Non-Sterile Products, Antimicrobial Effectiveness Testing, Container Closure Integrity Testing, and Environmental Monitoring and Facility Support.
* Expertise in meeting rigorous demands for product development and regulatory compliance.
**Reputation / proof points**
* Decades of expertise in microbiological testing.
* Advanced methodologies honed through years of experience.
Additional information
Alcami's microbiology testing services are designed to meet the stringent requirements of the biotech, pharmaceutical, and medical device sectors. Their offerings support clients throughout the product development lifecycle, from early-stage analysis to ensuring final product compliance. Key services include environmental monitoring, which is crucial for maintaining sterile manufacturing environments, and container closure integrity testing to guarantee product sterility and prevent contamination. They also conduct antimicrobial effectiveness testing and analysis of non-sterile products, providing a comprehensive suite of solutions for microbial risk assessment and control.
Key Highlights
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Offers advanced microbiology testing for biologic and biopharmaceutical products.
Source
“Our advanced methodologies, honed through years of experience in the biotech, pharmaceutical, and medical device industries, are designed to meet the rigorous demands of product development and regulatory compliance.”
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Provides comprehensive microbiological services supporting product development.
Source
“We offer a comprehensive range of microbiological services that support our clients’ needs throughout the development process.”
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Includes services such as Container Closure Integrity Testing and Environmental Monitoring.
Source
“Container Closure Integrity Testing Environmental Monitoring and Facility Support”
Certifications & Trust Signals
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Leverages decades of expertise in microbiological testing.
Source
“At Alcami, we leverage decades of expertise in microbiological testing to ensure the safety, efficacy, and quality of biologic and biopharmaceutical products.”
Buyer Snapshot
Best for
- Pharmaceutical companies
- Biopharmaceutical companies
- Medical device manufacturers
How engagement typically works
- Project-based support
- End-to-end development lifecycle
Typical deliverables
- Microbiology testing reports
- Sterilization validation support
- Environmental monitoring data
- Container closure integrity test results
Good to know
- Best when requiring specialized laboratory services for product safety and compliance.
HQ:
North Carolina, US
Languages:
English
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat)
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Revalidation
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11135 (EtO), ISO 17665 (Steam), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
Is Accredited:
Yes
Accreditation Body:
A2LA
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Sample Return Policy:
Dispose
Nda Support:
Yes
Minimum Project Size:
$25-50k
Additional sterilization_microbiology_testing Details
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring, Antimicrobial Effectiveness Testing, Container Closure Integrity Testing, Analysis of Non-Sterile Products
Pricing Model
Per project
