Cambrex Agawam

Cambrex Agawam

Cambrex Agawam offers a full suite of microbiological, analytical, and environmental monitoring services to support pharmaceutical and medical device product development.

About the plant

Our team in Agawam offers a full suite of microbiological, analytical, and environmental monitoring services to support pharmaceutical and medical device product development. The facility is FDA and DEA registered, has ANAB accreditation and a Massachusetts Radiation Materials License. Our satellite office in Marlborough, Massachusetts is located just 32 miles from the heart of the Cambridge-Boston area.

Facility Details

In Agawam, we have three laboratory service groups:

Microbiological

• *Sterility (direct immersion, open membrane filtration, closed membrane filtration)
• *Endotoxin (gel clot, chromogenic, turbidimetric methods)
• *Bioburden
• Microbial examination of non-sterile products (USP <60, , )
• Microbial identification (phenotypic, genotypic, and Gram staining)
• Antimicrobial effectiveness
• Disinfectant qualifications
• Growth promotion testing
• Filter validation (bacterial filter retention and bubble point testing)
• Biological indicators
• Water testing (bioburden, coliform)
• Mycoplasma
• Media fills
• CCIT
• Customized studies

Analytical

• Compendial testing per the USP, EP, BP, JP, JPE, ACS
• Compendial method verifications
• Analytical method validation and transfer studies
• Cleaning validation (specific and non-specific methods)
• ICH stability storage and testing
• CCIT
• *Residual ethylene oxide (EO) testing
• ASTM package testing

Environmental Monitoring & Cleanroom Services

We offer environmental monitoring services throughout New England and in the greater Albany, NY area, including:

• Routine environmental monitoring, qualification, and certification
• Total particulate
• Active viable air monitoring
• Passive viable air monitoring
• Viable surface monitoring
• Personnel monitoring
• Compressed air/gas monitoring (moisture, oil, N2, mixed gases)
• Water system monitoring (TOC, conductivity, nitrates, heterotrophic plate count)
• Temperature and humidity monitoring
• Differential pressure monitoring
• Incubation
• Enumeration and reporting
• Courier services for our clients within a 150-mile radius of the Agawam facility. Download our courier request form here.

For our Agawam site’s registration certifications, see our forms and certifications.

*ANAB accredited

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Certifications

• ISO
• FDA (cGMP)

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Activity

• SERVICES manufacturing

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Features

• Uses:
• Toxicity (OEB classification):
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU)

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Batch Size / Reactor

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Services

• Development services, Analytical / QC services, Quality Assurance services, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation

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