Pace Analytical Life Sciences operates a recently-expanded 26,000 ft2 laboratory in San German, Puerto Rico, offering testing services to clients in Puerto Rico and throughout the Latin Americas region.
The San German laboratory provides a wide range of service offerings with a current capacity available in all areas:
- Excipients and API testing
- Finished Product Release
- Stability Storage & Testing
The San German laboratory chemistry services include:
- Raw material testing (USP, EP, JP, JPE, BP, ACS, FCC)
- Finished product release testing
- Residual Ethylene Oxide (EO) / Ethylene Chlorohydrin (ECH)
Microbiology services include:
- Sterility testing
- Microbial Limits Testing (MLT)
- Antimicrobial Effectiveness Testing (AET)
- Disinfectant Efficacy (DE) studies
- Microbial Identification
- On-site Environmental Monitoring (EM) services / Facility Monitoring services provided by a team of qualified technicians who travel to customer manufacturing sites
Our employees are bilingual, speaking both English and Spanish. This allows us to easily support customers throughout the Caribbean, Central America and South America.
Pace Analytical Life Sciences in San German, Puerto Rico, is FDA registered and DEA registered for the handling of controlled substances (schedules II – V). Every year Pace Analytical continues to invest in upgraded and expanded facilities, in new technologies and in state-of-the-art equipment to support our client testing needs.
Pace Analytical has a long history of providing cGMP analytical laboratory services and has been FDA-registered for more than 25 years. The most recent copy of the FDA Establishment Inspection Report (EIR) for each facility can be found here.