Pace Analytical Life Sciences - San German, Puerto Rico
P.O Box 325
Calle B & Calle C
El Retiro Industrial Zone
San German, PR 00683
Pace Analytical Life Sciences,
Oakdale, MN Location
Pace Analytical's Life Science's Puerto Rico laboratory, known as Pace Analytical Inc., has been in operation since 2003. The laboratory was previously known as Caribbean Bio-Labs, Inc., which began operation in 1989. While the name changed, many key personnel remain with the operation. Pace Analytical Life Sciences is a full service, GMP contract laboratory providing chemistry and microbiology testing services to the pharmaceutical, medical device and biopharmaceutical industries.
Our San German, PR facility is a 12,000 ft2 laboratory that is equipped with state-of-the-art instrumentation. Our services include methods development/validation, raw material testing, product release testing, microbiology testing, residual chemical analysis and facility validation support. Our laboratory is FDA registered with over thirty years of FDA audit history and DEA registered.
Phone: (787) 892-2650
Fax: (787) 892-1054
General Manager:
Nilsa Martinez
Sales Contacts:
Heidy Rodriguez
Quality Manager:
Zulma Nazario
Major Instrumentation:
- 9 GC systems with FID, TCD and Headspace detectors
- 8 HPLC systems with UV/VIS, Photodiode Array, Refractive Index and Flourescence detectors
- 1 inductively Coupled Plasma (ICP) Spectrophotometer
- 1 Atomic Absorption - Graphite Furnace
- 1 Mercury Analyzer
- 1 Total Organic Carbon (TOC) Analyzer
- 3 Karl Fisher titrators
- 1 FT-IR Spectrophotometer
- 1 UV/VIS Spectrophotometer
- 1 Biolog Automated Microbial ID System
- 1 Vitek2 Automated Microbial ID System
- 2 Microbiological Clean Rooms
- 6 Laminar Flow Hoods
- 2 Biological Safety Cabinets
- For complete instrumentation list, click
here
Location Details
13,000 ft
2, full service laboratory, providing:
- Method Development/Method Validation
- Raw Material Testing (USP/NF, EP, JP)
- Quality Control Release Testing
- ISO 10993-7, Residual Chemical Analysis
- Cleaning Validation
- Bacterial Endotoxins/LAL
- Sterility Tests
- Particulate Matter in Injections
- Biological Indicator Testing
- Microbial Limit Tests (Current USP <61> and Proposed USP <61> and <62>)
- Antimicrobial Effectiveness Testing
- Bioburden Testing
- Facility Validation/Monitoring support including Process Water Testing, Compressed Air/Compressed Gas Testing, Sanitizer/Disinfectant Efficacy Testing, Clean Room/Controlled Environment Monitoring and On-Site Sampling.
- Microorganism Identification.