Pace Analytical Life Sciences - Oakdale, Minnesota

1311 Helmo Avenue No
Oakdale, MN 55128

Pace Analytical Life Sciences, San German, PR Location

Pace Analytical Life Sciences is a full service, GMP and ISO 17025 accredited, contract laboratory providing chemistry and microbiology testing services to the pharmaceutical, medical device, and biopharmaceutical industries. Pace Analytical began servicing the life sciences industry in 2003 with the purchase of the San German, Puerto Rico laboratory. In April 2007, Pace Analytical greatly expanded the life sciences service offerings when the assets of P3 Scientific were purchased.  P3 Scientific had been the dedicated contract laboratory to 3M's Pharmaceutical Division since 1996.

Our Oakdale, MN facility is a 40,000 ft ² laboratory that is equipped with state-of-the-art instrumentation. Our services include methods development/validation, extractables/leachables studies, raw material testing, stability testing and storage, product release testing, microbiology testing, chemical characterization, residual chemical analysis and biocompatibility studies. Our laboratory is FDA registered with over ten years of FDA audit history, DEA registered and ISO/IEC 17025:2005 accredited.

Phone: (651) 738-2728
Fax: (651) 714-9360

Vice President/COO: Greg Kupp

Director of Quality: Cynthia Hansen

Major Instrumentation:

• 26 HPLS's
• 3 HPLC/MS/MS Systems
• 12 GC's
• 5 GC/MS Systems
• 6 Dissolution Baths
• 1 ICP
• 1 Atomic Absorption Spectrophotometer
• 2 FTIR Spectrophotometer
• 2 Static Headspace/FTIR Spectrophotometer
• For complete instrumentation list, click here

Location Details:

40,000 ft ², full service laboratory, providing:

• Method Development/Method Validation
• Stability Testing and Storage
• Raw Material Testing (USP/NF, EP, JP)
• Quality Control Release Testing
• Extractable/Leachable Testing
• Chemical Analysis Supporting Biocompatability
• ISO 10993-7, Residual Chemical Analysis
• ISO 10993-18, Chemical Characterization
• Physical Testing
• Materials Characterization
• 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 Validations/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