Pace Analytical Life Sciences (PLS) operates three laboratory locations, each providing GMP testing services for the pharmaceutical, biopharmaceutical, and medical device manufacturing industries:
- Oakdale, Minnesota: 60,000 ft2 of laboratory space providing chemistry and microbiology testing services to industry for more than 30 years. This location is FDA registered, DEA registered for the handling of controlled substances, schedules I – V, equipped to handle narcotic chemicals and highly potent compounds (HPCs) safely, and ISO/IEC 17025 accredited.DEA registered for the handling of controlled substances, schedules I – V
- San German, Puerto Rico: 26,000 ft2 of laboratory space providing chemistry and microbiology testing services to industry for more than 30 years. This location is FDA registered, DEA registered for the handling of controlled substances, schedules II – V, and equipped to handle narcotic chemicals and highly potent compounds (HPCs) safely.
- Somerset, New Jersey: Our newest 5,000 ft2 laboratory providing facility monitoring and microbiology testing services to local industry. This location is FDA registered.
Each of the facilities represents the vibrant and growing laboratory business. Every year Pace Analytical continues to invest in new technologies and state-of-the-art equipment. This adds capacity to our current service offering, expands capabilities to new services, keeps our equipment current and up-to-date, and support the continuous growth of our businesses.
Our laboratories have long histories of providing cGMP analytical laboratory services to their markets. View the most recent copies of the FDA Establishment Inspection Report (EIR) here. Each of the laboratories operate independently to serve their customers but follow one common quality system and are under the direction of one management team.
The laboratories have similar equipment and a common quality system to provide redundancy and backup capacity for our clients. In the event of a contingency or natural disaster, PLS could shift work between the facilities to maintain project and business continuity for our clients. Of course, any shift of work requires client notification and approval, and PLS would work with our client to determine the suitability of the alternate site for testing on a case-by-case or method-by-method basis.
Our sister company, the LabOps division of Pace Analytical, operates an Instrument Services Group (ISG) that provides refurbished laboratory instruments and services. This synergy allows quick response to demand for increased capacity. Read more about the benefits of Pace's ISG, including minimized downtime here.
Each of the laboratories utilize robust risk-management strategies to ensure continuous reliable operations:
- Diesel-powered electrical generators supply backup power to key equipment, such as computer network systems, stability storage chambers and microbiology incubators.
- The computer network systems and certain laboratory areas utilize Uninterruptible Power Systems (UPS) to cover the momentary gaps in supply, ease the transition and ensure clean power to critical systems.
- A continuous monitoring system (CMS) captures data (e.g., temperature and/or humidity) every five minutes in designated ambient laboratory areas, stability storage chambers and microbiology incubator systems. These records provide assurance that environmental control systems are operating properly.
Equipment List / Instrumentation