Microtrac, the global pioneer of instrumentation and services for particle characterization, is pleased to announce that their Particle Analysis Laboratory (PAL), located in Largo, Florida is registered with the US Food and Drug Administration under the “FDA Drug Establishment Registration” program. With the PAL having acquired FDA registration, Microtrac will accept pharmaceutical ingredients, including those that are active and commonly referred to in the Pharmaceutical Industry as API’s. In addition, PAL adheres to the guidelines established by the FDA and ISO for Good Laboratory Practices as shown by audits conducted by major pharmaceutical companies, customers, and ISO.

Dr. Phil Plantz, Microtrac’s Application Manager says, “Customers in the Pharmaceutical industry can send us materials since we have, as in the past, proper sample and data security in place. We have operated for several years under the cGLP guidelines. Having FDA registration also demonstrates that our lab complies with FDA guidelines on electronic signatures (21 CFR Part 11). Very important is that our instruments undergo regularly scheduled, rigorous IQ/OQ evaluation conducted by the Microtrac Service Group.”

Phil continues: “We pride ourselves on being able to meet and exceed expectations for our lab service customers. When our customers send us materials for characterization, they are entrusting us with a small piece of a larger process and we take that responsibility very seriously. With over 30 years of lab operations and service experience, our customers appreciate our expertise and trust the data and results we provide to them.”

The PAL has been providing contract laboratory services to customers who outsource their particle characterization needs since 1981. The laboratory’s capabilities include: particle size distribution analysis of wet dispersions, slurries and dry powders by laser diffraction/dynamic light scattering, zeta potential/streaming potential measurements, dynamic image analyses, particle measurements of aerosols and sprays, particle count by light obscuration and general optical microscopy. Another capability that is part of the services portfolio is the ability to perform multipoint isotherm measurements for BET surface area calculations and porosity determinations.

In addition to a variety of particle analysis capabilities, customers can also take advantage of the following services: general consulting, SOP development, validated test method transfer services, validation development and testing, sample preparation development and Microtrac instrument trainin