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Scope of Services

Ultramikro, LLC is a consultant firm providing guidance for pharmaceutical and food industries in contamination control and in global pharmacopeial compliance.  Particulate matter in the pharmaceutical presentation may be foreign material or also form due to substances intrinsic to the formulation or package.  Removing the sub-visible (~ less than 100μm) and larger particles or reducing their impact is quite dependant upon their identification, which is facilitated through analysis by a variety of instruments and approaches.  Microscopical applications are foremost in the Ultramikro approach.

DS (Scott) Aldrich is owner and president of Ultramikro, and has 37 years of industrial experience in pharmaceutical development and processing in new product design and launch.  He has extensive experience in domestic pharmaceutical formulation development including active ingredient and excipient processing and in product forms such as oral liquid, oral solid dose (immediate and controlled release), emulsion, sterile parenteral and topical presentations.  Development and commercial product support includes packaging selection (glass, metal, rubber, plastic) for conventional and device industries, package presentation and release inspection procedures. We have audited and worked with site process improvement teams in Japan, Puerto Rico, and several EU countries for excipient manufacturers; glass, rubber and plastic package suppliers and modified natural and synthetic polymeric materials.

Scott Aldrich is a long-standing member of American Chemical Society and Microscopy Society of America.  He is currently a member of the United States Pharmacopeia (USP) Parenteral Products Industrial Expert Committee in the 2005-2010 term.  The USP committee proposes and revises standards for pharmaceutical products, and focuses on several official chapters; <1> Injections, <381> Elastomeric Closures for Injections, <788> Particulate Matter in Injections and <789> Particulate Matter in Ophthalmic Solutions and related monographs.

The firm provides, as primary services, the following:

Consultation in Pharmaceutical Development Systems, including Inspection, Analytical Methods and Process Review
Microscopy Training
Lab Design and Equipment Selection for Development Laboratories
Particulate Matter Detection and Characterization Process Training
Product Stability Methods and Consultation
USP Particulate Matter Assay Methodology Training
Product Process Auditing