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H I GG I NS ANA LYT I C A L

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Experience, Expertise, Continuity

Higgins Analytical was founded in early 1994, but that is only half of the story. The two founders had already been packing commercial HPLC columns for more than fifteen years before that. Besides a lot of exper tise, our experi-ence brings an unrivaled continuity to the field.

Total Quality Approach to all Aspects of Design, Manufacturing and Testing

Each HPLC column and analytical cartridge from Higgins Analytical is evaluated by a computerized perform-ance test prior to receiving a quality

control approval.This testing protocol involves a highly accurate statistical moments determination of the column’s performance characteristics. These sensitive peak shape and column efficiency measurements can only be made by computerized data logging methods.The raw digital chromatogram for every column we have manufactured since March 1994 is retrievable from our archives.

Product Traceability

The test data for these serialized columns include sorbent proper ties and lot number as well as complete descrip-tion of the test conditions.We are able to trace the serial number of every

column to the customer that originally purchased the column.

Comprehensive Record Keeping and Statistical Quality Control

Raw digital test data is automatically archived for every column and analytical car tridge we manufacture. As a result, it is a simple matter for us to retrieve comprehensive quality control informa-tion and routinely apply it to our statistical process control activities. This

commitment to quality manufacturing and comprehensive record keeping permits us to produce replacement Cer tificates of Analysis when requested by laboratories complying with their internal GLP needs. And, most

impor tantly, we are able to assist customers during the lengthy process beginning with method development and optimization to validation and NDA filing by providing comprehensive serial number, manufacturing date, sorbent lot, and performance data for every column they ever purchased.

Expert Manufacturing and State-of-the-Art Equipment

Two of Higgins Analytical’s staff have been involved with the chemical separa-tions business for over 30 years, others for only 10 or 15. By focusing this exper tise exclusively on the separations consumables business, high quality products as well as high quality processes are assured. A key element of this exper tise is the electronic manufacturing

lab book that we have developed. All of our column packing equipment is controlled by this electronic book, and all methods are electronically stored. It is impossible to pack a column without the electronic lab book being completely documented. Processes cannot be