Pharmaceutical Process Automation

A specialized pharmacy filled its pharmaceutical products by hand: a highly repetitive task that ties up skilled staff in processes they are overqualified for, and one that is hard to staff reliably amid skills shortages and turnover. Accordingly, weighing errors and complaints piled up, staffing effort was high, and growth was limited. What was needed was an automated, validated system that fills 5–25 g of product accurately, in a documented and economical way; the selection also weighed references, compliance considerations, acceptable delivery times, and additional costs such as customs.

To that end I analyzed the international market, contacted manufacturers in Europe, Asia and North America and held conversations, and specified and reviewed requirements, including steel, additional check-weighing steps, and options for (semi-)automated labeling and container sealing. I visited such a system, already in operation in a German pharmacy, on site, clarified compliance questions, and compared the quotes obtained.

In parallel I developed a four-stage validation concept to industry standard (DQ/IQ/OQ/PQ) with defined acceptance criteria, and integrated it into the purchase contract so that a right of return applied if the criteria were not met. That way, validation de-risked the matter before the contract was signed.

I handed over a well-founded vendor recommendation and a practical concept as the basis for an investment decision of around €100,000, together with full documentation.