Cleaning methods for all phases of pharmaceutical manufacturing.

Question:
Considering that there are different phases in pharmaceutical manufacturing, bench scale R&D, pilot studies and full-scale manufacturing, what are the best critical cleaning methods for each?

Answer:
According to FDA rationale, cleaning equipment is meant to be designed to "prevent contamination or adulteration of drug products". Typically pharmaceutical operations require transition from bench scale R&D to pilot studies to full-scale manufacturing. Each transitional stage requires careful consideration of changes to the processing equipment and cleaning techniques. In general, the size of the equipment gets larger as each stage is encountered. In this regard, manual and soak-cleaning procedures tend to be adequate for bench-scale equipment, whereas pilot and large-scale manufacturing process equipment usually requires clean-in-place (CIP) cleaning by automated spray or immersion systems and/or by manual cleaning. All stages of development and production may use manual cleaning or machine washers to clean various parts of equipment or utensils. If feasible, it is desirable to clean the pharmaceutical equipment in place without having to disassemble or move it in order to rapidly get the equipment back into service.

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