Pharmaceutical Manufacturing & Storage

General Design and Application Considerations:

Moisture control is a great concern in the pharmaceutical industry from product manufacturing to packaging, and from shipping to storage. Some applications for humidity and moisture control in pharmaceuticals relate to microbiological considerations, while many applications relate to processing in order to achieve correct moisture levels that will facilitate the filling of capsules, tablet forming, and packaging.

For example, gelatin capsules are often monitored closely for moisture content to allow them to be sufficiently supple for filling without cracking or breaking in the manufacturing process. Effervescent power manufacturers must maintain tight control of the plant’s humidity in order to avoid moisture regain in the powder.

Environmental Standards or Requirements:

Manufacturing Process
Millions of caplets, pills tablets and capsules are produced every year. This process involves hygroscopic powders such as the pharmaceutical components and other fillers such as starch and/or sugar. Dehumidification systems are used to prevent moisture regain throughout the manufacturing process.

Dehumidified air accelerates the drying of tablet coatings. The FDA cGMP (current Good Manufacturing Process) guidelines and regulations have the impact of law in maintaining manufacturing, packaging and storage conditions for pharmaceutical products. Part 212 of the CFR cites a temperature of 72°F (+/-3°F) and a relative humidity of 30-50%RH for manufacturing areas. However, because personnel are gowned, the temperature is often specified as 68°F by the design engineer or the owner.

More about this application (PDF Document)

Reference Sources:
1. Process/Industrial Instruments and Controls Handbook – 5th Edition, Gregory McMillan, McGraw-Hill Publisher, 1999
2. Good Storage And Shipping Practices, Chapter 1079 of 2009 USP32-NF27, U.S. Pharmacopeial