Application of Dry Granulation to Facilitate Raw Material Handling

Pharmaceutical and biopharmaceutical manufacturing relies on the timely and seamless orchestration of many steps to meet aggressive timelines and ensure operational efficiency. A fundamental element of the processing workflow that can impact schedules is the use of multi-ton quantities of bulk raw materials such as buffers, salts and stabilizing chemicals. These raw materials are typically prepared in a just-in-time manner to meet dynamic production needs and enable rapid changeovers.

Handling bulk powders can be especially challenging at a large scale as weighing and dispensing steps are time- and labor-intensive and the likelihood of dust formation puts operators at risk. In addition, raw materials such as potassium chloride, glycine and urea naturally tend to cake and can even completely solidify, especially when in long-term storage. An added difficulty is the fact that the amount of caking in a bulk container is hard to predict as it depends on transport and storage conditions; this unknown can lead to unexpected process delays and interruptions.

Caking of chemicals increases operational and safety risks as a manual de-caking process is often being employed to prepare the raw materials. Manual decaking of solid blocks of bulk powders, sometimes performed using a hammer, wastes valuable time and poses a risk of serious injury to the operator. Caking can also result in quality deviations, increase the risk of contamination, and escalate operational costs due to several factors including:

• The loss of time needed to break apart solidified blocks
• Difficulty in sampling and weighing the caked materials
• An inability to completely empty the primary packaging

A variety of approaches have been used to avoid caking, such as minimizing material storage time and ordering smaller packaging sizes. Unfortunately, such approaches do not prevent the caking process and may not be compatible with just-in-time manufacturing processes. They may simply lead to other production challenges and even create process interruptions. Given the impact that caking of bulk chemicals can have on the manufacturing workflow, an alternative solution is clearly needed to ensure that handling of raw materials align with manufacturing imperatives and business drivers of speed, quality, flexibility and cost.

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Article information: Thomas Briel, Strategic Marketing Manager at Merck/Millipore Sigma.