PEGP Exam case studies
PEGP Exam · Put your knowledge to work in context.
The PEGP - Pharmaceutical Engineering Graduate Program Exam - is a knowledge assessment for engineers, scientists, and graduate-level candidates moving into pharmaceutical manufacturing and process roles. It tests whether you can reason across the full lifecycle of a drug product: how unit operations behave, how processes are scaled and transferred, how quality is built in rather than tested in, and how GMP, validation, and safety obligations shape everyday engineering decisions. The PEGP Exam case studies are 5 cases and about 2,840 words.
1High-Shear Granulation Scale-Up: Oversized Granules and Capping
A 10 kg lab batch of an immediate-release tablet blend is wet-granulated in a high-shear mixer at 300 rpm impeller, 1500 rpm chopper, 3 min binder addition, and 4 min wet massing; endpoint is 1.8 kW. The granules have D50 240 µm, bulk density 0.48 g/mL, and tablets compress at 15 kN with 8 min disintegration.
590 words, about 3 min2Cleaning Validation Limits for a Shared Fluid-Bed Dryer
A shared fluid-bed dryer processes Product A, whose API has a permitted daily exposure (PDE) of 2 µg/day. The A batch size is 250 kg, and the product-contact surface area is 20 m².
588 words, about 3 min3Water-for-Injection Cooler Underperformance Before Sterile Filtration
A 5 m³/h water-for-injection stream must be cooled from 80°C to 25°C before a 0.22 µm filter. The existing plate heat exchanger has 8.0 m² of area; the vendor clean overall coefficient is 1200 W/m²K.
590 words, about 3 min4Post-Approval Excipient Source Change for a Generic Tablet
A marketed immediate-release 500 mg tablet uses microcrystalline cellulose (MCC) PH102 as a dry binder/filler. The approved supplier notifies a source change from wood pulp to cotton linter and a material shift: D50 falls from 110 to 85 µm, bulk density rises from 0.28 to 0.34 g/mL, and crystallinity rises from 78% to 82%.
554 words, about 3 min5Dust Explosion Risk in an Oral Solid Dosage Transfer Room
An oral solid dosage plant transfers 500 kg batches of a lactose–microcrystalline cellulose blend from a fluid-bed dryer to a bin through a pneumatic line. The dust has Kst 120 bar·m/s, MIE 25 mJ, and MEC 60 g/m³.
518 words, about 3 min