PEGP Exam flashcards
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37 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Reynolds number
- Dimensionless ratio of inertial to viscous forces, Re = ρvD/μ. Below 2100 flow is laminar; above 4000 it is turbulent in a pipe.
- Fick's first law
- Diffusive flux J equals −D times the concentration gradient dc/dx. It states that mass moves from high to low concentration proportional to the gradient.
- Overall heat transfer coefficient
- U combines convective and conductive resistances in series so that Q = UAΔT. It is the reciprocal of the total thermal resistance per unit area.
- Particle size span
- Span = (D90 − D10)/D50. It quantifies distribution width; a smaller span indicates a narrower, more uniform particle size distribution.
- NPSH and cavitation
- Net positive suction head available must exceed that required by the pump. Insufficient NPSH causes vapor bubbles that collapse and damage the impeller.
- Hausner ratio
- Ratio of tapped to bulk density of a powder. Values near 1.0 indicate good flow; higher values indicate poor flow and greater cohesiveness.
- Power per unit volume scaling
- For turbulent impellers P ∝ N³D⁵, so P/V is often held constant during scale-up. This preserves mixing intensity but not tip speed.
- Tip speed scale-up
- Tip speed equals πND. Holding it constant during scale-up limits shear damage to cells or crystals but reduces power per unit volume.
- Design of experiments
- A structured statistical approach varying multiple factors simultaneously to identify main effects and interactions, reducing runs versus one-factor-at-a-time experimentation.
- Critical process parameter
- A process variable whose variability impacts a critical quality attribute and therefore must be monitored or controlled to ensure product quality.
- Proven acceptable range
- The range of a process parameter demonstrated to produce material meeting specifications. It sits within the design space and supports normal operating ranges.
- Scale-down model
- A small-scale system that reproduces relevant commercial hydrodynamics, mixing, and residence time so that process changes can be studied predictively.
- Stokes' law
- Settling velocity v = d²(ρp − ρf)g/(18μ) for a sphere in the Stokes regime. Larger particles and greater density difference settle faster.
- Darcy's law for filtration
- Flow through a filter medium is proportional to pressure drop and inversely proportional to viscosity and cake resistance. Compressible cakes resist higher pressure.
- Minimum fluidization velocity
- The superficial gas velocity at which bed pressure drop equals the bed weight per unit area. Above it, particles become suspended and behave like a fluid.
- Log mean temperature difference
- LMTD is the driving force for heat exchanger design based on terminal temperatures. A correction factor F applies to multipass or crossflow configurations.
- Chromatographic resolution
- Resolution depends on selectivity, plate number, and retention factor. Baseline resolution of about 1.5 is typically targeted for reliable separation.
- Clean-in-place turbulence target
- CIP relies on turbulent flow, often at least 1.5 m/s velocity, plus validated temperature, detergent concentration, and contact time to remove residues.
- ICH Q7 scope
- Guidance on GMP for active pharmaceutical ingredients. It covers starting materials, intermediates, APIs, and their storage and distribution.
- ALCOA+ data integrity
- Records must be attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available. These principles underpin GMP documentation.
- Annual product quality review
- A periodic review of batches, deviations, complaints, changes, and stability data for a marketed product, used to confirm process consistency and identify improvements.
- CTD module structure
- Common Technical Document: Module 1 regional information, Module 2 summaries, Module 3 quality, Module 4 safety, Module 5 clinical study reports.
- Out-of-specification investigation
- A documented laboratory investigation performed before any retest or resampling. It determines whether the failure is laboratory error or product failure.
- Unidirectional airflow
- Air moving in parallel streams at controlled velocity to protect exposed product. Used in critical zones to prevent particle ingress from the operator or environment.
- Contemporaneous recording
- Recording data at the time the activity occurs. Corrections use a single line, initials, date, and reason, preserving the original entry.
- Water for injection limits
- WFI must meet specified conductivity, total organic carbon, and microbial limits, and is typically circulated continuously in validated loops at elevated temperature.
- Line clearance
- A verified removal of prior batch materials, documents, and components from equipment and areas before starting a new batch, preventing mix-ups.
- Environmental monitoring
- Routine sampling of viable and non-viable particles, surfaces, and personnel in classified areas to confirm the cleanroom remains within its design classification.
- V-model qualification
- Links user requirements to design, installation, operational, and performance qualification. Each phase has documented acceptance criteria traced back to requirements.
- Performance qualification
- Demonstrates that equipment or a process performs consistently under production conditions, typically with three consecutive successful batches meeting acceptance criteria.
- Process validation lifecycle
- Three stages: process design, process qualification, and continued process verification. It replaces the older one-time, three-batch validation paradigm.
- Cleaning validation limits
- Acceptance criteria derived from health-based exposure limits or traditional criteria such as 1/1000 of the minimum dose and 10 ppm residue in subsequent product.
- GAMP 5 categorization
- A risk-based framework for computer system validation that classifies software by category and scales validation effort according to risk and complexity.
- HAZOP study
- A structured process hazard analysis applying guide words to process parameters to identify deviations, causes, consequences, and safeguards.
- Dust explosion pentagon
- Five conditions needed for a dust explosion: combustible dust, oxygen, ignition source, dispersion, and confinement. Removing any one prevents the event.
- Occupational exposure limit
- An airborne concentration limit for a substance in the workplace. It drives containment design and monitoring for potent pharmaceutical compounds.
- Static bonding and grounding
- Connecting conductive equipment to earth to dissipate static charge. Essential when transferring flammable solvents to prevent ignition of vapors.