Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis part discusses the parts of a tablet press machine, how to set it up, and the settings for operation. It covers taking care of tools, controlling tablet weight and hardness, and usual problems like capping, lamination, and sticking, including ways to fix them.
Press types, main components, and guardsTooling selection, inspection, and cleaningFeed frame design and powder flow issuesWeight, hardness, and thickness controlCapping, lamination, sticking, and pickingLesson 2Granulation methods: wet granulation workflow, equipment operation, and critical parametersThis part explains the steps in wet granulation, choosing binders, and types of equipment used. It discusses key settings, scaling up production, and cleaning, focusing on controls that ensure good granule quality, flow, and performance in later compression stages.
Binder solution preparation and checksHigh-shear granulator setup and operationEnd-point determination and PAT toolsGranule transfer and wet screening stepsScale-up considerations and cleaning needsLesson 3Materials handling: APIs, excipients, sampling, quarantine, and release criteriaThis part looks at handling active ingredients and excipients from when they arrive until they are released for use. It includes sampling, quarantine, storage, and environmental controls, stressing prevention of cross-contamination and decisions based on specifications.
API and excipient receipt and labelingSampling plans, tools, and contamination riskQuarantine, approved, and rejected statusStorage conditions and segregation rulesCOA review, testing, and release criteriaLesson 4Packaging: blister line operation, checks for integrity, labeling, and serial traceabilityThis part describes primary and secondary packaging for solid oral medicines, with focus on blister packaging lines. It covers forming, feeding, sealing, coding, inspection, labeling, and serialisation, including controls to maintain product identity and integrity.
Blister forming, feeding, and sealing stepsCartoning, leaflet insertion, and bundlingOnline vision systems and seal integrityCoding, serialization, and aggregationPackaging line documentation and yieldsLesson 5Direct compression: formulation suitability, excipient selection, and process controlsThis part focuses on whether direct compression is suitable, including properties of active ingredients, choosing excipients, and flow characteristics. It explains lubrication, risks of segregation, and controls needed for strong tablets without granulation first.
API properties critical for direct compressionChoice of fillers, binders, and disintegrantsUse of pregranulated and co-processed excipientsLubricant level, mixing order, and impactProcess controls and typical failure modesLesson 6Coating and secondary operations (brief): when used and basic process considerationsThis part introduces film coating and other secondary processes like printing and capsule banding. It outlines when coating is applied, key variables in the process, basic equipment, and common defects with ways to troubleshoot them.
Functional and nonfunctional coating purposesCoating pan and spray system fundamentalsInlet air, exhaust, and spray rate controlCommon coating defects and root causesPrinting, debossing, and capsule bandingLesson 7Drying and milling: moisture control, drying validation, particle size reduction and its impactThis part explains principles of drying, moisture limits, and types of dryers. It covers how to load, determine endpoints, and validate drying, then connects milling, particle size, and heat to uniform blends and good compression.
Moisture targets and loss on drying testsFluid bed and tray dryer operation basicsDrying endpoint, sampling, and validationMilling equipment types and key settingsPSD effects on flow, compaction, and defectsLesson 8Handover between steps: line clearance, material transfer and in-process sampling pointsThis part explains controlled transfers between process steps, including clearing lines, labeling status, and moving materials. It details sampling points during process, responsibilities, and records to avoid mix-ups and missing data.
Line clearance scope and documentationMaterial status labels and transfer rulesDefined handover roles and responsibilitiesIn-process sampling plans and locationsSample handling, storage, and chain of custodyLesson 9Mixing and blending principles: blend uniformity, segregation risks, mixing validationThis part explains how mixing works, types of blenders, and testing for uniform blends. It addresses risks of segregation, order of adding materials, scaling up, and validation methods to show reliable mixing.
Blender types and loading strategiesMixing mechanisms and time determinationSampling plans for blend uniformity testsSegregation causes and mitigation methodsMixing validation and continued verificationLesson 10Weighing and dispensation: procedures, accuracy, tare, and traceabilityThis part covers design of weighing areas, qualifying balances, and using tare correctly. It explains sampling, identification, reconciliation, labeling, and controls for accurate dispensing and full tracking of materials.
Weighing room zoning and environmental controlsBalance calibration, verification, and maintenanceTare procedures and minimizing handling errorsMaterial ID, labels, and status controlWeighing records, reconciliation, and genealogyLesson 11Overview of tablet and capsule manufacturing stages from raw material receipt to final packagingThis part maps the entire manufacturing process from receiving raw materials to finished packages. It highlights records, sampling, in-process checks, and decisions, connecting each stage to good manufacturing practices, data integrity, and batch release.
Raw material receipt, sampling, and testingBatch record issuance and line preparationCore processing through compression or fillingCoating, printing, and visual inspectionFinal packaging, QA review, and release
