Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis lesson explains tablet press parts, how to set it up, and key operating settings. It covers caring for tools, controlling tablet weight and hardness, and fixing common problems like capping, lamination, and sticking.
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 lesson details wet granulation steps, choosing binders, and types of equipment. It highlights key settings, scaling up production, cleaning methods, and controls to ensure good granule quality, flow, and performance in compression.
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 lesson reviews how to handle active ingredients and excipients from arrival to release. It includes sampling, quarantine storage, environmental controls, preventing 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 lesson describes primary and secondary packaging for tablets and capsules, with focus on blister lines. It covers forming, feeding, sealing, coding, inspection, labelling, and serialisation to protect product identity and quality.
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 lesson focuses on when direct compression works, checking API properties, selecting excipients, and flow issues. It explains lubrication, segregation risks, and controls for strong tablets without granulation.
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 lesson introduces film coating and other steps like printing and capsule banding. It explains when coating is needed, key variables, basic equipment, common defects, and how to fix 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 lesson covers drying basics, moisture limits, dryer types, load setup, endpoint checks, and validation. It links milling, particle size, and heat effects to blend uniformity and compression success.
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 lesson explains safe handovers between process steps, including line clearance, status labels, material moves, sampling points, duties, 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 lesson explains mixing methods, blender types, uniformity tests, segregation risks, addition order, scale-up, and validation to prove reliable mixing every time.
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 lesson covers weighing room setup, balance checks, correct tare use, sampling, identification, reconciliation, labelling, and traceability for accurate material dispensing and full tracking.
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 lesson maps the full process from raw materials arriving to finished packs. It highlights records, sampling, in-process checks, decisions, GMP rules, data integrity, and batch release needs.
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
