Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis section explains tablet press components, setup procedures, and operating parameters. It covers tooling maintenance, weight and hardness control, and common issues like capping, lamination, and sticking, along with practical troubleshooting tips.
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 section details wet granulation steps, binder selection, and types of equipment. It highlights critical parameters, scale-up considerations, and cleaning procedures, focusing on process controls for granule quality, flow, and compression suitability.
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 section reviews handling of APIs and excipients from receipt to release. It includes sampling techniques, quarantine protocols, storage conditions, and environmental controls, stressing prevention of cross-contamination and spec-based release.
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 section describes primary and secondary packaging for solid orals, with focus on blister lines. It covers forming, feeding, sealing, coding, inspection, labelling, and serialisation, ensuring product identity and integrity protection.
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 section discusses direct compression feasibility, API properties, excipient choices, and flow properties. It explains lubrication, segregation risks, and controls for producing robust 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 section introduces film coating and secondary operations like printing and capsule banding. It outlines usage scenarios, key variables, equipment basics, common defects, and troubleshooting steps.
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 section covers drying principles, moisture specs, dryer types, load setup, endpoint checks, and validation. It links milling, particle size, and heat effects to blend uniformity and compression outcomes.
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 section explains controlled transitions between steps, including line clearance, status labelling, and material transfer. It details sampling points, responsibilities, and documentation to avoid mix-ups and data issues.
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 section explains mixing mechanisms, blender types, uniformity testing, segregation risks, addition order, scale-up, and validation methods for consistent, reproducible blends.
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 section covers weighing room setup, balance qualification, tare usage, sampling, identification, reconciliation, labelling, and traceability for accurate dispensation and material 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 section outlines the full flow from raw material receipt to finished packs. It highlights documentation, sampling, IPCs, decision points, GMP, data integrity, and batch release links.
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
