Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesDis section covers tablet press parts, setup, and operating parameters. E explain how to care for tooling, control weight and hardness, and common failure modes like capping, lamination, and sticking, plus troubleshooting strategies.
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 parametersDis section details wet granulation steps, binder selection, and equipment types. E explain critical parameters, scale-up, and cleaning, stressing process controls wey ensure granule quality, flow, and downstream compression performance.
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 criteriaDis section reviews handling of APIs and excipients from receipt to release. E covers sampling, quarantine, storage, and environmental controls, stressing prevention of cross-contamination and release 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 traceabilityDis section describes primary and secondary packaging for solid orals, focusing on blister lines. E covers forming, feeding, sealing, coding, inspection, labeling, and serialisation, with controls wey protect identity and product 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 controlsDis section focuses on direct compression feasibility, including API properties, excipient selection, and flow. E explains lubrication, segregation risks, and process controls needed for robust tablets without prior 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 considerationsDis section introduces film coating and other secondary steps like printing and capsule banding. E outlines when coating is used, key process variables, equipment basics, and typical defects with troubleshooting actions.
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 impactDis section explains drying principles, moisture specifications, and dryer types. E covers load configuration, endpoint determination, and validation, then links milling, particle size distribution, and heat to blend uniformity and 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 pointsDis section explains controlled handover between process steps, including line clearance, status labeling, and material transfer. E details in-process sampling points, responsibilities, and documentation to prevent mix-ups and data gaps.
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 validationDis section explains mixing mechanisms, blender types, and blend uniformity testing. E addresses segregation risks, order of addition, and scale-up, and describes validation approaches for robust, reproducible 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 traceabilityDis section covers weighing room design, balance qualification, and correct tare use. E explains sampling, identification, reconciliation, labeling, and traceability controls for accurate dispensation and full material genealogy.
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 packagingDis section maps di full manufacturing flow from raw material receipt to finished packs. E highlights documentation, sampling, IPCs, and decision points, linking each stage to GMP, data integrity, and batch release requirements.
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
