Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesDis section go cover tablet press components, setup, and operating parameters. E go explain tooling care, weight and hardness control, and common failure modes like capping, lamination, and sticking, with 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 go detail wet granulation steps, binder selection, and equipment types. E go explain critical parameters, scale-up, and cleaning, emphasizing process controls wey go 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 go review handling of APIs and excipients from receipt through release. E go cover sampling, quarantine, storage, and environmental controls, emphasizing cross-contamination prevention and specification-based release decisions.
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 go describe primary and secondary packaging for solid orals, focusing on blister lines. E go cover forming, feeding, sealing, coding, inspection, labeling, and serialisation, with controls wey go 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 go focus on direct compression feasibility, including API properties, excipient selection, and flow. E go explain lubrication, segregation risks, and process controls needed to achieve 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 go introduce film coating and other secondary steps such as printing and capsule banding. E go outline when coating is used, key process variables, equipment basics, and typical defects with associated 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 go explain drying principles, moisture specifications, and dryer types. E go cover load configuration, endpoint determination, and validation, then link 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 go explain controlled handover between process steps, including line clearance, status labeling, and material transfer. E go detail 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 go explain mixing mechanisms, blender types, and blend uniformity testing. E go address segregation risks, order of addition, and scale-up, and describe validation approaches to demonstrate 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 go cover weighing room design, balance qualification, and correct tare use. E go explain sampling, identification, reconciliation, labeling, and traceability controls wey go ensure 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 go map de full manufacturing flow from raw material receipt to finished packs. E go highlight 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
