Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis part discusses the parts of a tablet press, how to set it up, and running parameters. It covers caring for tools, controlling weight and hardness, and usual problems like capping, lamination, and sticking, plus ways to fix them in local production lines.
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. It highlights key parameters, scaling up, and cleaning, stressing controls that ensure good granule quality, flow, and performance in later compression stages for Nigerian factories.
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 reviews how to handle APIs and excipients from arrival to release. It includes sampling, quarantine, storage, and environmental controls, focusing on preventing cross-contamination and making release decisions based on specifications in a compliant manner.
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 orals, with focus on blister lines. It covers forming, feeding, sealing, coding, inspection, labeling, and serialisation, including controls to protect product identity and integrity during packaging.
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 works, including API properties, choosing excipients, and flow. It explains lubrication, risks of segregation, and controls needed for strong tablets without granulation first, suitable for small-scale Nigerian operations.
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 steps like printing and capsule banding. It outlines when coating is needed, key variables, basic equipment, and common defects with fixes, relevant for basic manufacturing in Nigeria.
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 drying basics, moisture specs, and dryer types. It covers load setup, endpoint checks, and validation, then connects milling, particle size, and heat to blend uniformity and compression in production.
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 safe handover between process steps, including line clearance, status labels, and material transfer. It details sampling points, duties, and records to avoid mix-ups and ensure data completeness in manufacturing.
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, blender types, and testing blend uniformity. It addresses segregation risks, addition order, scale-up, and validation methods to show reliable mixing in pharmaceutical production.
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 weighing room setup, balance checks, and proper tare use. It explains sampling, ID, reconciliation, labeling, and traceability to ensure accurate dispensing and full 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 part maps the entire manufacturing process from receiving raw materials to finished packs. It highlights records, sampling, checks, and decisions, connecting each stage to GMP, data integrity, and batch release in Nigeria.
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
