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 its operating settings. It covers caring for tools, controlling weight and hardness, and usual problems like capping, lamination, and sticking, along with ways to fix them.
Types of presses, key parts, and safety guardsSelecting, checking, and cleaning toolsDesign of feed frame and issues with powder flowControl of weight, hardness, and thicknessCapping, 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 settings, scaling up, and cleaning, stressing controls that ensure good granule quality, flow, and performance in later compression steps.
Preparing binder solution and checksSetting up and running high-shear granulatorDetermining end-point and using PAT toolsTransferring granules and wet screening stepsConsiderations for scale-up and cleaningLesson 3Materials handling: APIs, excipients, sampling, quarantine, and release criteriaThis part looks at handling APIs and excipients from when they arrive until release. It includes sampling, quarantine, storage, and environmental controls, focusing on preventing cross-contamination and making release decisions based on specifications.
Receipt and labelling of API and excipientsSampling plans, tools, and contamination risksQuarantine, approved, and rejected statusStorage conditions and segregation rulesReview of COA, testing, and release criteriaLesson 4Packaging: blister line operation, checks for integrity, labeling, and serial traceabilityThis part describes primary and secondary packaging for solid oral products, with focus on blister lines. It covers forming, feeding, sealing, coding, inspection, labelling, and serialisation, including controls to protect product identity and integrity.
Steps in blister forming, feeding, and sealingCartoning, inserting leaflets, and bundlingOnline vision systems and seal integrityCoding, serialisation, and aggregationDocumentation and yields for packaging linesLesson 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.
API properties key for direct compressionChoice of fillers, binders, and disintegrantsUse of pregranulated and co-processed excipientsLubricant levels, mixing order, and effectsProcess controls and common 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 process variables, basic equipment, and typical defects with ways to troubleshoot them.
Purposes of functional and nonfunctional coatingsFundamentals of coating pan and spray systemsControl of inlet air, exhaust, and spray rateCommon 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 principles, moisture specs, and dryer types. It covers load setup, end-point checks, and validation, then connects milling, particle size, and heat to blend uniformity and compression.
Moisture targets and loss on drying testsBasics of fluid bed and tray dryer operationDrying end-point, sampling, and validationTypes of milling equipment and key settingsEffects of PSD on flow, compaction, and defectsLesson 8Handover between steps: line clearance, material transfer and in-process sampling pointsThis part explains controlled handovers between process steps, including line clearance, status labelling, and material transfer. It details in-process sampling points, duties, and paperwork to avoid mix-ups and data issues.
Scope and documentation of line clearanceLabels for material status and transfer rulesRoles and responsibilities in handoversPlans and locations for in-process samplingHandling samples, storage, and chain of custodyLesson 9Mixing and blending principles: blend uniformity, segregation risks, mixing validationThis part explains how mixing works, types of blenders, and testing blend uniformity. It addresses segregation risks, addition order, scale-up, and validation methods to show reliable mixing.
Types of blenders and loading strategiesMixing mechanisms and time determinationSampling plans for blend uniformity testsCauses of segregation and mitigation methodsValidation of mixing and ongoing checksLesson 10Weighing and dispensation: procedures, accuracy, tare, and traceabilityThis part covers design of weighing rooms, qualifying balances, and using tare correctly. It explains sampling, identification, reconciliation, labelling, and traceability to ensure accurate dispensing and full material tracking.
Zoning and environmental controls in weighing roomsCalibration, verification, and maintenance of balancesTare procedures and reducing handling errorsControl of material ID, labels, and statusRecords of weighing, 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 documentation, sampling, IPCs, and decision points, connecting each stage to GMP, data integrity, and batch release needs.
Receipt, sampling, and testing of raw materialsIssuing batch records and preparing linesCore processing via compression or fillingCoating, printing, and visual inspectionFinal packaging, QA review, and release
