Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis lesson explores the components of a tablet press, its setup, and operational parameters. It discusses proper tooling maintenance, control of tablet weight and hardness, and frequent issues like capping, lamination, and sticking, along with practical troubleshooting methods suitable for local manufacturing setups.
Press types, main components, and safety guardsTooling selection, inspection, and cleaning proceduresFeed frame design and powder flow challengesWeight, hardness, and thickness control techniquesCapping, lamination, sticking, and picking issuesLesson 2Granulation methods: wet granulation workflow, equipment operation, and critical parametersThis lesson details the steps in wet granulation, selection of binders, and types of equipment used. It highlights key parameters, scaling up processes, and cleaning protocols, focusing on controls that guarantee granule quality, flow properties, and effective compression in subsequent stages.
Binder solution preparation and quality checksHigh-shear granulator setup and operationEnd-point determination and PAT toolsGranule transfer and wet screening processesScale-up considerations and cleaning requirementsLesson 3Materials handling: APIs, excipients, sampling, quarantine, and release criteriaThis lesson reviews the management of active pharmaceutical ingredients and excipients from receipt to release. It includes sampling techniques, quarantine procedures, storage conditions, and environmental controls, with emphasis on preventing cross-contamination and making release decisions based on specifications.
API and excipient receipt and labellingSampling plans, tools, and contamination risksQuarantine, approved, and rejected statusesStorage conditions and segregation protocolsCOA review, testing, and release criteriaLesson 4Packaging: blister line operation, checks for integrity, labeling, and serial traceabilityThis lesson describes primary and secondary packaging for solid oral products, with a focus on blister packaging lines. It covers forming, feeding, sealing, coding, inspection, labelling, and serialisation processes, including controls to maintain product identity and integrity throughout.
Blister forming, feeding, and sealing stepsCartoning, leaflet insertion, and bundlingOnline vision systems and seal integrity checksCoding, serialization, and aggregation methodsPackaging line documentation and yield trackingLesson 5Direct compression: formulation suitability, excipient selection, and process controlsThis lesson examines the feasibility of direct compression, considering API characteristics, excipient choices, and powder flow. It explains lubrication techniques, risks of segregation, and necessary process controls to produce stable tablets without prior granulation steps.
API properties essential for direct compressionSelection of fillers, binders, and disintegrantsUse of pregranulated and co-processed excipientsLubricant levels, mixing sequences, and effectsProcess controls and common failure modesLesson 6Coating and secondary operations (brief): when used and basic process considerationsThis lesson introduces film coating and other secondary processes like printing and capsule banding. It outlines the purposes of coating, key process variables, basic equipment, and typical defects, providing troubleshooting guidance for these operations.
Purposes of functional and nonfunctional coatingsFundamentals of coating pans and spray systemsControl of inlet air, exhaust, and spray ratesCommon coating defects and their root causesPrinting, debossing, and capsule banding techniquesLesson 7Drying and milling: moisture control, drying validation, particle size reduction and its impactThis lesson explains drying principles, moisture specifications, and types of dryers. It discusses load configurations, endpoint determination, validation methods, and connects milling, particle size distribution, and heat effects to blend uniformity and compression outcomes.
Moisture targets and loss on drying testsBasics of fluid bed and tray dryer operationsDrying endpoints, sampling, and validationTypes of milling equipment and key settingsPSD impacts on flow, compaction, and defectsLesson 8Handover between steps: line clearance, material transfer and in-process sampling pointsThis lesson covers controlled transitions between manufacturing steps, including line clearance, status labelling, and material transfers. It details in-process sampling locations, responsibilities, and documentation to avoid mix-ups and ensure complete data capture.
Scope and documentation of line clearanceMaterial status labels and transfer protocolsDefined roles and responsibilities in handoversIn-process sampling plans and locationsSample handling, storage, and chain of custodyLesson 9Mixing and blending principles: blend uniformity, segregation risks, mixing validationThis lesson explains mixing mechanisms, types of blenders, and testing for blend uniformity. It addresses segregation risks, addition sequences, scale-up challenges, and validation methods to ensure consistent and reproducible mixing results.
Types of blenders and loading strategiesMixing mechanisms and time calculationsSampling plans for blend uniformity testsCauses and mitigation of segregationMixing validation and ongoing verificationLesson 10Weighing and dispensation: procedures, accuracy, tare, and traceabilityThis lesson discusses weighing room design, balance qualification, and proper tare usage. It covers sampling, identification, reconciliation, labelling, and traceability measures to guarantee accurate dispensation and comprehensive material tracking.
Weighing room zoning and environmental controlsBalance calibration, verification, and maintenanceTare procedures and error minimisationMaterial identification, labels, and status controlWeighing records, reconciliation, and genealogyLesson 11Overview of tablet and capsule manufacturing stages from raw material receipt to final packagingThis lesson outlines the entire manufacturing process from raw material receipt to finished packaging. It emphasises documentation, sampling, in-process controls, and decision points, connecting each phase to GMP standards, data integrity, and batch release in local facilities.
Raw material receipt, sampling, and testingBatch record issuance and line preparationCore processing via compression or fillingCoating, printing, and visual inspectionFinal packaging, QA review, and release
