Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis lesson explores tablet press components, setup procedures, and operating parameters. It covers tooling maintenance, control of weight and hardness, and typical failure modes like capping, lamination, and sticking, including practical troubleshooting tips relevant to Australian manufacturing standards.
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 lesson details the steps in wet granulation, selection of binders, and types of equipment used. It discusses critical parameters, scaling up processes, and cleaning protocols, with a focus on controls that ensure granule quality, flow properties, and performance in downstream compression for Australian facilities.
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 lesson reviews the handling of active pharmaceutical ingredients (APIs) and excipients from receipt to release. It includes sampling techniques, quarantine procedures, storage conditions, and environmental controls, emphasising prevention of cross-contamination and decisions based on specifications in line with Australian regulations.
API and excipient receipt and labellingSampling 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, labelling, and serial traceabilityThis lesson describes primary and secondary packaging for solid oral products, with emphasis on blister packaging lines. It covers forming, feeding, sealing, coding, inspection, labelling, and serialisation processes, including controls to maintain product identity and integrity as per Australian TGA guidelines.
Blister forming, feeding, and sealing stepsCartoning, leaflet insertion, and bundlingOnline vision systems and seal integrityCoding, serialisation, and aggregationPackaging line documentation and yieldsLesson 5Direct compression: formulation suitability, excipient selection, and process controlsThis lesson focuses on assessing suitability for direct compression, including API characteristics, excipient choices, and powder flow. It explains lubrication techniques, risks of segregation, and process controls required to produce reliable tablets without granulation, tailored for small-scale Australian 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 lesson introduces film coating and other secondary processes like printing and capsule banding. It outlines reasons for coating, key process variables, basic equipment, and common defects with troubleshooting methods suitable for Australian pharmaceutical production.
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 lesson explains drying principles, moisture specifications, and dryer types. It covers load setup, endpoint detection, validation processes, and connects milling, particle size distribution, and heat effects to blend uniformity and compression outcomes in Australian contexts.
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 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 data completeness under Australian GMP.
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 lesson explains mixing mechanisms, blender types, and testing for blend uniformity. It addresses segregation risks, addition sequences, scale-up challenges, and validation methods to achieve consistent, reproducible mixing in pharmaceutical production in Australia.
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 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 complete material tracking as required in Australian facilities.
Weighing room zoning and environmental controlsBalance calibration, verification, and maintenanceTare procedures and minimising 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 lesson outlines the complete manufacturing process from raw material receipt to finished packaging. It highlights documentation, sampling, in-process controls, and decision points, connecting each stage to GMP, data integrity, and batch release standards in Australia.
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
