Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis section discusses tablet press components, setup procedures, and operating parameters. It covers proper tooling maintenance, control of weight and hardness, and frequent failure modes like capping, lamination, and sticking, along with practical troubleshooting methods.
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 section outlines wet granulation processes, selection of binders, and types of equipment used. It addresses key parameters, scaling up considerations, and cleaning protocols, highlighting process controls that ensure high-quality granules for smooth flow and effective compression downstream.
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 section examines the handling of active pharmaceutical ingredients (APIs) and excipients from receipt to release. It includes sampling techniques, quarantine procedures, storage conditions, and environmental controls, with a focus on preventing cross-contamination and making release decisions based on specifications.
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 section 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 safeguard product identity and integrity throughout.
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 section explores the feasibility of direct compression, considering API characteristics, excipient choices, and powder flow properties. It discusses lubrication techniques, risks of segregation, and necessary process controls to produce stable tablets without prior granulation steps.
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 section introduces film coating and other secondary processes like printing and capsule banding. It explains the purposes of coating, key process variables, basic equipment operations, and common defects along with troubleshooting approaches to resolve them effectively.
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 section explains drying fundamentals, moisture specifications, and various dryer types. It covers load arrangements, endpoint detection, and validation methods, then connects milling processes, particle size distribution, and thermal effects to blend uniformity and compression outcomes.
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 section details controlled transitions between manufacturing steps, including line clearance, status labelling, and material transfers. It specifies in-process sampling locations, responsibilities, and documentation to avoid mix-ups and ensure complete data capture without 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 validationThis section covers mixing mechanisms, types of blenders, and testing for blend uniformity. It addresses segregation risks, addition sequences, scale-up challenges, and validation methods to confirm consistent and reproducible mixing results in 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 section discusses weighing room layouts, balance qualification, and proper tare application. It explains sampling, identification, reconciliation, labelling, and traceability measures to guarantee precise dispensation and comprehensive material tracking throughout the process.
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 section outlines the entire manufacturing sequence from raw material intake to finished packaging. It emphasises documentation, sampling, in-process checks, and decision points, connecting each phase to good manufacturing practices, data integrity, and batch release standards.
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
