Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis section explores the components of a tablet press, its setup, and operational parameters. It covers the maintenance of tooling, control of weight and hardness, and frequent failure modes like capping, lamination, and sticking, along with practical troubleshooting methods suitable for UK 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 section outlines the steps in wet granulation, selection of binders, and types of equipment used. It discusses key parameters, scaling up processes, and cleaning procedures, highlighting controls that ensure granule quality, flow properties, and effective downstream compression in line with UK guidelines.
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 and excipients from receipt to release. It includes sampling techniques, quarantine protocols, storage conditions, and environmental controls, with a focus on preventing cross-contamination and making release decisions based on specifications as per UK 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 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 in compliance with UK standards.
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 addresses the feasibility of direct compression, considering API characteristics, excipient choices, and flow properties. It explains lubrication techniques, risks of segregation, and necessary process controls to produce reliable tablets without prior granulation, aligned with UK pharmaceutical practices.
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 such as printing and capsule banding. It explains the purposes of coating, key process variables, basic equipment, and common defects, providing troubleshooting guidance relevant to UK production facilities.
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 covers drying principles, moisture specifications, and types of dryers. It discusses load configurations, endpoint determination, validation processes, and connects milling, particle size distribution, and heat effects to blend uniformity and compression outcomes in UK-compliant settings.
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 explains the controlled transfer between manufacturing steps, including line clearance, status labelling, and material movement. It details in-process sampling locations, responsibilities, and documentation to avoid mix-ups and ensure data completeness as required in the UK.
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 ensure consistent and reproducible mixing in accordance with UK GMP standards.
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 the design of weighing areas, qualification of balances, and proper use of tare weights. It covers sampling, identification, reconciliation, labelling, and traceability measures to guarantee accurate dispensation and complete material tracking in UK 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 section provides a comprehensive map of the manufacturing process from raw material receipt to finished packaging. It emphasises documentation, sampling, in-process controls, and decision points, connecting each stage to GMP, data integrity, and batch release obligations under UK regulations.
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
