Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis lesson details the components of a tablet press, setup procedures, and operating parameters. It discusses proper tooling maintenance, methods for controlling tablet weight and hardness, and frequent issues like capping, lamination, and sticking, along with practical troubleshooting tips suitable for local operations.
Types of presses, key parts, and safety featuresSelecting, checking, and cleaning toolingFeed frame designs and powder flow problemsControlling weight, hardness, and thicknessIssues like capping, lamination, sticking, pickingLesson 2Granulation methods: wet granulation workflow, equipment operation, and critical parametersThis lesson explores the steps in wet granulation, choices for binders, and types of equipment used. It highlights important parameters, scaling up processes, cleaning protocols, and controls that ensure high-quality granules for smooth flow and effective compression in small-scale setups.
Preparing and verifying binder solutionsSetting up and running high-shear granulatorsDetermining endpoints with PAT toolsTransferring granules and wet screeningScaling up and cleaning requirementsLesson 3Materials handling: APIs, excipients, sampling, quarantine, and release criteriaThis lesson examines the management of active pharmaceutical ingredients and excipients from arrival to approval for use. It includes sampling techniques, quarantine procedures, storage conditions, environmental safeguards, and steps to avoid cross-contamination while making release decisions based on specifications.
Receiving and labelling APIs and excipientsSampling strategies, tools, and contamination risksStatuses for quarantine, approval, and rejectionStorage conditions and segregation guidelinesReviewing COAs, testing, and release standardsLesson 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, filling, sealing, coding, inspection, labelling, and serialisation processes, including controls to maintain product identity and integrity throughout.
Steps in blister forming, filling, and sealingCartoning, inserting leaflets, and bundlingVision systems and seal integrity checksCoding, serialisation, and aggregationDocumentation and yield tracking for packagingLesson 5Direct compression: formulation suitability, excipient selection, and process controlsThis lesson addresses the viability of direct compression, considering API characteristics, excipient choices, and powder flow. It explains lubrication techniques, risks of segregation, and necessary controls to produce stable tablets without granulation, ideal for efficient local production.
Key API properties for direct compressionSelecting fillers, binders, and disintegrantsUsing pregranulated and co-processed excipientsLubricant amounts, 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 explains when coating is applied, main process variables, basic equipment, common defects, and troubleshooting methods relevant to small-scale manufacturing.
Purposes of functional and nonfunctional coatingsBasics of coating pans and spray systemsControlling inlet air, exhaust, and spray ratesTypical coating defects and their causesPrinting, debossing, and capsule bandingLesson 7Drying and milling: moisture control, drying validation, particle size reduction and its impactThis lesson covers drying fundamentals, moisture targets, and dryer varieties. It discusses load setups, endpoint checks, validation processes, and connects milling, particle size distribution, and heat effects to blend consistency and compression outcomes in practical settings.
Moisture goals and loss on drying testsBasics of fluid bed and tray dryersDrying endpoints, sampling, and validationTypes of milling equipment and settingsPSD impacts on flow, compaction, and defectsLesson 8Handover between steps: line clearance, material transfer and in-process sampling pointsThis lesson outlines controlled transitions between manufacturing steps, covering line clearance, status labelling, and material movements. It details sampling locations, roles, and documentation to avoid mix-ups and ensure complete data records in production.
Scope and documentation of line clearanceLabels for material status and transfer rulesRoles and responsibilities in handoversPlans and locations for in-process samplingHandling, storing samples, and chain of custodyLesson 9Mixing and blending principles: blend uniformity, segregation risks, mixing validationThis lesson explains mixing mechanisms, types of blenders, and tests for blend uniformity. It addresses segregation dangers, addition sequences, scale-up challenges, and validation methods to prove reliable and repeatable mixing processes.
Types of blenders and loading methodsMixing mechanisms and timingSampling for blend uniformity testsCauses and ways to mitigate segregationValidation and ongoing checks for mixingLesson 10Weighing and dispensation: procedures, accuracy, tare, and traceabilityThis lesson discusses weighing area layouts, balance qualifications, and proper tare usage. It covers sampling, identification, reconciliation, labelling, and traceability measures to guarantee precise dispensation and full material tracking.
Zoning and environmental controls in weighing areasCalibrating, verifying, and maintaining balancesTare procedures and reducing handling errorsMaterial identification, labels, and status controlsRecords, reconciliation, and material genealogyLesson 11Overview of tablet and capsule manufacturing stages from raw material receipt to final packagingThis lesson provides a comprehensive map of the manufacturing process from receiving raw materials to completing packs. It emphasises documentation, sampling, in-process checks, and decision points, connecting them to GMP, data integrity, and batch release in local facilities.
Receiving, sampling, and testing raw materialsIssuing batch records and preparing linesCore processing via compression or fillingCoating, printing, and visual inspectionsFinal packaging, QA reviews, and releases
