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 settings. It covers proper tooling maintenance, controlling tablet weight and hardness, and typical issues like capping, lamination, and sticking, along with practical troubleshooting tips 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 methodsCapping, lamination, sticking, and picking issuesLesson 2Granulation methods: wet granulation workflow, equipment operation, and critical parametersDive into the steps of wet granulation, including binder choices and equipment varieties. Learn about key parameters, scaling up processes, and cleaning protocols, with a focus on controls that guarantee granule quality, flow properties, and success in subsequent compression 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 criteriaReview the management of active pharmaceutical ingredients (APIs) and excipients from arrival to approval. This includes sampling techniques, quarantine procedures, storage conditions, and environmental safeguards, stressing the prevention of cross-contamination and decisions based on specifications.
API and excipient receipt and labellingSampling plans, tools, and contamination risksQuarantine, approved, and rejected statusesStorage conditions and segregation guidelinesCOA review, testing, and release standardsLesson 4Packaging: blister line operation, checks for integrity, labeling, and serial traceabilityExplore primary and secondary packaging for solid oral products, with emphasis on blister packaging lines. Cover forming, feeding, sealing, coding, inspection, labelling, and serialisation, including controls to maintain product identity and integrity throughout the process.
Blister forming, feeding, and sealing stepsCartoning, leaflet insertion, and bundlingOnline vision systems and seal integrity checksCoding, serialization, and aggregation processesPackaging line documentation and yield trackingLesson 5Direct compression: formulation suitability, excipient selection, and process controlsFocus on the viability of direct compression, considering API characteristics, excipient choices, and powder flow. Discuss lubrication techniques, risks of segregation, and necessary controls to produce reliable 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 considerationsGet an introduction to film coating and other secondary processes like printing and capsule banding. Understand when coating is applied, main process variables, basic equipment, and frequent defects with troubleshooting approaches relevant to small-scale 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 impactUnderstand drying fundamentals, moisture targets, and dryer types. This lesson connects milling processes, particle size distribution, and heat effects to blend consistency and compression outcomes, with validation strategies for reliable results.
Moisture targets and loss on drying testsBasics of fluid bed and tray dryer operationsDrying endpoint, sampling, and validation methodsTypes of milling equipment and key settingsPSD impacts on flow, compaction, and defectsLesson 8Handover between steps: line clearance, material transfer and in-process sampling pointsLearn about managed transitions between manufacturing steps, covering line clearance, status labelling, and material movements. Detail in-process sampling locations, roles, and documentation to avoid mix-ups and ensure complete data capture.
Scope and documentation of line clearanceMaterial status labels and transfer protocolsDefined handover roles and responsibilitiesIn-process sampling plans and locationsSample handling, storage, and chain of custodyLesson 9Mixing and blending principles: blend uniformity, segregation risks, mixing validationExplore mixing mechanisms, types of blenders, and testing for blend uniformity. Address segregation risks, addition sequences, scale-up challenges, and validation methods to prove consistent and repeatable mixing performance.
Types of blenders and loading strategiesMixing mechanisms and time calculationsSampling plans for blend uniformity testsCauses of segregation and mitigation strategiesMixing validation and ongoing verificationLesson 10Weighing and dispensation: procedures, accuracy, tare, and traceabilityCover the design of weighing areas, balance qualification, and proper tare application. Explain sampling, identification, reconciliation, labelling, and traceability measures to guarantee precise dispensation and comprehensive material tracking.
Zoning and environmental controls in weighing roomsBalance calibration, verification, and maintenanceTare procedures and error minimisationMaterial ID, labels, and status controlsWeighing records, reconciliation, and genealogyLesson 11Overview of tablet and capsule manufacturing stages from raw material receipt to final packagingMap out the entire manufacturing journey from raw material intake to completed packages. Highlight documentation, sampling, in-process checks, and key decisions, connecting each phase to GMP standards, data integrity, and batch release in a compliant manner.
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
