Lesson 1Compression: tablet press operation, tooling, feed frame, weight control and main failure modesThis part discusses tablet press parts, setup, and running parameters. It covers caring for tools, controlling weight and hardness, and typical problems like capping, lamination, and sticking, including ways to fix them in local production environments.
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 steps, choosing binders, and types of equipment. It explains key parameters, scaling up, and cleaning, stressing controls that ensure good granule quality, flow, and performance in later compression stages for Zimbabwean 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 section looks at handling active ingredients and excipients from arrival to release. It includes sampling, quarantine, storage, and environmental controls, focusing on preventing cross-contamination and making release decisions based on specifications in a Zimbabwe context.
API and excipient receipt and labelingSampling 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, labeling, and serial traceabilityThis section describes primary and secondary packaging for solid orals, with focus on blister lines. It covers forming, feeding, sealing, coding, inspection, labeling, and serialisation, including controls to safeguard product identity and integrity in local packaging operations.
Blister forming, feeding, and sealing stepsCartoning, leaflet insertion, and bundlingOnline vision systems and seal integrityCoding, serialization, and aggregationPackaging line documentation and yieldsLesson 5Direct compression: formulation suitability, excipient selection, and process controlsThis section examines direct compression possibilities, including API properties, excipient choices, and flow. It explains lubrication, segregation risks, and controls needed for strong tablets without prior granulation, tailored for small-scale Zimbabwean production.
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 outlines when coating is applied, key variables, basic equipment, and common defects with troubleshooting tips relevant to Zimbabwean manufacturers.
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 basics, moisture specs, and dryer types. It covers load setup, endpoint checks, and validation, then connects milling, particle size, and heat to blend uniformity and compression in Zimbabwean 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 section explains managed handovers between process steps, including line clearance, status labeling, and material transfer. It details sampling points, duties, and documentation to avoid mix-ups and data issues in local production lines.
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, blender types, and uniformity testing. It addresses segregation risks, addition order, scale-up, and validation methods to show reliable, repeatable mixing for Zimbabwean solid dosage 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 setup, balance qualification, and proper tare use. It explains sampling, identification, reconciliation, labeling, and traceability to ensure accurate dispensing and full material tracking in Zimbabwe.
Weighing room zoning and environmental controlsBalance calibration, verification, and maintenanceTare procedures and minimizing 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 process from raw material arrival to finished packs. It highlights documentation, sampling, in-process checks, and decisions, connecting to GMP, data integrity, and batch release in Zimbabwean 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
