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 care of tooling, methods for controlling tablet weight and hardness, and frequent issues like capping, lamination, and sticking, along with practical troubleshooting tips suitable for local manufacturing.
Types of presses, key parts, and safety featuresSelecting, checking, and cleaning toolingDesign of feed frames and problems with powder flowControlling weight, hardness, and thicknessIssues like capping, lamination, sticking, and pickingLesson 2Granulation methods: wet granulation workflow, equipment operation, and critical parametersThis lesson outlines the steps in wet granulation, choices for binders, and types of equipment used. It discusses vital parameters, scaling up processes, cleaning procedures, and controls that guarantee high-quality granules for smooth flow and effective compression in small-scale Eritrean operations.
Preparing binder solutions and performing checksSetting up and running high-shear granulatorsDetermining endpoints using PAT toolsSteps for transferring and wet screening granulesConsiderations for scaling up and cleaning requirementsLesson 3Materials handling: APIs, excipients, sampling, quarantine, and release criteriaThis lesson examines the management of active ingredients and excipients from arrival to approval for use. It includes sampling techniques, quarantine protocols, storage conditions, environmental safeguards, and ways to avoid cross-contamination while making release decisions based on specifications in Eritrean contexts.
Receiving and labeling APIs and excipientsSampling strategies, tools, and contamination risksStatuses for quarantine, approval, and rejectionRules for storage conditions and segregationReviewing 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, feeding, sealing, coding, inspection, labeling, and serialization processes, including controls to maintain product identity and integrity in local production settings.
Steps in blister forming, feeding, and sealingCartoning, inserting leaflets, and bundlingVision systems for seals and integrity checksCoding, serialization, and product aggregationDocumentation and yield tracking for packaging linesLesson 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 controls required to produce stable tablets without granulation, adapted for Eritrean manufacturing practices.
Key API properties for direct compressionSelecting fillers, binders, and disintegrantsUsing pregranulated and co-processed excipientsLubricant amounts, mixing sequences, and effectsControls and common failure modes in processesLesson 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, important process variables, basic equipment, common defects, and troubleshooting methods relevant to small-scale operations in Eritrea.
Purposes of functional and nonfunctional coatingsBasics of coating pans and spray systemsControls for inlet air, exhaust, and spray ratesCommon defects in coating and their causesPrinting, debossing, and capsule banding techniquesLesson 7Drying and milling: moisture control, drying validation, particle size reduction and its impactThis lesson covers principles of drying, moisture limits, and dryer varieties. It discusses load setups, endpoint checks, validation methods, and how milling affects particle size, blend uniformity, and compression outcomes in pharmaceutical production.
Targets for moisture and loss on drying testsBasics of fluid bed and tray dryer operationsDetermining drying endpoints, sampling, validationTypes of milling equipment and settingsEffects of particle size distribution on flow and compactionLesson 8Handover between steps: line clearance, material transfer and in-process sampling pointsThis lesson explains secure transitions between production stages, including line clearance, status labeling, and material movement. It details sampling locations, roles, and documentation to avoid mix-ups and ensure complete records in manufacturing workflows.
Scope and documentation of line clearanceLabels for material status and transfer protocolsRoles and responsibilities in handoversPlans and locations for in-process samplingHandling, storage, and custody of samplesLesson 9Mixing and blending principles: blend uniformity, segregation risks, mixing validationThis lesson covers mixing mechanisms, types of blenders, and tests for blend uniformity. It addresses segregation dangers, addition sequences, scale-up challenges, and validation methods to ensure consistent and reliable mixing results.
Types of blenders and loading methodsMechanisms of mixing and time calculationsSampling for blend uniformity assessmentsCauses of segregation and prevention strategiesValidation of mixing and ongoing verificationLesson 10Weighing and dispensation: procedures, accuracy, tare, and traceabilityThis lesson discusses weighing room setups, balance qualifications, and proper tare usage. It covers sampling, identification, reconciliation, labeling, and traceability measures to guarantee precise dispensation and full material tracking.
Zoning and environmental controls in weighing roomsCalibration, verification, and maintenance of balancesProcedures for tare and reducing errorsControl of material IDs, labels, and statusRecords for weighing, reconciliation, and genealogyLesson 11Overview of tablet and capsule manufacturing stages from raw material receipt to final packagingThis lesson provides a map of the entire manufacturing process from receiving raw materials to completing packaged products. It emphasizes documentation, sampling, in-process checks, and decision points aligned with GMP and batch release standards.
Receipt, sampling, and testing of raw materialsIssuing batch records and preparing linesCore processing via compression or fillingCoating, printing, and inspection stepsFinal packaging, QA review, and product release
