Lesson 1Milling and sizing: objectives, equipment choices, pass/fail criteria for particle sizeTells about milling and sizing goals, including control of particle spread for flow and dissolve. Looks at common machines, work settings, and sort ways. Sets pass or fail rules and links to later work.
Impact of particle size on performanceMilling equipment types and usesKey operating parameters and risksParticle size analysis methodsSpecification setting and acceptanceLesson 2Raw material receipt, sampling and quarantine: identification, sampling plans, release testing requirementsCovers getting APIs and helpers, GMP-follow sampling, hold controls, and ID tests. Explains sample plans, release test needs, and papers to make sure only good stuff goes to making.
GMP requirements for material receiptQuarantine and status labeling controlSampling plans and sample integrityIdentity testing and CoA verificationRelease versus rejection decisionsLesson 3In-process analytical controls and release testing: assays, dissolution, disintegration and sterility considerations where relevantTells about in-process check tests and final release tests for tablets. Covers check, content evenness, dissolve, and break apart. Looks at germ-free and dirt load where needed, plus method check and data look.
Assay and content uniformity testsDissolution method design and limitsDisintegration testing and criteriaMicrobial and sterility aspectsReview and approval of test dataLesson 4Compression: tablet press modes, tooling selection, in-process controls (weight, hardness, thickness, visual inspection)Covers tablet press rules, press ways, and tool picks. Tells about in-process checks for weight, hard, thick, break, and look. Explains set-up, fix, and fix problems to keep steady tablet good.
Tablet press types and operationTooling design and material choiceSet-up, start-up and ramp-up checksRoutine compression IPC testingCommon compression defectsLesson 5Drying and moisture control: dryer types, endpoint determination, impact on downstream processing and QC checksLooks at dry work after wet lump, including tray, air bed, and empty dryers. Talks about water goals, end point ways, and how left water affects flow, press, steady, and in-process quality looks.
Dryer types and selection factorsMoisture targets and specificationsEndpoint determination techniquesEffect of moisture on compressionIn-process moisture testing methodsLesson 6Coating (optional): coating purposes, coater types, critical parameters and in-process checksLooks at coating as extra step, including work and look goals. Looks at coater types, key process settings, and mix parts. Details in-process checks like weight add, look, and fault watch.
Film versus sugar coating rolesPan and fluid bed coater typesCritical coating parametersCoating solution and suspension prepIn-process coating inspectionLesson 7Granulation options and selection criteria: wet granulation vs dry/granulation-less direct compression and purpose of granulationExplains lump choices, including wet lump, dry lump, and straight press. Compares pick rules like stuff features, steady, and bigger. Tells how lump helps flow, press good, and content even.
Objectives of granulation in tabletsWet granulation process overviewDry granulation and roller compactionDirect compression feasibility checksFormulation and material considerationsLesson 8Overview flowchart: material receipt to finished packaged tablets with process step sequenceShows full tablet making flow from stuff get to final pack. Points out key choice spots, extra steps like coating, and links between unit works, in-process checks, and papers for batch records.
Typical solid dose process mapCritical decision and hold pointsOptional coating and rework pathsLinking IPCs to process stepsBatch record and flowchart alignmentLesson 9Secondary packaging and labeling: batch traceability, serialization considerations, and final product release samplingExplains extra pack, label, and group. Covers batch track, series needs, and tamper-proof parts. Tells sample for final product release and papers for rule follow.
Cartoning and aggregation stepsLabel content and control checksSerialization and data managementBatch traceability and recallsFinal release sampling strategyLesson 10Primary packaging: tablet containment options (blister vs bottle), line speed matching, in-line weight/visual checksDetails main pack choices like blisters and bottles, including stuff pick and block features. Talks line speed match, in-line weight and look checks, and controls that keep product whole and patient safe.
Blister versus bottle selectionPackaging material compatibilityLine speed and equipment balanceIn-line weight and count checksAutomated visual inspectionLesson 11Dispensing and weighing: controlled weighing procedures, anti-mixup measures, and documentationLooks at controlled weigh of APIs and helpers, including machine pick, set, and place controls. Details anti-mix steps, match, and paper ways that keep track and stop cross-dirt.
Weighing room design and controlsBalance qualification and calibrationLabeling and anti-mixup strategiesMaterial reconciliation and yieldsWeighing documentation standardsLesson 12Final blending and lubricants: sequence, segregation risks, segregation mitigation and in-process testingFocuses on final mix and add of lubes, slides, and outer phase helpers. Looks at add order, split risks, and fix ways. Covers in-process tests that check mix good before press.
Roles of lubricants and glidantsOrder of addition and mixing timeSegregation mechanisms and risksSegregation mitigation techniquesFinal blend IPCs and releaseLesson 13Blending: blender types, blend time determination, blend uniformity testing (e.g., sampling plan and assay limits)Details mixer types and work rules, including V-mixers, bin mixers, and high-cut systems. Explains mix time set, sample plans, and number check of mix even to make sure steady check across batch.
Selection of blender typeBlend order and loading strategyDetermining optimal blend timeBlend sampling plans and locationsUniformity criteria and investigations
