Pharmaceutical and cosmetic industry technologies

Lecture with flipped classroom elements 10 hr

• History of the pharmaceutical and cosmetic industries.
• Basic legal regulations in the pharmaceutical and cosmetic industries.
• Natural and synthetic active substances.
• Example chemical syntheses of drugs (non-steroidal anti-inflammatory drugs, sulfonamides, etc.).
• Example syntheses of biopharmaceuticals and biosimilars (antibiotics, monoclonal antibodies, etc.).
• Dosage forms.
• Main manufacturing technologies in pharmacy and cosmetology.
• Shelf life and stability of pharmaceutical and cosmetic products.
• Sustainable development and green chemistry.

Project 10 hr

Development of the assumptions for a process design project for the production of a selected drug or cosmetic product: chemical or biochemical concept (selection of raw materials, determination of chemical—possibly also biochemical and physical—transformations, stoichiometric calculations, selection of method), technological concept (sequencing of processes and unit operations, conceptual flowsheet, material and energy balances, equipment selection, process flowsheet). The project is carried out in groups.

Other 3 hr

Study visit to a selected pharmaceutical or cosmetic manufacturing plant. Discussion of observations. Project consultations. Verification of learning outcomes.      

Colloids in pharmacy and cosmetics

Lecture 10hr

• Definition of colloids and their importance in pharmacy and cosmetology.
• Types of colloids (nanoemulsions, aerosols, colloidal suspensions).
• Particle size and specific surface area characterization.
• Stabilization mechanisms of colloidal systems (electrostatic, electrokinetic, steric).
• Methods for producing colloidal particles via precipitation and comminution (size reduction).
• Elements of population balance and practical aspects of applying colloidal systems.
• Drug carrier systems in pharmacy. Nanoemulsions and nanocapsules as carriers of active substances.
• Examples of innovative methods for delivering active ingredients in cosmetics.

Laboratory 10 hr

Production of colloidal particles for selected applications.

• Variants: preparation of emulsions, e.g., using surfactants for selected applications.
• Determination of colloidal system properties: particle size; determination of phase transition point using rheological methods and electrophoresis (zeta potential measurement); destabilization kinetics of dispersed systems (turbidimetric measurements).

Other 3 hr Consultations on preparing laboratory reports; verification of learning outcomes.

Cleanliness and Microbiological Safety in Production Areas

Lecture 4 hr

• Definitions and classification of clean environments (cleanrooms).
• Principles of cleanroom design and construction.
• Air and water purification technologies.
• Cleanroom environmental monitoring.
• HACCP as a tool for microbiological control.
• Disinfection.
• Response to microbiological incidents.

Laboratory 8 hr

Determination of the microbiological cleanliness of air and surfaces using selected methods.

Other 2 hr

Laboratory consultations for reading and interpreting experimental results.

Packaging and protection of pharmaceutical and cosmetic products

Lecture 2 hr

• Definition of packaging in the context of pharmacy and cosmetology.
• Stages of the packaging process.
• Selection of appropriate packaging and materials.
• Protecting products against external factors.
• Packaging of products with special properties.

Quality management systems (GMP, GLP) in pharmacy and cosmetology

Lecture with flipped classroom elements 4 hr

• Definition of quality in pharmacy and cosmetology.
• Importance and objectives of quality management systems.
• Brief overview of GMP and GLP.
• Key GMP principles in pharmaceutical and cosmetic manufacturing.
• GMP inspections and their significance. GLP in laboratory testing in pharmacy and cosmetology.

Other 2 hr

Participation in consultations preparing for the flipped classroom session. Verification of learning outcomes.      

A passing grade in the course tests. A minimum score of 60% is required. The tests may consist of multiple-choice questions or open-ended questions and may be supplemented by an oral examination.

Completion of laboratory exercises and preparation of reports.

Preparation and defense of the project (presentation).

1) Written assessment
A pass is awarded when the student:

• selects appropriate experimental and computational methods for the given soft-matter system and justifies the choice;
• correctly interprets typical results (parameters, curves, relationships) and identifies the limitations of the methods;
• provides examples of current trends/nanoengineering techniques and explains their impact on the system’s properties.

2) Oral assessment (during the laboratory class)
A pass is awarded when the student:

• can explain the purpose of the measurements/calculations, the principles of the method, and key settings/parameters;
• justifies the selection of experimental conditions and can identify sources of error as well as ways to minimize them;
• relates the observed results to soft-matter properties and nanoengineering solutions.

3) Analysis of research results
A pass is awarded when the student:

• presents results in a clear format (tables/plots) and performs correct calculations/analyses;
• draws conclusions linked to the system’s properties (e.g., structure–property relationships) and compares them with a model/expectations;
• explains the significance of the results in the context of current trends and nanoengineering applications.
   
   
   

1) Written assessment (test/exam)
A pass is awarded when the student:

• selects appropriate separation/purification processes for the given product/system (e.g., filtration, extraction, distillation, crystallization, membrane processes, centrifugation, etc.) and justifies the choice based on the properties of the product/mixture;
• identifies key process parameters (e.g., temperature, pH, pressure, time, mixing intensity, concentrations, flow rates) and explains how controlling them affects yield, purity, and product quality;
• proposes a simplified process flow scheme and identifies points for control/monitoring of parameters and quality;
  takes industrial specifics into account (scale-up, process safety, quality requirements/contamination risk, including in pharmaceutical and food contexts).

2) Laboratory report(s)
A pass is awarded when the report includes:

• a correct description of the applied separation method/operation and operating conditions (parameters, equipment), linked to the objective: product recovery/purification;
• processing and interpretation of results: calculations/plots/tables, assessment of process performance/quality (e.g., yield, degree of separation, stability, purity), and conclusions related to parameter control;
• an analysis of errors/sources of uncertainty and proposals for changes in parameters/method to improve the process;
• a brief reference to industrial practice requirements (e.g., repeatability, contamination risk, technological constraints).

3) Project
A pass is awarded when the project (and its defense) demonstrates that the student:

• developed a concept for a product manufacturing process (selection of unit operations, including separation and purification) and their sequence in the process system;
• identified and justified operating and control parameters (what is controlled, why, and how) as well as product quality criteria;
• prepared a conceptual/process scheme and (to the extent required in the course) mass balances and/or equipment selection;
• adapted the solution to industrial constraints (scalability, quality requirements, hygiene/safety, material and organizational limitations).

4) Multimedia presentation
A pass is awarded when the student:

• presents the designed product manufacturing method clearly and logically (sequence of stages, separation operations, parameters and their control);
• justifies engineering decisions (why this method and these parameters) and relates them to industrial requirements (including pharmaceutical/food);
• answers questions substantively, defends assumptions made, and uses sources (standards/guidelines/industry literature—within the scope required in the course). 
   
   

Laboratory report(s)
A pass is awarded when the report:
includes a comparison of experimental results with at least one literature source and/or a theoretical model (in the form of tables/plots);
presents the comparison method (e.g., relative error, uncertainty intervals, curve fitting) and correct calculations;
includes an interpretation of discrepancies, considering the influence of experimental conditions, model simplifications, measurement quality, uncertainty, and systematic errors;
formulates conclusions on whether the results agree within an acceptable range and what this implies for the validity of the study/method.
Project
A pass is awarded when the project:
uses literature to define reference values / the expected range of results and to select an appropriate theoretical model;
includes validation of results: comparison with literature and/or a model, together with an assessment of agreement (error metric, difference analysis);
provides a critical evaluation of sources and comparison conditions (comparability of systems, parameters, measurement methods);
identifies limitations (of the model and the data) and recommendations, i.e., what additional measurements/method modifications would increase the reliability of the verification.
Multimedia presentation
A pass is awarded when the student:
clearly presents the results plus the reference point (literature/model) and the comparison approach (plots, summaries, error metrics);
justifies the selection of sources and the model, stating assumptions and the range of applicability;
interprets agreement/discrepancies and defends conclusions during discussion (answers questions substantively);
cites sources correctly and demonstrates an understanding of how uncertainty and experimental conditions affect the comparison.
 
 
 

1) Analysis of research results
A pass is awarded when the student:

• interprets the results in relation to the objective and hypothesis and explains their significance;
• identifies limitations (uncertainty, errors, assumptions) and assesses the reliability of the conclusions;
• formulates specific recommendations on what should be repeated/changed/refined in further studies.

2) Project
A pass is awarded when the student:

• presents conclusions derived from the data/analyses and justifies them;
• proposes possible directions for implementation or further development, including conditions/limits of applicability;
• identifies risks, constraints, and corrective actions (e.g., additional tests, validation, optimization).

3) Multimedia presentation
A pass is awarded when the student:

• clearly communicates key results and conclusions and justifies the recommendations;
• can defend the interpretation during discussion, referring to limitations and alternative explanations;
• presents proposed next steps (research and/or implementation) in a specific and realistic manner.